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1. Kwok Y, Patchell RA: Commentary (Kwok/Patchell): Radiation Therapy in the Management of Brain Metastases From Renal Cell Carcinoma. Oncology (Williston Park); 2006 May 01;20(6)

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Commentary (Kwok/Patchell): Radiation Therapy in the Management of Brain Metastases From Renal Cell Carcinoma.

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  • (PMID = 28326511.001).
  • [ISSN] 0890-9091
  • [Journal-full-title] Oncology (Williston Park, N.Y.)
  • [ISO-abbreviation] Oncology (Williston Park, N.Y.)
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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2. Pollock BE: Commentary (Pollock): Radiation Therapy in the Management of Brain Metastases From Renal Cell Carcinoma. Oncology (Williston Park); 2006 May 01;20(6)

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Commentary (Pollock): Radiation Therapy in the Management of Brain Metastases From Renal Cell Carcinoma.

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  • (PMID = 28326510.001).
  • [ISSN] 0890-9091
  • [Journal-full-title] Oncology (Williston Park, N.Y.)
  • [ISO-abbreviation] Oncology (Williston Park, N.Y.)
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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3. Kopecký O, Lukešová Š, Vroblová V, Vokurková D, Morávek P, Šafránek H, Hlávková D, Souček P: Phenotype Analysis of Tumour-infiltrating Lymphocytes and Lymphocytes in Peripheral Blood in Patients with Renal Carcinoma. Acta Medica (Hradec Kralove); 2007;50(3):207-212

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phenotype Analysis of Tumour-infiltrating Lymphocytes and Lymphocytes in Peripheral Blood in Patients with Renal Carcinoma.
  • INTRODUCTION: When checking tumour growth, a number of observations indicate that the immune system plays a significant role in patients with renal cell carcinoma (RCC).
  • Infiltration by lymphocytes (tumour infiltrating lymphocytes, TILs) is more prevalent in RCC than any other tumours.
  • T lymphocytes are the dominant population of TIL cells.
  • Views concerning the role of T lymphocytic subpopulations, B lymphocytes and NK cells in an anti-tumour response are not established.
  • AIM: The aim is to determine the phenotype and activation of T and B lymphocytic subpopulations and NK cells and to compare their representation in tumour stroma and peripheral blood lymphocytes (PBL) in patients with RCC.
  • MATERIAL AND METHODS: Samples of peripheral blood taken from the cubital and renal veins and tumour stroma cells were obtained from 44 patients in the course of their surgeries carried out due to primary RCC.
  • TILs were isolated from mechanically disintegrated tumour tissue.
  • The number of CD3+/CD8+ T lymphocytes was significantly higher in TILs, 42.6 % (p+ T lymphocytes were the majority population in peripheral blood, 41.35 % (p +/69+ T lymphocytes was significantly higher in TILs, 32.9 %, compared to PBL (p+/CD25+, CD8+/57+ and CD4+/RA+ (naive CD4+ T lymphocytes) were higher in PBL (p-/16+56+) NK cells and CD3+/DR+ T cells in TILs and PBL were not significant.
  • CONCLUSION: The above-mentioned results prove that the characteristics and intensity of anti-tumour responses are different in compared compartments (tumour/PBL).
  • The knowledge of the phenotype and functions of effector cells, which are responsible for anti-tumour response, are the basic precondition for understanding the anti-tumour immune response and the cause of its failure.

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  • (PMID = 28795946.001).
  • [ISSN] 1211-4286
  • [Journal-full-title] Acta medica (Hradec Kralove)
  • [ISO-abbreviation] Acta Medica (Hradec Kralove)
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Czech Republic
  • [Keywords] NOTNLM ; CD4+ / CD8+ / Flow cytometry / Renal cell carcinoma / Tumour-infiltrating lymphocytes
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4. Corrigendum to "Enhanced Antitumor Effects of an Engineered Measles Virus Edmonston Strain Expressing the Wild-type N, P, L Genes on Human Renal Cell Carcinoma". Mol Ther; 2010 Jun;18(6):1248

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Corrigendum to "Enhanced Antitumor Effects of an Engineered Measles Virus Edmonston Strain Expressing the Wild-type N, P, L Genes on Human Renal Cell Carcinoma".

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  • (PMID = 28178499.001).
  • [ISSN] 1525-0024
  • [Journal-full-title] Molecular therapy : the journal of the American Society of Gene Therapy
  • [ISO-abbreviation] Mol. Ther.
  • [Language] eng
  • [Publication-type] Published Erratum
  • [Publication-country] United States
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5. Chaudry Q, Raza SH, Young AN, Wang MD: Automated Renal Cell Carcinoma Subtype Classification Using Morphological, Textural and Wavelets Based Features. J Signal Process Syst; 2009 Apr;55(1):15-23

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Automated Renal Cell Carcinoma Subtype Classification Using Morphological, Textural and Wavelets Based Features.
  • : We present a new image quantification and classification method for improved pathological diagnosis of human renal cell carcinoma.
  • The methodologies used for feature extraction include image morphological analysis, wavelet analysis and texture analysis, which are combined to develop a robust classification system based on a simple Bayesian classifier.
  • The misclassified images are significantly different from the rest of images in their class and therefore cannot be attributed to weakness in the classification system.

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  • (PMID = 28133502.001).
  • [ISSN] 1939-8018
  • [Journal-full-title] Journal of signal processing systems
  • [ISO-abbreviation] J Signal Process Syst
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U54 CA119338
  • [Publication-type] Journal Article
  • [Publication-country] United States
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6. Reşorlu B, Baltaci S, Reşorlu M, Kankaya D, Savaş B: Coexistence of papillary renal cell carcinoma and gastrointestinal stromal tumor in a case. Turk J Gastroenterol; 2007 Mar;18(1):47-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Coexistence of papillary renal cell carcinoma and gastrointestinal stromal tumor in a case.
  • Gastrointestinal stromal tumors are rare causes of gastrointestinal bleeding.
  • In most cases, these tumors are localized in the stomach and small intestine, more rarely in the esophagus and colon.
  • Papillary renal cell carcinoma and gastrointestinal stromal tumor may occur as recurrent familial tumors related to mutations in the protooncogenes, c-MET and c-KIT, both of which are tyrosine kinase receptor molecules.
  • However, these two tumors can sometimes occur simultaneously in sporadic cases.
  • Some authors blame imatinib mesylate (Gleevec), which is traditionally used in gastrointestinal stromal tumor therapy, as the etiological factor in certain secondary tumors, especially papillary renal cell cancer.
  • In this paper, we present the appearance and growth of papillary renal cell carcinoma in a patient receiving Gleevec therapy for gastrointestinal stromal tumor.
  • [MeSH-major] Carcinoma, Papillary / pathology. Carcinoma, Renal Cell / pathology. Gastrointestinal Stromal Tumors / pathology. Kidney Neoplasms / pathology. Neoplasms, Multiple Primary / pathology


7. Tsuda K, Kinouchi T, Tanikawa G, Yasuhara Y, Yanagawa M, Kakimoto K, Ono Y, Meguro N, Maeda O, Arisawa J, Usami M: Imaging characteristics of papillary renal cell carcinoma by computed tomography scan and magnetic resonance imaging. Int J Urol; 2005 Sep;12(9):795-800
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Imaging characteristics of papillary renal cell carcinoma by computed tomography scan and magnetic resonance imaging.
  • AIM: To analyse the differences in the patterns between clear and papillary renal cell carcinomas using magnetic resonance imaging (MRI) and dual-phase helical computed tomography (CT).
  • METHODS: We examined seven patients with papillary renal cell carcinoma, and six with clear cell carcinoma.
  • The highest attenuation value of tumors in the corticomedullary phase (CMP) and the excretory phase (EP) was measured using the observer-defined region of interest (ROI).
  • RESULTS: All five tumors except for one with papillary renal cell carcinoma showed homogenous hypointensity, but all six tumors with clear cell carcinoma showed heterogeneous hyperintensity on their T2-weighted images.
  • In the CMP, the mean CT numbers of the papillary renal cell carcinomas were significantly lower than those of the clear cell carcinomas.
  • The mean enhancement of the papillary renal cell carcinomas in the CMP and the EP was significantly lower than that of the clear renal cell carcinomas.
  • The mean CT numbers of the clear cell carcinomas in the CMP were markedly increased from those on the unenhanced CT; those in the EP were decreased gradually.
  • But the mean CT numbers of the papillary renal cell carcinomas in the EP were still slightly more increased than those in the CMP.
  • The enhancement patterns of the papillary renal cell carcinomas in the CMP and the EP were homogenous, but those of the clear cell carcinomas were heterogeneous.
  • CONCLUSIONS: We can speculate the differential diagnosis from clear to papillary renal cell carcinoma using MRI and dual-phase helical CT.
  • [MeSH-major] Carcinoma, Renal Cell / diagnosis. Kidney Neoplasms / diagnosis. Magnetic Resonance Imaging. Tomography, X-Ray Computed


8. Hara W, Tran P, Li G, Su Z, Puataweepong P, Adler JR, Soltys SG, Chang SD, Gibbs IC: Cyberknife for Brain Metastases of Malignant Melanoma and Renal Cell Carcinoma. Neurosurgery; 2009 Feb 01;64(suppl_2):A26-A32

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cyberknife for Brain Metastases of Malignant Melanoma and Renal Cell Carcinoma.

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  • (PMID = 28173174.001).
  • [ISSN] 1524-4040
  • [Journal-full-title] Neurosurgery
  • [ISO-abbreviation] Neurosurgery
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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9. Metastatic renal cell carcinoma presenting as a circumscribed orbital mass. Eur J Ophthalmol; 2008 May-Jun;18(3):483

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Metastatic renal cell carcinoma presenting as a circumscribed orbital mass.
  • PURPOSE: To report a case of renal cell carcinoma presenting as a well-circumscribed orbital tumor.
  • Imaging showed a well circumscribed tumor in the region of the medial rectus muscle.
  • Excision biopsy revealed a diagnosis of metastatic renal cell carcinoma that was confirmed on abdominal imaging.
  • CONCLUSIONS: Renal cell carcinoma can rarely present as a well-circumscribed orbital mass and should be included in the differential diagnosis of such lesions.

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  • (PMID = 28221622.001).
  • [ISSN] 1724-6016
  • [Journal-full-title] European journal of ophthalmology
  • [ISO-abbreviation] Eur J Ophthalmol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Italy
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10. Ying-Long S, Yue-Min X, Hong X, Xiao-Lin X: Papillary renal cell carcinoma in the horseshoe kidney. South Med J; 2010 Dec;103(12):1272-4
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Papillary renal cell carcinoma in the horseshoe kidney.
  • Papillary renal cell carcinoma in the horseshoe kidney is uncommon.
  • We report a case of papillary renal cell carcinoma in the horseshoe kidney and discuss its incidence, diagnosis, and treatment.
  • [MeSH-major] Carcinoma, Renal Cell / complications. Kidney / abnormalities. Kidney Neoplasms / complications


11. Pascual Samaniego M, González Núñez MA, Bravo Fernández I, Ruiz Serrano M, Ramos Martín JA, García González A: [Synchronous metastases of the spermatic cord from papillary renal cell carcinoma]. Actas Urol Esp; 2007 Apr;31(4):404-10
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Synchronous metastases of the spermatic cord from papillary renal cell carcinoma].
  • [Transliterated title] Carcinoma renal papilar con metástasis sincr6nica en el cordón espermático.
  • Papillary renal cell carcinoma has been related with higher survival rate and lower metastatic cancer mortality rate than clear renal cell carcinoma.
  • We present an aggressive case related to unusual features for this histological type, like a tumor size higher than ten cm, great perirrenal fat and suprarenal gland infiltration, tumoral thrombosis of the infrahepatic cava vein, retroperitoneal adenopatic tumoral infiltration, high nuclear grade and synchronous solitary distant organ metastases of the right spermatic cord, finding three previous cases in the literature with this last feature.
  • Prognostic implication of the papillary renal cell carcinoma type is unclear in cases like this, so probably we need better molecular and cytogenetic studies to get a correct classification of this histological type.
  • [MeSH-major] Carcinoma, Renal Cell / secondary. Genital Neoplasms, Male / secondary. Kidney Neoplasms / pathology. Spermatic Cord

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  • (PMID = 17633928.001).
  • [ISSN] 0210-4806
  • [Journal-full-title] Actas urologicas españolas
  • [ISO-abbreviation] Actas Urol Esp
  • [Language] spa
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Spain
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12. Lim JC, Wojcik EM: Fine-needle aspiration cytology of papillary renal cell carcinoma: the association with concomitant secondary malignancies. Diagn Cytopathol; 2006 Dec;34(12):797-800
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Fine-needle aspiration cytology of papillary renal cell carcinoma: the association with concomitant secondary malignancies.
  • Papillary renal cell carcinoma is a rare type of renal malignancy.
  • Cytogenetic findings characteristic for this tumor have been described as well as mutations of the proto-oncogene c-met.
  • Secondary malignancies occurring together with papillary renal cell carcinomas are rare, and are often of genitourinary tract origin.
  • We describe two cases of papillary renal cell carcinoma occurring in association with two other visceral malignancies, gastrointestinal stromal tumor and colon adenocarcinoma.Two cases of papillary renal cell carcinoma diagnosed by fine-needle aspiration (FNA), occurring in association with gastrointestinal malignancies were reviewed.
  • Both aspirates showed cytologic features characteristic for papillary renal cell carcinoma, namely papillary structures, foamy histiocytes, intracytoplasmic hemosiderin, and nuclear grooves.
  • Subsequent histology and immunohistochemical stains supported the cytologic diagnosis.
  • The histologic diagnosis of gastrointestinal stromal tumor and colon adenocarcinoma were confirmed.
  • Papillary renal cell carcinoma is a type of renal carcinoma that can be often accurately diagnosed by FNA.
  • The possible role of the protooncogene c-met in the development of these tumors was explored.
  • [MeSH-major] Adenocarcinoma / pathology. Carcinoma, Renal Cell / pathology. Colonic Neoplasms / pathology. Gastrointestinal Stromal Tumors / pathology. Kidney Neoplasms / pathology. Neoplasms, Multiple Primary


13. Albouy B, Billemont B, Massard C, Gross-Goupil M, Rixe O, Escudier B: Pancreatic metastasis from renal cell carcinoma: Presentation, recurrence, survival, and response to antiangiogenic therapy. J Clin Oncol; 2009 May 20;27(15_suppl):e16137

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Pancreatic metastasis from renal cell carcinoma: Presentation, recurrence, survival, and response to antiangiogenic therapy.
  • : e16137 Background: Pancreas represents an uncommon site of metastasis in renal cell carcinoma (RCC).
  • We examined the outcome in a series of RCC patients (pts) with pancreatic metastases, treated by either surgery or antiangiogenic therapy.
  • METHODS: We reviewed the charts of RCC pts treated for pancreatic metastases, between 2001 and 2008, in Institut Gustave Roussy and Pitié-Salpetrière Hospital.
  • Data base was reviewed to determine presentation, clinical symptoms, pancreatic metastases treatment, use of systemic therapy, disease-free survival (DFS) or progression-free survival (PFS) and overall survival (OS) after treatment.
  • RESULTS: A total of 40 pts with pancreatic metastases from RCC have been analyzed.
  • Best response was partial response in 30% of pts and stable disease in 50% of pts.
  • CONCLUSIONS: Patients with RCC pancreatic metastases seem to have a longer survival than the usual metastatic RCC pts.
  • Surgical resection must be discussed in pauci-metastatic disease, as it can be associated with prolonged survival.

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  • (PMID = 27963352.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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14. Spicer JF, Jameson MB, Savage P, Jodrell D, Rudman SM, Erlandsson F, Acton G, McKeage M: A phase I study of AS1409, a novel antibody-cytokine fusion protein, in patients with malignant melanoma (MM) or renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):3024

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I study of AS1409, a novel antibody-cytokine fusion protein, in patients with malignant melanoma (MM) or renal cell carcinoma (RCC).
  • ED-B-fibronectin is expressed in tumor vasculature.
  • IL-12 stimulates T and NK cell activity.
  • Responses to IL12 occur in MM and RCC, but with high systemic toxicity.
  • AS1409 is designed to target IL-12 to tumor vasculature.
  • METHODS: Patients with MM or RCC were treated in a dose-escalating trial of weekly i.v.
  • Patients without unacceptable toxicity or disease progression could continue therapy.
  • RESULTS: 13 patients (9 males; median age 53 years; 11 MM, 2 RCC) were treated (7 at 15mcg/kg, 6 at 25mcg/kg).
  • A partial response was seen in a patient with MM metastatic to lymph nodes treated at 15mcg/kg, and a best response of stable disease was seen in 4 patients.
  • Biomarker activation and objective radiological evidence of anticancer activity was observed at this dose.

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  • (PMID = 27962070.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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15. Godoy J, Cardona AF, Cáceres H, Otero JM, Lujan M, Lopera D, Pacheco JO, Spath A, Gis P: Cost-effectiveness analysis of first-line treatment for metastatic renal cell carcinoma (mRCC) in Colombia (ONCOLGroup study). J Clin Oncol; 2009 May 20;27(15_suppl):e16150

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cost-effectiveness analysis of first-line treatment for metastatic renal cell carcinoma (mRCC) in Colombia (ONCOLGroup study).
  • : e16150 Background: Renal cell carcinoma has increased its incidence by 126% since 1950.
  • A local study developed a complete economic evaluation of sunitinib versus IFN in first-line treatment of mRCC in Colombia, finding that sunitinib was more cost-useful and cost-effective.

