KEY TAKEAWAYS
- The MAGNITUDE phase 3 trial aimed to present PRO results from the BRCA1/2 cohort, focusing on pain, HRQoL, and side effects.
- The results revealed that NIRA+AAP delays pain worsening and minimizes treatment-associated side effects, supporting its benefit-risk profile.
In the Phase 3 MAGNITUDE study, niraparib (NIRA) alongside first-line abiraterone acetate plus prednisone (AAP) versus placebo (PBO) + AAP notably enhanced radiographic progression-free survival in metastatic castration-resistant prostate cancer (mCRPC).
Notably, the NIRA+AAP combination exhibited favorable overall survival and clinically relevant enhancements in time to symptomatic progression and cytotoxic chemotherapy, particularly in patients with a BRCA1/2 mutation. Patient-reported outcomes (PROs) were pivotal in assessing study outcomes.
Celine Nguyen and the team aimed to share the final analysis of PROs from the BRCA1/2 cohort in the MAGNITUDE study, covering pain, health-related quality of life (HRQoL), and side effect burden.
Eligible patients with mCRPC had Eastern Cooperative Oncology Group performance status of ≤1 and a Brief Pain Inventory–Short Form (BPI-SF) worst pain score of ≤3 on a scale of 0–10. Patients were randomized 1:1 to receive either NIRA+AAP or PBO+AAP.
Pain assessments (BPI-SF) and HRQoL evaluations (Functional Assessment of Cancer Therapy–Prostate [FACT-P]) were conducted on day 1 of specified cycles and during follow-up. Time to deterioration (TTD) in pain (BPI-SF worst, average, and pain interference) and FACT-P pain-related scale (PRS) were compared between treatment arms using proportional hazards regression models. Changes in HRQoL from baseline (FACT-P total score, range 0–156) were assessed using repeated measures analysis. Side effect bother was evaluated using FACT-P item GP5 in both treatment arms.
The results revealed that compliance with BPI-SF and FACT-P assessments exceeded 85% in 225 patients. At baseline, mean BPI-SF pain scores were 1.09 (SD, 1.57) in the NIRA+AAP arm and 1.35 (SD, 1.98) in the PBO+AAP arm. Mean FACT-P total scores were 116.33 (SD, 18.42) and 114.8 (SD, 18.9), respectively.
Regarding TTD, NIRA+AAP showed a numerically longer median TTD than PBO+AAP across pain measures (BPI-SF worst pain, pain interference, average pain) and FACT-P PRS.
The HRQoL remained stable during treatment, with no significant differences observed over time or between treatment arms for FACT-P total score. Across treatment cycles, 87% of NIRA+AAP and 92% of PBO+AAP subjects rated FACT-P item GP5, assessing the overall impact of treatment toxicity as “not at all” or “a little bit.”
The study concluded that NIRA+AAP effectively delayed pain worsening and resulted in minimal treatment-associated side effects. These findings provided additional evidence supporting the benefit-risk profile of NIRA+AAP for treating BRCA1/2-altered mCRPC.
The trial was sponsored by Janssen Research & Development, LLC.
Source: https://ons.confex.com/ons/2024/meetingapp.cgi/Paper/15603
Clinical Trial: https://clinicaltrials.gov/study/NCT03748641
Nguyen C, Rathkopf DE, N. Kim, et al. (2024). “Patient-Reported Outcomes in Patients with Metastatic Castration-Resistant Prostate Cancer and BRCA1/2 Mutations Receiving First-Line Niraparib with Abiraterone Acetate plus Prednisone (MAGNITUDE Study).” Presented at ONS 2024 (I34)
