Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib Journal Article


Authors: Hammel, P.; Kindler, H. L.; Reni, M.; Van Cutsem, E.; Macarulla, T.; Hall, M. J.; Park, J. O.; Hochhauser, D.; Arnold, D.; Oh, D. Y.; Reinacher-Schick, A.; Tortora, G.; Algül, H.; O'Reilly, E. M.; McGuinness, D.; Cui, K. Y.; Joo, S.; Yoo, H. K.; Patel, N.; Golan, T.; on behalf of the POLO Investigators
Article Title: Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib
Abstract: Background: Patients with metastatic pancreatic cancer often have a detriment in health-related quality of life (HRQoL). In the randomized, double-blind, phase III POLO trial progression-free survival was significantly longer with maintenance olaparib, a poly(ADP-ribose) polymerase inhibitor, than placebo in patients with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) and metastatic pancreatic cancer whose disease had not progressed during first-line platinum-based chemotherapy. The prespecified HRQoL evaluation is reported here. Patients and methods: Patients were randomized to receive maintenance olaparib (300 mg b.i.d.; tablets) or placebo. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module at baseline, every 4 weeks until disease progression, at discontinuation, and 30 days after last dose. Scores ranged from 0 to 100; a ≥10-point change or difference between arms was considered clinically meaningful. Adjusted mean change from baseline was analysed using a mixed model for repeated measures. Time to sustained clinically meaningful deterioration (TSCMD) was analysed using a log-rank test. Results: Of 154 randomized patients, 89 of 92 olaparib-arm and 58 of 62 placebo-arm patients were included in HRQoL analyses. The adjusted mean change in Global Health Status (GHS) score from baseline was <10 points in both arms and there was no significant between-group difference [-2.47; 95% confidence interval (CI) -7.27, 2.33; P = 0.31]. Analysis of physical functioning scores showed a significant between-group difference (-4.45 points; 95% CI -8.75, -0.16; P = 0.04). There was no difference in TSCMD for olaparib versus placebo for GHS [P = 0.25; hazard ratio (HR) 0.72; 95% CI 0.41, 1.27] or physical functioning (P = 0.32; HR 1.38; 95% CI 0.73, 2.63). Conclusions: HRQoL was preserved with maintenance olaparib treatment with no clinically meaningful difference compared with placebo. These results support the observed efficacy benefit of maintenance olaparib in patients with a gBRCAm and metastatic pancreatic cancer. ClincalTrials.gov number: NCT02184195. © 2019 The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
Keywords: adult; controlled study; major clinical study; placebo; cancer growth; drug efficacy; cancer patient; metastasis; quality of life; randomized controlled trial; maintenance therapy; oncogene; scoring system; pancreas adenocarcinoma; hazard ratio; phase 3 clinical trial; pancreatic cancer; health-related quality of life; double blind procedure; brca; statistical model; physical performance; metastatic; olaparib; log rank test; germline mutation; oncological parameters; mixed model; human; male; female; priority journal; article; brca gene; european organization for research and treatment of cancer quality of life questionnaire core 30; global health status score; time to sustained clinically meaningful deterioration
Journal Title: Annals of Oncology
Volume: 30
Issue: 12
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2019-12-01
Start Page: 1959
End Page: 1968
Language: English
DOI: 10.1093/annonc/mdz406
PUBMED: 31562758
PROVIDER: scopus
PMCID: PMC6938600
DOI/URL:
Notes: Source: Scopus
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  1. Eileen O'Reilly
    461 O'Reilly