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  • (PMID = 27963418.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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16. Arnault JP, Mateus C, Wechsler J, Spatz A, Tomasic G, Sibaud V, Aractingi S, Grange JD, Escudier B, Robert C: Paradoxical cutaneous squamous cell proliferations in patients treated with sorafenib. J Clin Oncol; 2009 May 20;27(15_suppl):9564

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Paradoxical cutaneous squamous cell proliferations in patients treated with sorafenib.
  • We report 12 patients presenting with solitary or multiple cutaneous squamous cell proliferations occurring in the months following initiation of sorafenib and we discuss the significance of this unexpected association.
  • RESULTS: Twelve patients treated by sorafenib for renal cell cancer or hepatocellular carcinoma presented one or several skin tumours with a typical keratoacanthoma (KA) appearance 3 to 9 months after the onset of sorafenib therapy.
  • Histologic examination of 22 lesions found classical non aggressive KAs in 16 cases and more aggressive squamous cell carcinoma-like lesions with deep dermis invasion and cellular atypias in 5 patients.
  • CONCLUSIONS: Sorafenib treatment can be associated with cutaneous squamous cell proliferation resembling KAs.
  • Although our observations suggest that these skin neoplasms have a low aggressive potential, these reports address the questions of the paradoxical proliferating effect of a drug that usually has an anti-proliferating effect.
  • They also reactivate the unresolved controversy about the relationship between KA and authentic squamous cell carcinoma.
  • Surgical excision is the treatment of choice in order to rule out authentic squamous cell carcinoma.

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  • (PMID = 27963671.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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17. Kroog GS, Feldman DR, Kondagunta GV, Ginsberg MS, Fischer PM, Trinos MJ, Patil S, Ishill NM, Motzer RJ: Phase I trial of RAD001 (everolimus) plus sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5037

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I trial of RAD001 (everolimus) plus sunitinib in patients with metastatic renal cell carcinoma.
  • : 5037^ Background: RAD001 (everolimus) and sunitinib (SUTENT) both have activity in metastatic renal cell carcinoma (mRCC).
  • RESULTS: Of 20 pts (median age 62; 13 clear cell (cc) and 7 non-cc RCC) enrolled, 19 are evaluable for DLT including 3 in cohort 1 (2.5 mg RAD001 daily/ 37.
  • 3/5 pts with confirmed partial responses have non-cc RCC (2 chromophobe; 1 papillary).
  • 5 mg sunitinib is recommended for phase II and shows responses in non-cc RCC.
  • (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research.
  • NIH-sponsored trials are exempt from the Policy restrictions.

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  • (PMID = 27962935.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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18. Kamai T, Tomosugi N, Abe H, Yoshida K: Protein profiling of tumor tissues by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry to discriminate between localized and metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16098

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Protein profiling of tumor tissues by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry to discriminate between localized and metastatic renal cell carcinoma.
  • : e16098 Background: We previously reported that mRNA of interferon-alpha receptor type 2 (IFNAR2) was upregulated in metastatic and IFN-a resistant renal cell carcinoma (RCC) in comparison to localized RCC or metastatic tumors with good response to IFN-a (BMC Cancer, 2007).
  • Protein profiling using human tumor tissues may give insight into cellular pathways leading to carcinogenesis and metastasis in RCC.
  • METHODS: We examined mRNAs expression for IFNAR2 in paired tumor and non-tumor samples from the surgical specimens of Japanese patients with RCC using a real-time reverse transcription polymerase chain reaction.
  • Then we selected representative five IFNAR2 upregulated clear cell carcinomas cases with metastatic tumor, five IFNAR2 upregulated metastatic sarcomatoid carcinomas, and five normal expression clear cell carcinomas with localized tumor.
  • We investigated protein profiling in the tumor tissues of above three groups using surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF MS) coupled with IMAC-Cu chips.
  • The heat map analysis based on the clustering distinguished completely metastatic tumors with IFNAR2 upregulated groups from localized tumors with IFNAR2 normal expression group.
  • Furthermore, the heat map discriminated metastatic sarcomatoid carcinomas from metastatic clear cell carcinomas with a sensitivity of 100% and a specificity of 80%.
  • CONCLUSIONS: SELDI-TOF MS profiling of tumor tissues can be applied to differentiate patients with three types of RCCs.
  • Our findings may reflect different molecular mechanism between localized and metastatic carcinomas, and the different response to immunotherapy with IFN-α.

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  • (PMID = 27963090.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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19. Goldberg J, Demetri GD, Choy E, Rosen L, Pappo A, Dubois S, Geller J, Chai F, Ferrari D, Wagner AJ: Preliminary results from a phase II study of ARQ 197 in patients with microphthalmia transcription factor family (MiT)-associated tumors. J Clin Oncol; 2009 May 20;27(15_suppl):10502

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preliminary results from a phase II study of ARQ 197 in patients with microphthalmia transcription factor family (MiT)-associated tumors.
  • : 10502 Background: ARQ 197 is a selective, non-ATP competitive inhibitor of c-Met, a receptor tyrosine kinase implicated in tumor cell migration, invasion, and proliferation.
  • The drug has demonstrated a favorable safety profile and preliminary anti-cancer activity in three phase 1 studies.
  • MiT tumors include clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS), and translocation-associated renal cell carcinoma (TLA RCC) and are linked biologically by a shared activated transcriptional mechanism which directly upregulates c-Met.
  • Tumors with this type of chromosomal abnormality are generally resistant to all approved therapies and, in the absence of complete surgical resection, prove invariably fatal.
  • METHODS: This is a multi-center, single arm, two-stage phase 2 trial in patients (pts) 13 years of age or older with MiT tumors.
  • If either a complete response (CR) or a partial response (PR) were to be observed in the 23 pts in stage 1, the study would be advanced to stage 2 where 16 additional patients will be enrolled.
  • Tumor responses are measured in 8-week intervals per RECIST criteria.
  • RESULTS: To date, 28 pts (19 females, 9 males; median age = 21; 7 CCS, 17 ASPS, 4 RCC) have been treated.
  • One pt with CCS demonstrated a confirmed PR, 15 pts (10 ASPS, 2 CCS, 3 RCC) demonstrated stable disease (SD) for durations up to 29+ weeks, and 4 pts progressed.
  • An overall response rate of 5% and a disease control rate (CR+PR+SD) of 80% were demonstrated among 20 pts who were evaluable for efficacy.
  • The most common drug-related adverse events (AEs) have been fatigue (35.7%), nausea (35.7%), vomiting (21.4%), decreased hemoglobin (10.7%).
  • CONCLUSIONS: To date, ARQ 197 has demonstrated an extremely favorable safety profile and preliminary evidence of anti-cancer activity in these young pts.
  • The criterion for advancing the study from stage 1 to stage 2 has been met.
  • Stage 2 enrollment is ongoing.

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  • (PMID = 27963690.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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20. Bhatia S, Heath E, Puzanov I, Miller W Jr, Curti B, Gordon M, Ernstoff M, Hausman D, Hunder N, Thompson J: Phase II study of recombinant IL-21 (rIL-21) plus sorafenib as second- or third-line therapy for metastatic renal cell cancer (mRCC): Final results. J Clin Oncol; 2009 May 20;27(15_suppl):3023

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of recombinant IL-21 (rIL-21) plus sorafenib as second- or third-line therapy for metastatic renal cell cancer (mRCC): Final results.
  • There is an unmet need for novel therapies after failure of vascular endothelial growth factor (VEGF)-directed agents. rIL-21, a cytokine that enhances CD8+ T-cell and NK cell activity, has single-agent antitumor activity (J Clin Oncol. 2008;26:2034).
  • Based on promising results of a phase I study of rIL-21 plus sorafenib, we initiated a phase II study to explore the safety and efficacy of this combination as second- or third-line treatment for mRCC.
  • Twelve patients remain on study; 13 withdrew for progressive disease (PD), 6 for toxicity, and 2 for other reasons.
  • IRR has been performed for the first 23 patients who completed at least 1 full TC, with 6 confirmed PR (26%), 1 unconfirmed PR (4%), 14 SD (61%), and 2 PD (9%).

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  • (PMID = 27962069.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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21. Gupta S, Parsa V, Heilbrun L, Smith D, Dickow B, Heath E, Vaishampayan U: Safety and efficacy analysis of sunitinib (S), bevacizumab (B), and M-Tor inhibitors in metastatic renal cell cancer (mRCC) patients (pts) with renal insufficiency (RI). J Clin Oncol; 2009 May 20;27(15_suppl):5108

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Safety and efficacy analysis of sunitinib (S), bevacizumab (B), and M-Tor inhibitors in metastatic renal cell cancer (mRCC) patients (pts) with renal insufficiency (RI).
  • There are limited data on the clinical toxicity profile and efficacy of these agents in pts with RI.
  • METHODS: The primary objective was to assess the safety and efficacy of S, B, T and E in pts with RI.
  • Pts with a calculated creatinine clearance (CrCl) of ≤ 60ml/min [chronic kidney disease stage 3 or higher per K/DOQI guidelines by the National Kidney Foundation] were deemed to have RI.
  • Data on safety and efficacy of the therapy were collected and analyzed with respect to renal function.
  • RESULTS: 19 of 51 (37%) pts had RI.
  • Pts with RI had a higher median rise in blood pressure (BP) with S and B than pts with normal renal function.
  • Patients with RI had an increased incidence of rash and higher dose interruption rates with m-TOR inhibitors.
  • No major differences in toxicities including cardiac, thyroid, renal, lipid profile abnormalities or hyperglycemia were observed.
  • CONCLUSIONS: More than a third of pts with mRCC receiving targeted therapy have RI, hence highlighting the importance of evaluating tolerability of therapies in pts with RI.

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  • (PMID = 27964365.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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22. Vermaat J, van der Tweel I, Mehra N, Sleijfer S, Engwegen JY, Korse CM, Schellens JH, Haanen JB, Beijnen JH, Voest EE: Use of serum proteins identified by proteomics to predict prognosis in patients with metastatic renal cell cancer (mRCC) and comparison to the currently used MSKCC survival model. J Clin Oncol; 2009 May 20;27(15_suppl):11078

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Use of serum proteins identified by proteomics to predict prognosis in patients with metastatic renal cell cancer (mRCC) and comparison to the currently used MSKCC survival model.
  • : 11078 Background: In mRCC the Memorial Sloan-Kettering Cancer Center (MSKCC) risk model (Motzer et al.,JCO2002) is widely used for clinical trial design and patient management.
  • METHODS: Sera from 125 mRCC patients, mostly interferon-treated, collected between 2001-2006 in three Dutch Cancer Centers, were screened by SELDI-TOF mass spectrometry (MS).

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  • (PMID = 27963200.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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23. LaRochelle JC, Dastane A, Rao N, Klatte T, Shuch B, Kabbinavar F, Said J, Belldegrun A, Pantuck A: Use of chromosome 9p status to identify a subset of high-risk localized renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5090

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Use of chromosome 9p status to identify a subset of high-risk localized renal cell carcinoma.
  • : 5090 Background: We investigated whether deletion of chromosome 9p in clear cell renal cell carcinoma (ccRCC) predicts worse disease-specific (DSS) and recurrence-free survival (RFS), and if it is associated with worse prognosis in tumors < 4 cm.
  • Tumor grade, stage, size, 9p status, nodal involvement, and the presence of metastasis were recorded.
  • Disease-specific and recurrence-free survival were determined, and independence was assessed using Cox proportional hazards models.
  • RESULTS: 9p deletions were detected in 14% of tumors.
  • 54% of 9p-deleted tumors were high grade (G3-4) vs. 38% without 9p deletions, and 60% of 9p-deleted tumors were T3-4 vs 38% without 9p deletions (p < 0.01).
  • In localized disease, median RFS for those with 9p deletions was 53 months and was not reached in those without 9p deletions (p<0.01).
  • In 188 patients presenting with localized RCC < 4 cm, loss of 9p occurred in 3/7 (42.9%) of patients with post-nephrectomy recurrence vs. 13/168 (7.2%) of patients without disease recurrence (p = 0.001).
  • DSS for patients with 9p deletion in tumors < 4 cm was significantly worse than DSS in those without 9p deletions (HR 6.18; p = 0.02), and an independent effect on RFS was seen for 9p deletions in localized RCC (HR 2.3, p < 0.01).
  • 9p status was not a significant predictor in metastatic RCC.
  • CONCLUSIONS: Deletion of chromosome 9p in ccRCC occurs in 14% of patients and is associated with higher grade and T stage, presence of nodal and distant disease, worse prognosis, and in patients with small NOMO tumors, 9p deletions but not tumor size was independently associated with RFS.

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  • (PMID = 27964298.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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24. Keefe S, Moyneur E, Barghout V, Flaherty KT: Dosing patterns in patients with renal cell carcinoma treated with sorafenib or sunitinib: A retrospective claims database analysis. J Clin Oncol; 2009 May 20;27(15_suppl):5097

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Dosing patterns in patients with renal cell carcinoma treated with sorafenib or sunitinib: A retrospective claims database analysis.
  • : 5097 Background: Tyrosine kinase inhibitors (TKIs; sorafenib [SR], sunitinib [SU]) are FDA approved for the treatment of advanced renal cell carcinoma (RCC).
  • We analyzed the dose reduction patterns in pts with RCC treated with SR, approved Dec 05, or SU, approved Jan 06.
  • Inclusion criteria were ≥2 claims for RCC (ICD9 189.0 or 198.0), continuous healthcare coverage, >180 days of coverage before RCC diagnosis, no claim for SR or SU prior to RCC diagnosis, initial standard daily RCC dose per package insert recommendation (800 mg for SR or 50 mg for SU), and ≥2 consecutive dispensings.
  • No significant differences in baseline demographics existed between the groups except for a higher incidence of stroke (7.9% vs 3.6%, p = 0.037) and other cancer site (93.7% vs 87.8%, p = 0.036) in the SR group.

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  • (PMID = 27964291.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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25. Thayer S, Cooke J, Kaura S: A retrospective database analysis to assess the impact of zoledronic acid (ZOL) on skeletal-related events (SREs) in solid tumor cancer and multiple myeloma (MM) patients (pts). J Clin Oncol; 2009 May 20;27(15_suppl):9518

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A retrospective database analysis to assess the impact of zoledronic acid (ZOL) on skeletal-related events (SREs) in solid tumor cancer and multiple myeloma (MM) patients (pts).
  • : 9518 Background: For cancer pts with malignant bone lesions (BM), SREs including pathologic fracture, spinal cord compression, hypercalcemia of malignancy, and radiotherapy and/or surgery to bone are associated with significant morbidity and mortality and reduced quality of life.
  • ZOL is an IV bisphosphonate (BP) proven to reduce and delay incidence of SREs in several tumor types.
  • Pts older than 18 years with solid tumors (breast, prostate, lung, bladder, or renal cell cancers) or MM and BM diagnosed between Jan 2001 and Dec 2006 were included.
  • CONCLUSIONS: This study showed that in cancer pts with BM, persistence with ZOL resulted in reduced risk of developing first and subsequent SREs.

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  • (PMID = 27964490.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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26. Cho DC, Figlin RA, Flaherty KT, Michaelson D, Sosman JA, Ghebremichael M, Bowers ME, Mier JW, Atkins MB, McDermott DF: A phase II trial of perifosine in patients with advanced renal cell carcinoma (RCC) who have failed tyrosine kinase inhibitors (TKI). J Clin Oncol; 2009 May 20;27(15_suppl):5101

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II trial of perifosine in patients with advanced renal cell carcinoma (RCC) who have failed tyrosine kinase inhibitors (TKI).
  • : 5101 Background: The recently demonstrated activity of inhibitors of TORC1 in RCC has raised the possibility that even greater effects may be achieved by targeting upstream of this pathway.
  • Perifosine is a synthetic alkylphospholipid which inhibits Akt activity and also has cell-dependent effects upon the MAP-kinase pathway.
  • Prior single-agent trials showed disease stabilization/regression in patients (pts) with advanced RCC; however, few pts were previously treated with a TKI.
  • Therefore, we conducted a multi-center phase II trial to determine the safety and efficacy of perifosine in pts with advanced RCC refractory to VEGFR TKI.
  • Secondary objectives included overall response rate (> PR), and safety, Eligibility: ECOG PS 0-1, pts with metastatic RCC who have RECIST defined progression on either sunitinib or sorafenib.
  • Median age 67 (range 47-78) and 16 were male; 90% of pts had predominantly clear cell histology.
  • CONCLUSIONS: Perifosine has promising activity in pts with RCC who have failed prior TKI therapy.
  • Additional studies are under consideration to evaluate perifosine for clinical benefit in pts with previously treated RCC.

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  • (PMID = 27964377.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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27. Srinivas S, Harshman L, Hauke RJ: Sorafenib monotherapy in patients with treatment-naïve metastatic renal cell cancer: preliminary results of a phase II intra-patient dose-escalation study. J Clin Oncol; 2009 May 20;27(15_suppl):e14564

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Sorafenib monotherapy in patients with treatment-naïve metastatic renal cell cancer: preliminary results of a phase II intra-patient dose-escalation study.
  • : e14564 Background: In a phase I dose finding study, the maximum tolerated dose of sorafenib was determined to be 400 mg bid.
  • METHODS: Patients with treatment-naïve metastatic renal cell with clear cell histology were enrolled at Stanford University and the University of Nebraska Medical Center.
  • One patient achieved a partial response and seven experienced disease stabilization.

