Association Between RECIST Changes and Survival in Patients with Metastatic Castration-resistant Prostate Cancer Receiving Docetaxel.

Abstract

UNLABELLED: We explored the association between Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 and 1.1 changes and overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) from the control arms of the VENICE and MAINSAIL phase 3 trials, respectively, receiving docetaxel, prednisone, and placebo. We used Cox proportional hazards regression to evaluate the OS prognostic ability of RECIST changes after adjusting for prognostic factors. In the VENICE trial, the OS hazard ratio (HR) was 0.64 (95% confidence interval [CI] 0.42-0.99; p=0.045) for patients with a partial response (PR) compared to those without PR, and 1.78 (95% CI 1.07-2.95; p=0.026) ..