Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from the Randomized Phase 3 MAGNITUDE Trial.
Abiraterone acetate plus prednisone
Brief Pain Inventory–Short Form
EQ-5D-5L
Functional Assessment of Cancer Therapy–Prostate
Health-related quality of life
Metastatic castration-resistant prostate cancer
Niraparib
Patient-reported outcomes
Journal
European urology
ISSN: 1873-7560
Titre abrégé: Eur Urol
Pays: Switzerland
ID NLM: 7512719
Informations de publication
Date de publication:
23 Sep 2024
23 Sep 2024
Historique:
received:
26
03
2024
revised:
26
08
2024
accepted:
05
09
2024
medline:
25
9
2024
pubmed:
25
9
2024
entrez:
24
9
2024
Statut:
aheadofprint
Résumé
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 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 Treatment with niraparib + AAP maintained HRQoL with minimal side-effect bother reported by most patients with BRCA
Sections du résumé
BACKGROUND AND OBJECTIVE
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
METHODS
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
UNASSIGNED
All patients with BRCA
CONCLUSIONS AND CLINICAL IMPLICATIONS
CONCLUSIONS
Treatment with niraparib + AAP maintained HRQoL with minimal side-effect bother reported by most patients with BRCA
Identifiants
pubmed: 39317633
pii: S0302-2838(24)02594-6
doi: 10.1016/j.eururo.2024.09.003
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03748641']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.