Zhu Xueru, Ma Xiumei, Li Hongxuan, Zhang Ming, Cheng Yan, Wu Jianguo, Yu Wen, Feng Wen, Zhao Lei, Li Zhigang, Fu Xiaolong, Liu Jun
Department of Radiation Oncology, Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Radiation Oncology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Ann Med. 2025 Dec;57(1):2443811. doi: 10.1080/07853890.2024.2443811. Epub 2024 Dec 23.
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.
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.
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.
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.
NCT04984096.
多项研究表明，将免疫检查点抑制剂（ICI）与抗血管生成酪氨酸激酶抑制剂联合应用对包括食管鳞状细胞癌（ESCC）在内的实体瘤有效。然而，这些研究大多集中在未接受过免疫治疗的患者身上。这项回顾性真实世界研究深入探讨了在先前接受ICI治疗后病情进展的局部晚期/转移性ESCC患者中，安罗替尼与ICI联合应用的疗效和安全性。
我们回顾性分析了安罗替尼联合PD-1抑制剂在接受PD-1抑制剂治疗后病情进展的局部晚期/转移性ESCC患者中的疗效和安全性。根据实体瘤疗效评价标准第1.1版（RECIST 1.1）评估疗效。主要终点为客观缓解率（ORR）和疾病控制率（DCR），次要终点为安全性、总生存期（OS）和无进展生存期（PFS）。在整个研究过程中记录基线特征和不良事件（AE）。
2020年7月至2022年3月期间，29例符合条件的患者纳入最终分析，其中23例（79.3%）先前接受过ESCC切除术。在这29例患者中，8例（27.6%）接受一线全身治疗，20例（69.0%）接受二线治疗，1例（3%）接受三线治疗。在数据截止时，ORR为31.0%，DCR为86.2%，9例患者达到部分缓解（PR），16例疾病稳定（SD），4例疾病进展（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）。所有患者均经历了与治疗相关的不良事件（TRAEs），贫血和淋巴细胞减少最为常见。只有2例患者（6.9%）发生3-4级淋巴细胞减少。所有AE均采用对症治疗，未发生与治疗相关的死亡。
对于先前接受ICI治疗后病情进展的局部晚期/转移性ESCC患者，安罗替尼与PD-1抑制剂联合应用显示出有前景的抗肿瘤疗效和可控的毒性。该方案是该患者群体可行且耐受性良好的治疗选择。
NCT04984096。
