@article{972f0b0b6e44453dae9d8c27c821419b,
title = "Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial",
abstract = "Background: The phase III OlympiAD study (NCT02000622) showed a statistically significant progression-free survival benefit with olaparib versus chemotherapy treatment of physician's choice (TPC) in patients with a germline BRCA mutation and human epidermal growth factor receptor 2-negative metastatic breast cancer. From this study, we report the effect of olaparib on health-related quality of life (HRQoL). Methods: Patients were randomised 2:1 to olaparib monotherapy (300 mg twice daily) or single-agent TPC. The primary HRQoL end-point was mean change from baseline in the two-item global health status/QoL score determined from patient-completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module (EORTC QLQ-C30) questionnaires and assessed using a mixed model for repeated measures. Symptoms and functioning domains, best overall response and time to deterioration of QoL were also evaluated. Results: Overall questionnaire compliance rates were 93.2% for olaparib and 76.3% for TPC. Between-treatment global health status/QoL comparison showed a significant improvement in the olaparib arm versus the TPC arm, with mean change of 3.9 (standard deviation 1.2) versus −3.6 (2.2), a difference of 7.5 points (95% confidence interval [CI]: 2.48, 12.44; P = 0.0035). A higher proportion of patients in the olaparib arm showed a best overall response of {\textquoteleft}improvement{\textquoteright} in global health status/QoL (33.7% vs 13.4%). Median time to global health status/QoL deterioration was not reached in olaparib patients and was 15.3 months for TPC patients (hazard ratio: 0.44 [95% CI: 0.25, 0.77]; P = 0.004). For EORTC QLQ-C30 symptoms and functioning subscales, only nausea/vomiting symptom score was worse in the olaparib arm than in the TPC arm (across all visits compared with baseline). Conclusion: HRQoL was consistently improved for patients treated with olaparib, compared with chemotherapy TPC.",
keywords = "BRCA, Breast cancer, EORTC QLQ-C30, Health-related quality of life, Olaparib, OlympiAD",
author = "Mark Robson and Ruddy, {Kathryn J.} and IM, {Seock Ah} and El{\.z}bieta Senkus and Binghe Xu and Domchek, {Susan M.} and Norikazu Masuda and Wei Li and Nadine Tung and Anne Armstrong and Suzette Delaloge and Wendy Bannister and Carsten Goessl and Arnold Degboe and Robert Hettle and Pierfranco Conte",
note = "Funding Information: This study was supported by AstraZeneca and Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, NJ, USA (MSD), who are co-developing olaparib. The study sponsor, AstraZeneca , was involved in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript and decision to submit the manuscript for publication. Funding Information: M.R. reports receiving honoraria (advisory) from AstraZeneca and has served a consulting or advisory role for AstraZeneca, Daiichi Sankyo (uncompensated), McKesson, Merck (uncompensated) and Pfizer (uncompensated). Research funding has been received from AbbVie (institution), AstraZeneca (institution), Invitae (institution, in-kind), Medivation (institution), Myriad Genetics (institution, in-kind), Pfizer (institution) and Tesaro (institution). Travel or accommodation expenses have been received from AstraZeneca, and other transfer of value items are from AstraZeneca (editorial services) and Pfizer (editorial services). K.J.R. reports intellectual property interests for herself and her spouse regarding a discovery or technology relating to health or medicine. S-.A.I. has served a consultant role for AstraZeneca, Novartis, Spectrum, Hanmi, Pfizer and Roche and reports receiving research funding from AstraZeneca. E.S. reports receiving honoraria from Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Clinigen, Egis, Eli Lilly, Janssen, Novartis, Pfizer, Pierre Fabre, prIME, Roche and Teva; travel support from Amgen, AstraZeneca, Egis, Novartis, Pfizer and Roche and research funding from Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche and Samsung. B.X. reports no conflicts of interest. S.M.D. reports receiving honoraria from AstraZeneca, Clovis Oncology and Bristol-Myers Squibb, and research funding to the University of Pennsylvania from AstraZeneca and Clovis Oncology. N.M. reports receiving honoraria from Chugai Pharma, AstraZeneca, Pfizer and Takeda, and institutional research funding from Chugai Pharma, AstraZeneca, Kyowa Hakka Kirin, MSD, Novartis, Pfizer, Eli-Lilly and Daiichi Sankyo. W.L. reports no conflicts of