Erlotinib has comparable clinical efficacy to chemotherapy in pretreated patients with advanced non-small cell lung cancer (NSCLC): A propensity-adjusted, outcomes research-based study
Erlotinib has comparable clinical efficacy to chemotherapy in pretreated patients with advanced non-small cell lung cancer (NSCLC): A propensity-adjusted, outcomes research-based study
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DOI：
10.1016/j.lungcan.2016.07.027
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发表时间：
2016-10-01
期刊：
影响因子：
5.3
通讯作者：
Joerger, M.
中科院分区：
文献类型：
--
作者：
Neumair, P.;Joos, L.;Joerger, M.
目的：关于厄洛替尼在 EGFR 野生型晚期 NSCLC 患者中的整合存在争议。材料和方法：我们纳入了在 2005 年 1 月至 2014 年 12 月期间接受至少两线姑息性全身治疗且不携带靶向驱动突变的晚期 NSCLC 患者。主要研究终点是总生存期（OS），次要终点是无进展生存期（PFS）。我们使用 Kaplan-Meier 统计、多变量 Cox 回归和倾向评分或逆概率权重 (IPW) 匹配来比较接受二线或二线治疗的厄洛替尼患者与仅接受化疗的患者之间的临床结果。该研究有 90% 的功效检测出 30% 的生存优势。 结果：从总共 827 名患者中，我们排除了 171 名可能治愈的患者、189 名在我们研究所外接受治疗的患者、206 名未接受或仅接受一种系统治疗的患者、6 名患有 ALK 易位的患者和 28 名患有 EGFR 突变的患者。在最终疗效分析的 227 名患者中，125 名患者在第二线（89 名患者）、第三线（28 名）或进一步线（8 名）接受厄洛替尼治疗，102 名患者仅接受化疗。厄洛替尼组中女性和从不吸烟者的比例明显过高。与化疗组相比，使用厄洛替尼作为时间依赖性协变量进行 IPW 调整的 Cox 回归分析，厄洛替尼的 OS（风险比 (HR) = 1.14，95% CI 0.80-1.63，P = 0.448）和 PFS（HR = 1.20，95% CI 0.95-1.52，P = 0.119）相似从二线治疗开始，根据 ECOG 表现状态和治疗线进行分层。 ECOG 表现状态是选择厄洛替尼治疗患者的最有力的协变量。结论：本研究表明，对于经治疗的晚期 NSCLC 且无已知分子靶向改变的患者，厄洛替尼与化疗相比具有相似的临床疗效。 (C) 2016 Elsevier Ireland Ltd. 保留所有权利。
Objectives: Controversy exists about the integration of erlotinib in patients with EGFR wildtype, advanced NSCLC.Materials and methods: We included patients with advanced NSCLC receiving at least two lines of palliative systemic treatment between January 2005 and December 2014 and not harbouring targetable driver mutations. Primary study endpoint was overall survival (OS), secondary endpoint progression-free survival (PFS). We used Kaplan-Meier statistics, multivariate Cox regression and Propensity score or Inverse Probability Weights (IPW) matching to compare clinical outcome between patients receiving erlotinib in second or further line and those receiving chemotherapy only. The study had a power of 90% to detect a survival superiority of 30%.Results: From a total of 827 patients, we excluded 171 patients with potentially curative treatment, 189 receiving treatment outside of our institute, 206 receiving no or only one line of systemic treatment, 6 with ALK translocations and 28 with EGFR mutations. From 227 patients in the final efficacy analysis, 125 patients received erlotinib in second (89 patients), third (28) or further-line (8), and 102 patients received chemotherapy only. Women and never smokers were significantly overrepresented in the erlotinib group. Both OS (hazard ratio (HR) = 1.14, 95% CI 0.80-1.63, P = 0.448) and PFS (HR = 1.20, 95% CI 0.95-1.52, P = 0.119) were similar in the erlotinib compared to the chemotherapy group using IPW-adjusted Cox regression analysis treating the use of erlotinib as a time-dependent covariate starting from second-line treatment and stratified for ECOG performance status and treatment line. ECOG performance status was the most powerful covariate to select patients for erlotinib treatment.Conclusion: The present study suggests erlotinib to have similar clinical efficacy compared to chemotherapy in patients with pretreated advanced NSCLC and no known molecular targetable alterations. (C) 2016 Elsevier Ireland Ltd. All rights reserved.