476pa Model Relating Overall Survival to Tumor Growth Inhibition in Renal Cell Carcinoma.

Aim: Tumor growth inhibition (TGI) metrics estimated with longitudinal tumor size (TS) models have been shown to be predictive of overall survival (OS) in a variety of tumor types. Methods: TS data from 2490 patients with 1 line or refractory RCC who received temsirolimus, interferon, sunitinib, sorafenib or axitinib in 10 Phase 2 or Phase 3 studies were used. TGI metrics (Early tumor shrinkage (ETS) at week 8, 10, 12, time to growth (TTG)) as well as baseline prognostic factors were tested in a multivariate log-normal model of OS. Model performances were evaluated by posterior predictive check of the OS and hazard ratio distributions.