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1. Fernández Rivera C, Alonso Hernández Á, Mosquera Reboredo J, Rodríguez Gómez I: Association of bladder adenocarcinoma and BK virus infection in a pancreatico-renal transplant recipient. NDT Plus; 2010 Jun;3(3):300-302
NCI CPTC Antibody Characterization Program. NCI CPTC Antibody Characterization Program .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association of bladder adenocarcinoma and BK virus infection in a pancreatico-renal transplant recipient.
  • Viral infection has been related to post-transplantation tumour development, particularly Epstein-Barr virus, human papillomavirus, hepatitis B and C viruses, and herpes virus 8.
  • Recently, BK virus (BKV) has emerged as an important cause of tumour formation in solid organ transplant recipients.
  • BKV oncogenic potential relates to the ability to inactivate the functions of tumour suppression proteins p53 and pRB family, and induction of chromosomal aberrations.
  • We report a case of urinary bladder adenocarcinoma in a pancreatico-renal transplant recipient which was diagnosed 2 years after BKV infection.
  • Immunohistochemical staining for SV-40 was positive in neoplastic cells but negative in non-neoplastic cells.

  • NCI CPTAC Assay Portal. NCI CPTAC Assay Portal .
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  • [Cites] Pediatr Transplant. 2008 Aug;12(5):600-5 [18652620.001]
  • [Cites] Oncogene. 2006 May 4;25(19):2727-35 [16547506.001]
  • [Cites] Transplantation. 2008 Apr 15;85(7 Suppl):S42-8 [18401263.001]
  • [Cites] NDT Plus. 2009 Jun;2(3):246-9 [25984002.001]
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  • [Cites] Transplantation. 2002 Jun 27;73(12):1933-6 [12131691.001]
  • (PMID = 28657060.001).
  • [ISSN] 1753-0784
  • [Journal-full-title] NDT plus
  • [ISO-abbreviation] NDT Plus
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Keywords] NOTNLM ; BK virus / kidney transplantation / renal transplantation / urinary bladder neoplasms
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2. Chaudry Q, Raza SH, Sharma Y, Young AN, Wang MD: Improving Renal Cell Carcinoma Classification by Automatic Region of Interest Selection. Proc IEEE Int Symp Bioinformatics Bioeng; 2008 Oct;2008

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Improving Renal Cell Carcinoma Classification by Automatic Region of Interest Selection.
  • In this paper, we present an improved automated system for classification of pathological image data of renal cell carcinoma.
  • The task of analyzing tissue biopsies, generally performed manually by expert pathologists, is extremely challenging due to the variability in the tissue morphology, the preparation of tissue specimen, and the image acquisition process.
  • In continuation of our previous work, which proposed a knowledge-based automated system, we observe that real life clinical biopsy images which contain necrotic regions and glands significantly degrade the classification process.

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  • (PMID = 28393153.001).
  • [Journal-full-title] Proceedings. IEEE International Symposium on Bioinformatics and Bioengineering
  • [ISO-abbreviation] Proc IEEE Int Symp Bioinformatics Bioeng
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / U54 CA119338
  • [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. 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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6. 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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7. 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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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
MedlinePlus Health Information. consumer health - Kidney Cancer.

  • [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. 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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12. Zigeuner R, Hutterer G, Chromecki T, Rehak P, Pummer K: Macroscopic versus microscopic vascular tumour invasion in patients with clear cell renal cell carcinoma: Does it make a difference? J Clin Oncol; 2009 May 20;27(15_suppl):5093

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Macroscopic versus microscopic vascular tumour invasion in patients with clear cell renal cell carcinoma: Does it make a difference?
  • : 5093 Background: We evaluated the prognostic impact of macroscopic vs. microscopic vascular invasion on metastasis-free survival in a large European single centre series of patients with RCC over a period of 23 years.
  • METHODS: The pathology reports of 2333 consecutive patients operated between 01/1984 and 12/2006 were re-evaluated with regard to histological subtype, pT categories (TNM 2002), tumor grade, lymph node status, tumor size, presence of necrosis, and vascular invasion (defined as either absent, microscopic, or macroscopic).
  • Only patients with unilateral clear cell (CC)-RCC and no distant metastases at operation were included.
  • RESULTS: Out of 1797 CC-RCC-patients fulfilling the selection criteria, 1754 (97.6%) with complete data including follow-up were evaluated.
  • Microscopic and macroscopic invasion was noted in 99 (5.6%) and 278 (15.8%) tumours, respectively.
  • Multivariate analysis proved pT-categories, grade, node status, size, necrosis and overall vascular invasion (p < 0.0001; RR = 2.09, 95%CI = 1.46-2.98) as independent predictors of metastatic disease.
  • Microscopic invasion was an independent predictor of metastatic disease, whereas macroscopic invasion which is directly related to categories pT3b/c was not.
  • Vascular invasion should be considered in prognostic models for patients with RCC.

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  • (PMID = 27964295.001).
  • [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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13. 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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14. 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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15. 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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16. Ravaud A, Oudard S, Gravis-Mescam G, Sevin E, Zanetta S, Théodore C, de Fromont M, Mahier-Aït Oukhatar C, Chêne G, Escudier B: First-line sunitinib in type I and II papillary renal cell carcinoma (PRCC): SUPAP, a phase II study of the French Genito-Urinary Group (GETUG) and the Group of Early Phase trials (GEP). J Clin Oncol; 2009 May 20;27(15_suppl):5146

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] First-line sunitinib in type I and II papillary renal cell carcinoma (PRCC): SUPAP, a phase II study of the French Genito-Urinary Group (GETUG) and the Group of Early Phase trials (GEP).
  • : 5146 Background: Sunitinib (Su) has been approved in metastatic clear cell carcinoma due to high objective response rates (ORR) and a prolonged progression-free survival (PFS).
  • Type I and II papillary RCC pts have a poor prognosis, with limited effective agents.
  • METHODS: SUPAP is a single-arm prospective study using a 2-stage design including 21 patients (pts) to achieve a 20% ORR and if ≥ 2 pts have an OR, 20 additional pts will be included.
  • Main eligibility criteria included type I or II PRCC confirmed by central pathological review, PS 0-1, measurable disease, first line of treatment.
  • Using the MSKCC scoring system : 5, 14 and 4 pts were in the favorable, intermediate or poor risk group, 4 undetermined.
  • In type II PRCC, 1/23 pts had a partial response (PR), 13/23 pts had a stable disease (SD) with 4 pts with a SD ≥ 12 weeks, 5/23 pts were progressive, 3/23 pts were too early for evaluation and 1/23 was not evaluable.
  • In type I PRCC, none had a partial response (PR), 3/5 pts had stable disease (SD) and 2/5 pts were too early for evaluation.
  • Toxicity of sunitinib was similar as reported in pivotal phase III with Su in metastatic RCC.
  • 12 pts required a dose reduction at any time mainly for non-hematologic toxicities.
  • CONCLUSIONS: Although some activity has been observed, response rate was lower than in clear cell tumors.

