(Prostate Cancer) Is Rezvilutamide Plus ADT Effective?
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Rezvilutamide Plus ADT in Hormone-Sensitive Metastatic Prostate Cancer
On September 5, 2022, Weijie Gu and colleagues at Fudan University Shanghai Cancer Center published in the medical journal The Lancet the efficacy and safety results of the CHART Phase 3 trial evaluating rezvilutamide plus androgen deprivation therapy (ADT) in patients with hormone-sensitive metastatic prostate cancer.
Trial Design
The CHART Phase 3 trial was an open-label, international multicenter trial. Patients with hormone-sensitive metastatic prostate cancer (N=654) were randomized 1:1 to:
- Rezvilutamide (240 mg once daily) + ADT group (N=326)
- Bicalutamide + ADT group (N=328)
Primary endpoints: progression-free survival (PFS) and overall survival (OS).
Efficacy Results
At a median follow-up of 21.2 months, median PFS:
- Rezvilutamide + ADT group: Not reached
- Bicalutamide + ADT group: 25.1 months
At a median follow-up of 29.3 months, median OS:
- Both groups: Not reached
Safety Profile
Grade 3 or higher adverse events:
- Hypertension: Rezvilutamide + ADT 8% (N=26/323) / Bicalutamide + ADT 7% (N=24/324)
- Hypertriglyceridemia: Rezvilutamide + ADT 7% (N=24/323) / Bicalutamide + ADT 2% (N=7/324)
- Weight gain: Rezvilutamide + ADT 6% (N=20/323) / Bicalutamide + ADT 4% (N=12/324)
- Anemia: Rezvilutamide + ADT 4% (N=12/323) / Bicalutamide + ADT 5% (N=16/324)
- Hypokalemia: Rezvilutamide + ADT 3% (N=11/323) / Bicalutamide + ADT 4% (N=1/324)
- Serious adverse events: Rezvilutamide + ADT 28% / Bicalutamide + ADT 21%
- No deaths due to adverse events were confirmed in the rezvilutamide + ADT group
Conclusions
Based on the CHART trial results, Weijie Gu and colleagues concluded that rezvilutamide plus ADT therapy significantly improved both PFS and OS in patients with hormone-sensitive metastatic prostate cancer, with an acceptable safety profile.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00507-1/fulltext
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