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- Title
Radium-223 plus Enzalutamide Versus Enzalutamide in Metastatic Castration-Refractory Prostate Cancer: Final Safety and Efficacy Results.
- Authors
MAUGHAN, BENJAMIN L.; KESSEL, ADAM; MCFARLAND, TAYLOR RYAN; SAYEGH, NICOLAS; NUSSENZVEIG, ROBERTO; HAHN, ANDREW W.; HOFFMAN, JOHN M.; MORTON, KATHYRN; SIROHI, DEEPIKA; KOHLI, MANISH; SWAMI, UMANG; BOUCHER, KENNETH; HAALAND, BENJAMIN; AGARWAL, NEERAJ
- Abstract
Background. Previously, we showed the combination of radium-223 and enzalutamide to be safe and associated with improved efficacy based on a concomitant decline in serum bone metabolism markers compared with enzalutamide alone in a phase II trial of men with metastatic castration-resistant prostate cancer (mCRPC) [1]. Methods. Secondary endpoints were not included in our initial report, and we include them herein, after a median follow-up of 22 months. These objectives included long-term safety, prostate-specific antigen (PSA)--progression-free survival (PFS), and radiographic progression-free survival; PSA-PFS2 (time from start of protocol therapy to PSA progression on subsequent therapy); time to next therapy (TTNT); and overall survival (OS). Survival analysis and log-rank tests were performed using the R statistical package v.4.0.2 (https://www.r-project.org). Statistical significance was defined as p < .05. Results. Of 47 patients (median age, 68 years), 35 received the combination and 12 enzalutamide alone. After a median follow-up of 22 months, final safety results did not show any increase in fractures or other adverse events in the combination arm. PSA-PFS2 was significantly improved, and other efficacy parameters were numerically improved in the combination over the enzalutamide arm. Conclusion. The combination of enzalutamide and radium-223 was found to be safe and associated with promising efficacy in men with mCRPC. These hypothesis-generating results portend well for the ongoing phase III PEACE III trial in this setting.
- Subjects
RADIUMTHERAPY; THERAPEUTIC use of antineoplastic agents; DRUG efficacy; ANTIANDROGENS; METASTASIS; TREATMENT effectiveness; RANDOMIZED controlled trials; DESCRIPTIVE statistics; DATA analysis software; PROSTATE tumors; PATIENT safety
- Publication
Oncologist, 2021, Vol 26, Issue 12, p1006
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1002/onco.13949