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  • (PMID = 27964444.001).
  • [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. Sahi C, Knox JJ, Hinder V, Deva S, Cole D, Clemons M, Broom RJ: The effects of sorafenib and sunitinib on bone turnover markers in patients with bone metastases from renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16145

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The effects of sorafenib and sunitinib on bone turnover markers in patients with bone metastases from renal cell carcinoma.
  • : e16145 Background: Bone metastases (BM) from renal cell carcinoma (RCC) are common and associated with poor outcomes.
  • While the multi-tyrosine kinase inhibitors (TKI's) sunitinib and sorafenib have advanced the treatment of metastatic RCC, their efficacy on BM is unknown.
  • In this pilot biomarker study we sought to prospectively evaluate the effects on BM of these multi-TKI's in RCC patients.
  • METHODS: Eligible patients had advanced RCC, at least one BM evident on imaging and no bisphosphonate exposure within 4 weeks.
  • The primary endpoint was the percentage change (Ch) in uNTX levels from baseline.
  • CONCLUSIONS: In patients with BM from RCC and at least moderately elevated uNTX levels at baseline, these multi-TKI's show a significant trend to decrease uNTX levels, but perhaps not as effectively as bone-specific therapies (e.g. bisphosphonates) do in other malignancies.
  • This pilot data raises questions about the activity of the multi-TKI's in BM from RCC and further research is needed.

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  • (PMID = 27963429.001).
  • [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. Bregni M, Bernardi M, Servida P, Pescarollo A, Crocchiolo R, Treppiedi E, Corradini P, Ciceri F, Peccatori J: Long-term follow-up of metastatic renal cancer patients undergoing reduced-intensity allografting. J Clin Oncol; 2009 May 20;27(15_suppl):7037

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term follow-up of metastatic renal cancer patients undergoing reduced-intensity allografting.
  • : 7037 Background: Stem cell transplantation from a HLA-compatible sibling donor is an adoptive immunotherapy for cytokine-refractory, metastatic clear-cell renal cell cancer (RCC).
  • METHODS: Twenty-five RCC patients (Table) received a reduced-intensity allograft from an HLA-identical sibling donor after a thiotepa, fludarabine, and cyclophosphamide conditioning regimen, and a cyclosporine-based GVHD prophylaxis.
  • Allogeneic peripheral blood hematopoietic cells were collected by apheresis after filgrastim treatment of the donor.
  • RESULTS: Best response to allograft was evaluable in 24 patients: 1 complete remission, 4 partial remissions, 12 minor response or stable disease, 7 progressive disease.
  • Cause of death was infection in four cases, GVHD in one case, and acute renal failure in one case.
  • Fourteen patients died for progressive disease at median 415 (36-958) days from transplant.
  • At a median observation time of 65 months, 5 patients are alive, one in CR, one in PR, and three with stable disease.
  • At multivariate analysis, CRP value before transplant, number of CD34+ infused cells and disease status at +90 significantly correlated with survival.
  • CONCLUSIONS: Transplantation is able to induce long-term disease control in a fraction (20%) of relapsed RCC patients.

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  • (PMID = 27961411.001).
  • [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. 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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20. 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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21. Hawkins RE, Hong SJ, Ulys A, Rolski J, Hong B, Sternberg C: An open-label extension study to evaluate safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5110

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] An open-label extension study to evaluate safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).
  • : 5110 Background: The efficacy and safety of pazopanib (paz), a multikinase angiogenesis inhibitor, was evaluated in a randomized, double-blind placebo-controlled phase III study (VEG105192), in treatment-naïve and cytokine-pretreated patients (pts) with advanced RCC.
  • Pts with progressive disease (PD) on placebo had the option to receive paz 800 mg QD via an extension study (VEG107769).
  • RR was described along with 95% confidence intervals (CIs).
  • PFS was summarized descriptively using Kaplan-Meier estimates for the median, quartiles and PFS rates at 6, 12, and 18 mo along with approximate 95% CIs.
  • The most common AEs were hypertension (46%; 4% Gr 3/4), hair color changes (39%; 0% Gr 3/4), diarrhea (38%; 1% Gr 3/4), anorexia (24%; 1% Gr 3/4), and nausea (24%; 0% Gr 3/4).
  • The most common Gr 3 chemistry laboratory abnormalities were hyponatremia (7%) and elevated ALT (7%) and AST (6%); no Gr 4.
  • CONCLUSIONS: Patients with advanced RCC who developed PD on placebo in a phase III study subsequently achieved clinical benefit from paz treatment in this extension study.
  • These findings support the continued evaluation of paz in advanced RCC.

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  • (PMID = 27964395.001).
  • [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. Haas N, Manola J, Pins M, Liu G, McDermott D, Nanus D, Heath E, Wilding G, Dutcher J: ECOG 8802: Phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features. J Clin Oncol; 2009 May 20;27(15_suppl):5038

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] ECOG 8802: Phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features.
  • : 5038 Background: Patients (pts) with RCC containing sarcomatoid features have poor prognoses.Cytokine therapy is ineffective, and experience with mTor inhibitors or multi-targeted tyrosine kinase inhibitors is early.
  • We evaluated Dox/Gem in these pts with locally advanced or metastatic disease to confirm previous activity of this regimen in a single institution trial.
  • METHODS: Pts received Dox 50mg/m<sup>2</sup> IV push and Gem 1500mg/m<sup>2</sup> IV over 30 minutes every 2 weeks (with G-CSF 5 mcg/kg/d days 2 or 3 to 10 or pegfilgrastim 6 mg day 2) until disease progression or unacceptable toxicity.
  • A 2-stage design was used; >4 responses were needed for efficacy.
  • RESULTS: From February 2004 to April 2007, 39 pts with RCC of sarcomatoid (47%) or mixed histology (53%) containing sarcomatoid features were accrued by ECOG (n = 35), NCCTG (n = 2), and CALGB (n = 2).
  • Pts were mostly male (81%), with cT3/T4 (68%), node negative (61%), M1 (58%) disease at diagnosis and ECOG PS 0-1.
  • 1 complete and 5 partial responses (PR) were observed (16%, 90% CI 7.1-28.8%).
  • A 7th patient had an unconfirmed PR and an eighth patient had > 50 percent decrease in tumor burden after an initial progression.
  • 9 patients had stable disease.
  • CONCLUSIONS: Dox/Gem met efficacy criteria in RCC with sarcomatoid features.

