Androgen Receptor Signaling Inhibitors for Metastatic Hormone Sensitive Prostate Cancer in Asians: Indirect...

Area of Science:

• Oncology
• Clinical Trials
• Prostate Cancer Research

Background:

• Androgen receptor signaling inhibitors (ARSI) combined with androgen deprivation therapy (ADT) improve survival in metastatic hormone-sensitive prostate cancer (mHSPC).
• Limited data exist for Asian patients, with subgroup analyses lacking statistical significance.
• This study addresses the need for more evidence in Asian mHSPC populations.

Purpose of the Study:

• To evaluate the efficacy of ARSI plus ADT in Asian patients with mHSPC.
• To provide pooled evidence on overall survival (OS) benefits in this demographic.
• To analyze survival trends in both overall Asian and Japanese subpopulations.

Main Methods:

• Systematic identification of clinical trials reporting OS outcomes for ARSI-based doublet therapy in Asian mHSPC patients.
• Reconstruction of individual patient data (IPD) from published Kaplan-Meier curves.
• Pooled survival analyses of reconstructed data from TITAN and LATITUDE trials for Asian and Japanese cohorts.

Main Results:

• Analysis of 291 reconstructed IPDs (146 ARSI + ADT, 145 placebo + ADT).
• Overall Asian cohort: 3-year OS of 85.2% (ARSI+ADT) vs 77.6% (placebo+ADT), HR=0.68 (p=0.07), a 32% reduction in death risk.
• Japanese subpopulation: 3-year OS of 77.4% vs 72.4%, HR=0.55 (p=0.07), a 45% reduction in death risk. Neither reached statistical significance.

Conclusions:

• An exploratory trend toward improved survival was observed with ARSI plus ADT in Asian mHSPC patients.
• The observed survival trend did not achieve statistical significance in this pooled analysis.
• Prospective studies are required to validate these exploratory findings and confirm efficacy in Asian populations.