Robert Dreicer MD describes this negative finding which was nevertheless a fine study, indicating the value of large phase III investigations. Orteronel is similar in action to abiraterone, and there were responses: in the non-USA patients these responses were significant and would have given a positive finding for overall survival if the US patients behaved similarly. Our commentator said this indicated just how difficult it is to establish new therapies among a range of good options already in existence for metastatic, castrate-resistant, taxane refractory disease and explained that the US patients in this study were more likely to have crossed over to other therapies during the course of the investigation. This could be a rather interesting discussion and opens the door to looking in depth at castration-resistant mPC.
Robert Dreicer MD, FACP, Cleveland Clinic, Cleveland, OH
“Results from a phase 3, randomized, double-blind, multicenter, placebo-controlled trial of orteronel (TAK-700) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy (ELM-PC 5 trial).”
Abstract No: 7^