奥林匹亚（OlympiAD）研究结果表明，对于生殖细胞BRCA突变且HER2阴性晚期乳腺癌患者，奥拉帕利与医师自选化疗方案相比，无进展生存获益显著（相关阅读：奥拉帕利对转移性乳腺癌伴基因突变患者优于标准化疗）。不过，奥拉帕利对于患者主观感受例如健康相关生活质量的影响尚不明确。
OlympiAD: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations (NCT02000622)
2019年8月22日，欧洲癌症治疗研究组织、欧洲癌症组织、欧洲乳腺癌专科医师学会《欧洲癌症杂志》在线发表美国阿斯利康、纽约纪念斯隆凯特林癌症中心、梅奥医学中心、宾夕法尼亚大学、哈佛大学贝斯以色列和新英格兰女执事医疗中心、达纳法伯癌症研究所哈佛癌症中心、韩国首尔大学、波兰格但斯克医科大学、日本大阪国立医院、英国阿斯利康、曼彻斯特大学克里斯蒂医院、法国古斯塔夫鲁西研究所、意大利帕多瓦大学、威尼托肿瘤研究所、中国医学科学院北京协和医学院附属肿瘤医院国家癌症中心徐兵河、吉林大学白求恩第一医院李薇等学者的研究报告，比较了奥拉帕利或化疗用于生殖细胞BRCA突变且HER2阴性晚期乳腺癌的患者报告结局。
该国际多中心非盲随机对照III期临床研究于2014年4月7日～2015年11月27日入组生殖细胞BRCA突变且HER2阴性晚期乳腺癌患者302例，按2∶1随机分组接受奥拉帕利单药治疗（300毫克每天2次）或医师自选单药化疗。主要健康相关生活质量终点为入组以来两项整体健康状况或生活质量评分的平均变化，数据来自患者完成的欧洲癌症研究与治疗组织（EORTC）生活质量问卷（QLQ）核心30项（C30），并且通过重复测量值混合模型分析进行评定。
结果，奥拉帕利组与医师选择组相比：
问卷完成率：93.2%、76.3%
整体健康状况或生活质量平均评分：提高3.9±1.2分、降低3.6±2.2分（相差7.5分，95%置信区间：2.48～12.44，P=0.0035）
整体健康状况或生活质量改善比例：33.7%比13.4%
整体健康状况或生活质量恶化时间：尚未恶化比15.3个月（风险比：0.44，95%置信区间：0.25～0.77，P=0.004）
症状和功能具体评分：仅恶心或呕吐的症状评分较低
因此，该研究结果表明，奥拉帕利与医师自选化疗方案相比，健康相关生活质量不断改善，仅恶心或呕吐的症状评分较低。
Eur J Cancer. 2019 Aug 22;120:20-30.
Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial.
Robson M, Ruddy KJ, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Li W, Tung N, Armstrong A, Delaloge S, Bannister W, Goessl C, Degboe A, Hettle R, Conte P.
Memorial Sloan Kettering Cancer Center, New York, NY, USA; Mayo Clinic College of Medicine, Rochester, MN, USA; Seoul National University College of Medicine, Seoul, South Korea; Medical University of Gdańsk, Gdańsk, Poland; National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; University of Pennsylvania, Philadelphia, PA, USA; Osaka National Hospital, Osaka, Japan; The First Hospital of Jilin University, Changchun, China; Beth Israel Deaconess Medical Center, Dana-Farber Harvard Cancer Center, Boston, MA, USA; Christie Hospital NHS Foundation Trust, The University of Manchester, Manchester, UK; Institut Gustave Roussy, Villejuif, France; AstraZeneca, Milton, Cambridge, UK; AstraZeneca, Gaithersburg, MD, USA; University of Padova, Padova, Italy; Istituto Oncologico Veneto IRCCS, Padova, Italy.
HIGHLIGHTS
Quality of life (QoL) during treatment was assessed by EORTC QLQ-C30 questionnaire.
There was significant improvement in QoL score for olaparib versus chemotherapy.
More patients receiving olaparib showed an improvement in functional subscales.
Only nausea/vomiting symptom score was worse with olaparib versus chemotherapy.
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: Olaparib, OlympiAD, Health-related quality of life, EORTC QLQ-C30, Breast cancer, BRCA
PMID: 31446213
DOI: 10.1016/j.ejca.2019.06.023
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