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+).
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.
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.
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.
European urology. 2024 Sep 23 [Epub ahead of print]
Dana E Rathkopf, Guilhem Roubaud, Kim N Chi, Eleni Efstathiou, Gerhardt Attard, David Olmos, Eric J Small, Marniza Saad, Elena Castro, Won Kim, Daphne Wu, Kristi Bertzos, Shiva Dibaj, Jenny Zhang, Peter Francis, Matthew R Smith
Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY, USA. Electronic address: ., Department of Medical Oncology, Institut Bergonié, Bordeaux, France., BC Cancer, University of British Columbia, Vancouver, Canada., Houston Methodist Cancer Center, Houston, TX, USA., University College London, London, UK., Department of Medical Oncology, Instituto de Investigación Sanitaria, Hospital Universitario, 12 de Octubre, Madrid, Spain., Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco, San Francisco, CA, USA., Department of Clinical Oncology, University of Malaya, Kuala Lumpur, Malaysia., Intercentre Clinical Management Unit for Medical Oncology, University Hospital Virgen de la Victoria, Málaga, Spain., Janssen Research & Development, LLC, Los Angeles, CA, USA., Janssen Global Services, LLC, Horsham, PA, USA., Janssen Research & Development, LLC, San Diego, CA, USA., Janssen Research & Development, LLC, Raritan, NJ, USA., Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.