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

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

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

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

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  • (PMID = 28326510.001).
  • [ISSN] 0890-9091
  • [Journal-full-title] Oncology (Williston Park, N.Y.)
  • [ISO-abbreviation] Oncology (Williston Park, N.Y.)
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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3. 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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4. 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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5. 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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6. 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]
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  • (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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7. 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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8. 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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9. Abascal Junquera JM, Esquena Fernández S, Martos Calvo R, Ramírez Sevilla C, Salvador Lacambra C, Celma Doménech A, Trilla Herrera E, De Torres I, Morote Robles J: [Renal hydatidic cyst simulating hypernephroma]. Actas Urol Esp; 2005 Feb;29(2):223-5
MedlinePlus Health Information. consumer health - Kidney Diseases.

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Renal hydatidic cyst simulating hypernephroma].
  • [Transliterated title] Quiste hidatídico renal simulando hipernefroma.
  • OBJECTIVE: To present a new case of hydatid cyst of the kidney with a difficult radiographic diagnosis.
  • MATERIAL AND METHODS: We describe the clinical, diagnosis and treatment of a complex renal mass and its histological confirmation after surgery.
  • CONCLUSIONS: kidney's hydatidose is an unusual placement of this pathology.
  • It is important to take care in the differential diagnosis in the context of complexes renal masses.
  • There are some diagnosis procedures which can help us to establish it.
  • [MeSH-major] Echinococcosis / radiography. Kidney / parasitology. Kidney Diseases / parasitology
  • [MeSH-minor] Aged. Animals. Carcinoma, Renal Cell / diagnosis. Diagnosis, Differential. Female. Humans. Nephrectomy. Tomography, X-Ray Computed. Treatment Outcome

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  • (PMID = 15881923.001).
  • [ISSN] 0210-4806
  • [Journal-full-title] Actas urologicas españolas
  • [ISO-abbreviation] Actas Urol Esp
  • [Language] spa
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Spain
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10. Almela Cortés R, Costa Climent MD, Aldasoro Martín J: [Hypernephroma as second neoplasm simultaneous in a patient whith larynx carcinoma]. An Otorrinolaringol Ibero Am; 2007;34(5):439-46
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] [Hypernephroma as second neoplasm simultaneous in a patient whith larynx carcinoma].
  • [Transliterated title] Hipernefroma como segunda neoplasia simultánea en una paciente con cancer de laringe.
  • The presence of two or more different histologic types of neoplasms in patients treated for head and neck cancer is well known.
  • It is provided the clinical case of a woman of 48 years old who developed two primary tumors, a squamous carcinoma of larynx and a clear cell carcinoma of kidney (hypernephroma).
  • The diagnosis of second primary tumor was a casual find when an abdominal TC was being carried out.
  • The more frequent association of a head and neck cancer is with a malignant tumors of lung, being unusual the malignant tumors of kidney association.
  • [MeSH-major] Carcinoma, Renal Cell / diagnosis. Kidney Neoplasms / diagnosis. Laryngeal Neoplasms / diagnosis. Neoplasms, Multiple Primary / diagnosis

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  • (PMID = 18030850.001).
  • [ISSN] 0303-8874
  • [Journal-full-title] Anales otorrinolaringológicos ibero-americanos
  • [ISO-abbreviation] An Otorrinolaringol Ibero Am
  • [Language] spa
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Spain
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11. Battaglia M, Gernone A: Long-term use of sorafenib (SOR) in metastatic renal cell carcinoma (mRCC) previously treated with systemic therapy. J Clin Oncol; 2009 May 20;27(15_suppl):e16123

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term use of sorafenib (SOR) in metastatic renal cell carcinoma (mRCC) previously treated with systemic therapy.
  • : e16123 Background: The recent development of new targeted agents for the treatment of advanced RCC has definitely changed the approach and the outcome of this disease.
  • RESULTS: To date, 20 pts are evaluable for response: of them, 13 (59%) achieved a partial response (PR) after 3 mos. of therapy whose median duration was 13 mos. (range, 7-18), while 7 (31%) remained with stable disease (SD) with a median length of 14 mos. (range, 5-17).
  • Among those who progressed (2 pts), the median time to disease progression was 7 mos.
  • However, notwithstanding the rather small sample size of pts., the overall clinical benefit rate (PR+SD) turned out particularly high (> 90%): chiefly, the evidence of a long lasting disease control both for patients achieving partial response and for those with stable disease makes SOR a very useful treatment for patients with mRCC.