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  • (PMID = 27963689.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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28. Kamoi K, Kawauchi A, Miki T, Aron M, Remer E, Haber G, Berger A, Crouzet S, Ricardo B, Gill I: Laparoscopic renal cryoablation: Risk factor analysis to predict oncologic outcomes with minimum 5-year follow-up. J Clin Oncol; 2009 May 20;27(15_suppl):5094

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Laparoscopic renal cryoablation: Risk factor analysis to predict oncologic outcomes with minimum 5-year follow-up.
  • : 5094 Background: We analysed risk factors to predict oncologic outcomes at 5-11 year after laparoscopic renal cryoablation (LRC).
  • METHODS: Between 09/1997 and 010/2008, we performed renal cryoablation in 340 patients.
  • Mean tumor size was 2.3 cm (0.9-5.0 cm).
  • Overall, there were 7 cancer deaths.
  • In the 69 patients with biopsy-proven renal cell cancer (median follow-up 81 mos; range 60-132 mos), 5-year overall, disease-specific, and disease- free survival was 75%, 92%, and 82%, respectively, while 10-year overall, disease-specific, and disease-free survival was 46%, 83%, and 79%, respectively.
  • On multivariate analysis, previous radical nephrectomy for RCC was the only significant predictor for both recurrence- free survival and cancer-specific survival (p = 0.023 and 0.030, respectively).
  • Relative risk of patients who has a history of radical nephrectomy for RCC treatment was 4.1 (95% CIs, 1.2 to 13.4), and 5.4 (95% CIs, 1.2 to 27.7) for disease-free survival and disease-specific survival, respectively.
  • CONCLUSIONS: Laparoscopic renal cryoablation is effective oncologic treatment for renal mass in select patients.
  • Disease-specific survival of 92% at 5-years and 83% at 10-years is possible.
  • Preceding radical nephrectomy for RCC treatment was the only independent predicting factor for both disease-free and disease-specific survival.

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  • (PMID = 27964294.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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29. Booth CM, Li G, Mackillop WJ: The impact of socioeconomic status (SES) on stage of cancer at time of diagnosis: A population-based study in Ontario, Canada. J Clin Oncol; 2009 May 20;27(15_suppl):6505

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The impact of socioeconomic status (SES) on stage of cancer at time of diagnosis: A population-based study in Ontario, Canada.
  • : 6505 Background: Lower SES is known to be associated with worsened cancer survival.
  • Here we evaluate the impact of SES on stage of cancer at diagnosis in Ontario which has universal health insurance.
  • METHODS: All incident cases of breast, colon, rectal, non-small cell lung, cervical and larynx cancer diagnosed in Ontario 2003-2005 were identified using the Ontario Cancer Registry.
  • Stage information is only captured routinely for patients seen at Ontario's 8 Regional Cancer Centers (RCCs).
  • Using a best stage grouping approach, cases were assigned stage based on pathologic TNM if available and clinical TNM otherwise.
  • Using postal code at time of diagnosis cases were assigned to quintiles (Q); Q1 represents the communities where the poorest 20% of the Ontario population resided.
  • A Cox model was used to evaluate overall survival, SES, stage, and age.
  • RESULTS: Stage at diagnosis was available for 19,239/23,254 (83%) of cases seen at RCCs.
  • Among cases with breast cancer, those in Q1 were less likely to have stage I disease (43 vs 47%, p = 0.004) and more likely to have stage IV disease (5 vs 4%, 0.008) than Q2-5.
  • With lung cancer, cases in Q1 were more likely to have stage I disease compared to Q2-5 (16 vs 13%, p = 0.015).
  • Distribution of stage I and stage IV disease did not differ by SES across other individual diseases.
  • However, for all 6 cancers combined, cases in Q1 were less likely than Q2-5 to have stage I disease (27 vs 30%, p = 0.001) and more likely to have stage IV disease (21 vs 18%, p < 0.0001).
  • We found significant gradients in 3-year overall survival across Q1-Q5 for breast (5% absolute difference in survival, p < 0.001), colon (4%, p = 0.049), and cervical (18%, p = 0.031) cancers.
  • Adjustment for stage and age only slightly diminished these survival gradients.
  • CONCLUSIONS: Despite universal health care, SES remains associated with survival among patients with cancer in Ontario.
  • These data suggest that the difference in outcome is only partially explained by differences in stage at diagnosis.

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  • (PMID = 27964005.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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30. Schrader AJ, Rauer-Bruening S, Olbert PJ, Hegele A, Rustemeier J, Hofmann R: Incidence and long term prognosis of papillary renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16020

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Incidence and long term prognosis of papillary renal cell carcinoma.
  • : e16020 Background: Papillary renal cell carcinoma (pRCC) represents the largest subgroup of non clear-cell kidney cancer.
  • In this study we assessed tumour characteristics and long-term prognosis of patients with pRCC in comparison with conventional clear-cell cancer (ccRCC).
  • METHODS: We evaluated 744 patients who had undergone renal surgery for RCC between 1990 and 2005.
  • RESULTS: Both groups pRCC and ccRCC were alike concerning age, body mass index, and the incidence of regional lymph node or distant metastasis at diagnosis.
  • Even though patients with pRCC presented more often with smaller (p = 0.039) and low grade tumours (p = 0.006), there was no statistically significant difference in tumour recurrence or tumour related death.
  • Moreover, looking at the whole cohort Kaplan-Meier curves revealed no differences regarding tumour specific survival between pRCC and ccRCC (p = 0.94; 5-year survival 78% vs. 77%).
  • However, we observed a trend towards an improved outcome for organ confined (pT1-2) cancer, but a significantly inferior prognosis for locally advanced stage (pT3-4) and/or metastatic papillary tumours at the time of renal surgery.
  • However, applying multivariate analysis including age, sex, and tumour grade, histology could neither be retained as a significant independent prognostic marker in the metastatic setting (p = 0.068, cox regression analysis) nor in a subgroup analysis focussing on patients with advanced cancer (pT3-4 and/or N+/M+; p = 0.064, cox regression analysis).
  • As we could not confirm a favourable clinical course for pRCC in general, standardized aftercare programmes and - if necessary - systemic treatment, especially in the era of novel targeted drugs, are also needed for this common RCC subtype.

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  • (PMID = 27962984.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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31. Amato R, Hernandez-McClain J, Harrop R, Cen P, Doshi G: Vaccination of renal cell cancer (RCC) patients with modified vaccinia Ankara (MVA) delivering tumor antigen 5T4 administered alone or with interleukin 2 (IL-2) or interferon-alpha (IFN). J Clin Oncol; 2009 May 20;27(15_suppl):3026

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Vaccination of renal cell cancer (RCC) patients with modified vaccinia Ankara (MVA) delivering tumor antigen 5T4 administered alone or with interleukin 2 (IL-2) or interferon-alpha (IFN).
  • : 3026 Background: The attenuated vaccinia virus (MVA) has been engineered to deliver the tumor antigen 5T4 (TroVax).
  • More than 90% of RCCs overexpress the 5T4 antigen.
  • METHODS: Eligibility: Pathologic diagnosis of clear cell or papillary RCC, progressive measurable metastases, any prior therapy, adequate physiological parameters, Karnofsky performance status ≥ 80%, and no active CNS involvement.
  • Clinical responses were assessed by measuring changes in tumor burden via computed tomography or magnetic resonance imaging scan.
  • 20 pts demonstrated disease stabilization for ≥ 3 months.

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  • (PMID = 27962068.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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32. Xia J Sr, Zhou J: Antitumor activity of patient-derived renal cell carcinoma cells fused with allogeneic dendritic cells: In vitro results and clinical responses. J Clin Oncol; 2009 May 20;27(15_suppl):3056

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Antitumor activity of patient-derived renal cell carcinoma cells fused with allogeneic dendritic cells: In vitro results and clinical responses.
  • : 3056 Background: Renal cell carcinoma (RCC) has been shown to be highly susceptible to immune-based treatment strategies.
  • METHODS: In the present study, patient-derived tumor cells were fused with allogeneic dendritic cells (DC) to elicit antitumor activity against RCC.
  • DC from HLA-A2+ healthy donors were fused with primary RCC cells from 10 patients.
  • Phenotype of fusion cells was characterized by flow cytometer and confocal microscopy.
  • In vitro, T-cell proliferation, IFN-γ secretion, and cytotocic T lymphocytes (CTL) activity elicited by allogeneic DC/RCC fusion cells were assessed.
  • Clinically, 10 patients were vaccinated with allogeneic DC/RCC fusion vaccine.
  • RESULTS: After fusion, the created hybrids expressed both tumor-associated antigen and DC-derived molecules and could stimulate the proliferation and IFN-γ secretion of T-cells as well as elicit strong CTL activity against RCC cells in vitro.
  • In vivo, neither serious adverse effects nor signs of autoimmune disease were observed after vaccination therapy.
  • Six patients showed stable disease with stabilization of previously progressive disease (follow-up 1.5 year).
  • CONCLUSIONS: The data suggest that allogeneic DC/RCC fusion vaccine is safe and can elicit immunological responses in patients with RCC.

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  • (PMID = 27961996.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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33. Shinohara N, Takahashi M, Kamishima T, Ikushima H, Sazawa A, Kanayama H, Nonomura K: Efficacy and thyroidal effects of sunitinib in Japanese patients with metastatic renal cell carcinoma: Hypothyroidism and thyroid atrophy as potential biomarkers for sunitinib? J Clin Oncol; 2009 May 20;27(15_suppl):e16097

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Efficacy and thyroidal effects of sunitinib in Japanese patients with metastatic renal cell carcinoma: Hypothyroidism and thyroid atrophy as potential biomarkers for sunitinib?
  • : e16097 Background: Although hypothyroidism is a well-known adverse effect of sunitinib in western patients (pts) with metastatic renal cell carcinoma (MRCC), the effects on thyroid gland of sunitinib in Japanese pts still remain unclear.
  • We therefore evaluated thyroid dysfunction and thyroid atrophy in Japanese RCC pts who received sunitinib.
  • CT volumetry of the thyroid gland was performed utilizing the data obtained for tumor assessment in a phase II trial.
  • Tumor response was evaluated based on the RECIST criteria.
  • CONCLUSIONS: In addition to high anti-tumor efficacy, hypothyroidism and thyroid atrophy were commonly observed in Japanese MRCC pts who received sunitinib.
  • Although further study should be required, these abnormal findings in thyroid gland following treatment with sunitinib may be potential biomarkers for tumor response to sunitinib.

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  • (PMID = 27963089.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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34. Benedict A, Figlin RA, Charbonneau C, Kreif N, Hariharan S, Négrier S: Economic evaluation of sunitinib versus other new targeted therapies as first-line treatment of metastatic renal cell carcinoma (mRCC) in the United States. J Clin Oncol; 2009 May 20;27(15_suppl):e17556

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Economic evaluation of sunitinib versus other new targeted therapies as first-line treatment of metastatic renal cell carcinoma (mRCC) in the United States.
  • : e17556 Background: RCC, the most prevalent kidney cancer, is a relatively rare malignancy that carries a poor prognosis.
  • Costs of drugs, routine follow-up, treatment-related adverse events, disease progression, and best supportive care of terminally-ill patients were included in the model.

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  • (PMID = 27963850.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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35. Mancuso AP, Donato De Paola E, Catalano A, Calabrò F, Messina C, Zivi A, Cerbone L, Vigna L, Caristo R, Sternberg CN: Phase II dose escalation study of sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have had prior treatment with VEGFR-TKI antiangiogenic treatment. J Clin Oncol; 2009 May 20;27(15_suppl):e16027

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II dose escalation study of sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have had prior treatment with VEGFR-TKI antiangiogenic treatment.
  • : e16027 Background: Sorafenib is an orally active multikinase inhibitor (Raf kinase, VEGFR 1, 2, 3 and PDGFR inhibitor) for the treatment of advanced RCC.
  • Pts with no progressive disease (evaluated at 12 weeks) continued to receive Sorafenib at the standard dose, while progressive pts received an increasing dose (600 mg BID) with early disease restaging after 4 weeks.
  • RESULTS: 18 pts were entered; baseline characteristics: PS 0-1: 94%; median age 62 years (41-82); nephrectomy: 100%; surgery for metastatic disease: 28%, clear-cell 78%, papillary-cell 16%, sarcomatoid 6%.
  • Overall, 72% of pts had disease control without significant correlations between response to prior therapy and hypertension.
  • The most common toxicity (NCIC 3.0, all pts) was grade (g) ≥ 1 diarrhea in 10 pts, g2-3 hand-foot syndrome in 7 pts and g-3 mucositis in 1 pt.
  • Other hematological and non-hematological toxicities were g1 with a frequency < 15%.

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  • (PMID = 27962966.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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36. Rizack T, Mega A, Berz D: Is squamous cell histology an adverse prognosticator for survival of malignancies of the upper urinary tract? J Clin Oncol; 2009 May 20;27(15_suppl):6617

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Is squamous cell histology an adverse prognosticator for survival of malignancies of the upper urinary tract?
  • : 6617 Background: Carcinomas of the renal pelvis and ureter are rare diseases, accounting for only about 1% of all urogenital malignancies.
  • Previous reports suggest that squamous cell histology is associated with inferior survival.
  • METHODS: We analyzed the Surveillance, Epidemiology and End Results database for cancer specific survival rates in patients with renal pelvis and ureteral malignancies who were diagnosed between 1973 and 2003 in the SEER catchment geographic areas.
  • The primary exposure of interest was the underlying histology, squamous cell versus transitional cell differentiation.
  • We performed descriptive statistics, non parametric survival analysis, and cox proportional hazard analysis.
  • RESULTS: We identified 13,213 eligible patients, 7,716 renal pelvis and 5,497 ureteral carcinomas.
  • Among this cohort, 179 patients had squamous cell carcinoma (SCC), 12,395 had transitional cell carcinoma (TCC), including 121 papillary, and 619 had other histologies.
  • The cox analysis revealed a HR 0.42 (95% CI 0.36-0.47) for TCC when compared to SCC and corrected for decade of diagnosis, age, gender, prior treatment, and race.
  • The difference between the two groups was entirely attributable to survival differences in patients with loco-regional disease.
  • CONCLUSIONS: SCCs of the upper urinary tract present at a higher clinical stage and appear to represent more aggressive disease when compared to other histologies.
  • However, when appropriately staged according to lymph node status, the survival of TCC and SCC of the upper urinary tract is identical when compared stage by stage.

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  • (PMID = 27961775.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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37. Garrido-Laguna I, Rudek M, Tan A, Uson M, Iacobuzio-Donahue C, Angenendt M, Jimeno A, Laheru D, Barret M, Hidalgo M: Preclinical identification of biomarkers of response to mTOR inhibitors and subsequent application in a phase II trial of sirolimus in pancreatic cancer patients refractory to gemcitabine. J Clin Oncol; 2009 May 20;27(15_suppl):4612

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preclinical identification of biomarkers of response to mTOR inhibitors and subsequent application in a phase II trial of sirolimus in pancreatic cancer patients refractory to gemcitabine.
  • : 4612 Background: Treatment for advanced pancreatic cancer refractory to gemcitabine has not been defined.
  • We conducted an efficacy study in pancreatic cancer xenografts to identify biomarkers of response to mTOR inhibition and attempted to translate the results by conducting a phase II trial of sirolimus in this patient population.
  • Tumors were profiled with array CGH and gene expression arrays at baseline.
  • RESULTS: In the preclinical study, mTOR sensitive tumors showed upregulation of genes involved in the renal cell cancer pathway.
  • Baseline tumor p-S6K was not predictive for survival.
  • The most common grade 3 adverse event was hyperglycemia in 10% of the patients.
  • 7 (23%) patients achieved stable disease.
  • Efficacy data is limited by the selection of a heavily pretreated and poor prognosis population (DFS≤47 days).

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  • (PMID = 27964189.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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38. Kim CY, Chu D, Baer L, Wu S: High-grade proteinuria associated with bevacizumab in patients with renal cell cancer and non-renal cell cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e16089

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] High-grade proteinuria associated with bevacizumab in patients with renal cell cancer and non-renal cell cancer.
  • It is a widely used angiogenesis inhibitor in the treatment of renal cell cancer (RCC) and other solid tumors.
  • This study was conducted to determine the risk of developing proteinuria among RCC and non-RCC patients receiving bevacizumab.
  • The risk of high-grade proteinuria may also depend on tumor type; the incidence of high-grade proteinuria was 10.0% (95% CI: 4.3-22.4%) with a RR 48.7 (95% CI: 9.7-244.3) among 703 RCC patients compared with an incidence of 1.7% (95% CI: 0.09-3.2%) and RR of 5.2 (95% CI: 3.3-8.4) among 5,999 non-RCC patients.
  • The risk may vary with bevacizumab dose and tumor type.
  • RCC patients may have higher risk than non-RCC patients.

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  • (PMID = 27963106.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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39. Botteman MF, Kaura S: Cost-effectiveness of zoledronic acid in the prevention of skeletal-related events in patients with bone metastases from renal cell carcinoma: Comparison between France, Germany, and the United Kingdom. J Clin Oncol; 2009 May 20;27(15_suppl):5106

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cost-effectiveness of zoledronic acid in the prevention of skeletal-related events in patients with bone metastases from renal cell carcinoma: Comparison between France, Germany, and the United Kingdom.
  • : 5106 Background: Zoledronic acid (ZOL) significantly reduces the risk of new skeletal-related events (SREs) in patients (pts) with bone metastases from RCC.
  • This study assessed and compared the cost-effectiveness of ZOL in pts with RCC from French, German, and United Kingdom (UK) societal perspectives.
  • METHODS: This analysis was based on a retrospective analysis of RCC pts with bone metastases who were enrolled in a 9-mo trial of ZOL or placebo (PBO) plus concomitant antineoplastic therapy.
  • SRE costs were estimated using diagnosis-related group tariff information and published literature.
  • CONCLUSIONS: Treatment with ZOL reduces SREs, improves QOL, and lowers health-related costs compared with PBO in French, German, and UK pts with bone metastases from RCC.

