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

Eur J Cancer. 2019 Oct:120:20-30. doi: 10.1016/j.ejca.2019.06.023. Epub 2019 Aug 22.

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.

Keywords: BRCA; Breast cancer; EORTC QLQ-C30; Health-related quality of life; Olaparib; OlympiAD.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • BRCA1 Protein / genetics*
  • BRCA2 Protein / genetics*
  • Biomarkers, Tumor / genetics
  • Biomarkers, Tumor / metabolism
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / genetics
  • Breast Neoplasms / metabolism
  • Breast Neoplasms / pathology
  • Capecitabine / administration & dosage
  • Female
  • Follow-Up Studies
  • Furans / administration & dosage
  • Germ-Line Mutation*
  • Humans
  • International Agencies
  • Ketones / administration & dosage
  • Middle Aged
  • Neoplasm Metastasis
  • Patient Reported Outcome Measures*
  • Phthalazines / administration & dosage
  • Piperazines / administration & dosage
  • Prognosis
  • Quality of Life
  • Receptor, ErbB-2 / metabolism*
  • Survival Rate
  • Time-to-Treatment
  • Vinorelbine / administration & dosage
  • Young Adult

Substances

  • BRCA1 Protein
  • BRCA1 protein, human
  • BRCA2 Protein
  • BRCA2 protein, human
  • Biomarkers, Tumor
  • Furans
  • Ketones
  • Phthalazines
  • Piperazines
  • Capecitabine
  • ERBB2 protein, human
  • Receptor, ErbB-2
  • eribulin
  • Vinorelbine
  • olaparib