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Sandy Srinivas, MD
Sandy Srinivas, MD
Posted: Thursday, December 1, 2022
According to findings from two interim analyses of the CHART trial, presented in The Lancet Oncology, rezvilutamide may be a better candidate than bicalutamide to join with androgen-deprivation therapy for some types of prostate cancer. In those with high-volume, metastatic, hormone-sensitive prostate cancer, rezvilutamide, a novel androgen receptor inhibitor, plus androgen-deprivation therapy significantly improved both radiographic progression–free and overall survival over bicalutamide plus androgen-deprivation, and it was found to have a tolerable safety profile.
“Our findings further validate the clinical benefit of adding second-generation androgen-receptor axis inhibitors to the androgen-deprivation therapy backbone in patients with metastatic, hormone-sensitive prostate cancer,” concluded Dingwei Ye, MD, of Fudan University Shanghai Cancer Center, and colleagues, on behalf of the CHART investigators.
The phase III study included 654 patients with high-volume metastatic, hormone-sensitive prostate cancer who were treated at 72 hospitals across China, Poland, Czech Republic, and Bulgaria between June 2018 and August 2020. Eligible participants were treatment-naive and had an Eastern Cooperative Oncology Group score of 0 or 1. Patients were randomly assigned to receive androgen-deprivation therapy plus either 240 mg of rezvilutamide daily (n = 326) or 50 mg of bicalutamide daily (n = 328).
The first interim analysis had a data cutoff of May 2021 and a median follow-up duration of 21.2 months. Median radiographic progression–free survival was significantly longer with rezvilutamide than with bicalutamide (not reached vs. 25.1 months). The second interim analysis had a data cutoff of February 2022 and a median follow-up duration of 29.3 months. Median overall survival was also significantly longer with rezvilutamide than with bicalutamide (not reached vs. not reached).
Common adverse events of grade III or higher with rezvilutamide included hypertension, hypertriglyceridemia, weight gain, anemia, and hypokalemia. Serious adverse events were reported in 28% of the rezvilutamide group (n = 90) and 21% of the bicalutamide group (n = 69). The sole treatment-related death occurred in the bicalutamide group.
Disclosure: For full disclosures of the study authors, visit thelancet.com.
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