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Abstract：
BACKGROUND: 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.
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.
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.
摘要：
背景：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。安洛替尼有效,可容忍,作为非小细胞肺癌的三线治疗，给药方便。本研究旨在评估铂类诱导化疗后安洛替尼维持治疗对晚期NSCLC患者的疗效和安全性。
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。
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。
