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

Mark Robson, Kathryn J. Ruddy, Seock Ah IM, Elżbieta Senkus, Binghe Xu, Susan M. Domchek, Norikazu Masuda, Wei Li, Nadine Tung, Anne Armstrong, Suzette Delaloge, Wendy Bannister, Carsten Goessl, Arnold Degboe, Robert Hettle, Pierfranco Conte

Research output: Contribution to journalArticle

6 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)20-30
Number of pages11
JournalEuropean Journal of Cancer
Volume120
DOIs
StatePublished - Oct 2019

Keywords

  • BRCA
  • Breast cancer
  • EORTC QLQ-C30
  • Health-related quality of life
  • Olaparib
  • OlympiAD

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of 'Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial'. Together they form a unique fingerprint.

  • Cite this

    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. (2019). Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial. European Journal of Cancer, 120, 20-30. https://doi.org/10.1016/j.ejca.2019.06.023