Abstract
315 Background: The TORAVA trial, reported at ASCO 2010, was a randomized phase II study aimed to determine the efficacy and safety of temsirolimus and bevacizumab combination. Both efficacy and safety were demonstrated as insufficient. Interestingly, 2 control arms were used in this study, sunitinib (arm B) or bevacizumab and a-interferon (arm C). Both PFS and RR were higher in arm C than arm B (16.8 mths and 39% vs. 8.6 mths and 23.8%). Post-hoc analysis were thus performed to determine the predictive factors for better efficacy. Methods: Overall, 171 pts were randomized in this study, 42 in arm B and 41 in arm C. The study was stratified on PS only, 0–1 vs 2. These 83 pts were analyzed regarding baseline characteristics, and dose reduction. Results: Some important differences were detected in the 2 arms, in favor of arm C: DFI>12mths (29 vs. 39%), good MSKCC risk (31 vs. 39%), Fuhrman grade 1–2 (32 vs. 38%), liver metastases (19 vs. 14.6%), high LDH (17.1 vs. 7.9%). Interestingly, pts who had dose reduction of interferon (27/41 pts) had a longer PFS than those who did not reduced the dose. Updated analyses will be presented. Conclusions: Small randomized trials such as randomized phase II trials are not guaranteed to balance predictive/ prognostic factors across treatment arms. Before interpreting RR and PFS in mRCC, careful analysis of pt characteristics should be performed. However, this study will probably help to determine a population more likely to benefit from bevacizumab-interferon combination. [Table: see text]
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