Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: LBA3
© 2006 American Society of Clinical Oncology

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Abstract

Phase III randomized trial of sunitinib malate (SU11248) versus interferon-alfa (IFN-) as first-line systemic therapy for patients with metastatic renal cell carcinoma (mRCC)

Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor-Sammons/Texas Oncology, PA, Dallas, TX; Klinika Oncologii Oddzial Chemioterapii, Poznan, Poland; Massachusetts General Hospital, Boston, MA; Cleveland Clinic Foundaton, Cleveland, OH; Hospital Pitie-Salpetriere, Paris, France; Georges Pompidou European Hospital, Paris, France; Pfizer Inc., La Jolla, CA; UCLA, Los Angeles, CA

LBA3

Background: Two multicenter phase II trials of 2^nd line monotherapy with sunitinib (SU11248) in patients (pts) with mRCC showed a response rate of approximately 40% (JCO 2006;24:16–24; Proc ASCO 23, 380s). This international, randomized phase III trial compared the efficacy and safety of sunitinib to IFN- in treatment naïve pts with mRCC. Methods: Untreated pts with clear-cell mRCC were randomized 1:1 to receive sunitinib (6-week cycles: 50 mg orally once daily for 4 weeks, followed by 2 weeks off) or IFN- (6-week cycles: subcutaneous injection 9 MU given three times weekly). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate, overall survival, and adverse events. Based on a planned sample size of 690 patients, the trial was designed to have 90% power to detect a 35% improvement in median PFS from 20 weeks to 27 weeks (4.6 months to 6.2 months; 2-sided unstratified log-rank test; significance level 0.05). Results of a planned analysis on the primary endpoint, PFS, are presented in this report. Results: From Aug 2004 to Oct 2005, 750 patients were randomized: 375 to sunitinib, 375 to IFN-. Baseline characteristics were well balanced, and included pooled median age = 60 and prior nephrectomy = 90%. Median PFS assessed by third-party independent review was 47.3 weeks (95% CI 40.9, not yet reached) for sunitinib vs. 24.9 weeks (95% CI 21.9, 37.1) for IFN- [hazard ratio 0.394 (95% CI 0.297, 0.521) (p < 0.000001)]. The objective response rate by third-party independent review was 24.8% (95% CI 19.7, 30.5) for sunitinib vs. 4.9% (95% CI 2.7, 8.1) for IFN- (p < 0.000001). The objective response rate by investigator assessment was 35.7% (95% CI 30.9, 40.8) for sunitinib vs. 8.8% (95% CI 6.1, 12.1) for IFN- (p < 0.000001). 632 pts (85%) are alive, with 49 deaths on sunitinib arm and 65 deaths on IFN- arm. 8% withdrew from the study due to adverse event on sunitinib arm vs. 13% on IFN- arm. Conclusions: These results demonstrate a statistically significant improvement in PFS and objective response rate for sunitinib over IFN- in first-line treatment of pts with mRCC.

Author Disclosure

Employment Consultant Stock Honoraria Research Expert Other Pfizer, Inc Pfizer, Inc Pfizer, Inc Pfizer, Inc Pfizer, Inc

Abstract presentation from the 2006 ASCO Annual Meeting