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Published on: February 6, 2015
Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene
Dana E Rathkopf1, Guilhem Roubaud2, Kim N Chi3
1Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY, USA.
Background And Objective:
The phase 3 MAGNITUDE trial assessed the efficacy and safety of niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) and alterations in homologous recombination repair (HRR) genes. Here we report final analysis results for patient-reported outcomes (PROs) in the HRR+ cohort with a focus on BRCA1/2 alterations (BRCA+).
Methods:
Protocol-specified endpoints evaluated patient-reported symptoms, health-related quality of life (HRQoL), and tolerability (side-effect bother) using the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EQ-5D-5L questionnaires. Evaluations were completed on day 1 of designated treatment cycles and during follow-up.
Key Findings And Limitations:
All patients with BRCA+ mCRPC (n = 225) were included in the PRO analyses with average on-treatment PRO compliance >80% when completed on-site. Time to deterioration in pain according to BPI-SF and FACT-P scores did not significantly differ between niraparib + AAP and placebo + AAP. During treatment, EQ-5D-5L revealed no clinically meaningful differences in overall HRQoL between treatment arms in the BRCA+ subgroup. Finally, tolerability was similar between arms; side effect bother rated as "not at all" or "a little bit" ranged from 79.8% to 95.9% during treatment. Limitations include a sample size that may not have been powered to detect a difference in PROs.
Conclusions And Clinical Implications:
Treatment with niraparib + AAP maintained HRQoL with minimal side-effect bother reported by most patients with BRCA+ mCRPC. Differences between treatment groups in time to pain deterioration did not meet conventional levels of statistical significance. The MAGNITUDE trial is registered on ClinicalTrials.gov as NCT03748641.
Insights
Niraparib plus abiraterone acetate maintained quality of life in patients with BRCA-positive metastatic castration-resistant prostate cancer. Most patients reported minimal side-effect bother, with no significant differences in pain deterioration between groups.
Area of Science:
- Oncology
- Genitourinary Cancer
- Prostate Cancer Research
Background:
- Metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene alterations presents treatment challenges.
- The MAGNITUDE trial investigated niraparib plus abiraterone acetate and prednisone (AAP) in mCRPC patients with HRR alterations.
Purpose of the Study:
- To report final patient-reported outcomes (PROs) from the MAGNITUDE trial in the HRR-positive (HRR+) cohort, focusing on BRCA1/2 alterations (BRCA+).
- To assess the impact of niraparib + AAP on patient-reported symptoms, health-related quality of life (HRQoL), and tolerability.
Main Methods:
- Utilized Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EQ-5D-5L questionnaires for PRO assessment.
- Evaluations were conducted systematically on designated treatment cycle days and during follow-up.
- PRO analyses included all 225 patients with BRCA+ mCRPC, with over 80% on-treatment compliance.
Main Results:
- Time to deterioration in pain (BPI-SF, FACT-P) did not significantly differ between niraparib + AAP and placebo + AAP arms.
- The EQ-5D-5L showed no clinically meaningful differences in overall HRQoL between treatment groups in the BRCA+ subgroup.
- Tolerability was comparable, with 79.8%-95.9% of patients reporting minimal side-effect bother during treatment.
Conclusions:
- Niraparib + AAP maintained HRQoL and was associated with minimal side-effect bother in most patients with BRCA+ mCRPC.
- Observed differences in time to pain deterioration did not reach conventional statistical significance.
- The study's sample size may limit the power to detect statistically significant differences in PROs.