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  • (PMID = 27963393.001).
  • [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. 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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13. Naito S, Eto M, Shinohara N, Tomita Y, Fujisawa M, Namiki M, Nishikido M, Usami M, Tsukamoto T, Akaza H: A phase II study of S-1 for the treatment of cytokine-refractory metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5100

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

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  • (PMID = 27964380.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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14. 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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15. de Martino M, Klatte T, Seligson DB, LaRochelle J, Shuch B, Caliliw RR, Li Z, Kabbinavar FF, Pantuck AJ, Belldegrun AS: Use of CA9 gene single nucleotide polymorphisms to predict prognosis and treatment response of metastatic renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5003

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Use of CA9 gene single nucleotide polymorphisms to predict prognosis and treatment response of metastatic renal cell carcinoma.
  • : 5003 Background: Carbonic anhydrase 9 gene (CA9) is located in a prognostically relevant chromosomal area on chromosome 9p and is encoding for one of the most significant protein markers in metastatic renal cell carcinoma (MRCC), CAIX.
  • In contrast to CAIX protein, however, no efforts have been made to date to study CA9 gene in metastatic RCC.
  • METHODS: Genomic DNA was extracted from frozen tumor samples of 54 patients with clear cell MRCC.
  • Patients with the C allele variant of rs12553173 had improved median survival (27.3 vs. 13.6 months, p = 0.0431) and a greater likelihood of response to IL-2 (57% vs. 22%, p = 0.081) Likewise, high CAIX expression was associated with longer median survival (25.5 vs. 8.5 months, p < 0.0001) and a greater IL-2 response rate (37% vs. 8%, p = 0.070).
  • The C allele variant of rs12553173 is associated with improved overall survival and a greater likelihood of response to IL-2.

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  • (PMID = 27962895.001).
  • [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. 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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17. Falchook GS, Wheler JJ, Tannir NM, Naing A, Jackson E, Hong D, Lawhorn KN, Ng C, Amin H, Kurzrock R: Hypoxia-inducible factor-1α (HIF-1α) modulation in combination with anti-angiogenic therapy. J Clin Oncol; 2009 May 20;27(15_suppl):3555

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Pharmacodynamic assessment included plasma VEGF, VEGFR2, 20S proteasome inhibition, DCE-MRI, and tumor expression of HIF-1α, VEGF, VEGFR2, and polymorphisms of VEGF and VEGFR2.
  • Two partial responses were observed in patients with renal cell carcinoma (RCC) (Total patients with RCC = 6).
  • Minor responses or stable disease lasting ≥4 months was achieved in 8 patients, including RCC (1), breast (1), leiomyosarcoma (1), nasopharyngeal (2), hepatocellular (1), neuroendocrine (1), lacrimal gland adenocystic carcinoma (1).
  • The most common drug-related toxicities observed included hypertension (36%), fatigue (34%), thrombocytopenia (29%), and myalgia (19%).

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  • (PMID = 27961363.001).
  • [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. 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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19. Hong M, Jeung H, Chung H, Ahn J, Roh J, Noh S, Rha S: Predictive factors associated with clinical outcome and safety in Korean patients with metastatic renal cell carcinoma treated with sunitinib. J Clin Oncol; 2009 May 20;27(15_suppl):e16111

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Predictive factors associated with clinical outcome and safety in Korean patients with metastatic renal cell carcinoma treated with sunitinib.
  • : e16111 Background: Sunitinib has become a standard treatment for metastatic renal cell carcinoma (RCC).
  • METHODS: In total, 81 histologically proven metastatic RCC patients who were treated with sunitinib were reviewed between Jan 2006 and Dec 2008.
  • Tumor response was evaluated according to the RECIST criteria, and safety was assessed by NCI-CTC (version 3.0).
  • Primary endpoint was progression-free survival (PFS) and secondary endpoints included overall survival (OS), overall response rate (ORR), disease control rate (DCR), and toxicities.
  • Clear cell type was predominant (85%).
  • The most common grade 3/4 adverse events of sunitinib was thrombocytopenia (32%).

