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首页> 外文期刊>Cancer: A Journal of the American Cancer Society >Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial
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Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial

机译：依维莫司联合依西美坦治疗与安慰剂联合依西美坦治疗的晚期乳腺癌患者的健康相关生活质量在3期随机，对照，BOLERO-2试验中

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BACKGROUND: The randomized, controlled BOLERO-2 (Breast Cancer Trials of Oral Everolimus) trial demonstrated significantly improved progression-free survival with the use of everolimus plus exemestane (EVE + EXE) versus placebo plus exemestane (PBO + EXE) in patients with advanced breast cancer who developed disease progression after treatment with nonsteroidal aromatase inhibitors. This analysis investigated the treatment effects on health-related quality of life (HRQOL). METHODS: Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire, HRQOL was assessed at baseline and every 6 weeks thereafter until disease progression and/or treatment discontinuation. The 30 items in 15 subscales of the QLQ-C30 include global health status wherein higher scores (range, 0-100) indicate better HRQOL. This analysis included a protocol-specified time to definitive deterioration (TDD) analysis at a 5% decrease in HRQOL versus baseline, with no subsequent increase above this threshold. The authors report additional sensitivity analyses using 10-point minimal important difference decreases in the global health status score versus baseline. Treatment arms were compared using the stratified log-rank test and Cox proportional hazards model adjusted for trial stratum (visceral metastases, previous hormone sensitivity), age, sex, race, baseline global health status score and Eastern Cooperative Oncology Group performance status, prognostic risk factors, and treatment history. RESULTS: Baseline global health status scores were found to be similar between treatment groups (64.7 vs 65.3). The median TDD in HRQOL was 8.3 months with EVE + EXE versus 5.8 months with PBO + EXE (hazard ratio, 0.74; P =.0084). At the 10-point minimal important difference, the median TDD with EVE + EXE was 11.7 months versus 8.4 months with PBO + EXE (hazard ratio, 0.80; P =.1017). CONCLUSIONS: In patients with advanced breast cancer who develop disease progression after treatment with nonsteroidal aromatase inhibitors, EVE + EXE was associated with a longer TDD in global HRQOL versus PBO + EXE. Cancer 2013.
机译：背景：随机对照BOLERO-2（口服依维莫司的乳腺癌试验）试验显示，与安慰剂联合依西美坦（PBO + EXE）相比，依维莫司+依西美坦（EVE + EXE）与安慰剂+依西美坦（PBO + EXE）相比可显着改善无进展生存非甾体芳香酶抑制剂治疗后疾病发展的乳腺癌患者。该分析调查了治疗对健康相关生活质量（HRQOL）的影响。方法：使用欧洲研究和治疗癌症生活质量调查问卷组织核心30（EORTC QLQ-C30）问卷，在基线以及此后每6周评估HRQOL，直至疾病进展和/或治疗中止。 QLQ-C30的15个子量表中的30个项目包括整体健康状况，其中较高的分数（范围0-100）表明HRQOL较好。该分析包括协议规定的最终恶化时间（TDD）分析，其中HRQOL与基线相比降低了5％，且随后没有超过该阈值的增加。作者报告了使用整体健康状况得分相对于基线的10点最小重要差异降低后的其他敏感性分析。使用分层对数秩检验和Cox比例风险模型对治疗组进行比较，该模型针对试验层（内脏转移，先前激素敏感性），年龄，性别，种族，基线总体健康状况评分和东部合作肿瘤小组的表现状况，预后风险进行了调整因素和治疗史。结果：治疗组之间的总体健康状况基线得分相似（64.7 vs 65.3）。 EVE + EXE的HRQOL中位数TDD为8.3个月，PBO + EXE的中位数TDD为5.8个月（危险比，0.74; P = .0084）。在10点最小重要差异处，EVE + EXE的TDD中位数为11.7个月，而PBO + EXE的中位数TDD为8.4个月（危险比，0.80; P = .1017）。结论：在晚期乳腺癌患者中，非甾体芳香酶抑制剂治疗后疾病进展，EVE + EXE与总体HRQOL的TDD较PBO + EXE更长。癌症2013。

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