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  • (PMID = 27962934.001).
  • [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. Sher AF, Chu D, Wu S: Risk of bleeding in cancer patients treated with the angiogenesis inhibitor bevacizumab: A meta-analysis. J Clin Oncol; 2009 May 20;27(15_suppl):9584

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Risk of bleeding in cancer patients treated with the angiogenesis inhibitor bevacizumab: A meta-analysis.
  • : 9584 Background: Bleeding is a serious adverse event associated with bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF) used extensively in the treatment of cancer.
  • This study was conducted to determine the overall risk of bleeding associated with bevacizumab in cancer patients by a meta-analysis of randomized controlled trials (RCT).
  • RESULTS: A total of 13048 patients with a variety of solid tumors from 20 RCTs were included for analysis.
  • The risk of bleeding with bevacizumab may vary with tumor type, with higher risk seen in patients with colorectal cancer (RR=6.6, 95% CI: 3.6-12.2) and renal cell cancer (RR=3.7, 95% CI: 2.6-5.5).
  • Bevacizumab is associated with different patterns of bleeding, with epistaxis being the most common.
  • CONCLUSIONS: There is a significant increase in the risk of bleeding in cancer patients receiving bevacizumab.
  • The risk may vary with the dose of bevacizumab and tumor type.

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  • (PMID = 27963709.001).
  • [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. 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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25. Jeppesen AN, Jensen HK, Donskov F, Marcussen N, von der Maase H: Serum-sodium as an independent prognostic factor in metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5102

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Serum-sodium as an independent prognostic factor in metastatic renal cell carcinoma.
  • : 5102 Background: Recently, low serum sodium has been associated with poor disease-free and overall survival in localized renal cell carcinoma (RCC) (Vasudev, Clin Can Res. 2008).
  • The present study investigated the prognostic impact of serum-sodium values below normal in patients with metastatic RCC (mRCC).
  • CONCLUSIONS: Low serum-sodium is a new, validated, independent prognostic factor in patients with metastatic RCC.

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  • (PMID = 27964376.001).
  • [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. Larbaoui B: Preoperative concomitant chemoradiotherapy with capecitabine in locally advanced rectal carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e15134

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preoperative concomitant chemoradiotherapy with capecitabine in locally advanced rectal carcinoma.
  • : e15134 Background: Preoperative concomitant chemoradiotherapy has shown to improve local control and sphincter preservation with decreased acute toxicity compared with postoperative treatment in locally advanced rectal carcinoma.
  • The primary endpoint of this phase II trial was pathologic tumor response.
  • METHODS: Inclusion criteria: rectal adenocarcinoma <12 cms from anal verge, clinical stage T3-4, adequate renal, hematological and liver function.
  • Clinical stage (determined by CT or RMI): T3: 70% and T4: 30%.
  • Tumor location (from anal verge): < 6 cm in 8pts, >6 cm in 7pts.
  • Tumor down staging was observed in 9pts (60%), including 5pts with complete pathological response (33.3%).
  • CONCLUSIONS: Preliminary results show that preoperative concomitant chemoradiotherapy with Capecitabine is an effective regimen with an acceptable safety profile for locally advanced rectal cancer, leading to a high probability of tumor downstaging.

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  • (PMID = 27960909.001).
  • [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. 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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28. Higgins B, Packman K, Zhang Y, Char H, Simcox M, Kolinsky K: In vivo activity of R1530 (R) alone and in combination with bevacizumab (B) and peginterferon alfa-2a (P) in a renal cell carcinoma (RCC) xenograft model. J Clin Oncol; 2009 May 20;27(15_suppl):e14629

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] In vivo activity of R1530 (R) alone and in combination with bevacizumab (B) and peginterferon alfa-2a (P) in a renal cell carcinoma (RCC) xenograft model.
  • Its inhibitory profile includes several kinases that play critical roles in cancer cell growth and division as well as tumor angiogenesis.
  • These properties translate into a potent cytotoxicity in a wide range of cancer cell lines in vitro and tumor growth inhibition in human tumor xenografts.
  • Preclinical studies were conducted to evaluate the effects of R alone and in combination with B and P in the Caki-1 RCC xenograft model.
  • A final study compared 1/2 OD R to OD R triplets to attempt to increase tumor growth inhibition (TGI) and increase life span (ILS).
  • Therefore, either agent can be alternatively dose reduced without a loss of tumor response or detriment to survival in this preclinical model of RCC.

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  • (PMID = 27964219.001).
  • [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. Molina AM, Tickoo SK, Ishill N, Trinos MJ, Schwartz LH, Russo P, Feldman DR, Patil S, Motzer RJ: Treatment outcome and survival for patients (pts) with sarcomatoid-variant metastatic renal cell carcinoma (RCC): Memorial Sloan-Kettering Cancer Center (MSKCC) experience. J Clin Oncol; 2009 May 20;27(15_suppl):e16017

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Treatment outcome and survival for patients (pts) with sarcomatoid-variant metastatic renal cell carcinoma (RCC): Memorial Sloan-Kettering Cancer Center (MSKCC) experience.
  • : e16017 Background: Sarcomatoid-variant represents a spindle cell phenotype of RCC that can be present in any subtype, usually showing aggressive biological behavior.
  • MSKCC experience was studied to provide data on outcome and survival to systemic therapy for metastatic, sarcomatoid-variant RCC.
  • METHODS: Clinical features, treatment outcome and survival were reviewed in 63 pts with sarcomatoid-variant metastatic RCC from a database of 650 pts treated at MSKCC with systemic therapy (cytokines, anti-angiogenesis targeted therapy and chemotherapy).
  • The percentage of sarcomatoid component in the tumors was assessed.
  • RESULTS: Histology subtypes with sarcomatoid-variant among the 63 pts included 46 clear cell, 5 papillary, 5 chromophobe, 1 collecting duct, and 6 unclassified.
  • Differences in PFS were observed based on therapy (sunitinib vs. all other) and histology (clear cell vs. non-clear cell).
  • The median PFS for sunitinib therapy was 4.4 months (95% CI 2.2-6.7) versus 2 months (95% CI 1.7-2.7) for all other therapies (p = 0.02); and 3 months (95% CI 2.3-4.5) for clear cell versus 1.6 months (95% CI 1.0-2.1) for non-clear cell histology (p = 0.007).
  • CONCLUSIONS: Metastatic sarcomatoid-variant RCC is associated with a poor prognosis.
  • Studies to assess outcome, characterize tumor biology, and develop novel treatment strategies are warranted.