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  • (PMID = 27963327.001).
  • [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. 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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21. 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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22. 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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23. Goldberg J, Demetri GD, Choy E, Rosen L, Pappo A, Dubois S, Geller J, Chai F, Ferrari D, Wagner AJ: Preliminary results from a phase II study of ARQ 197 in patients with microphthalmia transcription factor family (MiT)-associated tumors. J Clin Oncol; 2009 May 20;27(15_suppl):10502

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

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  • (PMID = 27963690.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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24. Wood CG, Srivastava P, Lacombe L, Gorelov AI, Gorelov S, Mulders P, Zielinski H, Teofilovici F, Isakov L, Escudier B: Survival update from a multicenter, randomized, phase III trial of vitespen versus observation as adjuvant therapy for renal cell carcinoma in patients at high risk of recurrence. J Clin Oncol; 2009 May 20;27(15_suppl):3009

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

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  • (PMID = 27962044.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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25. 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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26. 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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27. 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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28. 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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29. 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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30. 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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31. 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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32. 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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33. 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.

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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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34. 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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35. 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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36. 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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37. 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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38. Brahmer JR, Topalian SL, Powderly J, Wollner I, Picus J, Drake CG, Stankevich E, Korman A, Pardoll D, Lowy I: Phase II experience with MDX-1106 (Ono-4538), an anti-PD-1 monoclonal antibody, in patients with selected refractory or relapsed malignancies. J Clin Oncol; 2009 May 20;27(15_suppl):3018

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 3018 Background: Programmed death-1 (PD-1), an inhibitory receptor expressed on activated T cells, may suppress antitumor immunity.
  • METHODS: Patients (pts) with treatment refractory metastatic non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), colon cancer (CC), melanoma (MEL), or prostate cancer (CRPC), and no history of autoimmune disease received a single infusion of MDX-1106 at 10 mg/kg.
  • Disease status was evaluated at week (wk) 8 by RECIST criteria.
  • Pts with stable disease or lesional responses could receive additional MDX-1106 at wks 12 and 16.
  • Those with PR/CR were observed without retreatment.
  • RESULTS: 21 pts (5 CC, 2 NSCLC, 8 MEL, 5 HRPC, 1 RCC) were treated from 10/07 to present, and 6 were retreated.
  • One pt with RCC had a PR after 3 doses, lasting 5+ months (mo).
  • Biopsy of a regressing MEL lymph node metastasis showed a moderately increased and selective CD8+ T cell infiltrate post treatment.
  • Interestingly, in contrast to PK results, flow cytometric analysis demonstrated sustained occupancy of 60-80% PD-1 molecules on T cells for at least 3 mo following a single dose.
  • Analyses of circulating lymphocyte subsets and tumor B7-H1 expression are in progress.
  • CONCLUSIONS: Intermittent dosing of MDX-1106 at 10 mg/kg demonstrated clinical activity against RCC and MEL without serious toxicity.

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  • (PMID = 27962055.001).
  • [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. 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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40. Nathan PD, Vinayan A, Stott D, Goh V: CT response assessment combining reduction in size and arterial enhancement correlates with time to progression in metastatic renal cancer patients treated with TKIs. J Clin Oncol; 2009 May 20;27(15_suppl):e16062

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] CT response assessment combining reduction in size and arterial enhancement correlates with time to progression in metastatic renal cancer patients treated with TKIs.
  • : e16062 Background: Targeted therapy is now the standard of care in advanced Renal Carcinoma (RCC).
  • Response assessment by RECIST criteria is insensitive as treated tumours often have only a modest change in size despite the induction of significant necrosis and does not correlate with time to progression (TTP).
  • The Choi criteria (10% size reduction or 15% contrast enhancement reduction) are routinely used in the assessment of GIST tumours treated with targeted agents.
  • We report the use of combined size and density assessment in RCC metastases treated with either sunitinib or cediranib.
  • METHODS: CT scans from 32 patients with metastatic RCC treated with either sunitinib (18) or cediranib (14) were assessed.
  • Scans from 10 patients were not evaluable as non-contrast enhanced scans were performed due to impaired renal function.
  • Scans from 20 evaluable patients at baseline and 12 weeks on treatment were assessed using RECIST, Choi, and modified criteria in which both a 10% decrease in size and 15% decrease in enhancement in the arterial phase were required to define a response (PR).
  • Response assessment was performed using each of the three methods and correlated with time to disease progression (itself RECIST defined).
  • RESULTS: There was no difference in TTP between RECIST defined PR (346.8 days) and SD (328.5 days) (P=0.965).
  • TTP in Choi defined PR (358.4 days) and SD (189.6 days) groups showed improved but non-significant separation of TTP duration (P=0.266).
  • TTP in PR (421.5 days) and SD (200.3 days) groups defined by a combined assessment of reduction in size and enhancement showed greatly improved separation (P=0.064).
  • CONCLUSIONS: A combined reduction in both size and arterial phase enhancement of RCC metastases treated with TKIs correlates with time to progression.

