厄洛替尼100mg/天与吉非替尼250mg/天治疗表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌的疗效和耐受性比较（E100VG250）：一项开放标签、随机、2期研究
Efficacy and Tolerability of Erlotinib 100 mg/d vs. Gefitinib 250 mg/d in EGFR-Mutated Advanced Non-small Cell Lung Cancer (E100VG250): An Open-Label, Randomized, Phase 2 Study.
作者信息
Zhao Shen, Zhang Zhen, Fang Wenfeng, Zhang Yaxiong, Zhang Zhonghan, Hong Shaodong, Ma Yuxiang, Zhou Ting, Yang Yunpeng, Huang Yan, Zhao Hongyun, Zhang Li
机构信息
Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
State Key Laboratory of Oncology in South China, Guangzhou, China.
出版信息
Front Oncol. 2020 Nov 10;10:587849. doi: 10.3389/fonc.2020.587849. eCollection 2020.
Erlotinib-based combination therapy leads to increased efficacy but also toxicity for EGFR-mutated NSCLC. Reducing the dose of erlotinib could improve treatment tolerability, but few evidences are available regarding its efficacy at reduced dose. This randomized phase-2 study intends to compare the efficacy and tolerability between lower dose erlotinib (100 mg/d) and standard dose gefitinib (250 mg/d) in EGFR-mutated NSCLC. Patients with EGFR-mutated advanced NSCLC were randomized at 1:1 ratio to receive erlotinib 100 mg/d or gefitinib 250 mg/d until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR). Between April 2013 and September 2018, 171 patients were randomized to receive erlotinib ( = 85) and gefitinib ( = 86); 74 in the erlotinib group and 83 in the gefitinib group were include in analysis. DCR with erlotinib and gefitinib were 91% [95% CI 81.7-95.3] and 93% [85.1-96.6], respectively ( = 0.613). Response rate was 62% [50.8-72.4] in the erlotinib group and 53% [42.4-63.4] in the gefitinib group ( = 0.247). No significant difference was observed between erlotinib and gefitinib in median progression-free survival [10.1 vs. 11.3 months, HR = 1.295 [0.893-1.879], = 0.171] and median overall survival [26.6 vs. 28.7 months, HR = 0.999 [0.637-1.569], = 0.998]. Subgroup analyses by line of treatment, EGFR subtypes and status of central nervous system (CNS) metastasis found similar results. More toxicity [any-grade, 80 [96%] vs. 66 [89]; grade 3-4, 11 [13%] vs. 4 [5%]] and toxicity-related discontinuation [10 [12%] vs. 3 [4%]] occurred with gefitinib compared with erlotinib. But no significant difference was observed. Lower dose erlotinib (100 mg/d) achieved comparable efficacy compared with standard dose gefitinib (250 mg/d) in EGFR-mutated NSCLC. https://clinicaltrials.gov, identifier: NCT01955421.
基于厄洛替尼的联合治疗可提高疗效，但对表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）也会产生毒性。降低厄洛替尼剂量可提高治疗耐受性，但关于其低剂量疗效的证据较少。这项随机2期研究旨在比较低剂量厄洛替尼（100mg/天）与标准剂量吉非替尼（250mg/天）在EGFR突变NSCLC中的疗效和耐受性。EGFR突变的晚期NSCLC患者按1:1比例随机分组，接受100mg/天厄洛替尼或250mg/天吉非替尼治疗，直至疾病进展或出现不可接受的毒性。主要终点为疾病控制率（DCR）。2013年4月至2018年9月，171例患者被随机分组接受厄洛替尼（n = 85）和吉非替尼（n = 86）治疗；厄洛替尼组74例和吉非替尼组83例纳入分析。厄洛替尼和吉非替尼的DCR分别为91%[95%CI 81.7 - 95.3]和93%[85.1 - 96.6]（P = 0.613）。厄洛替尼组的缓解率为62%[50.8 - 72.4]，吉非替尼组为53%[42.4 - 63.4]（P = 0.247）。厄洛替尼和吉非替尼在中位无进展生存期[10.1对11.3个月，HR = 1.295[0.893 - 1.879]，P = 0.171]和中位总生存期[26.6对28.7个月，HR = 0.999[0.637 - 1.569]，P = 0.998]方面未观察到显著差异。按治疗线数、EGFR亚型和中枢神经系统（CNS）转移状态进行的亚组分析得出了类似结果。与厄洛替尼相比，吉非替尼出现更多毒性反应[任何级别，80例（96%）对66例（89%）；3 - 4级，11例（13%）对4例（5%）]和与毒性相关的停药情况[10例（12%）对3例（4%）]。但未观察到显著差异。低剂量厄洛替尼（100mg/天）在EGFR突变NSCLC中与标准剂量吉非替尼（250mg/天）疗效相当。https://clinicaltrials.gov，标识符：NCT01955421 。
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