• Yiqian Liu, Liyun Miao, Xiao Chen, Xiaoli Zhu, Yan Li, Jingdong He, Ping Chen, Shengbin Dai, Ziling Liu, Kewei Ma, Nanya Wang, Yuguang Zhao, Naifei Chen, Wei Song, Rilan Bai, Jiuwei Cui, and Yongqian Shu.
• Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
• Medicine (Baltimore). 2024 Jul 5; 103 (27): e38459e38459.

BackgroundMaintenance therapy could significantly improve the prognosis of patients with advanced non-small cell lung cancer (NSCLC) receiving chemotherapy. Anlotinib is effective, tolerable, and convenient in administration as a third-line treatment for NSCLC. This study aimed to evaluate the efficacy and safety of maintenance therapy with anlotinib after platinum-based induction chemotherapy for patients with advanced NSCLC.MethodsThis pooled analysis of 2 multicenter, open-label, single-arm, phase 2 clinical trials (ALTER-L014 and ALTER-L011) enrolled patients with locally advanced or metastatic NSCLC and without known sensitive mutations in China between September 2018 and January 2021. The primary outcome was progression-free survival. The secondary outcomes were objective response rate, disease control rate, overall survival, and safety.ResultsThe data of 23 patients were pooled, with 15 from ALTER-L014 and 8 from ALTER-L011. At the cutoff date of June 13, 2021, the median progression-free survival since the start of maintenance therapy was 5.95 (95% confidence interval, 4.30-8.80) months. Nineteen patients had stable disease, 1 had a partial response and 3 had progressive disease. The objective response rate was 4.35%, while disease control rate was 86.96%. The median overall survival of the patients since the start of maintenance therapy was 18.60 (95% confidence interval, 6.87-22.80) months. The incidence of adverse events of grade ≥ 3 was 21.7%.ConclusionAnlotinib might offer a new option for maintenance treatment in patients with locally advanced or metastatic NSCLC without known sensitive mutations after standard first-line platinum-based chemotherapy.Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.

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