SPARTAN Final Results on Apalutamide in Castration-Resistant Prostate Cancer
Posted: Thursday, July 2, 2020
Final data from the phase III SPARTAN trial in patients with nonmetastatic castration-resistant prostate cancer found that apalutamide plus androgen-deprivation therapy significantly improved overall survival compared with placebo plus androgen-deprivation therapy. Eric J. Small, MD, FASCO, of the Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, and colleagues presented the final results during the ASCO20 Virtual Scientific Program (Abstract 5516).
Patients on the combination of apalutamide and androgen-deprivation therapy had a median overall survival of 6 years, which was more than a 14-month improvement over those who received placebo plus androgen-deprivation therapy. Treatment discontinuation rates with apalutamide due to progressive disease were 42.7% versus 73.9% with placebo. Safety was consistent with previous reports. Adverse events of special interest were rash (5.2%), fractures (4.9%), falls (2.7%), and ischemic heart disease (2.6%).
Overall, 1,207 men were included in the trial, with 806 randomly assigned to apalutamide at 240 mg once daily and 401 patients to placebo. After the primary efficacy endpoint was met, 76 patients treated with placebo (19%) crossed over to apalutamide, and both overall survival and time to cytotoxic chemotherapy were evaluated. In addition, a sensitivity analysis for overall survival, accounting for crossover using a naive censoring approach, was conducted.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
