Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial Journal Article


Authors: Robson, M.; Ruddy, K. J.; Im, S. A.; Senkus, E.; Xu, B.; Domchek, S. M.; Masuda, N.; Li, W.; Tung, N.; Armstrong, A.; Delaloge, S.; Bannister, W.; Goessl, C.; Degboe, A.; Hettle, R.; Conte, P.
Article 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 ‘improvement’ 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. © 2019 Elsevier Ltd
Keywords: breast cancer; health-related quality of life; brca; olaparib; eortc qlq-c30; olympiad
Journal Title: European Journal of Cancer
Volume: 120
ISSN: 0959-8049
Publisher: Elsevier Inc.  
Date Published: 2019-10-01
Start Page: 20
End Page: 30
Language: English
DOI: 10.1016/j.ejca.2019.06.023
PROVIDER: scopus
PUBMED: 31446213
PMCID: PMC6836724
DOI/URL:
Notes: Article -- Source: Scopus
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  1. Mark E Robson
    488 Robson