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  • (PMID = 27962911.001).
  • [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. Hong T, Ryan DP, Blaszkowsky LS, Mamon HJ, Mino-Kenudson M, Adams J, Yeap B, Winrich B, DeLaney TF, Fernandez-Del Castillo C: Phase I study of preoperative (pre-op) short course chemoradiation (CRT) with proton beam therapy (PBT) and capecitabine (cape) for resectable pancreatic ductal adenocarcinoma (PDAC) of the head. J Clin Oncol; 2009 May 20;27(15_suppl):e15536

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I study of preoperative (pre-op) short course chemoradiation (CRT) with proton beam therapy (PBT) and capecitabine (cape) for resectable pancreatic ductal adenocarcinoma (PDAC) of the head.
  • We explore the feasibility of a one-week course of pre-op CRT with PBT and cape followed by pancreaticoduodenectomy (PD).
  • Eligibility included no CT involvement of SMA or celiac artery; adequate renal, hepatic and hematopoetic function; and ECOG PS 0/1.
  • Reasons for no resections were: metastatic disease-3 and unresectable tumor- 1.
  • Mean resected tumor diameter was 2.9 cm (2.2-4.3).
  • Average percentage of fibrosis in tumor mass was 74%.

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  • (PMID = 27962312.001).
  • [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. Hutson TE, Bellmunt J, Porta C, Staehler M, Szczylik C, Nadel A, Anderson S, Bukowski RM, Eisen T, Escudier B: Long-term safety of sorafenib (SOR) for the treatment (tx) of advanced clear-cell renal-cell carcinoma (RCC): Data analysis from patients (pts) treated for over 1 year in the phase III TARGET study. J Clin Oncol; 2009 May 20;27(15_suppl):e16057

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term safety of sorafenib (SOR) for the treatment (tx) of advanced clear-cell renal-cell carcinoma (RCC): Data analysis from patients (pts) treated for over 1 year in the phase III TARGET study.
  • : e16057 Background: Results of the phase III multicenter TARGET study, a randomized, double-blind, placebo (PBO)- controlled study of tx with SOR in pts with clear-cell RCC in whom 1 prior systemic therapy had failed, indicated that SOR is effective (PFS 5.5 vs 2.8 mo, HR=0.44, P<0.000001, and 39% increase in survival for SOR vs PBO, HR=0.71, P=0.015) and safe in pts with advanced RCC (Escudier et al.
  • METHODS: Pts (N=903) with advanced metastatic clear-cell RCC that had progressed after 1 systemic tx, ECOG PS 0-2, and low- or intermediate-risk MSKCC score were randomized 1:1 to SOR 400 mg BID or PBO.
  • Pts with preexisting cardiac disease or hypertension tolerated long-term tx with SOR; no dose reduction was required.
  • Long-term tx of pts with advanced RCC with SOR is medically manageable, with a predictable AE profile.

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  • (PMID = 27963000.001).
  • [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. 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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33. Busse A, Asemissen A, Schmittel A, Zimmermann K, Miller K, Rietz A, Ochsenreither S, Fusi A, Thiel E, Keilholz U: Immune self-tuning in renal cell carcinoma patients. J Clin Oncol; 2009 May 20;27(15_suppl):e22069

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Immune self-tuning in renal cell carcinoma patients.
  • : e22069 Background: Renal cell carcinoma (RCC) cells can inhibit protective antitumor immunity by secretion of immunosuppressive factors leading to the induction of regulatory T cells.
  • The objective of this study was to investigate the prognostic impact of mRNA expression levels of IL10, TGFβ and forkhead box transcription factor (FoxP3) mRNA in peripheral blood mononuclear cells (PBMCs) of metastatic RCC patients before receiving treatment with sorafenib.
  • Disease evaluation was performed every 8 weeks following RECIST criteria.
  • RESULTS: In contrast to FoxP3, mRNA expression levels of IL10 and TGFβ were significantly higher in the 46 RCC patients compared to healthy volunteers: Median expression levels [ratio marker /housekeeping gene PBGD] were 5.56E-05 vs 2.05E-04 (P=0.034) for IL10 and 7.38E-02 vs 3.04E- 01 (P=0.023) for TGFβ.
  • CONCLUSIONS: RCC caused an immune-suppressive phenotype in PBMC characterized by increased mRNA expression levels of IL10 and TGFβ.

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  • (PMID = 27963212.001).
  • [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. Ryan CW, Vuky J, Chan JS, Beer TM, Rothkopf M: Phase II study of everolimus (E) with imatinib (IM) in patients with previously-treated renal carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):e16075

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of everolimus (E) with imatinib (IM) in patients with previously-treated renal carcinoma (RCC).
  • : e16075 Background: Inhibitors of mTOR improve progression-free survival (PFS) in advanced RCC.
  • We hypothesized that co-administration of the mTOR inhibitor E with an upstream receptor tyrosine kinase inhibitor could augment activity in advanced RCC.
  • We chose to study IM due to its inhibition of PDGFR, a relevant target for RCC with potential activity at both the tumor cell and the pericyte.
  • METHODS: Eligible patients had metastatic or unresectable clear cell renal carcinoma, at least one prior systemic therapy, no prior mTOR inhibitor therapy, performance status 0-2, and measurable disease.
  • Treatment consisted of E 2.5 mg p.o. daily and IM 600 mg p.o. daily, a dose determined from a phase I study in GIST.
  • A two-stage design was employed to test for a 3-month PFS of ≥ 70% vs. ≤ 50%.
  • Best response was stable disease (67%) and progressive disease (33%).
  • Most common grade 3+ events were: fatigue (16%), pleural effusion (16%), edema (11%), and renal failure (11%).
  • The study was closed after the first stage as the 3-month PFS did not meet continuation criteria.
  • CONCLUSIONS: The combination of E 2.5 mg with IM 600 mg in previously-treated patients with advanced RCC did not meet the study-defined level of activity to warrant further investigation.
  • The natural history assumptions for this pretreated RCC population may have been overly optimistic.
  • Further development of this regimen for RCC is not recommended.

