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Motzer RJ , Michaelson MD , Rosenberg J , Bukowski RM , Curti BD , George DJ , Hudes GR , Redman BG , Margolin KA , Wilding G
Sunitinib efficacy against advanced renal cell carcinoma
Journal of Urology. 2007 Nov;178(5) :1883-1887
PMID: ISI:000250187000011   
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Abstract
Purpose: We assessed the efficacy of the oral multitargeted tyrosine kinase inhibitor sunitinib in patients with metastatic clear cell renal cell carcinoma. Materials and Methods: Patients with metastatic clear cell renal cell carcinoma were enrolled in this multicenter, phase II clinical trial. Major eligibility requirements were clear cell renal cell carcinoma histology, prior nephrectomy, measurable metastases and failed prior cytokine therapy as a result of disease progression. Sunitinib was given orally as second line therapy in 6-week cycles of 50 mg daily for 4 weeks, followed by 2 weeks off drug per treatment cycle. Response to sunitinib was rigorously assessed by an independent third party core imaging laboratory (central review). Results: Of 106 patients enrolled in the study 105 were evaluated for response. As determined by independent third party assessment, the objective response rate was 33% (95% Cl 24%-43%) with a median response duration of 14.0 months. Median time to progression and median progression-free survival in the 105 evaluable patients was 10.7 and 8.8 months, respectively. Median survival was 23.9 months and 43 patients remained alive at a median followup of 29.7 months. Conclusions: The results of this trial demonstrate the efficacy of sunitinib for metastatic renal cell carcinoma. The optimal integration of surgery and sunitinib treatment requires further prospective investigation.
Notes
ISI Document Delivery No.: 220WC Times Cited: 0 Cited Reference Count: 18 Cited References: ESCUDIER B, 2007, NEW ENGL J MED, V356, P125 FLANIGAN RC, 2001, NEW ENGL J MED, V345, P1655 HUDES G, 2006, J CLIN ONCOL S 2, V24, S930 KIM WY, 2004, J CLIN ONCOL, V22, P4991 LINEHAN WM, 2004, CLIN CANCER RES S 2, V10, S6282 MENDEL DB, 2003, CLIN CANCER RES, V9, P327 MICKISCH GHJ, 2001, LANCET, V358, P966 MOTZER RJ, 2000, J CLIN ONCOL, V18, P1928 MOTZER RJ, 2000, J UROLOGY, V163, P408 MOTZER RJ, 2002, J CLIN ONCOL, V20, P289 MOTZER RJ, 2004, J CLIN ONCOL, V22, P454 MOTZER RJ, 2006, J CLIN ONCOL, V24, P16 MOTZER RJ, 2006, JAMA-J AM MED ASSOC, V295, P2516 MOTZER RJ, 2007, NEW ENGL J MED, V356, P115 RINI BI, 2006, CLIN GENITOURIN CANC, V5, P232 RINI BI, 2007, J NATL CANCER I, V99, P81 THERASSE P, 2000, J NATL CANCER I, V92, P205 YANG JC, 2003, NEW ENGL J MED, V349, P427 Motzer, Robert J. Michaelson, M. Dror Rosenberg, Jonathan Bukowski, Ronald M. Curti, Brendan D. George, Daniel J. Hudes, Gary R. Redman, Bruce G. Margolin, Kim A. Wilding, George ELSEVIER SCIENCE INC; 360 PARK AVE SOUTH, NEW YORK, NY 10010-1710 USA