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) for those with progressive disease (PD) compared to those without PD. After adjusting for prostate-specific antigen (PSA) changes, PD remained significant (HR 1. 85, 95% CI 1. 10-3. 12; p=0. 020). Data from the MAINSAIL trial corroborated the association of PR (HR 0. 51, 95% CI 0. 22-1. 18; p=0. 12) and PD (HR 3. 51, 95% CI 1. 92-6. 43; p
In this study, we found an association between changes in objectively measurable tumors according to Response Evaluation Criteria in Solid Tumors (RECIST) and survival in patients with metastatic prostate cancer receiving docetaxel chemotherapy. Since bone scan and prostate-specific antigen changes are unreliable and measurable tumors are more frequently detected now because of better radiographic technology, a focus on RECIST changes should be considered during drug development to provide an objective signal of efficacy.
European urology. 2015 Oct 20 [Epub ahead of print]
Guru Sonpavde, Gregory R Pond, Arnoud J Templeton, Abderrahim Fandi, Bertrand Tombal, Mark Rosenthal, Andrew J Armstrong, Daniel P Petrylak
University of Alabama, Birmingham (UAB) School of Medicine, Birmingham, AL, USA. Electronic address: gsonpavde@uabmc. edu. , McMaster University, Hamilton, Ontario, Canada. , Department of Medical Oncology and Hematology, Kantonsspital St. Gallen, St. Gallen, Switzerland. , Celgene Corporation, Summit, NJ, USA. , Cliniques universitaires Saint Luc, Brussels, Belgium. , Royal Melbourne Hospital, Parkville, Australia. , Duke Cancer Institute, Durham, NC, USA. , Yale University, New Haven, CT, USA.