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  • (PMID = 27963048.001).
  • [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. Oudard S, Eisen T, Szczylik C, Siebels M, Negrier S, Chevreau C, Cihon F, Bukowski RM, Escudier B: Efficacy and safety of sorafenib in patients with advanced clear-cell renal cell carcinoma (RCC) with diabetes: Results from the phase III TARGET study. J Clin Oncol; 2009 May 20;27(15_suppl):e16099

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Efficacy and safety of sorafenib in patients with advanced clear-cell renal cell carcinoma (RCC) with diabetes: Results from the phase III TARGET study.
  • : e16099 Background: Results of the phase III TARGET trial, a randomized, double-blind, placebo-controlled study of sorafenib (SOR) treatment in pts with clear-cell RCC in whom 1 prior systemic therapy had failed, indicated that SOR is effective and safe for pts with advanced RCC, leading to the approval of SOR for the treatment of advanced RCC.
  • METHODS: Pts (N=903) with advanced clear-cell RCC, ECOG PS 0-2, and low- or intermediate-risk MSKCC score were randomized 1:1 to SOR 400 mg BID or placebo (PBO).
  • Trends in improved PFS were observed for SOR regardless of baseline diabetes status; however, the small diabetic subset limits interpretation of a SOR OS benefit in this subpopulation.

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  • (PMID = 27963086.001).
  • [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. 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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37. 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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38. Bhargava P, Esteves B, Nosov DA, Lipatov ON, Lyulko AA, Anischenko AA, Chacko RT, Lee P, Al-Adhami M, Ryan J: Updated activity and safety results of a phase II randomized discontinuation trial (RDT) of AV-951, a potent and selective VEGFR1, 2, and 3 kinase inhibitor, in patients with renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5032

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Updated activity and safety results of a phase II randomized discontinuation trial (RDT) of AV-951, a potent and selective VEGFR1, 2, and 3 kinase inhibitor, in patients with renal cell carcinoma (RCC).
  • In a phase II RDT of AV-951 (1.5 mg/day; 3 wks on, 1 wk off) in RCC, preliminary ORR at wk 16 was 28% (ASCO GU.
  • METHODS: Pts with locally advanced or metastatic RCC (any histology) and no prior VEGF-targeted therapy received AV-951 for 16 wks, after which further treatment was assigned based on response.
  • Pts with ≥ 25% tumor shrinkage continued treatment with AV-951, while pts with < 25% change from baseline were randomly assigned to receive AV-951 or placebo for 12 wks (double-blinded).
  • 53% pts were treatement naïve, 72% had undergone nephrectomy and 83% had RCC with clear cell component.
  • With a median duration of treatment of 5 mo (range 0-12 mo), the investigator assessed ORR (CR+PR) is 27.2% (30% in clear cell RCC), SD 60.5% and Disease Control Rate (CR/PR + SD) 88%.
  • The most common treatment-related AEs (all grades) were hypertension (HTN, 42%) and dysphonia (16%).
  • CONCLUSIONS: Interim results of this phase II study demonstrate that AV-951 is active in RCC.
  • The AE profile of AV-951 is consistent with that of a selective VEGFR inhibitor, with minimal off-target toxicities.

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  • (PMID = 27962939.001).
  • [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. Djellali L, Larbaoui B, Boukerche A, Ghazi S, Chaiba I, Meziane N, Yekrou D, Youcef DF: Preoperative concomitant chemoradiotherapy with oxaliplatin and 5-fluorouracil in locally advanced rectal carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e15108

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preoperative concomitant chemoradiotherapy with oxaliplatin and 5-fluorouracil in locally advanced rectal carcinoma.
  • : e15108 Background: Preoperative concomitant chemoradiotherapy has shown to improve local control and sphincter preservation with decreased acute toxicity compared with postoperative treatment in locally advanced rectal carcinoma.
  • The primary endpoint of this phase II trial was pathologic tumor response.
  • Secondary endpoint was sphincter preservation and toxicity Methods: Inclusion criteria: rectal adenocarcinoma <12 cms from anal verge, clinical stage T3-4, adequate renal, hematological and liver function.
  • Clinical stage (determined by CT or RMI): T3: 66.6% and T4: 33.3%.
  • Tumor location (from anal verge): < 6 cm in 10pts, >6 cm in 5pts.
  • Tumor down-staging was observed in 10pts (66.6%), including 5pts with complete pathological response (33.3%).
  • Main adverse effects (NCI-CTC): diarrhea G3-4: 14.2%, sensitive peripheral neurotoxicity G1: 26.6%, nausea/vomiting G3-4: 11%, Anemia G3-4: 7.1%, neutropenia G3-4: 14.2% Conclusions: Preliminary results show that preoperative concomitant chemoradiotherapy with oxaliplatin and 5FU-folinic acid is an effective regimen with an acceptable safety profile for locally advanced rectal cancer, leading to a high probability of tumor downstaging.

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  • (PMID = 27964340.001).
  • [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. 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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41. 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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42. Witteles RM, Harshman LC, Telli M, Srinivas S: Prospective cardiotoxicity screening during tyrosine kinase inhibitor therapy for renal cell carcinoma: An institutional experience. J Clin Oncol; 2009 May 20;27(15_suppl):e16003

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prospective cardiotoxicity screening during tyrosine kinase inhibitor therapy for renal cell carcinoma: An institutional experience.
  • In light of prior studies at our institution documenting a high rate of symptomatic heart failure in patients with renal cell carcinoma undergoing treatment with sunitinib, we instituted a prospective screening protocol to characterize the incidence and natural history of TKI-associated cardiotoxicity.
  • METHODS: From March-December 2008, patients receiving TKI therapy for renal cell carcinoma received cardiac biomarker screening (NT- BNP and Troponin I at baseline and after week 4 of each cycle) and transthoracic echocardiography (baseline, 1 month, 3 months, and every 3 months thereafter).
  • TKI treatment appeared to 'unmask' previously subclinical cardiac injury, including prior silent myocardial infarction (one patient), left ventricular hypertrophy (four patients), and valvular disease (three patients).

