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
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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