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  • (PMID = 27964368.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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40. Shek DW, Longmate J, Quinn D, Margolin K, Twardowski P, Gandara D, Pan C, Lara P: A phase II trial of gefitinib and pegylated interferon alfa 2b (PEG-IFN) in previously-treated renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):e16115

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II trial of gefitinib and pegylated interferon alfa 2b (PEG-IFN) in previously-treated renal cell carcinoma (RCC).
  • : e16115 Background: Modulation of the epidermal growth factor receptor (EGFR) pathway is relevant to IFN activity in RCC.
  • Cell lines sensitive to IFN's antiproliferative effects downregulate EGFR, while IFN treatment of resistant cells precludes such an effect. (Eisenkraft et al, Cancer Res.
  • To explore this hypothesis, we conducted a trial of the EGFR tyrosine kinase inhibitor gefitinib plus PEG-IFN in RCC patients (pts).
  • METHODS: Unresectable or metastatic RCC pts (no limit on prior therapies; performance status 0-2, and adequate end-organ function) were eligible.
  • A 6-month progression free survival (PFS) rate of 50% was considered promising (vs. 30%) in a two-stage design incorporating the Green-Dahlberg rule.
  • We accrued 21 patients in the first-stage of accrual.
  • Accrual slowed with increased use of small molecule kinase inhibitors, bevacizumab, and temsirolimus for RCC.
  • Response duration: CR (35+ months) and PR (3, 5, 5, 38+ months).
  • Most common treatment-related toxicities were leucopenia, thrombocytopenia, rash, nausea, diarrhea, and hyperglycemia.

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  • (PMID = 27963312.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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41. Floercken A, Takvorian A, Singh A, Hopfenmüller W, Pezzutto A, Dörken B, Westermann J: Modulation of regulatory T cells and myeloid-derived suppressor cells by sorafenib and sunitinib in renal cell carcinoma patients. J Clin Oncol; 2009 May 20;27(15_suppl):e16002

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Modulation of regulatory T cells and myeloid-derived suppressor cells by sorafenib and sunitinib in renal cell carcinoma patients.
  • : e16002 Background: Induction of regulatory T (Treg) and myeloid-derived suppressor cells (MDSC) is a major mechanism for the escape of tumors from immunological control.
  • Increased levels of Treg cells have been described in renal cell cancer (RCC) patients and seem to correlate with an adverse outcome.
  • Furthermore, reduction of Treg has been reported for RCC patients under sunitinib therapy.
  • The aim of our study was to analyse the influence of sorafenib and sunitinib on the frequency of Treg and MDSC in patients with metastatic RCC (mRCC).
  • However, there was a significant increase of CD3+CD4+CD25+FOXp3+Treg (13,5% vs. 36,3% of gated cells, p= 0.02) and the ratio FOXp3+/FOXp3- CD3+CD4+ T cells (0,16% vs. 0,56% of gated cells, p= 0.02) in the group of sorafenib-treated patients compared to sunitinib-treated patients during the 1st month of therapy and thereafter.
  • A negative influence of sorafenib on primary immune responses has been described and has mainly been attributed to functional impairment of dendritic cells (DC).
  • Whether altered DC function under sorafenib is responsible for the induction of Treg in RCC patients will have to be addressed in future studies.
  • In immunoresponsive tumors such as RCC, immunological effects of kinase inhibitors are particularly relevant for the design of combination trials with immunotherapeutic agents.

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  • (PMID = 27962943.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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42. Vogelzang NJ, Hutson TE, Samlowski W, Somer B, Richey S, Alemany C, Loesch D, Richards P, Gardner L, Sportelli P: Phase II study of perifosine in metastatic renal cell carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF receptor inhibitor. J Clin Oncol; 2009 May 20;27(15_suppl):5034

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of perifosine in metastatic renal cell carcinoma (RCC) progressing after prior therapy (Rx) with a VEGF receptor inhibitor.
  • In a prior trial, 15 RCC patients (pts) were enrolled in a randomized dose finding study, 9 were evaluable for response and 3 (33%) had a partial response (PR).
  • Median age 64 (range 46-80) and 36 were male; Median prior Rx was 2 (range 1 - 5); Clear cell = 37, non clear cell = 6, data n/a = 3.
  • Most common toxicity was grade 1 & 2 nausea (56%), arthralgia (47%), vomiting (36%), fatigue (33%) and cognitive changes (28%).
  • CONCLUSIONS: Perifosine, similar to mTOR inhibitors, appears to have clinical benefit in mRCC as reflected by the PR rate and a 15 wk median overall PFS.

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  • (PMID = 27962937.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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43. Secter M, MacKenzie MJ, O'Brien P, Whiston F: Skeletal related events in patients with metastatic renal cell carcinoma: A retrospective review. J Clin Oncol; 2009 May 20;27(15_suppl):e16118

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Skeletal related events in patients with metastatic renal cell carcinoma: A retrospective review.
  • : e16118 Background: Approximately one third of patients with renal cell carcinoma (RCC) will develop bone metastases during the course of their disease.
  • Previous studies suggest that the rate of skeletal related events (SREs) in patients with metastatic renal cell carcinoma is high, and that bisphosphonate therapy can lower the rate of SREs.
  • We conducted a retrospective review of patients with metastatic renal cell carcinoma and bone metastases seen at our academic cancer centre.
  • METHODS: After approval by the Research Ethics Board, a retrospective review of all patients seen at the London Regional Cancer Centre with a diagnosis of RCC between January 2006 and December 2008 was performed.
  • RESULTS: 196 patients with metastatic RCC were identified.
  • Common sites of metastases were vertebra (66%), pelvis (50%), and femur (42%).
  • CONCLUSIONS: Despite significant recent improvements in the overall care of RCC, and expansion of the number of therapeutic options, bone metastases and consequent SREs continue to cause significant morbidity.
  • Our rate of SREs is actually higher than that documented in the placebo arm of a randomized trial of a bisphosphonate in RCC from the pre-tyrosine kinase era.

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  • (PMID = 27963309.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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44. Lettieri JT, Dubowy R, Xia C, Rotolo C, Zinny MA: Bioavailability of sorafenib tablets administered as a liquid suspension. J Clin Oncol; 2009 May 20;27(15_suppl):e14549

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e14549 Background: Sorafenib is a multikinase inhibitor currently approved by the FDA for the treatment of advanced renal-cell carcinoma (RCC) and unresectable hepatocellular carcinoma (HCC), and by the EMEA for the treatment of HCC and advanced RCC.
  • Utilizing a randomized, crossover design, subjects received either two 200-mg intact tablets (IT) with 8 ounces water, or two 200-mg tablets disintegrated over 10 minutes in 2 ounces of water (ST), with an additional 6 ounces of water swallowed as a rinse of the dosing vessel.

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  • (PMID = 27963627.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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45. Cen P, Daleiden A, Doshi G, Amato R: A phase I study of everolimus plus sorafenib in patients with metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):e16056

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I study of everolimus plus sorafenib in patients with metastatic renal cell carcinoma (mRCC).
  • : e16056 Background: Everolimus, a mTOR inhibitor and Sorafenib, a Raf kinase inhibitor had shown their efficacy in RCC, as single agents.
  • METHODS: Patients predominantly had clear cell RCC, and progressive measurable diseases on prior treatments including immunotherapy, TKI and/or Everolimus.
  • Patients were evaluated weekly for toxicities and every 8 weeks for radiological response, including at least both PET/CT and CT scans at baseline and 1<sup>st</sup> staging.
  • The most common side effect was grade 1/2 hand-foot syndrome (4/15, 27%).
  • 47% (7/15) of the patients had stable disease.
  • CONCLUSIONS: The MTD of combining daily Everolimus 10mg and twice daily sorafenib 400mg are safe and effective for progressive metastatic RCC.

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  • (PMID = 27962999.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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46. Vickers MM, Choueiri TK, Zama I, Cheng T, North S, Knox JJ, Kollmannsberger C, McDermott DF, Rini BI, Heng DY: Failure of initial VEGF-targeted therapy in metastatic renal cell carcinoma (mRCC): What next? J Clin Oncol; 2009 May 20;27(15_suppl):5098

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Failure of initial VEGF-targeted therapy in metastatic renal cell carcinoma (mRCC): What next?
  • : 5098 Background: The characterization and efficacy of second-line targeted therapy in patients with metastatic RCC who failed first-line VEGF-targeted therapy in a population-based setting is of clinical relevance but remains to be assessed.
  • METHODS: Provincial registries and clinical databases from seven cancer centers (3 in US and 4 in Canada) identified patients with mRCC who received first-line anti-VEGF targeted therapy between 2005-2007.
  • Of these, 218 patients (34%) received second-line targeted therapy: the median age was 62 yrs (range, 41-87), median KPS was 90%, 90% had prior nephrectomy, 3.8% had non-clear cell histology, 5.8% had brain metastases and 79% had > 1 metastatic site.
  • Patient characteristics were similar aside from more non-clear cell histology in patients receiving second-line mTOR-inhibiting agents (14% vs 3% p = 0.045).
  • However, patient selection may account for this finding and overall survival was not significantly different.

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  • (PMID = 27964309.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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47. Harzstark AL, Rosenberg JE, Weinberg VK, Sun J, Ryan CJ, Lin AM, Fong L, Brocks DR, Small EJ: A phase I study of sorafenib and RAD001 for metastatic clear cell renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5104

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I study of sorafenib and RAD001 for metastatic clear cell renal cell carcinoma.
  • : 5104 Background: Both RAD001 and sorafenib have activity against advanced clear cell renal cell carcinoma (ccRCC).
  • Independently-reviewed best objective responses in 13 evaluable pts include 3 confirmed partial responses (10, 17+, and 23+ months), 6 stable disease (2+, 4+, 4.5, 6+, 13, and 23+ months), and 4 progressive disease.

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  • (PMID = 27964372.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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48. Di Lorenzo G, De Placido S, Cartenì G, Autorino R, Gonnella A, Rizzo M, Perdona S, Ricevuto E, Aieta M, Ewer M: Cardiovascular toxicity follwing sunitinib therapy in metastatic renal cell cancer: A multicenter analysis. J Clin Oncol; 2009 May 20;27(15_suppl):e16051

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cardiovascular toxicity follwing sunitinib therapy in metastatic renal cell cancer: A multicenter analysis.
  • We reviewed cardiac adverse events in patients with metastatic renal cell carcinoma (RCC) who underwent treatment with this agent.
  • METHODS: The medical records of 175 patients with metastatic RCC treated with sunitinib at eight Italian Institutions were retrospectively reviewed.
  • Among these 17 patients, 12 (70.6%) also experienced left-ventricular systolic (LVEF) dysfunction; in all, 33 of the 175 patients (18.9%) developed some degree of cardiac abnormality, of which 12 were of classified as grade 3 LVEF dysfunction and/or congestive heart failure (CHF) (6.9%).
  • A significant univariate association for predictors of CHF were history of hypertension (p=0.008), history of coronary heart disease (p=0.0005) and prior treatment with an angiotensin converting enzyme inhibitor (ACE) (p= 0.04).
  • Multivariate analysis suggested that a history of coronary artery disease (OR 18, 95% CI, 4-160 p 0.005) and hypertension (OR 3, 95% CI, 1.5-80 p 0.04) were the only significant independent predictors of CHF.
  • CONCLUSIONS: Patients undergoing sunitinib, especially those with a previous history of hypertension and coronary heart disease, are at increased risk for cardiovascular events and should be monitored for exacerbations of their hypertension and for evidence of LVEF dysfunction during treatment.

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  • (PMID = 27963002.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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49. Chung EK, Posadas EM, Kasza K, Karrison T, Manchen E, Michalak L, Hahn OM, Stadler WM: A phase II trial of gemcitabine(G), capecitabine (C), and bevacizumab (B) in patients (pts) with metastatic renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):e16072

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II trial of gemcitabine(G), capecitabine (C), and bevacizumab (B) in patients (pts) with metastatic renal cell carcinoma (RCC).
  • : e16072 Background: RCC is resistant to most traditional DNA and DNA repair targeted chemotherapy; although modest response rates to nucleotide analog based therapy, including GC, have been reported.
  • Bevacizumab has activity in RCC.
  • We thus performed a single center phase II trial of GCB in pts with metastatic RCC.
  • METHODS: Eligibility included clear cell or unclassified histologies, performance status 0-1, measurable disease, normal organ function and no prior treatment with VEGF binding agents or pyramidine analogs.
  • Following significant hematotoxicity in the first 7 of 8 pts, chemotherapy was modified to G 1,000 mg/m2 (days 1, 8), C 1,000 mg po bid (days 1-14) and B 15 mg/kg (day 1) on a 21 day cycle with disease re-evaluation every 3 cycles.

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  • (PMID = 27963038.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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50. Hongyun L, Zhihong C, Xiangqing Y, Lu S, Chuanliang C, Xinan S, Lin S, Jun G: Phase II study of sorafenib combined with gemcitabine and 5-fluorouracil in patients with metastatic renal cell carcinoma: Preliminary results. J Clin Oncol; 2009 May 20;27(15_suppl):e16093

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of sorafenib combined with gemcitabine and 5-fluorouracil in patients with metastatic renal cell carcinoma: Preliminary results.
  • : e16093 Background: The tyrosine kinase inhibitors sorafenib and sunitinib have been approved for use in patients with advanced RCC and have supplanted immunotherapy as first-line therapy.
  • Nevertheless, complete responses have been observed only rarely with these agents and only 10% of patients experience PR.
  • In order to improve the objective response rate and the durability of those responses in patients, we conducted a single-institution, single-arm phase II trial of gemcitabine and 5-fluorouracil (5-FU) combined with sorafenib in patients with RCC.
  • METHODS: Eligibility criteria included advanced, histologically confirmed RCC; age >18 years; ECOG PS ≤ 2, adequate bone marrow, renal and hepatic function; measurable/evaluable lesions.
  • The rate of objective response and disease control (including stable disease, complete responses and partial responses) were 38% (95% CI, 18-62%) and 86% (95% CI, 64-97%), respectively.
  • CONCLUSIONS: The combination of sorafenib with gemcitabine and 5-FU shows promising activity for patients with metastatic RCC.

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  • (PMID = 27963083.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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51. Grozav AG, Willard B, Kinter M, Vaziri SA, Bukowski RM, Rini BI, Ganapathi MK, Ganapathi R: Target identification by phosphoproteomics: RIN1 modulation of sorafenib-induced cytotoxicity in renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e14543

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Target identification by phosphoproteomics: RIN1 modulation of sorafenib-induced cytotoxicity in renal cell carcinoma.
  • : e14543 Background: Sorafenib (SFB) is a multi-tyrosine kinase inhibitor clinically useful in treatment of metastatic renal cancer.
  • METHODS: In this study we used targeted phosphoproteomics to identify tyrosine phosphorylated proteins that are differentially affected in control and SFB-treated human CAKI-1 renal cell carcinoma cells.
  • RESULTS: Among identified proteins, signal transducer and activator of transcription 1 (STAT1) and Ras and Rab interactor 1 (RIN1) were found to be hypophosphorylated in SFB-treated compared to untreated CAKI-1 cells based on quantitative MS analysis, by peptide counts and native peptide reference method.
  • A ∼4-fold decrease in expression and phosphorylation of STAT1 was observed in cells treated with 10 μM SFB for 48h.
  • Similar effects on decreased phosphorylation of STAT1 and RIN1 were also observed in 786-O renal cell carcinoma treated with SFB.
  • Hypophosphorylation of RIN1 at tyrosine 36 was observed in CAKI-1 cells treated with 5 μM sunitinib but not with imatinib (≤ 10 μM).
  • Treatment of CAKI-1 cells with RIN1 targeted, but not control si-RNA led to down-regulation of RIN1 expression and attenuation of antiproliferative effects of SFB.
  • Notably, ∼2-fold higher expression of RIN1 protein (total and phosphorylated) was observed in CAKI-1 cells selected for resistance following continuous exposure to 7.5 μM SFB.
  • However, unlike parent CAKI-1 cells, prolonged exposure of these SFB-resistant CAKI-1 cells to 7.5 μM SFB did not completely abrogate phosphorylation of RIN1 at tyrosine 36.
  • CONCLUSIONS: These results demonstrate that RIN1, a Ras effector protein with multiple biochemical functions, is a target for the anti-tumor effects of SFB in kidney cancer cells.

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  • (PMID = 27963618.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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52. Dial E, Duh M, Fournier A, Antras L, Rodermund D, Neary MP, Oh WK: Cost implications of intravenous bevacizumab treatment in patients with renal cell carcinoma (RCC): A retrospective claims database analysis. J Clin Oncol; 2009 May 20;27(15_suppl):5112

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cost implications of intravenous bevacizumab treatment in patients with renal cell carcinoma (RCC): A retrospective claims database analysis.
  • : 5112 Background: Angiogenesis inhibitor (AI) therapies are promising novel treatments for patients with RCC.
  • The incremental costs associated with IV vs. oral administration of selected AI therapies (oral sunitinib or sorafenib, or IV bevacizumab off-label) for the treatment of RCC were evaluated.
  • METHODS: Patients with ≥ 2 RCC claims (ICD-9 189.0, 198.0) were identified from a large US commercial health insurance claims database from 1/02 to 12/07.
  • Cost comparisons between the IV AI group and each separate oral AI group were performed using multivariate Tobit regressions for each category separately, adjusting for age, gender, region, health plan, time from first RCC claim and first metastasis claim to treatment initiation.
  • CONCLUSIONS: Patients with RCC treated with bevacizumab incur an incremental $58,826 to $60,546 total medical cost per patient per year compared to those treated with sunitinib or sorafenib.

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  • (PMID = 27964393.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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53. Merchan JR, Pitot HC, Qin R, Liu G, Fitch TR, Picus J, Maples WJ, Erlichman C: Phase I/II trial of CCI 779 and bevacizumab in advanced renal cell carcinoma (RCC): Safety and activity in RTKI refractory RCC patients. J Clin Oncol; 2009 May 20;27(15_suppl):5039

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I/II trial of CCI 779 and bevacizumab in advanced renal cell carcinoma (RCC): Safety and activity in RTKI refractory RCC patients.
  • : 5039 Background: Combined mTOR and VEGF blockade is a potentially promising and rational strategy for the treatment of advanced RCC.
  • We previously reported the phase I safety and efficacy results of CCI 779 (C) +bevacizumab (B) n RTKI naïve stage IV RCC patients (pts) (J Clin Oncol.
  • We now report the interim results of the phase 2 study of C+B in RTKI refractory RCC patients.
  • METHODS: Design: Open label, phase I/II study of C+B in advanced RCC pts.
  • Patients with measurable stage IV RCC with a component of clear/conventional cell type, performance status 0-2 and good organ function were eligible.
  • Most common (>5%) Gr 3-4 AEs (N = 29) included fatigue (6), hypercholesterolemia (2), hypertriglyceridemia (2), anorexia (2), rash (2), and anemia (2).
  • Responses were: PR/SD/PD = 4 (16%)/18 (72%)/3 (12%).
  • Clinical benefit rates (PR/SD) in RTKI refractory RCC patients (88%) are encouraging.
  • Correlative studies on available plasma, serum and tumor samples for angiogenic and molecular biomarkers are underway.

