Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial
Autor: | C. Goessl, Nadine Tung, Suzette Delaloge, Wendy Bannister, Elżbieta Senkus, Binghe Xu, Arnold Degboe, Pierfranco Conte, Norikazu Masuda, Robert Hettle, Seock Ah Im, Kathryn J. Ruddy, Susan M. Domchek, Anne C Armstrong, Wei Li, Mark E. Robson |
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Rok vydání: | 2019 |
Předmět: |
0301 basic medicine
Oncology Male Cancer Research Receptor ErbB-2 Health-related quality of life BRCA OlympiAD Piperazines chemistry.chemical_compound 0302 clinical medicine Breast cancer Olaparib Quality of life Antineoplastic Combined Chemotherapy Protocols Neoplasm Metastasis Aged 80 and over BRCA1 Protein Hazard ratio Vinorelbine Ketones Middle Aged Prognosis Metastatic breast cancer EORTC QLQ-C30 humanities Survival Rate 030220 oncology & carcinogenesis Female medicine.symptom Adult medicine.medical_specialty Adolescent Nausea Breast Neoplasms Article Time-to-Treatment 03 medical and health sciences Young Adult Internal medicine medicine Biomarkers Tumor Humans Patient Reported Outcome Measures Furans Capecitabine Germ-Line Mutation Aged BRCA2 Protein business.industry BRCA mutation Repeated measures design International Agencies medicine.disease 030104 developmental biology chemistry Quality of Life Phthalazines business Follow-Up Studies |
Zdroj: | Eur J Cancer |
ISSN: | 1879-0852 |
Popis: | 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. |
Databáze: | OpenAIRE |
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