LUX-Lung 6 研究：阿法替尼对比顺铂/吉西他滨用于亚洲 EGFR 突变阳性晚期非小细胞肺癌患者的开放标签 III 期研究：症状和生活质量改善。
Symptom and Quality of Life Improvement in LUX-Lung 6: An Open-Label Phase III Study of Afatinib Versus Cisplatin/Gemcitabine in Asian Patients With EGFR Mutation-Positive Advanced Non-small-cell Lung Cancer.
机构信息
*Division of Respiratory and Respiratory Critical Care Medicine, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand; †Guangdong Lung Cancer Institute, Guangdong Provincial Key Laboratory of Translational Medicine in Lung Cancer, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; ‡Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China; §Department of Pulmonary Medicine, Xiangya Hospital, Central South University, Changsha, China; ‖Department of Internal Medicine, Jiangsu Provincial Tumor Hospital, Nanjing, Jiangsu, China; ¶Shanghai Lung Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China; #Yunnan Tumor Hospital (The Third Affiliated Hospital of Kunming Medical University), Kunming, Yunnan Province, China; **Cancer Center, First Hospital of Jilin University, Changchun, China; ††Department of Oncology Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China; ‡‡Oncology Department, Lin Yi Tumor Hospital, Linyi, Shandong Province, China; §§Department of Internal Medicine, Konkuk University Medical Center, Seoul, South Korea; ‖‖Medical Statistics Department, Keele University, Keele, United Kingdom; ¶¶Boehringer Ingelheim International Trading, Shanghai, China; and ##Boehringer Ingelheim GmbH, Ingelheim, Germany.
出版信息
J Thorac Oncol. 2015 Jun;10(6):883-9. doi: 10.1097/JTO.0000000000000517.
INTRODUCTION
In the phase III, LUX-Lung 6 trial, afatinib prolonged progression-free survival (PFS) versus cisplatin/gemcitabine in Asian patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). This article provides detailed assessments of patient-reported outcomes (PROs), a LUX-Lung 6 secondary end point, and explores the relationship between PFS and health-related quality of life (QoL) in these patients.
METHODS
Patients (n = 364) were randomized (2:1) to oral afatinib (40 mg/day) or up to six cycles of cisplatin/gemcitabine (21-day cycle; cisplatin 75 mg/m(2) [d1]; gemcitabine 1000 mg/m(2) [d1,8]). QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and its lung cancer-specific module. The relationship between PFS (investigator assessment and independent review) and QoL was evaluated using analysis of covariance and a longitudinal model.
RESULTS
More patients treated with afatinib versus cisplatin/gemcitabine showed improvements in global health status/QoL (p < 0.0001) and physical (p < 0.0001), role (p = 0.013), and social (p < 0.001) functioning scales. Delayed symptom deterioration and better QoL over time was also observed with afatinib. QoL measured before tumor assessment was considerably poorer for patients with progression than those without progression, with significant differences in mean scores at multiple assessment time points. Results from the longitudinal analysis consistently demonstrated a significant negative impact of progression on QoL (p < 0.0001).
CONCLUSION
Afatinib improved PFS and PROs versus chemotherapy in EGFR mutation-positive NSCLC patients. Progression was associated with statistically significant worsening in QoL measured before tumor assessment, underscoring the value of PFS as a clinically relevant end point.
简介
在 III 期 LUX-Lung 6 试验中，阿法替尼与顺铂/吉西他滨相比，延长了表皮生长因子受体（EGFR）突变阳性非小细胞肺癌（NSCLC）亚洲患者的无进展生存期（PFS）。本文详细评估了患者报告的结果（PROs），这是 LUX-Lung 6 的次要终点，并探讨了这些患者的 PFS 与健康相关生活质量（QoL）之间的关系。
方法
患者（n = 364）按 2:1 随机分为口服阿法替尼（40mg/天）或最多六个周期的顺铂/吉西他滨（21 天周期；顺铂 75mg/m²[第 1 天]；吉西他滨 1000mg/m²[第 1、8 天]）。使用欧洲癌症研究与治疗组织生活质量问卷及其肺癌特定模块评估 QoL。使用协方差分析和纵向模型评估 PFS（研究者评估和独立审查）与 QoL 之间的关系。
结果
与顺铂/吉西他滨相比，更多接受阿法替尼治疗的患者在整体健康状况/QoL（p < 0.0001）、身体（p < 0.0001）、角色（p = 0.013）和社会（p < 0.001）功能方面有改善。阿法替尼还观察到症状恶化延迟和随时间推移 QoL 改善。与未进展的患者相比，进展患者的肿瘤评估前的 QoL 测量值明显更差，在多个评估时间点的平均得分存在显著差异。纵向分析的结果一致表明，进展对 QoL 有显著的负面影响（p < 0.0001）。
结论
阿法替尼与化疗相比，改善了 EGFR 突变阳性 NSCLC 患者的 PFS 和 PROs。进展与肿瘤评估前 QoL 的统计学显著恶化相关，强调了 PFS 作为临床相关终点的价值。
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