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  • (PMID = 27962933.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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54. Shah M, Sreenivasappa S, Kouz R, Ciobanu B, Mullane M, Yim B: Demographics, response, and overall survival of patients with advanced renal cell cancer to sunitinib in a cohort of minority patient population. J Clin Oncol; 2009 May 20;27(15_suppl):e16164

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Demographics, response, and overall survival of patients with advanced renal cell cancer to sunitinib in a cohort of minority patient population.
  • : e16164 Background: Sunitinib is a tyrosine kinase inhibitor active in renal cell cancer (RCC).
  • METHODS: 21 patients (pts) with RCC who received sunitinib between February 2006-September 2007 were identified and studied as a retrospective cohort.
  • Median age at diagnosis was 59 years (32-74).
  • 7 (33.3%) had clear cell and 3 (14.3%) sarcomatoid pathology.
  • Mixed, poorly differentiated, papillary and unknown histology were 2 (9.5%) each.
  • 12 (57%) pts had stage 4 disease at diagnosis, stage 3 in 3 (14.3%), stage 2 in 1 (4.8%) and 5 (23%) had missing data.
  • Common grade 3-4 toxicities observed were hand foot syndrome (n = 2), hypertension (n = 2) and thrombocytopenia (n = 1).
  • 5 (23.8%) has stable disease and 13 (61.9%) had progressive disease.
  • CONCLUSIONS: In this minority cohort of pts with RCC treated with sunitinib, response and median survival is much lower than the historical controls.
  • Prospective studies are warranted in the treatment of RCC with sunitinib in ethnic minority population.

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  • (PMID = 27963440.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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55. Bloch J, Mouawad R, Spano J, Vigniot S, Magné N, Khayat D: Long-term follow-up of endogenous erythropoietin, VEGF levels and red blood count in patients receiving different antiangiogenic treatment. J Clin Oncol; 2009 May 20;27(15_suppl):e14648

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term follow-up of endogenous erythropoietin, VEGF levels and red blood count in patients receiving different antiangiogenic treatment.
  • : e14648 Background: Anemia, commonly defined as a hemoglobin level of <12 g/dL, occurs in over 30% of cancer patients at any time point and its incidence increases with treatment.
  • The concept of antiangiogenic treatment for solid tumors has recently emerged and we wondered why patients under such kind of treatment did not experience anemia requiring transfusion or the use of erythropoietin.
  • The goal of this study is to follow-up endogenous serum EPO, VEGF concentrations, hemoglobin (Hb) and hematocrit (Ht) levels in various metastatic cancers patients receiving different anti-angiogenic treatment and to try to establish the possible relation between these parameters.
  • PATIENTS AND METHODS: 30 patients (20 men and 10 women) with different cancer type (20 RCC and 10 thyroids) with a median age of 56 year were included in this study.

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  • (PMID = 27964238.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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56. Heath EI, Blumenschein GR Jr, Cohen RB, LoRusso PM, LoConte N, Kim ST, Chao R, Wilding G: Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results. J Clin Oncol; 2009 May 20;27(15_suppl):e14509

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results.
  • : e14509 Background: Sunitinib (SU) is an oral, multitargeted tyrosine kinase inhibitor of VEGFRs, PDGFRs, KIT, FLT3, and RET, approved for the treatment of advanced RCC and imatinib-resistant/intolerant GIST.
  • METHODS: Successive pt cohorts with advanced solid tumors (STs) received oral SU at 25, 37.5, or 50 mg for 2 wks during 3-wk cycles (Schedule 2/1) or for continuous 3 wk cycles (CDD schedule) with P (175-200 mg/m<sup>2</sup>) plus C (AUC=6 mg·min/mL) on day 1 of each of 4 cycles.
  • Response was evaluated for pts with measurable disease.
  • Tumor types included NSCLC (n=10), SCLC, esophageal, and pancreatic (n=4 of each), and other (n=21).

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  • (PMID = 27963544.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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57. Clisant S, Adenis A, Dansin E, Desauw C, Degardin M, Mortier L, Fournier C, Penel N: Oral metronomic chemotherapy using cyclophosphamide in metastatic patients (pts) after standard treatment: Results of a randomized phase II trial. J Clin Oncol; 2009 May 20;27(15_suppl):e13519

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Oral metronomic chemotherapy using cyclophosphamide in metastatic patients (pts) after standard treatment: Results of a randomized phase II trial.
  • We hypothesized that each treatment offer disease control without significant severe toxicity.
  • METHODS: This multi-center-randomized study was aimed to assess the efficacy and tolerance of both treatments.
  • Primary endpoint was stable disease rate at 2 months: 2mSD (RECIST).
  • Main eligibility criteria were as follows: non-breast cancer, pts with progressive disease refractory to standard therapies or without established standard care, ECOG=0-1, neither hypercalcemia nor hypoalbuminemia.
  • The second stage was allowed because at least 2mSD were seen among 12 first pts.
  • Most common primaries were: colorectal cancer (30 pts), soft tissue sarcoma (17), lung cancer (13), head & neck (8) and unknown primaries (4).
  • Three long-lasting SD (6 months +) are currently being observed in 3 pts receiving OMC (2 sarcomas and 1 RCC).
  • CONCLUSIONS: OMC and MA offer SD in patients with advanced, refractory and progressive tumors, without any significant toxicity.
  • The non-progression rate with OMC (15%) is in a same range of efficacy that was recently reported with new targeted therapy or anti-angiogenic agents administered in such pts.

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  • (PMID = 27961314.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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58. LoRusso P, Markman B, Tabernero J, Shazer R, Nguyen L, Heath E, Patnaik A, Papadopoulos K: A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):3502

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors.
  • XL765 has shown dose-dependent target modulation and tumor growth inhibition or shrinkage in multiple human xenografts.
  • Tumor response is assessed by RECIST every 8 weeks.
  • Non-specific neurological complaints (1) and rash (1) were the DLTs that occurred at 100 mg qd.
  • The most common (> 10% of pts) related adverse events were elevated liver enzymes, nausea and diarrhea.
  • Robust pharmacodynamic modulation of PI3K pathway signaling in PBMCs, hair follicles, skin, and tumors was evident following administration of XL765.
  • Five pts had durable stable disease (> 3 months): appendiceal cancer (15 mg bid) 8 cycles; RCC (15 mg bid) 4 cycles; NSCLC (30 mg bid) 4 cycles; mesothelioma (60 mg bid) 10 cycles; CRC (100 mg qd) 6 cycles.

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  • (PMID = 27961282.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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59. Flaig TW, Costa L, Breaker K, Schultz M, Crighton F, Kim FJ, Drabkin HA: Erlotinib with sirolimus for advanced renal cell carcinoma: Preliminary efficacy results. J Clin Oncol; 2009 May 20;27(15_suppl):e16037

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Erlotinib with sirolimus for advanced renal cell carcinoma: Preliminary efficacy results.
  • : e16037 Background: The mammalian target of rapamycin (mTOR) is an important therapeutic target in the treatment of renal cell carcinoma (RCC).
  • Temsirolimus, an analog of rapamycin, prolongs survival when used to treat high-risk RCC patients and is approved for the treatment of advanced RCC.
  • Pre-clinical data indicate that the combined inhibition of the epidermal growth factor receptor (EGFR) and mTOR results in enhanced anti-cancer activity, especially in cell lines with wt-VHL.
  • METHODS: All patients on this study had metastatic or unresectable renal cell carcinoma with progression despite sunitinib and/or sorafenib.
  • No confirmed complete or partial responses were observed, but meaningful stable disease (SD) (e.g., > 6 months) was noted in a small group of patients.
  • The most common adverse events were rash and diarrhea with the majority of these observed as a grade 1 event.
  • Grade 3 and 4 toxicities included rash, mucositis, neurological motor weakness, dehydration, worsening cardiac function, non-ST elevation MI, and anemia.
  • CONCLUSIONS: The combination of erlotinib and sirolimus produces a median PFS of 12 weeks in a significantly pretreated RCC population, which is not dissimilar to recent results with other mTOR inhibitors in this setting.
  • The toxicity profile of this combination is consistent with the expectations of this pre-treated patient population with advanced RCC.

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  • (PMID = 27962945.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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60. Matin SF, McCutcheon IE, Gombos DS, Waguespack SG, Wen S, Smith LA, Zhang Y, Davis DW, Fuller G, Jonasch E: Treatment of VHL patients with sunitinib: Clinical observations and translational studies. J Clin Oncol; 2009 May 20;27(15_suppl):e22047

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e22047 Background: Von Hippel Lindau (VHL) disease induces vascular lesions in multiple organs.
  • Eligibility criteria included retinal angiomas, hemangioblastomas (HBs) measuring at least 5mm, renal cell carcinoma (RCC) 1 to 3 cm and pancreatic neuroendocrine tumors (NETs) 1 to 3 cm.
  • A separate set of 20 formalin-fixed paraffin embedded HBs and 20 RCCs were used for laser scanning cytometry (LSC) analysis of total and phospho vascular endothelial growth factor receptor (pVEGFR) and phospho platelet derived growth factor receptor (pPDGFR) levels in tumor endothelium.
  • Eight had RCCs, nine had CNS lesions, and three had pancreatic NETs.
  • Tumor size reduction was seen in 16/19 evaluable RCC lesions (95%CI 0.60, 0.97), 3/5 NETs (95%CI 0.15, 0.95) and 6/19 HBs (95%CI 0.13, 0.57).
  • LSC analysis demonstrated significantly lower phospho VEGFR levels in HBs when compared with RCC.
  • The mean (SD) of pVEGFR levels in log-transformation were 11.27 (0.49) and 11.75 (0.37) for HBs and RCC respectively (p = 0.003).
  • The mean (SD) of pVEGFR to VEGFR ratio was .21 (0.12) versus 0.37 (0.43), for HBs and RCC respsectively (p = 0.043).
  • CONCLUSIONS: Sunitinib treatment of patients with VHL resulted in consistent decrease of RCC and NET tumor size.
  • The discrepant response to sunitinib in RCC and HBs may be explained by differential dependence on VEGFR activation in tumor endothelium.

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  • (PMID = 27963229.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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61. Josephs DH, Hutson TE, Pickering LM, Larkin JM, Choueiri TK, Patel TV, Mcdermott DF, Powles T, Harper PG, Chowdhury S: Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma (mRCC) with severe renal impairment or on haemodialysis. J Clin Oncol; 2009 May 20;27(15_suppl):5109

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma (mRCC) with severe renal impairment or on haemodialysis.
  • Due to the inclusion criteria of clinical trials, no studies of sunitinib have enrolled patients with severe renal impairment or those undergoing haemodialysis, and thus further investigation of the effect of sunitinib in this population is required.
  • Medical records were searched to identify only those patients with a creatinine clearance (CL<sub>cr</sub>) of <30ml/min or who had end stage renal disease (ESRD) requiring haemodialysis.
  • PR or SD was observed as best response in 17 (81%) patients.
  • The most common treatment-related adverse events (AEs) included fatigue, diarrhoea, hand foot skin reaction (HFSR), nausea and vomiting and rash.
  • CONCLUSIONS: These data suggest that patients treated with sunitinib who have severe renal impairment, or ESRD on haemodialysis, have a PFS that is comparable to patients with normal renal function.

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  • (PMID = 27964363.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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62. Patil S, Figlin RA, Hutson TE, Michaelson MD, Négrier S, Kim ST, Huang X, Motzer RJ: Prognostic factors for overall survival with sunitinib as first-line therapy in patients with metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5042

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic factors for overall survival with sunitinib as first-line therapy in patients with metastatic renal cell carcinoma (mRCC).
  • RESULTS: In multivariate analysis of sunitinib patients, factors associated with longer OS include: interval from diagnosis to treatment ≥1 yr, ECOG PS of 0, lower corrected calcium, absence of bone metastases, lower lactic dehydrogenase (LDH), and higher hemoglobin (Hgb) ( table ).
  • For the IFN-α treatment arm, male gender, absence of bone or lymph node metastases, lower LDH, higher Hgb, lower corrected calcium, higher neutrophil count, and interval from diagnosis to treatment ≥1 yr were associated with longer OS.
  • Further studies are warranted to independently validate these findings as well as to identify tumor-specific prognostic factors.

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  • (PMID = 27962940.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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63. Elrafei TN, Hazza M, Tindel N: Use of percutaneous kyphoplasty to treat painful vertebral compression fractures (VCF) in solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):e20568

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Use of percutaneous kyphoplasty to treat painful vertebral compression fractures (VCF) in solid tumors.
  • : e20568 Background: Vertebral compression fractures are a major source of morbidity in metastatic carcinoma.
  • Kyphoplasty involves inflation of a balloon for painful kyphotic deformity restoring the vertebral body to its original height and creating a cavity for percutaneous injection of polymethylmethacrylate (PMMA).
  • Although it is FDA approved for cancer-associated VCF most of the data is in the myeloma population.
  • RESULTS: Review of 447 consecutive orthopedic spine cases identified 40 kyphoplasty patients, 30 of which met the inclusion criteria - 21 with benign compression fractures secondary to osteoporosis/trauma and 9 with malignant disease (3 breast CA, 2 lung, 1 cervix, 1 RCC, 2 myeloma).
  • Median age was in the cancer group was 55 (37-81) vs. 68(41-93) in benign group.
  • One patient had prior radiation in the cancer group.
  • The average preoperative visual analog pain score was 7 (range 3-9) and postoperative pain score was 2.0 (0-9) in the cancer group.
  • CONCLUSIONS: Kyphoplasty provided marked pain relief in patients with VCF secondary to solid tumors and myeloma.
  • The results are comparable to non-cancer population in safety and efficacy, and are feasible in selected cancer patients with pain due to pathologic compression fractures.

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  • (PMID = 27961129.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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64. Wozniak AJ, Kalemkerian GP, Gadgeel SM, Schneider BJ, Valdivieso M, Venkatramanamoorthy R, Hackstock DM, Chen W, Heilbrun LK, Ruckdeschel JD: A phase II trial of pemetrexed (P), gemcitabine (G), and bevacizumab (BV) in untreated patients (pts) with advanced non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):e19099

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II trial of pemetrexed (P), gemcitabine (G), and bevacizumab (BV) in untreated patients (pts) with advanced non-small cell lung cancer (NSCLC).
  • The addition of BV to chemotherapy has resulted in a significant improvement in survival for pts with non-squamous NSCLC.
  • METHODS: Advanced, non-squamous NSCLC pts with measurable/evaluable disease, no prior treatment for advanced disease, PS 0-1, adequate hepatic, renal and bone marrow function, treated brain metastases were eligible.
  • No unstable hypertension/cardiac disease/vascular disease, hemoptysis, anti-coagulation, recent major surgery, no cavitation or close proximity of primary cancer to a major vessel were allowed.
  • BV was continued until disease progression or toxicity.
  • Median age 57.5 yrs, males-55%, stage IV 90%, adenocarcinoma 75%.
  • 11/18 (61%) pts had a response (1 CR, 7 PR, 3 unconfirmed PR) (90% CI for RR is 0.42 - 0.77), and 3 had SD ( 17%) for a disease control rate of 78%.

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  • (PMID = 27962253.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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65. Miller L, Lal LS, Tannir NM, DaCosta Byfield S, Atkinson B, Feng C, Lau JK, Yin L, Jonasch E: Treatment of poor-risk metastatic renal carcinoma patients with combination gemcitabine, capecitabine, and bevacizumab at a tertiary cancer center. J Clin Oncol; 2009 May 20;27(15_suppl):e16112

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Treatment of poor-risk metastatic renal carcinoma patients with combination gemcitabine, capecitabine, and bevacizumab at a tertiary cancer center.
  • : e16112 Background: Treatment of poor risk metastatic renal carcinoma (mRCC) is challenging, and empiric combinations may be attempted in practice once conventional therapies fail.
  • Evaluation of mRCC patients given an empiric combination of gemcitabine (gem) capecitabine (cap), and bevacizumab (bev) at a tertiary care center was performed.
  • METHODS: After obtaining IRB approval, non investigational use of gem in combination with cap and bev in mRCC patients was identified using institutional databases.
  • Twenty-two patients (61%) had clear cell histology, 13 patients (36%) had sarcomatoid features, 20 patients (56%) had undergone previous nephrectomy, 20 patients (56%) had four or more sites of metastasis and 27 patients (75%) were diagnosed within 1 year of therapy.
  • Based on these observations, a phase II is now underway assessing gemcitabine, capecitabine and becacizumab in patients with sarcomatoid RCC.

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  • (PMID = 27963328.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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66. Schipperus M, Cornfeld M, Rijnbeek B, Berns B, Rossi J: CNTO328 (Anti-IL-6 mAb) treatment and hemoglobin (Hb) levels in renal cell cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e20648

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] CNTO328 (Anti-IL-6 mAb) treatment and hemoglobin (Hb) levels in renal cell cancer.
  • Hepcidin is an important factor in the pathogenesis of 'anemia of chronic disease'.
  • CNTO328 treatment has previously been shown to produce profound Hb increases in Castleman's disease, a disorder caused by deregulated IL-6 production.
  • We subsequently conducted this retrospective review to assess whether CNTO328 treatment is associated with an increase in Hb level in renal cell cancer patients (pts).
  • METHODS: All laboratory results for pts with metastatic renal cell carcinoma in this open label phase 2 study were reviewed.
  • Pts were treated with CNTO328 (6 mg/kg) IV infusions Q2 weeks and were evaluated for tumor response and markers of pharmacodynamic effect.
  • Of 18 pts evaluable for tumor response, 11 (61%) had SD and 7 (39%) had PD.
  • Hb responses were early (by day 8) and independent of tumor response.
  • CONCLUSIONS: Though pts were not anemic at baseline, our results suggest that CNTO328 leads to sustained increase in Hb levels, not correlated with tumor response.
  • This increase in Hb is presumably due to the reduction of hepcidin via IL-6 blockade and targeting the hepcidin pathway may lead to new therapies for anemia of cancer.

