METHODS: 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.
RESULTS: 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%.
CONCLUSIONS: 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.
方法:对2个多中心的汇总分析,开放标签,单臂,2期临床试验(ALTER-L014和ALTER-L011)纳入了2018年9月至2021年1月在中国患有局部晚期或转移性NSCLC且无已知敏感突变的患者.主要结果是无进展生存期。次要结果是客观反应率,疾病控制率,总生存率,和安全。
结果:收集了23例患者的数据,15来自ALTER-L014,8来自ALTER-L011。在2021年6月13日的截止日期,自维持治疗开始以来的中位无进展生存期为5.95(95%置信区间,4.30-8.80)个月。19名患者病情稳定,1有部分反应,3有进行性疾病。客观应答率为4.35%,疾病控制率为86.96%。自维持治疗开始以来,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%。
结论:安洛替尼可能为没有已知敏感突变的局部晚期或转移性NSCLC患者在标准的一线铂类化疗后维持治疗提供新的选择。