Mark Robson1, Kathryn J Ruddy2, Seock-Ah Im3, Elżbieta Senkus4, Binghe Xu5, Susan M Domchek6, Norikazu Masuda7, Wei Li8, Nadine Tung9, Anne Armstrong10, Suzette Delaloge11, Wendy Bannister12, Carsten Goessl13, Arnold Degboe13, Robert Hettle12, Pierfranco Conte14. 1. Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: robsonm@mskcc.org. 2. Department of Oncology, Mayo Clinic College of Medicine, Rochester, MN, USA. 3. Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea. 4. Medical University of Gdańsk, Gdańsk, Poland. 5. National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 6. Basser Center, University of Pennsylvania, Philadelphia, PA, USA; Memorial Sloan Kettering Cancer Center, New York, NY, USA. 7. National Hospital Organization, Osaka National Hospital, Osaka, Japan. 8. The First Hospital of Jilin University, Changchun, China. 9. Beth Israel Deaconess Medical Center, Dana-Farber Harvard Cancer Center, Boston, MA, USA. 10. Christie Hospital NHS Foundation Trust and Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK. 11. Institut Gustave Roussy, Villejuif, France. 12. AstraZeneca, Milton, Cambridge, UK. 13. AstraZeneca, Gaithersburg, MD, USA. 14. University of Padova, Padova, Italy; Istituto Oncologico Veneto IRCCS, Padova, Italy.
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 olaparibpatients and was 15.3 months for TPCpatients (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.
RCT Entities:
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 humanepidermal 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 olaparibpatients and was 15.3 months for TPCpatients (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.
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