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  • (PMID = 27961655.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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67. Richey SL, Culp SH, Wood CG, Corn PG, Jonasch E, Tannir NM: Outcome of patients (pts) with metastatic renal cell carcinoma (mRCC) treated with systemic therapy without cytoreductive nephrectomy (CN). J Clin Oncol; 2009 May 20;27(15_suppl):e16035

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Outcome of patients (pts) with metastatic renal cell carcinoma (mRCC) treated with systemic therapy without cytoreductive nephrectomy (CN).
  • We calculated OS time from date of diagnosis until date of death or last follow up.
  • We excluded pts who had embolization, radiofrequency ablation or cryotherapy of the primary tumor.
  • 55 pts (62.5%) had clear-cell and 33 (37.5%) had non-clear cell histology, with median OS times of 15.1 mos (95% CI: 9.6-17.7) and 7.4 mos (95% CI: 4.4-13.0), respectively.
  • ECOG performance status (PS) at time of diagnosis was correlated with OS (HR 1.54; 95% CI: 1.16-2.05; p<0.01).
  • Pts with clinical evidence of lymph node (LN) involvement had worse outcome,with median OS time of 7.6 mos (95% CI: 5.6-9.8) versus 17.2 mos (95% CI: 9.8-35.5) for pts without clinical evidence of LN involvement.
  • CONCLUSIONS: In this analysis, median OS time for pts with mRCC treated in the modern era with TT without CN is superior to historical experience with IFN- α.Compromised PS, LN involvement, and non-clear cell histology were associated with worse outcome.

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  • (PMID = 27962960.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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68. Kim JJ, Vaziri SA, Elson P, Rini BI, Ganapathi MK, Ganapathi R: VEGF single nucleotide polymorphisms (SNPs) and correlation to sunitinib-induced hypertension (HTN) in metastatic renal cell carcinoma (mRCC) patients (pts). J Clin Oncol; 2009 May 20;27(15_suppl):5005

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] VEGF single nucleotide polymorphisms (SNPs) and correlation to sunitinib-induced hypertension (HTN) in metastatic renal cell carcinoma (mRCC) patients (pts).
  • : 5005 Background: VEGF SNPs (-634 C/C and -1498 T/T) have been associated with protection from grade III/IV HTN in breast cancer pts receiving bevacizumab plus paclitaxel (J Clin Oncol. 26:4672-4678).
  • Data were analyzed using parametric and non-parametric methods.
  • There was no association between VEGF SNPs and tumor volume reduction or PFS.

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  • (PMID = 27962893.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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69. Braun DP, Johnson DM, Katsantonis NG, Bhesaniya K, Staren ED: Apoptotic and immunomodulatory effects of green tea extracts (GTE) on chemoresistant human tumor cells. J Clin Oncol; 2009 May 20;27(15_suppl):e22101

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Apoptotic and immunomodulatory effects of green tea extracts (GTE) on chemoresistant human tumor cells.
  • : e22101 Background: GTE and Epigallocatechin 3-gallate (EGCG), the most abundant polyphenol in GTE, have been shown to exert inhibitory effects on carcinogenesis; modulatory effects on tumor proliferation and differentiation; and immunomodulatory effects on tumor immunity in different pre-clinical models.
  • These pluripotent effects suggest that GTE may have clinical activity that could be exploited for treatment of chemo-insensitive but immunologically responsive tumors.
  • Thus, the present study investigated the effects of EGCG on the proliferation and immunologic sensitivity of human renal cell cancer (RCC) and malignant melanoma (MM) cell lines.
  • METHODS: Human RCC (769-P) and MM (A375) cell lines were tested following incubation in media ± 21.8μM EGCG, a pharmacologically-achievable concentration produced by 8, 200mg capsules GTE daily.
  • Tumor proliferation was assessed by MTS assay; lytic sensitivity to IL2-activated human peripheral blood lymphocytes (IL2PBL) by <sup>51</sup>Chromium release assay; and gene expression by quantitative RT-PCR assay.
  • RESULTS: EGCG produced significant inhibition of proliferation of both RCC and MM cells (61.5% and 67.3% of media control values respectively; p<0.01 by 2-tailed, paired t test).
  • EGCG also caused significantly increased expression (≥ 2 times (×) media control values) of pro-apoptotic genes in both RCC: BCL2L1 (5.4×); BCL2L10 (7.9×); BIK (2.9×); Caspase 5 (6.3×); and Caspase 14 (6.3×) and MM cells: Caspase8 (2X) and Card6 (2.5X).
  • Unfortunately, EGCG pre-treatment also decreased the sensitivity of RCC (43% of control) and MM (53% of control) to IL2PBL-mediated lysis (p<0.01 respectively).
  • This occured in association with significant upregulation of Fas ligand mRNA in RCC (6.3×) and TRAF2 mRNA in MM (33 ×).
  • CONCLUSIONS: The results of this pre-clinical study demonstrate that EGCG exerts significant antiproliferative effects against human RCC and MM cells in vitro in association with increased expression of different pro-apoptotic genes.
  • Unfortunately, EGCG-treated cells also demonstrated reduced sensitivity to lysis by IL2-activated human lymphocytes.
  • Taken together, the results suggest that GTE may have activity in vivo in patients against chemoresistant RCC or MM but should not be used in conjunction with IL2 therapy.

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  • (PMID = 27963498.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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70. Eisen T, Joensuu H, Nathan P, Harper P, Wojtukiewicz M, Nicholson S, Bahl A, Tomczak P, Wagner A, Quinn D: Phase II study of BAY 73-4506, a multikinase inhibitor, in previously untreated patients with metastatic or unresectable renal cell cancer. J Clin Oncol; 2009 May 20;27(15_suppl):5033

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of BAY 73-4506, a multikinase inhibitor, in previously untreated patients with metastatic or unresectable renal cell cancer.
  • : 5033 Background: BAY 73-4506 is an orally active, potent multikinase inhibitor targeting both tumor cell proliferation and tumor vasculature through inhibition of receptors of tyrosine kinases (VEGFR, KIT, RET, FGFR, and PDGFR) and serine/threonine kinases (RAF and p38MAPK).
  • In tumor xenograft models, BAY 73-4506 demonstrated a broad spectrum of antitumor activity.
  • The results of a phase I study (3 weeks on/1 week off schedule) indicated good tolerability and antitumor activity, including objective responses.
  • METHODS: Previously untreated patients with predominantly clear cell renal cell carcinoma (RCC) and measurable disease according to RECIST were enrolled in this multicenter, open-label, phase II study.
  • The most common drug-related adverse events (all grades) reported in >20% of patients were hand-foot skin reaction (HFSR) (48%), fatigue (48%), hypertension (43%), mucositis (35%), dysphonia (33%), rash (30%), diarrhea (25%), and anorexia (23%).
  • Grade 3-4 drug related toxicities (in >5% of patients) included HFSR (13%), rash (8%), fatigue (8%), and renal failure (8%).
  • Renal failure occurred only in patients who continued taking study medication despite having inadequate fluid intake and/or diarrhea.
  • Preliminary efficacy data of the 33 patients evaluable for response show a 27% partial response (PR) and a 42% stable disease (SD) rate.
  • Further tumor assessments are scheduled for the patients (n = 35) remaining on study.
  • CONCLUSIONS: Preliminary data show promising antitumor activity and good tolerability of BAY 73-4506 in patients with RCC.

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  • (PMID = 27962938.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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71. Sternberg CN, Szczylik C, Lee E, Salman PV, Mardiak J, Davis ID, Pandite L, Chen M, McCann L, Hawkins R: A randomized, double-blind phase III study of pazopanib in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5021

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A randomized, double-blind phase III study of pazopanib in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC).
  • : 5021^ Background: Pazopanib, an oral multikinase angiogenesis inhibitor, has shown clinical efficacy in patients (pts) with advanced RCC.
  • In this study (VEG105192), the efficacy and safety of pazopanib was compared with placebo in advanced RCC.
  • METHODS: Pts (N = 400 planned) with clear cell advanced RCC and measurable disease with no prior treatment or 1 prior cytokine-based treatment, were stratified and randomized (2:1) to pazopanib 800 mg QD or placebo.
  • Pts received continuous treatment until disease progression (PD), death or unacceptable toxicity.
  • Most common AEs in pazopanib-treated pts were diarrhea (52%; 4% Gr 3/4), hypertension (40%; 4% Gr 3/4), hair color change (38%; <1% Gr 3/4), nausea (26%; <1% Gr 3/4), anorexia (22%; 2% Gr 3/4), and vomiting (21%; 2% Gr 3/4).
  • The most common laboratory abnormality was ALT elevation (53%; 10% Gr 3; 2% Gr 4).
  • (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research.
  • NIH-sponsored trials are exempt from the Policy restrictions.

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  • (PMID = 27962920.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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72. Montero AJ, Diaz-Montero CM, Liu J, Do K, Millikan RE, Tannir NM: Cytokines and angiogenic factors in metastatic renal cell cancer: Association of pretreatment serum levels with survival. J Clin Oncol; 2009 May 20;27(15_suppl):e16036

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cytokines and angiogenic factors in metastatic renal cell cancer: Association of pretreatment serum levels with survival.
  • : e16036 Background: To correlate serum cytokine and angiogenic factor (CAF) levels and overall survival (OS) in metastatic renal cell cancer (mRCC) treated with interferon-alpha (IFN-α).
  • RESULTS: Pretreatment serum interleukin (IL)-5, IL-12p40, VEGF<sub>A</sub>, and IL-6 levels, and Memorial Sloan-Kettering Cancer Center risk grouping were independently correlated with OS, with hazard ratios of 2.33, 2.00, 2.07, 1.82 and 0.39, respectively (concordance index = 0.69 for the combined model versus 0.60 for the CAF model versus 0.52 for the clinical model).

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  • (PMID = 27962961.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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73. Norum J, Nieder C, Kondo M: Sunitinib, sorafenib, temsirolimus, or bevacizumab in the treatment of metastatic renal cell carcinoma (RCC): A review of health economic evaluations. J Clin Oncol; 2009 May 20;27(15_suppl):e17539

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Sunitinib, sorafenib, temsirolimus, or bevacizumab in the treatment of metastatic renal cell carcinoma (RCC): A review of health economic evaluations.
  • : e17539 Background: Renal cell carcinoma (RCC) is the most prevalent kidney cancer and the 5-year overall survival figure in metastatic disease (mRCC) is about 10%.
  • The PubMed, ASCO abstracts, Google, and the Igaku Chuo Zasshi databases were searched in November 2008 with key terms: kidney, renal, cancer, cost, sunitinib, sorafenib, temsirolimus, and bevacizumab.
  • As long as cross-over to the experimental arm is allowed (based on improvement in progression free survival) overall survival data are difficult to interpret and the cost difference between the treatment and the control arm minimised.

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  • (PMID = 27963791.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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74. Plimack ER, Wong Y, Von Mehren M, Malizzia L, Roethke SK, Li T, Litwin S, Hudes GR, Haas NB: A phase I study of temsirolimus (TEM) and bryostatin (BRYO) in patients with metastatic renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5111

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I study of temsirolimus (TEM) and bryostatin (BRYO) in patients with metastatic renal cell carcinoma (RCC).
  • : 5111 Background: TEM, an inhibitor of mTOR complex 1 (TORC1), is approved for the treatment of metastatic RCC.
  • BRYO inhibits protein kinase C, a downstream effector of mTOR complex 2 (TORC2).
  • We observed additive effects of TEM and BRYO against RCC in vitro.
  • Eighteen pts had RCC: clear cell (12), papillary (3), clear cell with sarcomatoid/spindle features (2), unclassified (1), Among RCC pts, 3 had no prior therapy.
  • Five non-RCC pts (4 sarcoma, 1 paraganglioma) received up to 3 cycles of treatment.
  • One additional non-RCC pt (prior radiation) experienced DLT (Gr 3 neutropenia) at TEM 37.5 mg.
  • Among RCC pts, there were no 1<sup>st</sup> cycle DLT's.
  • One RCC pt withdrew prior to receiving treatment.
  • Of the 17 remaining RCC pts, 3 had PRs and 9 had SD.
  • One treatment naïve pt (TEM 15 mg) continues with PR for 2+ years after discontinuing treatment.
  • One pt (had progressed on sunitinib) continues in a PR at 14+ months.
  • PR was seen in both clear cell and papillary histologies.
  • Two pts, both with PR, remain on treatment, having received 18 and 8 cycles.
  • CONCLUSIONS: The TEM/Bryo combination is feasible for multiple cycles on a weekly schedule at full doses of each agent with durable PR and SD in RCC refractory to other therapies.

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  • (PMID = 27964394.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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75. Gordon MS, Stein M, Shannon P, Eddy S, Tyler A, Catlett L, Hsyu P, Huang B, Healey D, Rini BI: Phase I dose escalation trial of tremelimumab plus sunitinib in patients (pts) with metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5115

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I dose escalation trial of tremelimumab plus sunitinib in patients (pts) with metastatic renal cell carcinoma (mRCC).
  • Recent data show sunitinib reduces levels of myeloid-derived suppressor cells and prevents T-cell suppression in pts with mRCC.
  • CTLA4 blockade with tremelimumab is an immunotherapy that enhances T-cell activation and proliferation, and is associated with durable objective responses in metastatic melanoma.
  • In the SU 37.5 mg QD continuous cohorts, no DLTs were observed at 6 mg/kg tremelimumab (n = 3), 1 of 6 pts treated with 10 mg/kg tremelimumab in the protocol-defined cohort suffered sudden death, and 3 of 6 pts treated with 15 mg/kg tremelimumab + SU experienced DLTs, including: 1 pt with G3 acute renal failure and G3 lymphopenia, 1 pt with G3 elevated creatinine, and 1 pt with worsening G3 dyspnea.

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  • (PMID = 27964390.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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76. Golshayan AR, Elson P, Wood LS, Garcia JA, Dreicer R, Rini BI: Association of tumor burden characteristics with outcomes in patients (pts) with metastatic renal cell carcinoma (mRCC) treated with sunitinib. J Clin Oncol; 2009 May 20;27(15_suppl):5043

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association of tumor burden characteristics with outcomes in patients (pts) with metastatic renal cell carcinoma (mRCC) treated with sunitinib.
  • : 5043 Background: An important goal of non-curative therapy for mRCC is tumor burden (TB) control.
  • However, the impact of tumor burden characteristics on clinical outcome has not been studied in mRCC pts treated with VEGF-targeted therapy.
  • METHODS: Pts with clear-cell mRCC treated with sunitinib from June 1, 2004, to October 5, 2007, were retrospectively identified.
  • CT scan images were re-reviewed from baseline, at the time of maximal tumor burden shrinkage (TS), at time of disease progression and at time of last assessment prior to death.
  • Sites of metastases included: lung (87%), mediastinal lymph nodes (52%), retroperitoneal lymph nodes (36%), adrenal (29%), bone (38%), liver (22%), pancreas (14%), kidney (7%), and brain (6%).
  • In multivariable analysis, disease confined to above the diaphragm (p = 0.03) and total TB <13cm (p = 0.09) prior to sunitinib were independent positive predictors of PFS.
  • Total number of metastases <10 (p < 0.001) and tumor volume above the diaphragm <6.5 cm (p = 0.05) were independent positive predictors of OS.
  • At time of disease progression (PD), tumor location and pattern of progression were not associated with OS.
  • CONCLUSIONS: Tumor burden shrinkage and tumor burden at time of disease progression are associated with overall survival in pts with mRCC treated with sunitinib.

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  • (PMID = 27962954.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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77. Lee S, Baig M, Rusciano V, Gao Y, Malik S, Wiernik PH, Dutcher JP: Survival advantage in patients treated with high-dose interleukin-2 (HDIL2) for metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):e16039

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Survival advantage in patients treated with high-dose interleukin-2 (HDIL2) for metastatic renal cell carcinoma (mRCC).
  • : e16039 Background: A prognostic index developed at MSKCC(Memorial-Sloan-Kettering Cancer Center) relates to survival in mRCC patients (pts) treated with interferon.
  • Pts were categorized into favorable, intermediate & poor risk category according to MSKCC prognostic index, which includes time from diagnosis to treatment, serum calcium & LDH, hemoglobin and PS.

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  • (PMID = 27962947.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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78. Biagi JJ, Wong R, Brierley J, Rahal R, Ross J: Assessing compliance with practice treatment guidelines by treatment centers and the reasons for noncompliance. J Clin Oncol; 2009 May 20;27(15_suppl):e17506

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Assessing compliance with practice treatment guidelines by treatment centers and the reasons for noncompliance.
  • : e17506 Background: Cancer Care Ontario (CCO) is the chief advisor on cancer care to the government of Ontario, a province with a population of more than 12 million.
  • One of the many roles of CCO is to develop evidence based consensus-derived treatment practice guidelines for all major cancer types, through its Program in Evidence-based Care (PEBC).
  • To determine province-wide compliance with these guidelines, a pilot project assessed the proportion of patients with stage III colon cancer (CC) treated in concordance with the corresponding treatment guideline.
  • Initial results are made available to the regional cancer centers (RCC) in the province and to the public through web based Cancer Systems Quality Index (CSQI, http://www.cancercare.on.ca/qualityindex2007/ ).
  • METHODS: The guideline (http://www.cancercare.on.ca/pdf/pebc2-29s.pdf) states that patients with resected stage 3 CC will have adjuvant fluoropyrimidine-based chemotherapy within eight weeks of resection.
  • Patients at each of 11 RCC who presented in 2007/2008 with stage III CC and the proportion treated according to the guidelines were identified.
  • RESULTS: Across eight RCC with complete chart results to date 376 patients with stage 3 CC were identified, 244 (65%, range 47% to 72%) treated in concordance with the guideline, including 13% treated with capecitabine and 6% on clinical trials.
  • The reasons for non-concordance of the 132 remaining cases were: age and co morbid conditions 48 (13%), patient choice 36 (10%), referred for treatment outside the RCC system 16 (4%), stage incorrect and other 32 (9%).
  • CONCLUSIONS: Adjuvant chemotherapy treatment of stage III CC at the RCC across the Province of Ontario was concordant with the guideline in the majority of patients, and appropriate clinical reasons for non-compliance were identified.
  • Data from all 11 RCC will be presented along with concordance within the eight-week time frame stated in the guideline .

