Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC
Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC
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DOI：
10.1016/j.jtho.2018.05.015
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发表时间：
2018-09-01
影响因子：
20.4
通讯作者：
Rizvi, Naiyer
中科院分区：
文献类型：
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作者：
Gettinger, Scott;Hellmann, Matthew D.;Rizvi, Naiyer
简介：方法：对EGFR酪氨酸激酶抑制剂（TKI）初治或TKI治疗但未接受化疗的晚期EGFR突变NSCLC患者，给予nivolumab 3 mg/kg，每2周1次，厄洛替尼150 mg/d，直至疾病进展或出现不可接受的毒性反应。主要目标是安全性和耐受性。结果：20例TKI治疗的患者和1例TKI初治EGFR突变型NSCLC患者接受纳武单抗加厄洛替尼治疗。治疗相关的3级毒性发生在5名患者中（肝酶升高，n = 2;腹泻，n = 2;体重减轻，n = 1），没有≥ 4级毒性。在TKI治疗人群中，客观缓解率为15%（3/20，包括1例完全缓解），24周无进展生存率为48%。根据研究者记录，缓解持续13.8、17.6和38.2个月。第四名患者的非常规免疫相关反应持续了12.5个月。在这四名患者中，两人从不吸烟，各有一人吸烟35- 50次。
Introduction: This phase I study evaluated nivolumab combined with erlotinib in patients with advanced EGFR-mutant NSCLC.Methods: Patients with advanced EGFR-mutant NSCLC who were EGFR tyrosine kinase inhibitor (TKI)-naive or TKI-treated but had not received chemotherapy were treated with nivolumab 3 mg/kg every 2 weeks and erlotinib 150 mg/d until disease progression or unacceptable toxicity. The primary objective was safety and tolerability.Results: Twenty patients with TKI-treated and one with TKI-naive EGFR-mutant NSCLC were treated with nivolumab plus erlotinib. Treatment-related grade 3 toxicities occurred in five patients (liver enzyme elevations, n = 2; diarrhea, n = 2; weight loss, n = 1), with no grade >= 4 toxicities. In the TKI-treated population, the objective response rate was 15% (3 of 20, including one complete response), and the 24-week progression-free survival rate was 48%. Responses lasted 13.8, 17.6, and 38.2 months per investigator records. A fourth patient had a nonconventional immune-related response lasting 12.5 months. Among these four patients, two were never-smokers and one each had 35-and