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  • (PMID = 27963066.001).
  • [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. 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).

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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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42. 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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43. 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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44. 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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45. 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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46. 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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47. Montero AJ, Diaz-Montero CM, Liu J, Do K, Millikan RE, Tannir NM: Cytokines and angiogenic factors in metastatic renal cell cancer: Association of pretreatment serum levels with survival. J Clin Oncol; 2009 May 20;27(15_suppl):e16036

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

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  • (PMID = 27962961.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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48. 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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49. Plimack ER, Wong Y, Von Mehren M, Malizzia L, Roethke SK, Li T, Litwin S, Hudes GR, Haas NB: A phase I study of temsirolimus (TEM) and bryostatin (BRYO) in patients with metastatic renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5111

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

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  • (PMID = 27964394.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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50. 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.
  • 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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51. Francesca F, Pomara G, Campo G, Casale P: Elective open nephron-sparing surgery for renal masses: Single-center experience with 223 consecutive patients. J Clin Oncol; 2009 May 20;27(15_suppl):e16139

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

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

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

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  • (PMID = 27963088.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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53. 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).
  • METHODS: Cohorts of 3 or 6 patients with ccRCC were treated with a 7 day run-in period of sorafenib 400 mg PO BID continuously followed by RAD001 (dose level I: 2.5 mg, dose level II: 5 mg) PO QD and sorafenib 400 mg PO BID continuously.
  • 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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54. Tunn U, Stenzl A, Kindler M, Strauss A, Miller K, Ruebel A, Albrecht M, Gruenwald V: The effect of zoledronic acid on bone metastasis in patients suffering from renal cell cancer (RCC): A German prospective single-arm clinical trial. J Clin Oncol; 2009 May 20;27(15_suppl):5107

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The effect of zoledronic acid on bone metastasis in patients suffering from renal cell cancer (RCC): A German prospective single-arm clinical trial.
  • : 5107 Background: The incidence of RCC increased over the last decades and about 30% of patients will develop bone metastasis.
  • These pts. face considerable skeletal morbidity e.g. bone pain, pathologic fractures, spinal cord compression or tumor induced hypercalcemia (TIH).
  • A prospective trial was initiated in RCC metastatic to bone evaluating the SRE (skeletal related event) rate under therapy with zoledronic acid (ZA).
  • METHODS: Patients with RCC must have had ≥1 bone metastasis and ≤2 prior applications of a bisphosphonate.
  • Bone lesions response was observed in 3 pts. (2 CR, 1 PR) out of 33 pts. currently available.

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  • (PMID = 27964367.001).
  • [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. 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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56. Grozav AG, Willard B, Kinter M, Vaziri SA, Bukowski RM, Rini BI, Ganapathi MK, Ganapathi R: Target identification by phosphoproteomics: RIN1 modulation of sorafenib-induced cytotoxicity in renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):e14543

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

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  • (PMID = 27963618.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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57. Billemont B, Hornecker M, Ropert S, Blanchet B, Jais J, Blanchard P, Meric J, Alexandre J, Tod M, Goldwasser F: Correlation of sorafenib plasma concentrations and clinical toxicity: A prospective population pharmacodynamic and pharmacokinetic study. J Clin Oncol; 2009 May 20;27(15_suppl):e14585

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

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

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

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  • (PMID = 27961877.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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59. 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.
  • The expression of VEGF-C, VECF-D and sVEGFR-3 were significantly higher in pRCC than ccRCC (p=0.02, 0.01 and 0.035 respectively).
  • 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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60. 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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61. Klatte T, Remzi M, Said JW, Haitel A, Kabbinavar FF, Waldert M, de Martino M, Marberger M, Belldegrun AS, Pantuck AJ: A nomogram predicting disease-specific survival after nephrectomy for papillary renal cell carcinoma. J Clin Oncol; 2009 May 20;27(15_suppl):5091

