安罗替尼联合卡瑞利珠单抗与安罗替尼联合S-1作为晚期食管鳞状细胞癌二线治疗的疗效和毒性：一项真实世界回顾性研究
Efficacy and toxicity of anlotinib plus camrelizumab versus anlotinib plus S-1 as second-line therapy for advanced esophageal squamous cell carcinoma: A real-world retrospective study.
作者信息
Zhang Wei, Chen Mingyu, Dai Hong, Sun Wei
机构信息
Department of Oncology, Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu 210029, China.
The First School of Clinical Medicine, Nanjing University of Chinese Medicine, Nanjing, Jiangsu 210023, China.
出版信息
Cancer Pathog Ther. 2023 Dec 14;2(4):276-284. doi: 10.1016/j.cpt.2023.12.003. eCollection 2024 Oct.
BACKGROUND
No data exist on the efficacy and safety of anlotinib plus camrelizumab doublet as second-line therapy for advanced esophageal squamous cell carcinoma (ESCC). Although anlotinib and the programmed death-1 (PD-1) inhibitor camrelizumab are used as treatments for ESCC, the combined use of anlotinib and camrelizumab as a second-line therapy has not been reported. Therefore, this study explored the efficacy and toxicity of anlotinib plus camrelizumab as second-line therapy for advanced ESCC.
METHODS
Fifty-eight patients with advanced ESCC undergoing second-line therapy, either with anlotinib plus camrelizumab or anlotinib plus S-1, were enrolled and retrospectively analyzed at Jiangsu Province Hospital of Chinese Medicine from January 2020 to December 2021. The primary endpoint was progression-free survival (PFS), with secondary endpoints including the objective response rate (ORR), disease control rate (DCR), and assessment of toxicity.
RESULTS
In patients with advanced ESCC, the anlotinib plus camrelizumab group ( = 32) exhibited longer PFS (8.00 4.53 months, < 0.001), higher ORR (28.1 19.2%, = 0.431), and higher DCR (87.5 65.4%, = 0.045) than those in the anlotinib plus S-1 group ( = 26). Treatment-related adverse events (TRAEs) were predominantly grade 1/2 in both groups, with a higher incidence of grade 1/2 skin toxicity in patients treated with anlotinib plus camrelizumab ( = 0.033). Two patients (6.3%) developed grade 1/2 immune-related pneumonia. The incidence of grade 3/4 TRAEs did not differ significantly between the two groups. Multivariable Cox regression analysis identified that the drug regimen ( < 0.001), Eastern Cooperative Oncology Group performance status ( = 0.008), and differentiation grade ( = 0.008) were independent prognostic factors for PFS.
CONCLUSIONS
Anlotinib plus camrelizumab exhibited promising antitumor efficacy and manageable toxicity when used as a second-line treatment for advanced ESCC.
背景
关于安罗替尼联合卡瑞利珠单抗双药方案作为晚期食管鳞状细胞癌（ESCC）二线治疗的疗效和安全性，目前尚无相关数据。尽管安罗替尼和程序性死亡受体1（PD-1）抑制剂卡瑞利珠单抗均用于ESCC的治疗，但安罗替尼和卡瑞利珠单抗联合作为二线治疗的情况尚未见报道。因此，本研究探讨了安罗替尼联合卡瑞利珠单抗作为晚期ESCC二线治疗的疗效和毒性。
方法
选取2020年1月至2021年12月在江苏省中医院接受二线治疗的58例晚期ESCC患者，这些患者接受了安罗替尼联合卡瑞利珠单抗或安罗替尼联合S-1治疗，并进行回顾性分析。主要终点为无进展生存期（PFS），次要终点包括客观缓解率（ORR）、疾病控制率（DCR）以及毒性评估。
结果
在晚期ESCC患者中，安罗替尼联合卡瑞利珠单抗组（n = 32）的PFS长于安罗替尼联合S-1组（n = 26）（8.00 ± 4.53个月，P < 0.001），ORR更高（28.1% ± 19.2%，P = 0.431），DCR也更高（87.5% ± 65.4%，P = 0.045）。两组治疗相关不良事件（TRAEs）大多为1/2级，安罗替尼联合卡瑞利珠单抗治疗的患者1/2级皮肤毒性发生率更高（P = 0.033）。2例患者（6.3%）发生1/2级免疫相关肺炎。两组3/4级TRAEs的发生率无显著差异。多变量Cox回归分析确定，药物方案（P < 0.001）、东部肿瘤协作组体能状态（P = 0.008）和分化程度（P = 0.008）是PFS的独立预后因素。
结论
安罗替尼联合卡瑞利珠单抗作为晚期ESCC的二线治疗方案，显示出有前景的抗肿瘤疗效和可管理的毒性。
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