Tuesday, March 24, 2015

NCCN Guidance on New Castration-Resistant Prostate Therapies Neil Osterweil March 17, 2015 part 3

Recent changes to the NCCN guidelines include a recognition that docetaxel can be repurposed in metastatic CRPC, as supported by the CHAARTED trial. It was demonstrated in that trial that median overall survival was 13.6 months longer with the combination of androgen-deprivation therapy (ADT) plus docetaxel than with ADT alone, and in men with high-volume metastatic disease, median overall survival was 17.0 months longer.
The guidelines also include recommendations about sipuleucel-T, supported by the IMPACT trial, in which median overall survival was 4.1 months longer with sipuleucel-T than with placebo, translating into a 22% reduction in the risk for death.
Data from the PREVAIL trial supported new recommendations on the use of enzalutamide. In that trial, enzalutamide was better than placebo at extending progression-free survival and reducing the risk for death. And in subsets of men with metastases to visceral organs, bone, or lymph nodes — all of whom have generally worse outcomes — enzalutamide prolonged progression-free survival.
New recommendations on the use of abiraterone acetate plus prednisone are based on results from the phase 3 COU-AA-302 registration trial, in which the abiraterone combination was associated with a doubling of progression-free survival over prednisone and placebo (16.5 vs 8.3 months). In addition, median overall survival was significantly better in the abiraterone group than in the placebo group (not reached vs 27.2 months; hazard ratio, 0.57; P = .01).
For men diagnosed with metastatic CRPC, options recommended in the guidelines for first-line therapy are enzalutamide, abiraterone plus prednisone, and docetaxel plus prednisone.



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