目前，化疗加免疫治疗，随后联合免疫单药维持治疗是广泛期小细胞肺癌（ES-SCLC）的首选一线治疗选择，但总生存期（OS）和无进展生存期（PFS）有限好处。抗血管生成药物与免疫疗法的结合显示出令人鼓舞的抗肿瘤活性和耐受性，并在一定程度上克服了免疫抵抗力。本研究旨在评价安罗替尼联合抗程序性细胞死亡1/配体1（抗PD-1/PD-L1）抗体作为ES-SCLC一线化疗联合免疫治疗后维持治疗的有效性和安全性。回顾性分析2020年6月和2021年12月陆军军医大学第一附属医院收治的12例初诊ES-SCLC患者。所有经过 4-6 个周期的一线含铂化疗加抗 PD-1/PD-L1 抗体治疗后未出现疾病进展的患者均接受安罗替尼治疗（12 mg 口服/天，第 1-14 天，随后停药 1 周，每每个周期 3 周）加抗 PD-1/PD-L1 抗体作为维持治疗。几名患者在维持治疗前接受了胸部放射治疗（使用 6 MV X 射线的强度调节放射治疗），疾病没有进展。评价安罗替尼联合抗PD-1/PD-L1抗体作为ES-SCLC一线化疗联合免疫治疗后维持治疗的有效性和安全性。中位随访时间为31.1个月。一线治疗（含维持治疗）期间，1例患者获得完全缓解，8例患者获得部分缓解（PR），3例患者病情稳定，客观缓解率为75.0%，疾病控制率为100.0 %。安罗替尼联合抗PD-1/PD-L1抗体维持治疗期间，50.0%的患者在前期初始治疗的基础上获得进一步的病灶缓解，其中1例患者达到PR。中位 PFS 为 13.6 [95% 置信区间 (CI)：11.2-15.6] 个月，中位 OS 为 19.5 (95% CI：14.5-24.5) 个月。与治疗相关的任何级别和 3-4 级不良事件 (AE) 的报告率分别为 100.0% 和 58.3%。没有观察到危及生命的 AE。 3-4 级 AE 包括白细胞减少症（58.3%，7/12）、血小板减少症（33.3%，4/12）、恶心（33.3%，4/12）、贫血（16.7%，2/12）和疲劳（8.3 ％，1/12）。维持治疗期间的所有 AE 均为耐受性，并被视为 1-2 级，其中大多数为疲劳、恶心、皮疹和咯血。安罗替尼与抗 PD-1/PD-L1 抗体联合治疗显示出令人鼓舞的有效性和安全性。治疗ES-SCLC患者，提示其可能成为一线化疗联合免疫治疗后维持治疗的首选。2024年胸科疾病杂志。版权所有。

Currently, chemotherapy plus immunotherapy followed by maintenance therapy with immune monotherapy is the preferred first-line treatment option for extensive-stage small cell lung cancer (ES-SCLC), but with limited overall survival (OS) and progression-free survival (PFS) benefits. The combination of anti-angiogenic drugs with immunotherapy has shown encouraging anti-tumor activity and tolerability, with some degree of overcoming immune resistance. This study aimed to evaluate the effectiveness and safety of anlotinib plus anti-programmed cell death 1/ligand 1 (anti-PD-1/PD-L1) antibodies as maintenance therapy after first-line chemotherapy combined with immunotherapy in ES-SCLC.Between June 2020 and December 2021, 12 patients with newly diagnosed ES-SCLC in the First Affiliated Hospital of Army Medical University were retrospectively analyzed. All patients without disease progression after 4-6 cycles of first-line platinum-containing chemotherapy plus anti-PD-1/PD-L1 antibodies received anlotinib (12 mg oral/day, days 1-14, followed by 1 week off, every 3 weeks per cycle) plus anti-PD-1/PD-L1 antibodies as maintenance therapy. Several patients underwent chest radiotherapy (intensity-modulated radiotherapy using a 6 MV X-ray) without disease progression before maintenance therapy. The effectiveness and safety of anlotinib plus anti-PD-1/PD-L1 antibodies as maintenance therapy after first-line chemotherapy combined with immunotherapy in ES-SCLC were evaluated.The median follow-up time was 31.1 months. During first-line treatment (including maintenance therapy), one patient achieved a complete response, eight patients achieved a partial response (PR), and three patients had stable disease, with an objective response rate of 75.0% and a disease control rate of 100.0%. During maintenance therapy with anlotinib plus anti-PD-1/PD-L1 antibodies, 50.0% of patients achieved further lesion remission on the basis of the prior initial treatment, of which one patient achieved a PR. The median PFS was 13.6 [95% confidence interval (CI): 11.2-15.6] months, and the median OS was 19.5 (95% CI: 14.5-24.5) months. Treatment-related any grade and grade 3-4 adverse events (AEs) were reported in 100.0% and 58.3% of patients, respectively. No life-threatening AEs were observed. Grade 3-4 AEs included leukocytopenia (58.3%, 7/12), thrombocytopenia (33.3%, 4/12), nausea (33.3%, 4/12), anemia (16.7%, 2/12), and fatigue (8.3%, 1/12). All AEs during maintenance therapy were tolerated and were regarded as grade 1-2, with the majority being fatigue, nausea, rash, and hemoptysis.The combination of anlotinib with anti-PD-1/PD-L1 antibodies demonstrated encouraging effectiveness and safety in treating patients with ES-SCLC, suggesting that it may be a preferred option for maintenance therapy after first-line chemotherapy combined with immunotherapy.2024 Journal of Thoracic Disease. All rights reserved.