Real-world efficacy and safety of darolutamide-based triplet therapy in Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC): A multicenter analysis from Zhejiang province (YHCG-006 study).

Abstract

e17090 Background: The ARASENS trial established that androgen deprivation therapy (ADT) combined with Darolutamide and Docetaxel improves survival in mHSPC. Given the lower chemotherapy tolerance reported in Asian populations and the paucity of Chinese real-world data, The Yi-Huan Genitourinary Cancer Group conducted a multicenter analysis (YHCG-006) to validate the efficacy and safety of this triplet regimen in a Chinese cohort in Zhejiang Province. Methods: We retrospectively analyzed 100 consecutive mHSPC patients (pts) treated with ADT, Darolutamide, and Docetaxel across 18 centers in Zhejiang Province, China (Aug 2022–Jan 2026). Evaluations included baseline characteristics, Docetaxel utilization, PSA dynamics, and treatment-related adverse events (AEs). Results: 100 mHSPC pts were included. The median age was 70 years (range, 43–87). All pts had metastatic disease at baseline, distributed as non-regional lymph nodes (M1a) 12%, bone (M1b) 70% with a median of 8 lesions, and visceral metastasis (M1c) 18%. High-grade histology was common (Gleason score ≥8 in 83%), and performance status was favorable in most (ECOG PS 0–1 in 86%; ECOG PS 2 in 12%). A high-risk classification was present in 80%, and high-volume disease was prevalent (69%). The median baseline PSA was 121.76 ng/ml (IQR, 33.60–375.07). With a median follow-up of 9.2 months (range, 0.8–37.3), ≥6 cycles of Docetaxel were administered in 62% of pts. Dose modifications included Docetaxel reduction in 18 pts (typically to 60 mg/m²) and Darolutamide reduction in 1 patient (to 600 mg/day due to rash). Supportive care included bone-protective agents in 41% and granulocyte colony-stimulating factor (G-CSF) in 32% (prophylactic in 5 pts). At 3 and 6 months, PSA 90 rates were 95.5% (84/88) and 97.8% (90/92), respectively. The proportions achieving PSA < 0.2 ng/ml were 44.3% (39/88) at 3 months and 59.1% (55/93) at 6 months. During follow-up, 67% of pts achieved a nadir PSA < 0.2 ng/ml, and 44% reached an ultra-low nadir PSA < 0.02 ng/ml. The median time to PSA < 0.2 ng/ml was 4.7 months. 9 pts experienced disease progression; median radiographic progression-free survival (rPFS) and overall survival (OS) were not reached at the time of analysis. 38 of 100 pts experienced ≥grade 3 AEs. Neutropenia was the most frequent grade 3 or 4 AE (30 cases), with febrile neutropenia in 13.3% (4/30) of these neutropenia cases. Conclusions: In this real-world Chinese cohort characterized by predominantly high-volume and high-risk disease, Darolutamide-based triplet therapy yielded rapid and deep PSA responses with acceptable toxicity. These findings support the feasibility and clinical utility of this regimen in Chinese mHSPC pts, while underscoring the importance of vigilant monitoring for chemotherapy-related AEs, particularly neutropenia.