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  • (PMID = 27963242.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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79. Wolter P, Wildiers H, Vanderschueren D, Dumez H, Clement P, Schöffski P: Hypogonadism in male cancer patients treated with the tyrosine kinase inhibitors sunitinib (SUN) or sorafenib (SOR). J Clin Oncol; 2009 May 20;27(15_suppl):3565

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Hypogonadism in male cancer patients treated with the tyrosine kinase inhibitors sunitinib (SUN) or sorafenib (SOR).
  • SUN is approved for treatment of imatinib-resistant gastrointestinal stromal tumors (GIST) and metastatic renal cell carcinoma (RCC), SOR is used for RCC and hepatocellular carcinoma.
  • METHODS: Gonadal status (serum total testosterone (TT), free testosterone (FT), sex-hormone binding globulin (SHBG), luteinizing hormone (LH) and follicle-stimulating hormone (FSH) were evaluated in pts with RCC or GIST under SUN or SOR.
  • RESULTS: We identified 27 pts (median age 63, range: 27-77), for which data on gonadal function were available, 23 RCC (85 %), 4 GIST (15%), with 22 (85.5%) receiving SUN and 5 (18.5%) SOR.
  • CONCLUSIONS: We observed a high incidence of hypogonadism in male RCC and GIST pts under treatment with SUN or SOR.

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  • (PMID = 27961686.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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80. Wulfing C, Herrmann E, Trojan L, Schrader A, Becker F, Stähler M, Haferkamp A, Legal W, Brenner W, Hartmann A, German Papillary Renal Cancer Study Group: Independent validation of the 2002 UICC TNM staging system for papillary renal cell carcinoma in a multicenter cohort. J Clin Oncol; 2009 May 20;27(15_suppl):5092

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Independent validation of the 2002 UICC TNM staging system for papillary renal cell carcinoma in a multicenter cohort.
  • : 5092 Background: Papillary renal cell carcinoma (pRCC) is the second most malignant histologic subtype in nephrectomy specimens.
  • To date, the most recognized staging system to stratify renal cancer patients is the 2002 UICC TNM classification system.
  • The Kaplan-Meier method was used to derive the cumulative cancer-specific survival.
  • RESULTS: 498 (74.1%) patients had organ-confined tumor stages (≤pT2).
  • Synchronous distant metastases in the entire group occurred in 58 (8.7%) patients and 69 (11.2%) others developed metastatic disease during follow-up.
  • Cancer-specific survival (CSS) was significantly related to TNM stage and histologic grading in univariate as well as in multivariate analysis (all p < 0.0001).
  • 5-year CSS in pT1b tumors (90.0%) was significantly shorter compared to pT1a tumors (98.3%) (p = 0.017).
  • Patients with ≥pT3 were at high risk for metastases (50.6%), while metastatic disease associated with ≤pT2 tumors occurred in 7.8% (p < 0.0001).
  • Once metastatic disease was present, prognosis was poor (5-year CSS: 7.2%).
  • Age was associated with a worse prognosis in the subgroup of ≥pT3 tumors in univariate (p = 0.026), but not in multivariate analysis.
  • CONCLUSIONS: The 2002 UICC TNM staging system is applicable for pRCC.
  • Clinical and radiologic follow-ups should be offered in frequent intervals to patients with venous thrombus and/or locally advanced disease.
  • The role of age remains unclear, but should not be underestimated at risk stratification after tumor resection.

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  • (PMID = 27964296.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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81. Mouawad R, Comperat E, Spano JP, Izzedine H, Cajfinger F, Deray G, Capron F, Khayat D: Expression and circulating levels of lymphangiogenic parameters in renal cell cancer: Implication for antiangiogenic treatments. J Clin Oncol; 2009 May 20;27(15_suppl):e16144

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Expression and circulating levels of lymphangiogenic parameters in renal cell cancer: Implication for antiangiogenic treatments.
  • In renal cell cancer (RCC) lymphatic tumor spread exist but data focusing on lymphangiogenesis are rare.
  • Since the VEGF-C/VEGF-D/VEGFR-2, R-3 axis appears to be the signaling pathway for tumor-induced lymphangiogenesis and an attractive target for therapeutic intervention; we analyzed the expression and the presence of the soluble forms in 30 RCC patients and results were correlated with clinicopathological parameters.
  • METHODS: Tumor and sera from 30 RCC patients (20 clear cell (ccRCC)&10 papillary (pRCC) were included in this study.
  • The expressions of VEGFR-2,R-3 &VEGF-C,-D expressions on tumor were evaluated by immunohistochemestry.
  • Using ELISA assays, sVEGFR-2, R-3 &sVEGF-C,-D were measured in sera of RCC patients in comparison to 20 healthy controls.
  • RESULTS: In overall patients, a high expression of VEGF-C,-D and their receptors were observed in more than 55%of the patients as compared to the negative control.
  • Only median sVEGF- R3 level was significantly higher (p=0.005) in RCC patients as compared to healthy donors.
  • CONCLUSIONS: we showed that in RCC the lymphangiogenic factors are expressed or present as soluble form, a different expression pattern in ccRCC and pRCC existe.
  • Therefore, further studies are necessary to determine if lymphangiogenesis can play a role as a prognostic tool or a target for therapeutic intervention in renal cell carcinoma.

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  • (PMID = 27963428.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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82. Gyergyay F, Nagyványi K, Bodrogi I: Decreased toxicity schedule of suitinib in renal cell cancer: 2 weeks on/1 week off. J Clin Oncol; 2009 May 20;27(15_suppl):e16113

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Decreased toxicity schedule of suitinib in renal cell cancer: 2 weeks on/1 week off.
  • : e16113 Background: Sunitinib (SU) is an oral multitargeted tyrosine kinase inhibitor of VEGFRs, PDGFRs, KIT, FLT3, CSF-1R and RET approved for treatment of metastatic renal cell cancer (mRCC).
  • METHODS: Pts with mRCC, measurable disease, ECOG PS 0-2 received SU 50 mg po daily 4 weeks on/2 weeks off.
  • Objective response occurred: PR (13) 42%; CR (2) 5%; SD (9) 25%.

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  • (PMID = 27963329.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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83. Rixe O, Dutcher J, Motzer R, Wilding G, Stadler WM, Garrett M, Pithavala Y, Kim S, Tarazi J, Rini BI: Diastolic blood pressure (dBP) and pharmacokinetics (PK) as predictors of axitinib efficacy in metastatic renal cell cancer (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5045

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Diastolic blood pressure (dBP) and pharmacokinetics (PK) as predictors of axitinib efficacy in metastatic renal cell cancer (mRCC).
  • An 82% increase in probability of a partial response was predicted for a 10 mmHg higher dBP during therapy.

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  • (PMID = 27962952.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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84. Schwandt A, Garcia JA, Elson P, Wyckhouse J, Finke JH, Ireland J, Triozzi P, Zhou M, Dreicer R, Rini BI: A translational phase II trial of celecoxib plus interferon-alpha (IFN-α2b) in metastatic renal cell carcinoma (RCC) patients (pts) with 3+ COX-2 tumor immunostaining. J Clin Oncol; 2009 May 20;27(15_suppl):5116

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A translational phase II trial of celecoxib plus interferon-alpha (IFN-α2b) in metastatic renal cell carcinoma (RCC) patients (pts) with 3+ COX-2 tumor immunostaining.
  • : 5116 Background: Cyclooxygenase-2 (COX-2) has been correlated with RCC stage and grade, and overexpression can lead to dysregulation of dendritic cells (DC) and CD4+/CD25+/FOXP3+ regulatory T cells (Treg).
  • A previous trial of celecoxib in combination with IFNα2b in RCC (Rini et al, Cancer.
  • 2006) demonstrated an association between more intense COX-2 RCC tumor staining and clinical response.
  • METHODS: Pts with cytokine-naïve mRCC with at least 10% maximal COX-2 tumor staining received IFNα2b MU five times/week plus celecoxib 400 mg BID continuously.
  • Baseline tumor tissue was stained for COX-2, CD4+ and CD8+ T cells, Treg and DC (s100 and CD208).
  • Peripheral blood prostaglandin E2 (PGE2), DC and Treg number/function and intracellular T cell cytokine production were measured at baseline, at the end of cycles 2 and 4 and at end of treatment.
  • Immune parameters were analyzed using non-parametric methods.
  • The ORR was 21% and 69% of pts experienced tumor shrinkage.
  • Baseline 3+ COX-2 staining was associated with elevated peripheral blood PGE2 levels (p = 0.02), reduced DC IL-12 expression (p = 0.04) and reduction in IFN gamma-producing CD3+CD4+ T-cells (p = 0.04) compared to a control group of RCC pts with <10% 3+ COX-2 staining (n = 21).
  • No significant changes in immunomodulatory cells were observed with therapy.
  • COX-2 RCC tumor expression promotes an immunosuppressive phenotype.

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  • (PMID = 27964389.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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85. Sumiyoshi Y, Hashine K, Niwakawa M, Yamaguchi R, Fujii H, Hamamoto Y, Fukino K: Phase I trial of sorafenib in combination with interferon-alpha in Japanese patients with unresectable or metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16107

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I trial of sorafenib in combination with interferon-alpha in Japanese patients with unresectable or metastatic renal cell carcinoma.
  • : e16107 Background: Sorafenib (SOR) is a multi-kinase inhibitor, targeting Raf kinase and the receptor tyrosine kinases VEGFR-2 and PDGFR-β.
  • Interferon-α (IFN) is most commonly used for metastatic renal cell carcinoma (RCC) in Japan.
  • In this phase I study, we investigated the safety profile, pharmacokinetics (PK), and tumor response of SOR/(recombinant)IFN combination in Japanese patients (pts) with RCC.
  • METHODS: After 2 weeks of IFN-alone treatment, a total of 18 pts (6 in each cohort) with unresectable/metastatic RCC received 28-day cycles of continuous SOR 200 (Cohort 1 [C1]) or (Cohorts 2 and 3 [C2 and C3]) 400 mg bid combined with intramuscular IFN 6 (C1 and C2) or 9 (C3) MIU three times a week (tiw).
  • Objectives were safety/tolerability and recommended dose of SOR/IFN as primary, and tumor response and PK as secondary.
  • Common drug-related grade 3/4 adverse events (AEs) included fatigue (50%), lipase increased (44%) and neutropenia (39%), all of which were reversible and manageable.
  • It seemed attributable to DIC accompanied by RCC.
  • Five PR (1 in C1 and 4 in C3) and 11 SD (4 in C1, 5 in C2, and 2 in C3) were achieved as the best response.
  • CONCLUSIONS: SOR/IFN combination has promise for clinical benefit in RCC, and its recommended dose was continuous SOR 400 mg bid and IFN 6 MIU tiw.

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  • (PMID = 27963330.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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86. Wosnitzer M, Lee DJ, Hirsch AJ, McKiernan JM: Predictors of renal function in nephron sparing surgery for renal cell carcinoma in solitary kidneys. J Clin Oncol; 2009 May 20;27(15_suppl):e16045

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Predictors of renal function in nephron sparing surgery for renal cell carcinoma in solitary kidneys.
  • : e16045 Background: Partial nephrectomy (PN) is an effective option for the treatment of renal cell carcinoma (RCC) in patients who need to preserve renal function.
  • However, the oncologic safety and functional outcome after PN in solitary kidneys have not been fully examined.
  • We assessed the outcomes after PN, and evaluated predictors of post-operative renal function.
  • METHODS: A retrospective analysis of the Columbia Urologic Oncology database found 1327 patients were treated for RCC from 1988 - 2008, of whom 38 consecutive patients underwent PN on a solitary kidney.
  • Glomerular filtration rate (GFR) was estimated with the Modification of Diet in Renal Disease (MDRD) equation.
  • Severe chronic kidney disease (CKD) and renal failure were defined as GFR of 15-30 cc/min/1.73m2 and GFR<15, respectively.
  • RESULTS: The study group included 30 men and 8 women with unilateral RCC.
  • The mean estimated blood loss was 465cc, the mean tumor diameter was 3.9cm, and 6 (17%) of the patients had a positive surgical margin.
  • 9 patients (30%) had recurrence of RCC at a mean of 23 months postoperatively.
  • Recurrence occurred in the kidneys of 4 patients, lung in 3 patients, bone in 3 patients, and the ipsilateral adrenal gland in one patient.
  • Preoperative GFR (HR=1.01, p<0.01) and the volume of kidney removed (HR=0.93, p=0.01) were associated with severe CKD and renal failure on a univariate Cox regression analysis, but were not independent predictors after adjusting for age, race, tumor stage and grade.
  • Preoperative GFR, volume removed, age, tumor stage or grade were not independent predictors of RCC recurrence.
  • CONCLUSIONS: PN in solitary kidneys pose difficult challenges for surgical and clinical management.
  • Nephron sparing surgery for the treatment of RCC is feasible with acceptable morbidity and renal function outcome.
  • The volume of renal parenchyma removed and the preoperative GFR are associated with renal function loss several months after surgery, and may be useful in predicting long-term renal function.

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  • (PMID = 27963019.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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87. Sgambato A, Camerini A, De Luca F, Valsuani C, Siclari O, Genovese G, Boninsegna A, Cecchi M, Cittadini A, Amoroso D: Expression of the CDK inhibitor p27&lt;sup&gt;kip1&lt;/sup&gt; and oxidative DNA damage in renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16008

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Expression of the CDK inhibitor p27<sup>kip1</sup> and oxidative DNA damage in renal cell carcinoma.
  • : e16008 Background: Deregulation of the normal cell cycle is a frequent event in human tumors and plays an important role in malignant transformation. p27<sup>kip1</sup> is a negative regulator of the G1 phase, is frequently lost in tumor cells and, in some cases, its alteration is coupled with oxidative DNA damage.
  • METHODS: We evaluated the expression of p27<sup>kip1</sup> and the extent of endogenous oxidative DNA damage (by means of 8-hydroxydeoxyguanosine [8-OHdG] levels) by immunostaining in a series of 125 (median age 64[range23-86]yrs) renal cell carcinomas (RCCs); furthermore, the prognostic significance of their alterations was tested.
  • Median values of expression were used as cut-off. p27<sup>kip1</sup> expression was also evaluated by Western Blot in a second series of 34 fresh-frozen RCCs.
  • RESULTS: to date, median follow-up is 29[range 4 - 104] months. p27<sup>kip1</sup>expression was lost in a significant fraction of tumors (55%) with a median percentage of positive cells of 20% [range 0-60%).
  • Loss of p27<sup>kip1</sup> staining correlated with higher tumor grade (p=0.049).
  • Recurrence (p=0.007) and death (p=0.006) from RCCs were significantly more frequent in patients p27<sup>kip1</sup>-negative compared with positive ones.
  • Kaplan-Meier analysis showed a significant separation between high vs low p27<sup>kip1</sup> expression groups for both disease-free (p=0.011) and overall (p=0.002) survival.
  • At multivariate analysis, loss of p27<sup>kip1</sup>expression was the only independent risk predictor for recurrence (HR=4.326, p=0.014) and death (HR=4.915, p=0.012) from RCCs when tumor size, tumor grade and stage were included.
  • CONCLUSIONS: loss of p27<sup>kip1</sup> is frequent in human RCCs and is a powerful predictor of poor outcome. p27<sup>kip1</sup> alteration are not related to endogenous oxidative DNA damage.

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  • (PMID = 27962927.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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88. Wood CG, Srivastava P, Lacombe L, Gorelov AI, Gorelov S, Mulders P, Zielinski H, Teofilovici F, Isakov L, Escudier B: Survival update from a multicenter, randomized, phase III trial of vitespen versus observation as adjuvant therapy for renal cell carcinoma in patients at high risk of recurrence. J Clin Oncol; 2009 May 20;27(15_suppl):3009

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Survival update from a multicenter, randomized, phase III trial of vitespen versus observation as adjuvant therapy for renal cell carcinoma in patients at high risk of recurrence.
  • : 3009 Background: Vitespen (formerly HSPPC-96) is a novel, autologous, heat shock protein (gp96)-peptide complex vaccine.
  • The survival registry is investigating long-term efficacy of vitespen in renal cell carcinoma (RCC) patients at high risk for recurrence postnephrectomy.
  • Patients randomized in C-100-12 (1:1, vitespen vs. observation) had AJCC stage I (T1b), II (≥5 cm; Fuhrman grade 3/4), stage III, or stage IV (M0) RCC, ≥25% clear cells, ECOG performance score 0/1 and ≥7 g viable tumor tissue for vaccine production.
  • Descriptively, updated OS data show a favorable trend in the vitespen arm vs. observation in all analysis sets, especially among patients with earlier-stage disease (stage I/II high grade; n = 118) or at intermediate risk for recurrence (stage I/II high grade, III T1, T2, T3a, low grade; n = 184 ), with 13/125 (10.4%) vs. 21/115 (18.3%), and 18/184 (9.8%) vs. 33/178 (18.5%) deaths reported in the vitespen and observation arms, respectively.
  • CONCLUSIONS: The registry provides an opportunity to confirm whether the emerging survival advantage demonstrated at the data cutoff for the C-100-12 trial improves with prolonged follow-up.

