Department of Oncology, San Luigi Hospital, University of Torino, Torino, Italy.
Global Oncology R&D, Daiichi Sankyo, Inc., Basking Ridge, New Jersey.
J Thorac Oncol. 2018 Jun;13(6):849-854. doi: 10.1016/j.jtho.2017.12.009. Epub 2017 Dec 27.
This exploratory subgroup analysis of the MARQUEE study evaluated the efficacy and safety of erlotinib plus tivantinib in patients with EGFR-mutant NSCLC.
Patients with advanced, nonsquamous, EGFR and mesenchymal-epithelial transition inhibitor-naive NSCLC previously treated with one or two lines of systemic therapy were randomized to oral erlotinib (150 mg once daily) plus tivantinib (360 mg twice daily) or to erlotinib plus placebo. The primary end point was overall survival.
Among 1048 patients enrolled, 109 (10.4%) had EGFR-mutant disease. Erlotinib plus tivantinib improved progression-free survival in this subpopulation; median progression-free survival was 13.0 months for erlotinib plus tivantinib (n = 56) and 7.5 months for erlotinib plus placebo (n = 53) (hazard ratio = 0.49, 95% confidence interval: 0.31-0.77). Deaths occurred in 73 patients (67%), and median overall survival was 25.5 months in the erlotinib plus tivantinib arm versus 20.3 months in the erlotinib plus placebo arm (hazard ratio = 0.68, 95% confidence interval: 0.43-1.08). Common adverse events included diarrhea, rash, and asthenia. Neutropenia and febrile neutropenia were more common with erlotinib plus tivantinib.
Erlotinib plus tivantinib was tolerable and showed improved efficacy over erlotinib monotherapy in previously treated EGFR-mutant NSCLC.
这项 MARQUEE 研究的探索性亚组分析评估了厄洛替尼联合替沃替尼在 EGFR 突变型 NSCLC 患者中的疗效和安全性。
先前接受过一线或二线系统治疗的晚期非鳞状、EGFR 且间质上皮转化抑制剂初治的 NSCLC 患者，按 1:1 比例随机分配至口服厄洛替尼（每日 150mg）联合替沃替尼（每日 2 次，每次 360mg）或厄洛替尼联合安慰剂组。主要终点为总生存期。
在纳入的 1048 例患者中，有 109 例（10.4%）患有 EGFR 突变型疾病。厄洛替尼联合替沃替尼改善了该亚组患者的无进展生存期；厄洛替尼联合替沃替尼组（n=56）的中位无进展生存期为 13.0 个月，厄洛替尼联合安慰剂组（n=53）的中位无进展生存期为 7.5 个月（风险比=0.49，95%置信区间：0.31-0.77）。共有 73 例患者（67%）死亡，厄洛替尼联合替沃替尼组的中位总生存期为 25.5 个月，厄洛替尼联合安慰剂组的中位总生存期为 20.3 个月（风险比=0.68，95%置信区间：0.43-1.08）。常见的不良反应包括腹泻、皮疹和乏力。中性粒细胞减少和发热性中性粒细胞减少在厄洛替尼联合替沃替尼组更为常见。
厄洛替尼联合替沃替尼在先前接受治疗的 EGFR 突变型 NSCLC 患者中耐受良好，与厄洛替尼单药治疗相比疗效提高。