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A nomogram predicting disease-specific survival after nephrectomy for papillary renal cell carcinoma.
  • : 5091 Background: Whereas multiple nomograms have been developed to assess outcomes of patients with clear cell renal cell carcinoma, a model to assess prognosis of papillary renal cell carcinoma (PRCC) has not yet been developed.
  • After data collection and slide review of a large cohort of patients, the aim of this study was to develop and to internally validate a nomogram for prediction of disease-specific survival for PRCC.
  • METHODS: Out of 2,687 patients who underwent surgery for a renal tumor between 1989 and 2008 at two institutions, 258 (10%) were found to have PRCC.
  • H&E slides were reviewed by one uro-pathologist at each institution for papillary sub-type, tumor grade, microvascular invasion, sarcomatoid features, collecting system invasion and presence and extent of tumor necrosis.
  • A nomogram was constructed as a graphical representation of significant variables of disease-specific survival in multivariate Cox proportional hazards regression analysis.
  • In univariate analysis, incidental detection, T, N, M stage, grade, microvascular invasion, collecting system invasion, papillary sub-type, sarcomatoid features, and necrosis were all associated with prognosis.
  • Multivariate Cox proportional hazards analysis, however, identified incidental detection, T stage, M stage, microvascular invasion, and necrosis, but not papillary sub-type as independent prognostic factors of disease-specific survival.
  • These variables formed the basis of the nomogram that predicted 5-year disease-specific survival probability.
  • CONCLUSIONS: A highly accurate tool utilizing basic clinical and pathological information for predicting disease-specific survival was developed specifically for PRCC.

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  • (PMID = 27964297.001).
  • [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. 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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63. 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.
  • The percentage of male patients was higher in pRCC than in ccRCC (73.8 vs. 60.3%, p = 0.006).
  • 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).
  • CONCLUSIONS: Even though pRCC and ccRCC differ significantly in many aspects including histology and genetic alterations, in all, their long term prognosis is comparable.
  • 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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64. 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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65. 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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66. 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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67. 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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68. 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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69. 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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70. Ganapathi R, Mekhail T, Wu C, Fischer B, Gong J, Iyer RA, Gan J, Pursley J, Patricia D, Masson E: Mass balance, pharmacokinetics, and metabolism of [&lt;sup&gt;14&lt;/sup&gt;C] brivanib (BMS-582664), prodrug of BMS-540215, in subjects with advanced or metastatic solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):3566

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Mass balance, pharmacokinetics, and metabolism of [<sup>14</sup>C] brivanib (BMS-582664), prodrug of BMS-540215, in subjects with advanced or metastatic solid tumors.
  • : 3566 Background: Brivanib alaninate (BMS-582664, B) is an oral prodrug of BMS-540215, a dual tyrosine kinase inhibitor of VEGFR and FGFR signaling pathways which are important for angiogenesis and tumor growth.
  • METHODS: A two-part, open-label, single-dose study was conducted in subjects with advanced or metastatic solid tumors.
  • Subjects continued in this study until disease progression or unacceptable toxicity.
  • RESULTS: 4 subjects (2 NSCLC, 1 ovarian, 1 renal cell carcinoma) were treated with B in both parts A & B.

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  • (PMID = 27961680.001).
  • [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. 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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72. 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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73. Lewis L, Frank R, Dandamudi UB, Gallagher J, Zhao L, Woo M, Hirawat S, Shapiro GI: Influence of food on the pharmacokinetics (PK) of panobinostat (LBH589), an orally active histone deacetylase inhibitor, in patients with advanced cancer. J Clin Oncol; 2009 May 20;27(15_suppl):2550

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Influence of food on the pharmacokinetics (PK) of panobinostat (LBH589), an orally active histone deacetylase inhibitor, in patients with advanced cancer.
  • : 2550 Background: The effect of food on the bioavailability and PK of panobinostat (PAN) are of considerable importance in allowing appropriate dosing of chronic oral cancer therapy.
  • METHODS: Patients (pts) with advanced cancer received 20 mg PAN twice a week of a 21-day cycle and were randomized to receive 1 of 6 treatment sequences where PAN PK was evaluated weekly under fasting, high fat and normal breakfast.
  • PK parameters were estimated by using non-compartmental analysis.
  • Although tumor response was not the main objective, a pt with recurrent RCC, following sunitinib and sorafenib treatment, has achieved a PR after ∼6 cycles of PAN and is continued on study.
  • CONCLUSIONS: Since the overall extent of absorption and variability was not changed due to food, PAN administration with or without food is unlikely to significantly impact systemic PAN exposure in cancer patients.