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  • (PMID = 27962044.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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89. Bellmunt J, Trigo J, Calvo E, Carles J, Perez-Gracia J, Rubió J, Virizuela J, López R, Lázaro M, Albanell J: Activity of a multitargeted, metronomic, and maximum-tolerated dose "chemo-switch" regimen in metastatic renal cell carcinoma (mRCC): A phase II study of sorafenib, gemcitabine (Gem), and metronomic capecitabine (Cap) in patients with advanced mRCC (SOGUG-02-06). J Clin Oncol; 2009 May 20;27(15_suppl):5040

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Activity of a multitargeted, metronomic, and maximum-tolerated dose "chemo-switch" regimen in metastatic renal cell carcinoma (mRCC): A phase II study of sorafenib, gemcitabine (Gem), and metronomic capecitabine (Cap) in patients with advanced mRCC (SOGUG-02-06).
  • : 5040 Background: Maximal tolerated dose (MTD) chemotherapy followed by metronomic chemotherapy (low doses administered on a frequent schedule) acts on tumor vascular endothelial cells and enhances the antitumor effect of anti-angiogenic agents (Pietras et al.
  • Study endpoints included median progression-free survival (PFS, primary endpoint), disease control rate according to Response Evaluation Criteria in Solid Tumors, and safety.
  • Among 36 evaluable patients, 17 (47%) had a partial response and 17 (47%) achieved stable disease.
  • The most common adverse events (AEs) were fatigue/asthenia (78%) hand-foot syndrome (75%) and mucositis (69%).

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  • (PMID = 27962942.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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90. Wiederkehr D, Casciano R, Stern L, Zheng J, Baladi J: Therapeutic care in metastatic renal cell carcinoma during the follow-up phase of the RECORD-1 phase III trial. J Clin Oncol; 2009 May 20;27(15_suppl):e17531

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Therapeutic care in metastatic renal cell carcinoma during the follow-up phase of the RECORD-1 phase III trial.
  • : e17531 Background: Following drug discontinuation for progression or adverse event in a clinical trial for relapsed or stage IV kidney cancer, supportive care including surgery, palliative radiotherapy, or bisphosphonates continue to be recommended by National Comprehensive Cancer Network (NCCN).
  • METHODS: World Health Organization Anatomical Therapeutic Chemical codes or therapeutic names, captured from the follow-up phase in a phase III clinical trial (RECORD-1) of patients with metastatic renal cell carcinoma (mRCC) patients, were used to describe antineoplastic therapies following discontinuation of study drug.
  • While the placebo control with supportive care in a double-blind phase is acceptable to evaluate the efficacy and safety of a therapy for regulatory approval purposes, decision makers must also consider how these data may inform comparisons with the usual alternatives available to and used by physicians and patients in the non-trial setting.

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  • (PMID = 27963810.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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91. Choueiri TK, Regan M, Oh W, Clement J, Amato A, McDermott D, Cho D, Atkins M, Signoretti S: Prognostic and predictive values of carbonic anhydrase IX (CAIX) and pathologic features in patients with metastatic clear cell renal cell carcinoma receiving targeted therapy. J Clin Oncol; 2009 May 20;27(15_suppl):e16067

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic and predictive values of carbonic anhydrase IX (CAIX) and pathologic features in patients with metastatic clear cell renal cell carcinoma receiving targeted therapy.
  • : e16067 Background: Tumor Carbonic Anhydrase IX (CAIX) expression and histologic features can predict outcome in patients with metastatic renal cell carcinoma (mRCC) treated with immunotherapy.
  • METHODS: We identified 118 patients with mRCC initiating first- line VEGF-targeted therapy including 94 with clinical data, clear cell histology and available tissue.
  • Tumors were evaluated for specific histologic features and for CAIX expression by immunohistochemistry using the MN75 antibody.
  • The relationship between these pathology findings and tumor shrinkage and other treatment outcomes was assessed.
  • RESULTS: Higher tumor clear cell component was independently associated with greater tumor shrinkage (p=0.02), response (p=0.02) and treatment duration (p=0.02).
  • Patients with high vs. low tumor CAIX expression had mean tumor shrinkages of -12% vs. -5%, respectively (p=.38).
  • There was heterogeneity in tumor responsiveness to sunitinib or sorafenib according to CAIX status (p=0.055 for interaction): mean shrinkage was -17% vs. -25% (mean difference +8%, 95% CI -14% to +31%) for sunitinib-treated patients with high vs. low tumor CAIX expression compared to -13% vs. +9% (mean difference -22%, 95% CI -42% to -1%) for sorafenib-treated patients.
  • CONCLUSIONS: Patients with higher clear cell component in their tumors are likely to experience superior clinical benefit from VEGF-targeted therapy.
  • Although CAIX expression was not found to be of prognostic value in patients with clear cell mRCC treated with VEGF-targeted therapy, it may be a predictive biomarker for response to sorafenib treatment.

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  • (PMID = 27963063.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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92. Francesca F, Pomara G, Campo G, Casale P: Elective open nephron-sparing surgery for renal masses: Single-center experience with 223 consecutive patients. J Clin Oncol; 2009 May 20;27(15_suppl):e16139

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Elective open nephron-sparing surgery for renal masses: Single-center experience with 223 consecutive patients.
  • : e16139 Background: To present our experience with elective, open, nephron-sparing surgery for renal masses in a contemporary, consecutive series.
  • The preoperative workup included laboratory analysis, renal ultrasonography and abdominal computed tomography.
  • The mean tumor size was 4.6 cm (1.1-12cm).
  • 52 patients presented renal masses > 4cm.
  • Renal cell carcinoma was present in 177 patients (76.6%), benign renal masses were diagnosed in in 54 pazienti (23.3%): angiomyolipoma (35%), oncocytoma (40%), complicated cyst (25%).
  • Worthy of note among these 54 patients, pre-operative diagnosis was present in 12 patients.
  • After a median follow-up of 84 months (range 5 to 120), no patient had developed local recurrence, 19 (8.9%) died for other causes, 2 (0.9%) died for other tumor.
  • CONCLUSIONS: The results of this contemporary, monocenter experience underline the role of open, elective, nephron-sparing surgery for patients with renal masses, confirming good results even for renal masses > 4cm.

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  • (PMID = 27963354.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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93. Johnson ED, Tannir NN, Olejeme KA, Logothetis CJ, Jonasch E: Survival benefit in bevacizumab-based therapy in sickle cell trait patients diagnosed with renal medullary carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16096

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Survival benefit in bevacizumab-based therapy in sickle cell trait patients diagnosed with renal medullary carcinoma.
  • : e16096 Background: Renal medullary carcinoma (RMC) is an epithelial malignant tumor arising from collecting duct epithelium.
  • The tumor is almost exclusive to young black patients with the sickle cell hemoglobinopathies, primarily sickle cell trait.
  • This is a rare and highly aggressive tumor that is shown to be most resistant to chemotherapy.
  • Anderson Cancer Center for patient diagnosed between 1999-2008 with histology proven RMC.
  • In addition, detailed chemotherapy regimen as well as medical and radiological data were also obtained.
  • RESULTS: All patients had metastatic disease (stage IV) to at least one distant site at presentation.
  • CONCLUSIONS: Sickle cell trait was confirmed for all in this group diagnosed with RMC.
  • Future studies, including genetic studies on the tumor types are essential to determining the SNP profiles of renal cell carcinoma in black patients.
  • Furthermore, a prospective multicenter trial should be developed to evaluate the efficacy of bevacizumab based regimens in renal medullary carcinoma in this population.

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  • (PMID = 27963088.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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94. Atkinson B, Hart J, Lin E, Tannir N, Jonasch E: Patient characteristics associated with dose-limiting sunitinib adverse events. J Clin Oncol; 2009 May 20;27(15_suppl):e16110

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e16110 Background: Sunitinib, an inhibitor of multiple tyrosine kinases, is FDA approved for metastatic renal cell cancer (mRCC).
  • We sought to identify 1) baseline patient (pt) characteristics that predispose for DM, 2) the most common AEs requiring DM in a non-protocol setting, and 3) the impact of dose limiting AEs on treatment continuation.
  • METHODS: Single-center, retrospective chart review.
  • Pts ≥ 18 years of age with mRCC of clear-cell histology on sunitinib therapy with active follow-up at MDACC were eligible.
  • By univariate analysis, increased age (p=0.04; OR 1.04, 1.002-1.081 CI) and elevated BUN (p=0.03; OR 1.06, 1.006 -1.108 CI) were directly associated with increased incidence of dose-limiting AEs.
  • In a multivariate analysis, only BUN remained significant.
  • DM were often attributed to multiple AEs (55%), with fatigue, mucositis, hand-foot syndrome and nausea being the most common.
  • CONCLUSIONS: Elevated baseline BUN is associated with an increased rate of DM in patients with RCC receiving sunitinib.

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  • (PMID = 27963325.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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95. Wood L, Garcia JA, Elson P, Salas RN, Lane BR, Klein E, Stephenson A, Dreicer R, Campbell SC, Rini BI: Sunitinib in patients (pts) with unresectable primary renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5096

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Sunitinib in patients (pts) with unresectable primary renal cell carcinoma (RCC).
  • : 5096 Background: Sunitinib inhibits VEGF and related receptors, with high tumor shrinkage rates in metastatic (met) RCC.
  • Shrinkage of primary tumors has been observed, although prospective investigation is lacking.
  • The ability of sunitinib to convert primary RCC tumors from unresectable to resectable is of high clinical interest.
  • METHODS: Pts with histologically-confirmed RCC with an unresectable primary tumor with or without met disease were enrolled on a single-arm phase II trial.
  • Primary tumors were unresectable due to ≥ 1 of the following: large tumor size, bulky lymphadenopathy, encasement of renal vessels, IVC thrombosis or proximity to vital structures.
  • A Simon 2-stage design was employed to test the alternative hypothesis of a conversion to resectability rate of 20% versus the null hypothesis of 5%; β = 0.8, α = 0.05 (n = 31).
  • RESULTS: 18 pts have been enrolled; 1 excluded due to a non-RCC diagnosis.
  • Pts were unresectable due to bulky lymphadenopathy (6), IVC thrombosis (4), proximity to vital structures (4) or tumor size (3), although most pts had multiple factors.
  • Median age among 14 evaluable pts was 61 years (range, 37-80), 59% male, 76% ECOG PS 0; 79% had distant met disease.
  • Three pts (21%) have undergone primary tumor resection; viable RCC was identified in all specimens with no unexpected surgical morbidity.
  • Nine pts (53%) had primary tumor reduction (median 19%; range, -64% to -1%).
  • Overall, median best % change in tumor burden was 4.9% reduction for primary tumors (range, -43.1% to +8.5%) and 10.7% reduction for met sites (range, -89.5% to +28.6%).
  • Eleven pts (79%) discontinued therapy; 8 for PD, 1 for adverse events and 2 following surgery which removed all visible disease.
  • CONCLUSIONS: Sunitinib has activity in unresectable primary RCC tumors, permitting resection in some pts.

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  • (PMID = 27964292.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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96. Quinn D, Barghout V, Moyneur E: Medical costs of sorafenib compared with sunitinib in treatment of patients &lt;65 years with renal cell carcinoma: A retrospective claims database analysis. J Clin Oncol; 2009 May 20;27(15_suppl):e17536

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Medical costs of sorafenib compared with sunitinib in treatment of patients <65 years with renal cell carcinoma: A retrospective claims database analysis.
  • : e17536 Background: Sorafenib (SR) and sunitinib (SU) are FDA approved (12/05 and 1/06, respectively) tyrosine kinase inhibitors for patients (pts) with advanced renal cell carcinoma (RCC).
  • Given differences between private and public insurer payment scales, pts ≥65 y were not included in this study but are the subject of a planned further analysis.
  • Inclusion criteria were ≥2 RCC claims (ICD-9 189.0, 198.0), continuous health care coverage, >180 days of coverage before RCC diagnosis.
  • SR and SU pts were identified based on oral therapy after initial RCC-related claim (intent-to-treat).
  • Univariate and multivariate Tobit analyses were conducted; control factors included age, sex, region, plan type, comorbidity, prior Tx/procedures, and time since RCC Dx.
  • RESULTS: Of 10,462 RCC pts identified, 144 and 220 received initial therapy with SR and SU, respectively.
  • In the 180 days before RCC diagnosis, total direct medical costs, baseline demographics, and comorbidities were similar between groups.
  • CONCLUSIONS: Retrospective analysis of this US claims database for RCC pts <65 treated first with SR showed statistically significant lower total medical costs (particularly inpatient costs) than for pts treated first with SU.

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  • (PMID = 27963796.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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97. Procopio G, Verzoni E, Bracarda S, Ricci S, Sacco C, Ridolfi L, Porta C, Miceli R, Zilembo N, Bajetta E, ITMO Study Group: A randomized, open label, prospective study comparing the association between sorafenib (So) and interleukin-2 (IL-2) versus So alone in advanced untreated renal cell cancer (RCC): Rosorc Trial. J Clin Oncol; 2009 May 20;27(15_suppl):5099

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A randomized, open label, prospective study comparing the association between sorafenib (So) and interleukin-2 (IL-2) versus So alone in advanced untreated renal cell cancer (RCC): Rosorc Trial.
  • : 5099 Background: So is an orally active multikinase inhibitor with a well documented activity in advanced RCC.
  • METHODS: In this multicenter, randomized, open label, phase II study, 128 previously untreated metastatic RCC patients (pts) were randomized to receive 400 mg of So, orally given twice daily continuously, in combination with IL-2, 4.5 MIU administered subcutaneously, five times a week for six consecutive weeks any eight weeks (arm A), or So alone (arm B) at the same dose.
  • Therapy continued until progression of disease or unacceptable toxicity.
  • Eligible pts had histological diagnosis of RCC, ECOG 0-2, no brain metastases, measurable disease and any Motzer's score.
  • Response rates (all partial responses, PR) were 23 % and 10 % in arm A and B respectively.
  • Overall disease control rates (PR + stable disease SD) were 81 % versus 74 %.
  • Tumour shrinkage was reported in 52 % and 34 % of arm A and B therapies respectively.
  • The most common adverse events (AEs) were asthenia, hand foot syndrome, hypertension, fever, diarrhoea and mucositis.
  • CONCLUSIONS: The safety and efficacy data suggest that the association So + IL-2 is safe and feasible and, compared to So alone, improves tumour shrinkage, disease control rate and PFS.

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  • (PMID = 27964308.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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98. Billemont B, Hornecker M, Ropert S, Blanchet B, Jais J, Blanchard P, Meric J, Alexandre J, Tod M, Goldwasser F: Correlation of sorafenib plasma concentrations and clinical toxicity: A prospective population pharmacodynamic and pharmacokinetic study. J Clin Oncol; 2009 May 20;27(15_suppl):e14585

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e14585 Background: Sorafenib is an angiogenesis inhibitor recently approved for the treatment of metastatic renal cell carcinoma and hepatocarcinoma.
  • Toxicity events were graded according to National Cancer Institute Common Toxicity Criteria 3.0.
  • RESULTS: Pts (23 males), ECOG 0-1 (27 pts), median age 62.8 years (range 37-78), with metastatic hepato-carcinoma (11), melanoma (6), thyroid cancer (8), renal cell carcinoma (7), received a median treatment duration of 94 days (range : 7-330).

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  • (PMID = 27963746.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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99. Hug B, Boni J, Leister C, Burns J, Sonnichsen D: A single-dose, placebo- and moxifloxacin-controlled 3-period study of the effects of temsirolimus on cardiac repolarization in healthy subjects. J Clin Oncol; 2009 May 20;27(15_suppl):2551

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 2551 Background: Temsirolimus (CCI-779) is a novel selective inhibitor of the mammalian target of rapamycin (mTOR) approved by the US FDA for the treatment of patients with advanced renal cell carcinoma.
  • This study was designed to assess the effect of a single dose of 25 mg IV temsirolimus on the corrected QT interval (QTc) in healthy subjects.
  • At 11 of 12 secondary time points, the upper bound for the temsirolimus QTc 90% CIs for the time-matched change from baseline difference from placebo was less than 10 msec without evidence of QTc trends or relationship to temsirolimus or sirolimus whole blood concentrations.
  • Mean concentrations were comparable to those observed in patients with renal cell carcinoma following administration of 25 mg IV temsirolimus.
  • The findings are consistent with the lack of QTc interval prolongation observed in studies of cancer patients.

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  • (PMID = 27961877.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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100. Naito S, Eto M, Shinohara N, Tomita Y, Fujisawa M, Namiki M, Nishikido M, Usami M, Tsukamoto T, Akaza H: A phase II study of S-1 for the treatment of cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5100

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II study of S-1 for the treatment of cytokine-refractory metastatic renal cell carcinoma.
  • The purpose of this study was to evaluate the efficacy and safety of S-1 in cytokine-refractory metastatic renal cell carcinoma (mRCC), and to examine the relation between response and mRNA expression levels of 5-FU-related enzymes.
  • METHODS: Eligible patients had a histologically confirmed diagnosis of clear cell or papillary type of RCC, measurable lesions, treatment histories with cytokines, an ECOG performance status of 0 or 1 (2 was allowed in patients with bone metastasis), an age of at least 20 years, prior nephrectomy, and adequate organ functions.
  • The most common grade 3-4 adverse events assessed according to the CTCAE v.3.0 included anemia (6.7%), neutropenia (8.9%), anorexia (8.9%), hyperglycemia (6.7%), stomatitis (4.4%), diarrhea (4.4%), and fatigue (4.4%).
  • Measurement of the mRNA level of 5-FU-related enzyme in tumors before treatment may facilitate prediction of the response to S-1.

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  • (PMID = 27964380.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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