Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Department of Respiratory and Critical Care Medicine, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medicine School, Nanjing, China.
Medicine (Baltimore). 2024 Jul 5;103(27):e38459. doi: 10.1097/MD.0000000000038459.
Maintenance 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.
This 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.
The 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%.
Anlotinib 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.
维持治疗可显著改善接受化疗的晚期非小细胞肺癌（NSCLC）患者的预后。安罗替尼作为三线治疗药物，对 NSCLC 具有疗效、耐受性和给药便利性。本研究旨在评估安罗替尼维持治疗在晚期 NSCLC 患者铂类为基础的诱导化疗后的疗效和安全性。
这是一项在中国进行的 2 项多中心、开放标签、单臂、2 期临床研究（ALTER-L014 和 ALTER-L011）的汇总分析，纳入了 2018 年 9 月至 2021 年 1 月间局部晚期或转移性 NSCLC 且无已知敏感突变的患者。主要终点是无进展生存期。次要终点是客观缓解率、疾病控制率、总生存期和安全性。
汇总了 23 例患者的数据，其中 15 例来自 ALTER-L014，8 例来自 ALTER-L011。在 2021 年 6 月 13 日的截止日期，维持治疗开始后中位无进展生存期为 5.95（95%置信区间，4.30-8.80）个月。19 例患者疾病稳定，1 例部分缓解，3 例疾病进展。客观缓解率为 4.35%，疾病控制率为 86.96%。维持治疗开始后患者的中位总生存期为 18.60（95%置信区间，6.87-22.80）个月。≥3 级不良事件发生率为 21.7%。
在标准一线铂类为基础化疗后，对于无已知敏感突变的局部晚期或转移性 NSCLC 患者，安罗替尼可能为维持治疗提供新选择。
