Multicenter phase 2 trial of radium-223 with or without olaparib for mCRPC with bone metastases: PROs from COMRADE

In the multicenter, randomized phase 2 COMRADE trial, addition of olaparib to radium-223 improved progression-free survival in patients with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases (BM). Patient-reported outcome (PRO) analysis of the trial has now been published. Patients were randomized 1:1 to olaparib plus radium-223 (arm A) or radium-223 alone (arm B). PROs were assessed via the FACT-P and BPI at baseline and every 12 weeks. Clinically meaningful changes were defined as a ≥ 10-point change in FACT-P total score and a ≥ 30% or ≥ 2-point change in BPI score. Of 114 treated patients, 74 were evaluable (40 in arm A and 34 in arm B). Baseline characteristics were balanced. No significant differences in FACT-P total score change at week 12 (-4.87; 95% CI -13.4 to 3.62) or week 24 (-1.79; -8.28 to 11.9). BPI pain severity did not differ at week 12 (0.44; 95% CI -0.44 to 1.33) or week 24 (-0.20; -1.32 to 0.93). Arm B showed greater improvement in BPI pain interference at week 12 (1.09; 95% CI 0.14 to 2.05), which was not sustained at week 24. The authors conclude that addition of olaparib to radium-223 was not associated with significant detriment in PROs or pain among patients with mCRPC with BM.