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Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib Hammel, Pascal Kindler, H. L. Reni, M. Van Cutsem, Eric Hall, Michael J Macarulla Mercadé, Teresa Institut Català de la Salut [Hammel P] Department of Digestive Oncology, Hôpital Beaujon (AP-HP), Clichy, and University Paris VII, Paris, France. [Kindler HL] Department of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, USA. [Reni M] Department of Oncology, IRCCS Ospedale San Raffaele Scientific Institute, Milan, Italy. [Van Cutsem E] Division of Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium. [Macarulla T] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology, Barcelona, Spain. [Hall MJ] Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, USA Vall d'Hebron Barcelona Hospital Campus Pàncrees - Càncer Metàstasi Medicaments antineoplàstics DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis HEALTH CARE::Environment and Public Health::Public Health::Epidemiologic Measurements::Demography::Health Status::Quality of Life ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica ATENCIÓN DE SALUD::ambiente y salud pública::salud pública::medidas epidemiológicas::demografía::estado de salud::calidad de vida Qualitat de vida relacionada amb la salut; Olaparib; Càncer de pàncrees Calidad de vida relacionada con la salud; Olaparib, Cáncer de páncreas Health-related quality of life; Olaparib; Pancreatic cancer 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. This study was sponsored by AstraZeneca and is part of an alliance between AstraZeneca and MSD (no grant number). This research was funded in part through the NIH/NCI Cancer Center Support Grant P30-17 CA008748. 2021-04-20T11:30:52Z 2021-04-20T11:30:52Z 2019-12 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Hammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, et al. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959–68. 1569-8041 https://hdl.handle.net/11351/5879 10.1093/annonc/mdz406 31562758 000507595800013 eng Annals of Oncology;30 https://www.sciencedirect.com/science/article/pii/S092375342032559X?via%3Dihub Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess application/pdf Oxford University Press Scientia