The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096).

Annals of medicine Pub Date : 2025-12-01 Epub Date: 2024-12-23 DOI:10.1080/07853890.2024.2443811
Xueru Zhu, Xiumei Ma, Hongxuan Li, Ming Zhang, Yan Cheng, Jianguo Wu, Wen Yu, Wen Feng, Lei Zhao, Zhigang Li, Xiaolong Fu, Jun Liu
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Abstract

Background: Several studies have shown that combining immune checkpoint inhibitors (ICIs) with antiangiogenic tyrosine kinase inhibitors is effective for solid tumors, including esophageal squamous cell carcinoma (ESCC). However, most of these studies were focused on immunotherapy-naive patients. This retrospective real-world study offers insights into the efficacy and safety of combining anlotinib with ICIs in locally advanced/metastatic ESCC patients who progressed on prior ICI.

Methods: We retrospectively analyzed the efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic ESCC patients who had progressed on PD-1 inhibitor. Efficacy was assessed according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The primary endpoints were the objective response rate (ORR) and disease control rate (DCR), while secondary endpoints were safety, overall survival (OS) and progression-free survival (PFS). Baseline characteristics and adverse events (AEs) were documented throughout the study.

Results: Between July 2020 and March 2022, 29 eligible patients were included in the final analysis, with 23 (79.3%) having previously undergone resection for ESCC. Of these 29 patients, 8 (27.6%) received first-line systemic therapy, 20 (69.0%) received second-line therapy, and 1 patient (3%) received third-line therapy. At the data cutoff, the ORR was 31.0%, and the DCR was 86.2%, with 9 patients achieving partial response (PR), 16 patients with stable disease (SD) and 4 patients with disease progression (PD). The median PFS was 5.33 months (95% CI: 4.28-6.38), and the median OS was 10.37 months (95% CI: 6.26-14.46). All patients experienced treatment-related adverse events (TRAEs), with anemia and lymphopenia being the most common. Only 2 patients (6.9%) experiencing grade 3-4 lymphopenia. All AEs were managed with symptomatic treatment and no treatment-related deaths occurred.

Conclusion: The combination of anlotinib and a PD-1 inhibitor demonstrated promising antitumor efficacy and manageable toxicity in patients with locally advanced/metastatic ESCC who progressed on prior ICI. This regimen represents a feasible and well-tolerated treatment option for this patient population.

Trial registration number: NCT04984096.

anlotinib + PD-1抑制剂在既往免疫检查点抑制剂(ICIs)进展的局部晚期/转移性食管鳞状细胞癌(ESCC)患者中的疗效和安全性:一项回顾性现实世界研究(NCT 04984096)。
背景:几项研究表明,免疫检查点抑制剂(ICIs)联合抗血管生成酪氨酸激酶抑制剂对包括食管鳞状细胞癌(ESCC)在内的实体肿瘤有效。然而,这些研究大多集中在免疫治疗新手患者身上。这项真实世界的回顾性研究为anlotinib联合ICIs治疗既往ICI进展的局部晚期/转移性ESCC患者的有效性和安全性提供了见解。方法:回顾性分析安洛替尼联合PD-1抑制剂治疗局部晚期/转移性ESCC患者PD-1抑制剂治疗进展的疗效和安全性。根据实体瘤应答评价标准1.1版(RECIST 1.1)评估疗效。主要终点是客观缓解率(ORR)和疾病控制率(DCR),次要终点是安全性、总生存期(OS)和无进展生存期(PFS)。在整个研究过程中记录了基线特征和不良事件(ae)。结果:在2020年7月至2022年3月期间,29名符合条件的患者被纳入最终分析,其中23名(79.3%)先前接受过ESCC切除术。在这29例患者中,8例(27.6%)接受了一线全身治疗,20例(69.0%)接受了二线治疗,1例(3%)接受了三线治疗。截止数据时,ORR为31.0%,DCR为86.2%,9例患者部分缓解(PR), 16例患者病情稳定(SD), 4例患者病情进展(PD)。中位PFS为5.33个月(95% CI: 4.28-6.38),中位OS为10.37个月(95% CI: 6.26-14.46)。所有患者均出现治疗相关不良事件(TRAEs),其中贫血和淋巴细胞减少最为常见。仅有2例(6.9%)出现3-4级淋巴细胞减少。所有不良事件均经对症治疗,无治疗相关死亡发生。结论:anlotinib联合PD-1抑制剂对既往ICI进展的局部晚期/转移性ESCC患者显示出良好的抗肿瘤疗效和可控的毒性。该方案为这类患者提供了一种可行且耐受性良好的治疗方案。试验注册号:NCT04984096。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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