Overall survival with sunitinib versus interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC)

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Abstract
5024 Background: In a randomized, phase III trial, sunitinib demonstrated statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) compared to IFN-alfa as first-line therapy in mRCC patients (pts) (P<0.001) [Motzer et al. NEJM 2007;356:115], establishing sunitinib as a new reference standard of care. At the time of last analysis, survival data were not mature. Median overall survival (OS) had not been reached in both treatment groups (HR=0.65; P=0.0219). Methods: Pts with mRCC were randomized 1:1 to receive sunitinib 50 mg orally once daily in 6-wk cycles (4 wks on treatment, 2 wks off) or IFN-alfa (9 MU subcutaneously thrice weekly). The primary endpoint was PFS. Secondary endpoints included ORR, safety and OS. For survival analysis, 390 events are required for a 2-sided, unstratified log-rank test with an overall 2-sided significance level of 0.05 and power of 0.85. Patients were followed for survival and post-study cancer treatment information was collected. The influence of baseline clinical features and previously identified prognostic factors on treatment effect will be analyzed with the use of a Cox proportional hazards model. Results: 750 pts were randomized to study treatment, 375 pts in each arm. Median duration of treatment was 11 mos (range: <1–39) for sunitinib vs 4 mos (range: <1–37) for IFN-alfa. 72 pts on sunitinib (including pts who crossed over from IFN-alfa) and 7 pts on IFN-alfa continue on the study. The updated ORR is 47% (95% CI: 42, 52) for sunitinib vs 12% (95% CI: 9, 16) for IFN-alfa (P<0.000001), including 11 complete responses for sunitinib and 4 for IFN-alfa. Median PFS remains the same as reported previously (11 mos vs 5 mos [P<0.000001]). The most common grade 3/4 treatment-related AEs for the sunitinib group are hypertension (12%), fatigue (11%), diarrhea and hand-foot syndrome (both 8%), and, for IFN-alfa, fatigue (13%) and anorexia (2%). No new unexpected grade 3/4 treatment-related AEs have been observed. Events are sufficient for final OS analysis. Conclusions: Sunitinib remains a reference standard for the first-line treatment of mRCC, with significantly superior efficacy over IFN-alfa. Final survival analysis will be presented.

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