Patient‐reported outcomes in castration‐resistant prostate cancer with bone metastases treated with radium‐223 with or without olaparib
Rana R. McKay, Wanling Xie, Archana Ajmera, Arlene Araneta, Edmund Folefac, Arif Hussain, Christos E. Kyriakopoulos, Adam Olson, Mamta Parikh, Rahul Parikh, Biren Saraiya, Geoffrey I. ShapiroAbstract
Background
The combination of olaparib plus radium‐223 improved progression‐free survival in patients with metastatic castration‐resistant prostate cancer with bone metastases (BM) in the multicenter, randomized, phase 2 COMRADE trial (NCT03317391). Here, the patient‐reported outcome (PRO) analysis of this trial is reported.
Methods
Patients were randomized 1:1 to olaparib plus radium‐223 (arm A) or radium‐223 alone (arm B). PROs were assessed via the Functional Assessment of Cancer Therapy–Prostate (FACT‐P) and Brief Pain Inventory (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. Mixed‐effects analysis‐of‐covariance models assessed PRO changes with adjustment for baseline characteristics among patients with baseline and ≥1 postbaseline assessment within 24 weeks.
Results
Of 114 treated patients, 74 (65%) were evaluable (arm A, n = 40; arm B, n = 34). Baseline characteristics were balanced, with a median age of 70–72 years and Eastern Cooperative Oncology Group performance status of 1 in 60%–62%, prior docetaxel in 50%–55%, >20 BM in 45%–47%, and pain medication use in 60%–72% of patients. No significant differences in FACT‐P total score change was observed at Week 12 (−4.87; 95% CI, −13.4 to 3.62) or Week 24 (1.79; 95% CI, −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; 95% CI, −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.
Conclusions
The addition of olaparib to radium‐223 was not associated with significant detriment to PROs or pain, which supports the tolerability of this combination.