在 LUX-Lung 8 中,阿法替尼二线治疗对比厄洛替尼一线化疗后晚期鳞状非小细胞肺癌患者的症状和生活质量改善:一项开放标签的 III 期研究。
Symptom and Quality of Life Improvement in LUX-Lung 8, an Open-Label Phase III Study of Second-Line Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung After First-Line Platinum-Based Chemotherapy.
机构信息
Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
Faculty of Medicine/Oncology, McGill University Health Centre, Royal Victoria Hospital, Montreal, Quebec, Canada.
出版信息
Clin Lung Cancer. 2018 Jan;19(1):74-83.e11. doi: 10.1016/j.cllc.2017.06.002. Epub 2017 Jun 23.
INTRODUCTION
In the phase III LUX-Lung 8 trial, afatinib significantly improved progression-free survival (PFS) and overall survival (OS) versus erlotinib in patients with squamous cell carcinoma (SCC) of the lung progressing during or after platinum-based chemotherapy. Patient-reported outcomes (PROs) and health-related quality of life (QoL) in these patients are presented.
PATIENTS AND METHODS
Patients (n = 795) were randomized 1:1 to oral afatinib (40 mg/d) or erlotinib (150 mg/d). PROs were collected (baseline, every 28 days until progression, 28 days after discontinuation) using the European Organization for Research and Treatment of Cancer QoL questionnaire and lung cancer-specific module. The percentage of patients improved during therapy, time to deterioration (TTD), and changes over time were analyzed for prespecified lung cancer-related symptoms and global health status (GHS)/QoL.
RESULTS
Questionnaire compliance was 77.3% to 99.0% and 68.7% to 99.0% with afatinib and erlotinib, respectively. Significantly more patients who received afatinib versus erlotinib experienced improved scores for GHS/QoL (36% vs. 28%; P = .041) and cough (43% vs. 35%; P = .029). Afatinib significantly delayed TTD in dyspnea (P = .008) versus erlotinib, but not cough (P = .256) or pain (P = .869). Changes in mean scores favored afatinib for cough (P = .0022), dyspnea (P = .0007), pain (P = .0224), GHS/QoL (P = .0320), and all functional scales. Differences in adverse events between afatinib and erlotinib, specifically diarrhea, did not affect GHS/QoL.
CONCLUSION
In patients with SCC of the lung, second-line afatinib was associated with improved prespecified disease-related symptoms and GHS/QoL versus erlotinib, complementing PFS and OS benefits with afatinib.
介绍
在 III 期 LUX-Lung 8 试验中,与厄洛替尼相比,阿法替尼显著改善了鳞状细胞癌(SCC)患者的无进展生存期(PFS)和总生存期(OS),这些患者在铂类化疗期间或之后进展。现将这些患者的患者报告结局(PROs)和健康相关生活质量(QoL)结果呈现出来。
患者和方法
患者(n=795)以 1:1 的比例随机分配至口服阿法替尼(40mg/d)或厄洛替尼(150mg/d)。使用欧洲癌症研究与治疗组织 QoL 问卷和肺癌特异性模块在基线、每 28 天直至疾病进展、停药后 28 天采集 PROs。分析了预设的肺癌相关症状和总体健康状况(GHS)/QoL 的治疗期间改善、恶化时间(TTD)和随时间的变化,以分析 GHS/QoL。
结果
阿法替尼和厄洛替尼的问卷依从性分别为 77.3%至 99.0%和 68.7%至 99.0%。与厄洛替尼相比,接受阿法替尼治疗的患者 GHS/QoL(36%比 28%;P=0.041)和咳嗽(43%比 35%;P=0.029)的评分改善更为显著。阿法替尼显著延迟了呼吸困难(P=0.008)的 TTD,而不是咳嗽(P=0.256)或疼痛(P=0.869)。咳嗽(P=0.0022)、呼吸困难(P=0.0007)、疼痛(P=0.0224)、GHS/QoL(P=0.0320)和所有功能量表的平均评分均有利于阿法替尼,这些变化有利于阿法替尼。阿法替尼和厄洛替尼之间的不良反应差异,特别是腹泻,并不影响 GHS/QoL。
结论
在 SCC 患者中,二线阿法替尼与厄洛替尼相比,改善了预设的疾病相关症状和 GHS/QoL,补充了阿法替尼的 PFS 和 OS 获益。