Drug development in metastatic prostate cancer: lessons from ACIS.

Abstract

Metastatic castration-resistant prostate cancer (mCRPC) remains fatal with current therapies. In The Lancet Oncology, Fred Saad and colleagues 1 Saad F Efstathiou E Attard G et al. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2021; (published online Sept 30.)https://doi.org/10.1016/S1470-2045(21)00402-2 Summary Full Text Full Text PDF PubMed Scopus (8) Google Scholar report the results of the ACIS trial, which was a randomised, phase 3, placebo-controlled study evaluating apalutamide plus abiraterone–prednisone versus placebo plus abiraterone–prednisone, in patients with mCRPC. The results showed that compared with abiraterone–prednisone alone, the combination of abiraterone–prednisone plus apalutamide significantly improved the primary endpoint of investigator-assessed radiographic progression-free survival, but did not improve the secondary endpoints of overall survival, time to initiation of cytotoxic chemotherapy, time to chronic opioid use, or time to pain progression. Although these results are unlikely to change clinical practice, several important lessons could be learned to guide future drug development. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 studyDespite the use of an active and established therapy as the comparator, apalutamide plus abiraterone–prednisone improved radiographic progression-free survival. Additional studies to identify subgroups of patients who might benefit the most from combination therapy are needed to further refine the treatment of mCRPC. Full-Text PDF