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  • (PMID = 27961876.001).
  • [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. 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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75. Shah M, Sreenivasappa S, Kouz R, Ciobanu B, Mullane M, Yim B: Demographics, response, and overall survival of patients with advanced renal cell cancer to sunitinib in a cohort of minority patient population. J Clin Oncol; 2009 May 20;27(15_suppl):e16164

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

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  • (PMID = 27963440.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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76. 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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77. 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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78. 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.
  • 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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79. 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).

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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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80. Quinn D, Barghout V, Moyneur E: Medical costs of sorafenib compared with sunitinib in treatment of patients &lt;65 years with renal cell carcinoma: A retrospective claims database analysis. J Clin Oncol; 2009 May 20;27(15_suppl):e17536

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Medical costs of sorafenib compared with sunitinib in treatment of patients <65 years with renal cell carcinoma: A retrospective claims database analysis.
  • : e17536 Background: Sorafenib (SR) and sunitinib (SU) are FDA approved (12/05 and 1/06, respectively) tyrosine kinase inhibitors for patients (pts) with advanced renal cell carcinoma (RCC).
  • Inclusion criteria were ≥2 RCC claims (ICD-9 189.0, 198.0), continuous health care coverage, >180 days of coverage before RCC diagnosis.
  • SR and SU pts were identified based on oral therapy after initial RCC-related claim (intent-to-treat).
  • Univariate and multivariate Tobit analyses were conducted; control factors included age, sex, region, plan type, comorbidity, prior Tx/procedures, and time since RCC Dx.
  • RESULTS: Of 10,462 RCC pts identified, 144 and 220 received initial therapy with SR and SU, respectively.
  • In the 180 days before RCC diagnosis, total direct medical costs, baseline demographics, and comorbidities were similar between groups.
  • CONCLUSIONS: Retrospective analysis of this US claims database for RCC pts <65 treated first with SR showed statistically significant lower total medical costs (particularly inpatient costs) than for pts treated first with SU.

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  • (PMID = 27963796.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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81. 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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82. 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.
  • 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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83. 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.
  • 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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84. 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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85. 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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86. 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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87. Srkalovic G, Hussein M, Bolejack V, Hoering A, Zonder J, Barlogie B: A phase II trial of sorafenib in patients with relapsing and resistant multiple myeloma (MM) previously treated with bortezomib (S0434). J Clin Oncol; 2009 May 20;27(15_suppl):e19517

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : e19517 Background: The multikinase inhibitor sorafenib targets several serine/threonine and receptor tyrosine kinases by blocking RAF kinase, a critical component of the RAF/MEK/ERK signaling pathway regulated by the Ras oncogene, which is mutated both in primary patient samples and in human MM lines (35-50%).
  • As the frequency of these mutations increases with advancing disease and increasing drug resistance, inhibition of the RAF/MEK/ERK signaling pathway, as well the angiogenic VEGFR-2/PDGFR beta cascade by sorafenib may be a useful new approach for the treatment of MM.
  • This dose was based on the label for metastatic renal cell carcinoma.
  • Three patients experienced Grade 4 toxicity consisting of thrombocytopenia, anemia and renal failure.
  • 3 patients had stable disease (2.4-15.9 months) and the remainder progressed.

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  • (PMID = 27960944.001).
  • [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. 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.
  • 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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89. Delea TE, Khuu A, Kay A, Zheng J, Baladi JF: Association between treatment effects on disease progression (DP) endpoints and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5105

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Association between treatment effects on disease progression (DP) endpoints and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC).
  • While the association between DP endpoints and OS has been established in other cancers, it has not been rigorously examined in patients with mRCC.