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  • (PMID = 27962944.001).
  • [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. Ritch C, Lee DJ, Desai M, McKiernan JM: Role of obesity and race in predicting recurrence rates and survival in renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16052

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Role of obesity and race in predicting recurrence rates and survival in renal cell carcinoma.
  • However, the relationship between obesity, race, and renal cell carcinoma (RCC) is highly debated.
  • We sought to explore the relationship between BMI and race, and determine the predictors for survival and recurrence after nephrectomy (Nx) for RCC.
  • METHODS: A retrospective analysis of the Columbia Urologic Oncology Database found that 1118 consecutive patients underwent partial or radical Nx for RCC between 1988 and 2008.
  • The two year cancer-specific survival was 89.6%, 92.7%, and 96.1% for normal weight, overweight, and obese patients, respectively (p=0.036).
  • A multivariate Cox regression found that male sex, BMI, size of tumor removed, tumor stage, and margin were independent predictors of RFS.
  • Overweight and obese patients were more likely to survive from RCC without recurrence than normal weight patients (p=0.04).
  • CONCLUSIONS: BMI is an independent predictor of RFS in patients undergoing partial or radical Nx for RCC.

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  • (PMID = 27963003.001).
  • [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. 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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45. 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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46. 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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47. 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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48. 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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49. 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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50. 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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51. Tannir N, Wong Y, Kollmannsberger C, Ernstoff MS, Perry DJ, Appleman LJ, Posadas E, Qian J, Ricker JL, Michaelson DM: Phase II trial of ABT-869 in advanced renal cell cancer (RCC) after sunitinib failure: Efficacy and safety results. J Clin Oncol; 2009 May 20;27(15_suppl):5036

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II trial of ABT-869 in advanced renal cell cancer (RCC) after sunitinib failure: Efficacy and safety results.
  • : 5036 Background: ABT-869 is a novel, orally active and potent inhibitor of all VEGF and PDGF receptor tyrosine kinases.
  • Results from a phase I study suggested antitumor activity in advanced solid tumors including RCC.
  • METHODS: We conducted an open-label, multicenter phase II trial of oral ABT-869 in advanced RCC.
  • Eligibility criteria included progressive disease (PD) within 100 days of enrollment after at least 2 cycles of sunitinib, prior nephrectomy, and adequate organ function.
  • RESULTS: 53 patients (pts, median age, 61 y [range, 40-80]; clear-cell histology [41 pts]; median number of prior therapies, 2 [range, 1-4]) were enrolled from 8/07 to 10/08.
  • The most common adverse events (AEs) were diarrhea (78%), fatigue (67%), hypertension (53%), nausea (51%) and vomiting (39%).
  • CONCLUSIONS: ABT-869 has activity in RCC after sunitinib failure.

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  • (PMID = 27962936.001).
  • [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. 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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53. 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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54. Gruenwald V, Fenner M, Varvenne M, Reuter C, Ganser A, Ivanyi P: Association of therapy with sunitinib and treatment-related hyperparathyroidism in renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e16023

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association of therapy with sunitinib and treatment-related hyperparathyroidism in renal cell carcinoma.
  • Here, we report on abnormalities of the mineral metabolism in patients with renal cell carcinoma (RCC) treated with MTKI.
  • METHODS: We identified a total of 61 patients with metastatic RCC and evaluable markers of bone metabolism, which were either treated at our institution (N=53) or followed (N=8) during March 2005 and December 2008.
  • Patients received either sunitinib (4 weeks on/2 weeks off schedule) or sorafenib (continuous dosing) for metastatic disease.

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  • (PMID = 27962981.001).
  • [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. Nishikimi T, Tsuzuki T, Fujita T, Sassa N, Araki H, Fukatsu A, Katsuno S, Yoshino Y, Hattori R, Gotoh M: Prognostic factors of clear renal cell carcinoma in pT1a cases. J Clin Oncol; 2009 May 20;27(15_suppl):e16064

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic factors of clear renal cell carcinoma in pT1a cases.
  • : e16064 Background: The proportion of clear cell renal cell carcinoma (CRCC) cases diagnosed at pT1a is known to be increasing significantly.
  • For each case, the following pathological parameters were analyzed: patient age, tumor location (upper, middle, low), Furhman grade, presence of capsule, presence of lympho-vascular invasion, growth pattern (expansive or infiltrating), presence of scar, presence of hemorrhage, and presence of necrosis.

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  • (PMID = 27963068.001).
  • [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. 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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57. 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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58. 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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59. Drabkin HA, Sharma G, Costa LJ, Korch C, Gemmill RM: Synergistic growth inhibition of RCC and NSCLC cell lines by sorafenib plus vorinostat and induction of angiogenic genes by ER stress. J Clin Oncol; 2009 May 20;27(15_suppl):e16114

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Synergistic growth inhibition of RCC and NSCLC cell lines by sorafenib plus vorinostat and induction of angiogenic genes by ER stress.
  • : e16114 Sorafenib, vorinostat and the combination were examined in 34 RCC and NSCLC cell lines.
  • At baseline, bFGF, VEGF and IL-8 were highly expressed in RCCs, whereas Gro-α, VEGF, and IL-8 predominated in NSCLCs.
  • Importantly, sorafenib at 8 μM, but not lower doses, induced ER stress in these cell lines and thapsigargin or tunicamycin treatment recapitulated many, but not all, of the observed angiogenic gene responses to sorafenib.
  • In summary, sorafenib plus vorinostat potently inhibits the in vitro growth of RCC and NSCLC cell lines.

