Patient-reported outcomes (PROs) for rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy (ADT) in high-volume, metastatic, hormone-sensitive prostate cancer (mHSPC): An analysis of the CHART randomized, open-label, phase 3 trial.

5048 Background: In the CHART trial, rezvilutamide plus ADT significantly improved radiographic PFS and OS compared with bicalutamide plus ADT in patients with high-volume mHSPC (Gu et al., Lancet Oncol 2022). Here, we report the PRO results from the CHART trial. Methods: Eligible patients were men ≥18 years old with high-volume mHSPC and without previous chemotherapy or other localized treatment for prostate cancer. Patients were randomly assigned (1:1) to receive ADT plus either rezvilutamide (240 mg) or bicalutamide (50 mg) orally once daily. PROs were exploratory endpoints and were assessed in all randomized patients by using the Brief Pain Inventory-Short Form (BPI-SF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P). PROs were collected within 7 days prior to the first dose, on Day 1 of each cycle (28 days) in Cycles 2–12, once every 2 cycles in Cycles 13–36, once every 4 cycles afterwards, and on Day 30 after the last dose. Results: Between Jun 28, 2018, and Aug 6, 2020, a total of 654 patients were randomly assigned to receive either rezvilutamide plus ADT (n=326) or bicalutamide plus ADT (n=328). The data cutoff for this PRO analysis was Feb 28, 2022, and the median follow-up was 29.3 months (IQR 21.0–33.3). Baseline pain scores and functional status scores were comparable between the two study groups. The median time to progression of pain (both intensity and interference) was not reached in either group. The 25th percentile for the time to average pain progression was 25.8 months (95% CI 14.8–31.4) in the rezvilutamide plus ADT group and 11.7 months (95% CI 8.7–22.1) in the bicalutamide plus ADT group (HR 0.79, 95% CI 0.58–1.08; p=0.133). Patients in the rezvilutamide group exhibited a longer time to pain interference progression compared to the bicalutamide group (25th percentile, 20.2 months [95% CI 12.9–31.3] vs 10.2 months [95% CI 7.4–11.1]; HR 0.70 [95% CI 0.52–0.93]; p=0.015). Regarding functional status, the time to deterioration of the FACT-P total score was prolonged in the rezvilutamide plus ADT group compared to the bicalutamide plus ADT group (25th percentile, 12.8 months [95% CI 7.4–20.3] vs 6.0 months [95% CI 4.6–9.2]; HR 0.66, 95% CI 0.50–0.86; p=0.002). Additionally, the rezvilutamide plus ADT group exhibited delayed deterioration in all FACT-P subscale scores compared to the bicalutamide plus ADT group. Conclusions: Rezvilutamide plus ADT demonstrated superiority over bicalutamide plus ADT in delaying pain progression and functional status deterioration in high-volume mHSPC. Clinical trial information: NCT03520478 .