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  • (PMID = 27964370.001).
  • [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. 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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91. Wulfing C, Herrmann E, Trojan L, Schrader A, Becker F, Stähler M, Haferkamp A, Legal W, Brenner W, Hartmann A, German Papillary Renal Cancer Study Group: Independent validation of the 2002 UICC TNM staging system for papillary renal cell carcinoma in a multicenter cohort. J Clin Oncol; 2009 May 20;27(15_suppl):5092

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

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  • (PMID = 27964296.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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92. Wood L, Garcia JA, Elson P, Salas RN, Lane BR, Klein E, Stephenson A, Dreicer R, Campbell SC, Rini BI: Sunitinib in patients (pts) with unresectable primary renal cell carcinoma (RCC). J Clin Oncol; 2009 May 20;27(15_suppl):5096

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

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  • (PMID = 27964292.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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93. Mateus C, Massard C, Tomasic G, Wechsler J, Boige V, Le Cesne A, Soria JC, Escudier B, Robert C: Cutaneous genital complications of antiangiogenic agents. J Clin Oncol; 2009 May 20;27(15_suppl):e14568

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • They were treated with sorafenib (3 pts), sunitinib (5 pts), and a new pan-HER and VEGFR inhibitor (BMS 514, EVRI) (1 pt) for renal cell cancer (4 pts), hepatocellular carcinoma (2 pts), lung cancer (1 pt) and sarcoma (1 pt).
  • CONCLUSIONS: Polymorphous genital inflammatory rash is a new skin side effect that can be associated with any cancer therapies targeting VEGFR in men and in women.

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  • (PMID = 27963696.001).
  • [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. Azad NS, Henning R, Yu M, Davidson B, Figg WD, Calvo K, Venkatasen A, Annunziata C, Meltzer P, Kohn E: Translational proof of mechanism (PoM) for sorafenib with bevacizumab: Endpoint analysis and clinical activity. J Clin Oncol; 2009 May 20;27(15_suppl):3574

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 3574 Background: We hypothesized that molecular targeting of tumor and its microenvironment with rational combination therapy would yield improved outcome.
  • Bevacizumab (B) is a monocolonal antibody to vascular endothelial growth factor (VEGFF) and sorafenib (S) is a small molecule inhibitor of the VEGF receptor-2 and RAF-kinase.We have previously reported that S 200mg bid with B 5mg/kg q2wk resulted in partial responses and prolonged disease stabilization (ovarian cancers, renal cell cancer, leiomyosarcoma).
  • Serial tumor biopsies were obtained for translational proof of mechanism analysis.
  • RESULTS: 18 sets of 3 biopsies were obtained, assessed for morphologic response (MR; decrease to <60% viable tumor seen), and processed for TLA and IHC.
  • 11 pts had morphologic response including all 4 PR and 6/12 SD pts.
  • CONCLUSIONS: These exploratory results demonstrate proof of mechanism in the tumor and its microenvironment for the combination of S and B.
  • Phase II studies in multiple tumor types are ongoing.

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  • (PMID = 27961719.001).
  • [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. Fleischmann AM, Waser B, Reubi JC: Gastrin-releasing peptide receptors in the tumor vascular bed of various human cancers: high incidence in urinary tract cancers. J Clin Oncol; 2009 May 20;27(15_suppl):e14575

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Gastrin-releasing peptide receptors in the tumor vascular bed of various human cancers: high incidence in urinary tract cancers.
  • : e14575 Background: Tumoral Gastrin-releasing peptide (GRP) receptors are potential targets for diagnosis and therapy using radiolabeled or cytotoxic GRP analogs.
  • GRP-receptor overexpression has been detected in cancer cells and, more recently, also in the vascular bed of selected tumors.
  • More information on vascular GRP-receptors in cancer is required to asses their potential for vascular targeting applications.
  • METHODS: Frequent human cancers from the breast (n=134), lung (n=57), prostate (n=50), kidney (n=32), colon (n=46), urinary tract (n=26) and biliary tract (n=23) were analyzed using in vitro GRP-receptor autoradiography on tissue sections with the <sup>125</sup>I-[Tyr<sup>4</sup>]-bombesin radioligand and/or the universal radioligand <sup>125</sup>I-[D-Tyr<sup>6</sup>, ß-Ala<sup>11</sup>, Phe<sup>13</sup>, Nle<sup>14</sup>]-bombesin(6-14).
  • GRP-receptor expressing tumoral vessels were evaluated in each tumor group for prevalence, quantity (vascular score) and GRP-receptor density.
  • RESULTS: Prevalence of vascular GRP-receptors is variable, ranging from 13% (prostate cancer) to 92% (urinary tract cancer).
  • Different tumor-types within a given site may have divergent prevalence of vascular GRP-receptors (e.g. lung: small cell cancer: 0%; adenocarcinoma: 59%; squamous carcinoma: 83%).
  • Also the vascular score varies widely, with highest score in urinary tract cancer (1.69), moderate scores in lung (0.91), colon (0.88), kidney (0.84) and biliary tract (0.69) cancers and low scores in breast (0.39) and prostate (0.14) cancers.
  • Normal non- neoplastic control tissues from these organs lack vascular GRP-receptors.
  • CONCLUSIONS: Tumoral vessels in all evaluated sites overexpress GRP-receptors, suggesting a major biological function of GRP-receptors in the tumor vascular bed.
  • Vascular GRP-receptor expression varies between the tumor-types indicating tumor-specific mechanisms in their regulation.
  • Urinary tract cancers express vascular GRP-receptors so abundantly, that they are promising candidates for vascular targeting applications.