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  • (PMID = 27963311.001).
  • [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. 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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61. 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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62. 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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63. 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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64. 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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65. 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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66. 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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67. 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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68. 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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69. 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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70. Brown JE, Lipton A, Cook RJ, Michaelson D, Coleman RE, Saad F: Correlation of N-telopeptide of type I collagen (NTX) with survival and fractures in patients (pts) with bone metastases from renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):e16016

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Correlation of N-telopeptide of type I collagen (NTX) with survival and fractures in patients (pts) with bone metastases from renal cell carcinoma (RCC).
  • : e16016 Background: The osteolysis marker NTX has shown prognostic significance in pts with bone metastases from a broad range of solid tumors, but its potential in pts with RCC has not been investigated.
  • METHODS: This was an exploratory correlative analysis of NTX levels and outcomes in the RCC subset of pts treated with zoledronic acid (ZOL) in a 21-month phase III trial (Rosen et al.
  • Endpoints included overall survival (OS), disease progression in bone, and pathologic fractures.
  • RESULTS: Among 55 ZOL-treated RCC pts, 29 had baseline NTX data (median = 60 nmol/mmol CR).
  • CONCLUSIONS: In pts with RCC receiving ZOL, serial NTX assessments may provide important prognostic insight.
  • Although based on a small sample size, correlations between recent NTX levels and outcomes in RCC pts are more profound than those previously reported in pts with other solid tumors (Brown et al.
  • J Natl Cancer Inst. 2005).
  • Elevated NTX could alert physicians to the need to more closely monitor bone lesions and intervene to prevent fractures in RCC pts.
  • This may be especially important in the context of new systemic therapies that are improving the outlook in the advanced RCC setting.

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  • (PMID = 27962910.001).
  • [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. 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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72. 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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73. 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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74. 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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75. 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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76. 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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77. 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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78. 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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79. 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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80. 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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81. 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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82. 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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83. 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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84. Rose PG, Drake R, Braly PS, Bell MC, Wenham RM, Hines JH, Alvarez-Secord A, Soltes-Rak E, Childs BH, Herzog TJ: Preliminary results of a phase II study of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube. J Clin Oncol; 2009 May 20;27(15_suppl):5546

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preliminary results of a phase II study of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube.
  • : 5546 Background: Objectives are to estimate efficacy and safety of a novel taxane/platinum chemotherapy doublet in combination with bevacizumab (B), as first-line treatment of advanced cancer of the ovary, peritoneum or fallopian tube (FT), after initial debulking surgery.
  • METHODS: Eligibility criteria included histological confirmation of primary disease, previous debulking surgery, and normal renal, hepatic, hematological, and neurological function.
  • The primary endpoint is progression-free survival (PFS) of pts with measurable disease at 1 year.
  • RESULTS: A total of 110 subjects are included in safety and 95 in efficacy analyses (55 with measurable disease).
  • Tumors were mostly ovary as primary site (84%), poorly differentiated (65%), serous adenocarcinoma pathology (73%) and FIGO stage IIIC (68.2%) or IV (14.6%).
  • 85 (77%) subjects have stopped study treatment [including 33 completed study treatment, 29 disease progression, 15 adverse event (AE), 8 other reasons].
  • The most common grade 3-4 AEs were: neutropenia (39%), leukopenia (11%), hypertension (9%), and fatigue (7%) Grade 3-4 peripheral sensory neuropathy (PSN) occurred in 2 patients (1.3%).
  • Investigator-determined best overall confirmed response rates were: complete response 32.8%; partial response, 29.1%; stable disease 32.7%; and progressive disease (PD), 1.8%.
  • The 1-year PFS probability is 70.1% (95% C.I., 56.8%-83.4%) in the 55 patients with measurable disease.

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  • (PMID = 27962510.001).
  • [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. Keegan KA, Hellenthal NJ, Chamie K, Koppie TM: Histopathology in surgically treated renal cell carcinoma: Is there a survival difference when stratified by stage? J Clin Oncol; 2009 May 20;27(15_suppl):5089

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Histopathology in surgically treated renal cell carcinoma: Is there a survival difference when stratified by stage?
  • : 5089 Background: The impact of renal cell carcinoma histopathology (RCC) on survival has been conflicting and limited to retrospective institutional studies.
  • Therefore, we sought to determine the role of RCC histopathology on stage-specific survival rates in a population-based cohort.
  • METHODS: We utilized the National Cancer Institute's Surveillance, Epidemiology, and End Results database and identified 21,258 patients who underwent partial or radical nephrectomy for RCC between 1996 and 2004.
  • Patients were stratified based on histopathologic diagnosis (clear cell, papillary, chromophobe, sarcomatoid, and collecting duct) and pathologic stage.
  • We performed Cox-proportional hazard modeling and Kaplan-Meier survival analyses to determine overall- and cancer-specific survival.
  • RESULTS: Using univariate analysis, histopathology significantly impacted overall- and cancer-specific survival (p< 0.001).
  • Specifically, patients with papillary and chromophobe variants had lower stage disease at the time of surgery and had improved survival compared to clear cell subtypes, (HR: 0.50; 95% CI, 0.42-0.60 and HR: 0.31; 95% CI, 0.22-0.44, respectively).
  • When controlled for stage, improved outcomes for chromophobe and papillary histologies persisted, although it did not achieve statistical significance at all stages.
  • On the other hand, patients with sarcomatoid disease were more likely to present with high stage disease and invariably had worse survival compared to clear cell carcinoma (HR: 8.74; 95%, CI 7.70-9.91).
  • When controlled for stage, this difference achieved statistical significance across all stages (p< 0.001).
  • CONCLUSIONS: Histopathologic subtype in patients with RCC does predict overall- and cancer-specific survival.
  • Patients with sarcomatoid RCC, even those presenting with low-stage disease, have poor survival.
  • These findings may give further value to recent data suggesting the increased utility of percutaneous renal biopsy and its potential impact on management.