interest. N.T. reports consulting for AstraZeneca and receiving grant support from Myriad Genetics and Ambry Genetics. A.A. reports receiving fees for serving on an advisory board from Roche and Syndax Pharmaceuticals and her spouse holding stock options in AstraZeneca. S.D. reports receiving honoraria from Novartis, Roche, AstraZeneca, Pfizer, GE Healthcare and Puma Biotechnology; consulting fees for Novartis, Roche, Pfizer, AstraZeneca and Puma Biotechnology; research funding from Novartis, Roche, AstraZeneca, Pfizer and Puma Biotechnology; and travel and accommodation expenses from Pfizer, AstraZeneca and Novartis. W.B., C.G., A.D. and R.H. are employees of AstraZeneca. P.C. reports being a member of speakers? bureaus of Roche, Novartis, AstraZeneca and GlaxoSmithKline and receiving travel and accommodation expenses from Novartis, GlaxoSmithKline and Celgene, and research funding from Roche, Novartis and Merck Serono.Medical writing assistance was provided by Debbi Gorman, PhD, and Martin Goulding, DPhil, from Mudskipper Business Ltd, funded by AstraZeneca and MSD.This study was supported by AstraZeneca and Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, NJ, USA (MSD), who are co-developing olaparib. The study sponsor, AstraZeneca, was involved in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript and decision to submit the manuscript for publication. Funding Information: M.R. reports receiving honoraria (advisory) from AstraZeneca and has served a consulting or advisory role for AstraZeneca, Daiichi Sankyo (uncompensated), McKesson, Merck (uncompensated) and Pfizer (uncompensated). Research funding has been received from AbbVie (institution), AstraZeneca (institution), Invitae (institution, in-kind), Medivation (institution), Myriad Genetics (institution, in-kind), Pfizer (institution) and Tesaro (institution). Travel or accommodation expenses have been received from AstraZeneca, and other transfer of value items are from AstraZeneca (editorial services) and Pfizer (editorial services). K.J.R. reports intellectual property interests for herself and her spouse regarding a discovery or technology relating to health or medicine. S-.A.I. has served a consultant role for AstraZeneca , Novartis , Spectrum , Hanmi, Pfizer and Roche and reports receiving research funding from AstraZeneca . E.S. reports receiving honoraria from Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Clinigen, Egis, Eli Lilly, Janssen, Novartis, Pfizer, Pierre Fabre, prIME, Roche and Teva; travel support from Amgen, AstraZeneca, Egis, Novartis, Pfizer and Roche and research funding from Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche and Samsung. B.X. reports no conflicts of interest. S.M.D. reports receiving honoraria from AstraZeneca , Clovis Oncology and Bristol-Myers Squibb , and research funding to the University of Pennsylvania from AstraZeneca and Clovis Oncology . N.M. reports receiving honoraria from Chugai Pharma, AstraZeneca , Pfizer and Takeda, and institutional research funding from Chugai Pharma, AstraZeneca , Kyowa Hakka Kirin, MSD , Novartis , Pfizer , Eli- Lilly and Daiichi Sankyo. W.L. reports no conflicts of interest. N.T. reports consulting for AstraZeneca and receiving grant support from Myriad Genetics and Ambry Genetics. A.A . reports receiving fees for serving on an advisory board from Roche and Syndax Pharmaceuticals and her spouse holding stock options in AstraZeneca . S.D. reports receiving honoraria from Novartis , Roche , AstraZeneca , Pfizer , GE Healthcare and Puma Biotechnology; consulting fees for Novartis , Roche , Pfizer , AstraZeneca and Puma Biotechnology; research funding from Novartis , Roche , AstraZeneca , Pfizer and Puma Biotechnology; and travel and accommodation expenses from Pfizer , AstraZeneca and Novartis . W.B., C.G., A.D. and R.H. are employees of AstraZeneca. P.C . reports being a member of speakers{\textquoteright} bureaus of Roche , Novartis , AstraZeneca and GlaxoSmithKline and receiving travel and accommodation expenses from Novartis , GlaxoSmithKline and Celgene, and research funding from Roche , Novartis and Merck Serono. Funding Information: Medical writing assistance was provided by Debbi Gorman, PhD, and Martin Goulding, DPhil, from Mudskipper Business Ltd, funded by AstraZeneca and MSD . Publisher Copyright: {\textcopyright} 2019 Elsevier Ltd",
year = "2019",
month = oct,
doi = "10.1016/j.ejca.2019.06.023",
language = "English (US)",
volume = "120",
pages = "20--30",
journal = "European Journal of Cancer",
issn = "0959-8049",
publisher = "Elsevier Limited",
}