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  • (PMID = 27963648.001).
  • [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. 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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97. Perez-Gracia J, Prior C, Guillen-Grima F, Gonzalez A, Panizo A, Segura V, Grande-Pulido E, Gurpide A, Melero I, Calvo A: Identification of baseline predictive markers of sunitinib activity using a human cytokine antibody array in patients with metastatic renal cell carcinoma (MRCC). J Clin Oncol; 2009 May 20;27(15_suppl):5113

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Identification of baseline predictive markers of sunitinib activity using a human cytokine antibody array in patients with metastatic renal cell carcinoma (MRCC).
  • Serums of 6 patients with extreme phenotypes of marked responses (3) or clear progressions (3) were analyzed with a Human Cytokine Antibody Array (Series 2000, RayBiotech, Norcross, GA.
  • USA) which evaluates 174 cytokines related to angiogenesis and tumor proliferation pathways and has been validated in clinical studies.
  • Following array data normalization, the most relevant cytokines based on statistical significance and on biological plausibility, were assessed with ELISA in the whole group of patients and the results were correlated with clinical benefit (response or disease stabilization) or progression.
  • TNF-α and MMP-9 baseline levels were significantly increased in non-responders and they were significantly associated with progression-free and overall survival respectively.

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  • (PMID = 27964392.001).
  • [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. Pelz HF, Krekeler G, Bergmann L, Roigas J, Steiner T, Loeschmann PA, Kosch M: Evaluation of safety, tolerability, and activity: A registry for temsirolimus-treated patients with advanced or metastatic renal cell carcinoma (aRCC) in the usual health care setting. J Clin Oncol; 2009 May 20;27(15_suppl):e16127

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Evaluation of safety, tolerability, and activity: A registry for temsirolimus-treated patients with advanced or metastatic renal cell carcinoma (aRCC) in the usual health care setting.
  • Up to the December 15, 2008, 124 centers have recruited 130 patients.

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  • (PMID = 27963375.001).
  • [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. Harrison MR, Pili R, Logan T, Wilding G, Eickhoff J, Sidor C, Staab M, Arnott J, Liu G: Phase II study of 2-methoxyestradiol NanoCrystal dispersion (2ME2) alone and in combination with sunitinib (SU) in patients with metastatic renal cell carcinoma (mRCC) progressing on SU. J Clin Oncol; 2009 May 20;27(15_suppl):e16116

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of 2-methoxyestradiol NanoCrystal dispersion (2ME2) alone and in combination with sunitinib (SU) in patients with metastatic renal cell carcinoma (mRCC) progressing on SU.
  • : e16116 Background: Panzem NCD (2ME2) is a non-estrogenic derivative of estradiol with antiproliferative and antiangiogenic activity that downregulates HIF-1α.
  • METHODS: Pts with clear cell mRCC who had previously received or were currently receiving SU with disease progression were eligible.
  • Simon optimal 2-stage design was used with plans to enroll 21 pts/arm, and if activity was seen to continue enrollment for a total of 41 pts/arm.
  • Reasons for treatment discontinuation include: disease progression (7), pt/doctor discretion (3), AE (3), and noncompliance (1).
  • CONCLUSIONS: 2ME2 appears to have some single-agent activity, with an MR in a pt removed from study due to AE and a metabolic PR (ΔSUVmax -84%) in a pt with SD by RECIST.

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  • (PMID = 27963313.001).
  • [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. Rini BI, Halabi S, Rosenberg J, Stadler WM, Vaena DA, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ: Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206. J Clin Oncol; 2009 May 20;27(15_suppl):LBA5019

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206.

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  • (PMID = 27961198.001).
  • [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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