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  • (PMID = 27964288.001).
  • [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. 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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87. 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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88. 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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89. 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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90. 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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91. Casal J, Vázquez S, León L, Lázaro M, Fírvida JL, Amenedo M, Alonso G, Santomé L, Afonso FJ: Erlotinib as maintenance therapy after concurrent chemoradiotherapy in patients (p) with stage III non-small cell lung cancer (NSCLC): A Galician Lung Cancer Group phase II study. J Clin Oncol; 2009 May 20;27(15_suppl):7537

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Erlotinib as maintenance therapy after concurrent chemoradiotherapy in patients (p) with stage III non-small cell lung cancer (NSCLC): A Galician Lung Cancer Group phase II study.
  • : 7537 Background: Combination of platinum-based chemotherapy and radiotherapy is the standard treatment for p with unresectable stage III NSCLC, but considering the high rates of recurrence, it is necessary to improve these results.
  • In this study, we aim to evaluate the role of erlotinib as maintenance therapy after a standard concurrent chemo-radiotherapy regimen in p with stage III NSCLC.
  • METHODS: P with unresectable stage IIIA/IIIB-without malignant effusions-NSCLC who had received a standard concurrent chemo-radiotherapy regimen and had no evidence of tumor progression were enrolled in this single arm, open-label phase II study and received erlotinib 150 mg/day po for 6 months.
  • Main eligibility criteria were: PS 0-2, adequate bone marrow, hepatic and renal function and measurable disease by RECIST criteria.
  • Primary endpoint was the percentage of p without evidence of disease progression after 6 months of erlotinib therapy and secondary endpoints were: PFS, OS, ORR and safety profile.
  • Baseline characteristics: median age 62 years (range 41-76); male 94.6%; caucasian 100%; smokers/never smokers (%) 97.3/2.7; ECOG PS 0/1/2 (%) 18.9/75.7/2.7; adenocarcinoma/squamous cell carcinoma/large cell carcinoma (%) 16.2/75.7/5.4; stage IIIA/IIIB (%) 16.2/83.8.
  • Most common previous chemo-radiotherapy regimen is cisplatin/docetaxel/RT (83.8%).
  • 27 p were evaluable for tumor response: CR 22.2%; PR 12.8%; SD 55.6%; PD 7.4%.
  • Most common adverse events related to erlotinib were rash 30.6% (3 p gr.
  • CONCLUSIONS: Erlotinib as maintenance therapy is an active and well tolerated treatment after concurrent chemo- radiotherapy in p with stage III NSCLC.
  • In spite of the majority of patients are caucasian, males, smokers with squamous cell carcinoma, maintenance with single agent erlotinib reached a promising median OS of 18.7 months.

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  • (PMID = 27963306.001).
  • [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. Cobo M, Martinez J, Montesa A, Gil-Calle S, Villar-Chamorro E, Ales I, Gutierrez V, Durán G, Carabantes-Ocón F, Benavides M: Phase II trial of erlotinib maintenance therapy after platinun-based chemotherapy in advanced non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):e19013

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II trial of erlotinib maintenance therapy after platinun-based chemotherapy in advanced non-small cell lung cancer (NSCLC).
  • : e19013 Background: phase II trial-efficacy & toxicity of sequential erlotinib in advanced NSCLC after platinum-based CT Methods: Pts with adv NSCLC, PS 0/1, adequate renal, hepatic and bone marrow function, no PD after CT.
  • Safety was evaluated monthly and tumor evaluation bimonthly.
  • HISTOLOGY: adenocarcinoma 8(61.7%), bronquioloalveolar 3(6.4%), large cell 3(6.4%), squamous12(25.5%).
  • RESPONSE: CR: 1(2.1%), PR: 2(51.1%), EE: 22 (46%).
  • No significant differences in TTP according to age, sex, PS, histology or previous response to CT, but yes depending on RR to erlotinib: PR: 31.5 m (95% CI 15.37-47.63), EE: 12.8 m (95% CI, 10.58-15.03), PD: 6.3 m (95% CI, 5.36-7.3), p < 0.001; and moreover depending on smoking status: Never: 21.67 m(95% CI, 5.39-37.94), previous smoker > 5 years: 14.03 m(95% CI, 10.77-17.30), previous smoker 1 year: 7.77 m(95% CI, 7.62-7.91), current smoker: 5.9 m(95% CI, 5.12-6.34), p <0.001.

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  • (PMID = 27962630.001).
  • [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. 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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94. 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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95. 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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96. 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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97. 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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98. 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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99. Sonnichsen D, Liao S, Berkenblit A, Boni J: Population pharmacokinetic modeling for intravenous temsirolimus and sirolimus metabolite in subjects with various solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):2522

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Population pharmacokinetic modeling for intravenous temsirolimus and sirolimus metabolite in subjects with various solid tumors.
  • : 2522 Background: Temsirolimus (TEMSR) is an mTOR inhibitor approved for treatment of patients with advanced renal cell carcinoma, and under development for relapsed/refractory mantle cell lymphoma (MCL).
  • Modeling for TEMSR employed a 4-compartment model with saturable distribution to red cells and peripheral tissue, and modeling for SIR utilized a linear 2- compartment model with factor for dose.
  • Covariates included demographic factors, clinical labs, and disease condition.
  • In a typical patient (56-year-old male weighing 76.5 kg), disease affected TEMSR clearance (62.4 L/h in MCL, 92.1 L/h in breast cancer vs. 112 L/h for other subjects).
  • CONCLUSIONS: No significant differential effects were observed for age, gender, race, or hepatic and renal laboratory measures.
  • Covariates of disease, while significant, have only modest effects on the exposure profile.

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  • (PMID = 27961845.001).
  • [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. Gupta N, Diderichsen PM, Steinberg J, Ricker JL, Humerickhouse R, Awni W, Pradhan R: Population pharmacokinetic (PK) analysis of ABT-869 in solid tumors and acute myelogenous leukemia (AML) patients. J Clin Oncol; 2009 May 20;27(15_suppl):3567

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Population pharmacokinetic (PK) analysis of ABT-869 in solid tumors and acute myelogenous leukemia (AML) patients.
  • : 3567 Background: ABT-869 is an orally bioavailable, potent and specific inhibitor of all vascular endothelial growth factor and platelet derived growth factor family receptor tyrosine kinases.
  • The objectives of this analysis were to understand the population pharmacokinetics of ABT-869 and explore the effect of several demographic/disease state covariates influencing ABT-869 disposition.
  • METHODS: A population PK analysis of 181 patients (pts) enrolled in two phase 1 (multiple types of solid tumors and AML) and three phase 2 monotherapy studies (non-small cell lung cancer, hepatocellular carcinoma [HCC] and renal cell carcinoma) was conducted.
  • Available plasma concentrations obtained after intensive and sparse pre-dose PK sampling were analyzed by population PK using the non linear mixed effects modeling (NONMEM) approach.
  • Potential covariates including body weight, body surface area (BSA), age, sex, creatinine clearance (CrCL) and disease state (HCC vs. non-HCC pts) were tested.
  • Race and impaired renal function does not appear to alter PK.

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  • (PMID = 27961681.001).
  • [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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