Triplet therapy in metastatic hormone-sensitive prostate cancer: A real-world Indian multicentre study.

e17086 Background: The survival benefit of upfront triplet therapy in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has been demonstrated in two prospective randomised trials using a combination of androgen deprivation therapy (ADT), docetaxel and an androgen receptor signalling inhibitor (ARSi) among abiraterone or darolutamide. This study aimed to evaluate the real-world outcomes of first-line triplet therapy in treating Indian mHSPC patients. Methods: In this multicentre retrospective study, patients with mHSPC started on upfront triplet therapy at three Eastern Indian centres between May 2022 and December 2023 were included. Patients were included if they received at least one cycle of triplet therapy. Descriptive statistics were used for reporting baseline patient and disease characteristics, treatments, and adverse events. Kaplan-Meier and life-table analyses were used for survival estimates. Results: Fifty-eight patients with mHSPC were included in this study. Most of the patients had de novo metastatic disease (93.1%). The mean age was 64 years (range 49-82), and the majority had Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (90%). High-volume disease was present in 94.8%, and 69% of patients had a Gleason score of 8 or higher. Comorbidities were present in 89.7% (2 or more in 37.9%). All the patients received a triplet combination of docetaxel, ADT, and abiraterone. The median number of triplet cycles received was 6. Grade 3 or worse adverse events occurred in 22.4% of patients without any treatment-related deaths. The most common grade ≥3 adverse events were hypertension (6.9%), febrile neutropenia (5.2%), hyperglycemia (5.2%), and urinary tract infection (3.4%). Dose reduction was required in 24.1%. Undetectable PSA (<0.2 ng/mL) as response was achieved in 62%. The 12-month overall survival rate was 98.3%, and the 12-month biochemical progression-free survival rate was 96.6%. Conclusions: First-line triplet therapy in Indian mHSPC patients was effective and tolerable with rare serious adverse events.