国际肿瘤学杂志

国际肿瘤学杂志 ›› 2024, Vol. 51 ›› Issue (3): 151-156.doi: 10.3760/cma.j.cn371439-20230506-00024

• 论著 • 上一篇    下一篇

Ⅲ~ⅣA期食管鳞状细胞癌根治性放化疗后行免疫检查点抑制剂维持治疗的真实世界临床研究

钱晓涛(), 石子宜, 胡格   

  1. 中国科学院合肥肿瘤医院肿瘤科，合肥 230000
  • 收稿日期:2023-05-06 修回日期:2023-08-30 出版日期:2024-03-08 发布日期:2024-04-10
  • 通讯作者: 钱晓涛，Email： moranqxt@163.com

A real-world clinical study of immunocheckpoint inhibitor maintenance therapy after radical radiotherapy and chemotherapy in stage Ⅲ-ⅣA esophageal squamous cell carcinoma

Qian Xiaotao(), Shi Ziyi, Hu Ge   

  1. Department of Oncology， Hefei Cancer Hospital， Chinese Academy of Sciences， Hefei 230000， China
  • Received:2023-05-06 Revised:2023-08-30 Online:2024-03-08 Published:2024-04-10
  • Contact: Qian Xiaotao， Email： moranqxt@163.com

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摘要：

目的 探讨Ⅲ~ⅣA期食管鳞状细胞癌（ESCC）根治性放化疗后行免疫检查点抑制剂维持治疗在真实世界的疗效。方法 回顾性分析2018年1月1日至2022年12月31日中国科学院合肥肿瘤医院收治的65例Ⅲ~ⅣA期行根治性放化疗ESCC患者的临床资料。根据患者根治性放化疗后是否行免疫检查点抑制剂维持治疗，将患者分为对照组（n=29）和免疫维持治疗组（n=36）。比较两组客观缓解率（ORR）、无进展生存期（PFS）及总生存期（OS）。采用Kaplan-Meier法绘制生存曲线并行log-rank检验，采用Cox回归模型行单因素和多因素分析。结果 对照组ORR为34.5%（10/29），免疫维持治疗组为61.1%（22/36），差异有统计学意义（χ2=4.56，P=0.032）。对照组和免疫维持治疗组患者中位PFS分别为7.2、17.9个月，差异有统计学意义（χ2=7.86，P=0.005）；中位OS分别为14.1、27.8个月，差异有统计学意义（χ2=5.40，P=0.020）。单因素分析显示，客观缓解（HR=0.09，95%CI为0.03~0.28，P<0.001）、免疫维持治疗（HR=0.38，95%CI为0.17~0.88，P=0.024）均是Ⅲ~ⅣA期行根治性放化疗ESCC患者OS的影响因素。多因素分析显示，客观缓解（HR=0.09，95%CI为0.03~0.29，P<0.001）、免疫维持治疗（HR=0.40，95%CI为0.17~0.92，P=0.032）均是Ⅲ~ⅣA期行根治性放化疗ESCC患者OS的独立影响因素。免疫维持治疗组不良反应发生率为22.22%（8/36），对照组为10.34%（3/29），差异无统计学意义（χ2=1.61，P=0.204）。不良反应均为1~2级，经对症处理后症状均得到缓解。结论 Ⅲ~ⅣA 期ESCC根治性放化疗后行免疫检查点抑制剂维持治疗可显著改善患者预后，安全性良好。

关键词: 食道鳞癌, 化放疗, 免疫检查点抑制剂

Abstract:

Objective To investigate the efficacy of immune checkpoint inhibitor maintenance therapy after radical radiotherapy and chemotherapy for stage Ⅲ-ⅣA esophageal squamous cell carcinoma （ESCC） in the real world. Methods The clinical data of 65 patients with stage Ⅲ-ⅣA ESCC treated by radical radiotherapy and chemotherapy from January 1， 2018 to December 31， 2022 in Hefei Cancer Hospital， Chinese Academy of Sciences were retrospectively analyzed. According to whether to undergo immune checkpoint inhibitor maintenance therapy after radical radiotherapy and chemotherapy， the patients were divided into a control group （n=29） and an immune maintenance therapy group （n=36）. The objective response rate （ORR）， progression-free survival （PFS）， and overall survival （OS） between the two groups were compared. Kaplan-Meier method was used to draw the survival curve accompanied with log-rank test. Cox regression model was used to conduct both univariate and multivariate analyses. Results The ORR was 34.5% （10/29） in the control group and 61.1% （22/36） in the immune maintenance therapy group， with a statistically significant difference （χ2=4.56， P=0.032）. The median PFS of control group and immune maintenance therapy group were 7.2 and 17.9 months， respectively， with a statistically significant difference （χ2=7.86， P=0.005）. The median OS was 14.1 and 27.8 months， respectively， with a statistically significant difference （χ2=5.40， P=0.020）. Univariate analysis showed that， objective response （HR=0.09， 95%CI： 0.03-0.28， P<0.001） and immune maintenance therapy （HR=0.38， 95%CI： 0.17-0.88， P=0.024） were the influential factors of OS in ESCC patients treaded by radical chemoradiotherapy in stage Ⅲ-ⅣA. Multivariate analysis showed that， objective response （HR=0.09， 95%CI： 0.03-0.29， P<0.001） and immune maintenance therapy （HR=0.40， 95%CI： 0.17-0.92， P=0.032） were the independent influencing factors for OS in ESCC patients treaded by radical chemoracial therapy in stage Ⅲ-ⅣA. The incidence of adverse reactions was 22.22% （8/36） in the immune maintenance therapy group and 10.34% （3/29） in the control group， with no statistically significant difference （χ2=1.61， P=0.204）. All the adverse reactions were grade 1-2， and the symptoms were relieved after symptomatic treatment. Conclusion Maintenance therapy with immune checkpoint inhibitors after radical chemoradiotherapy of stage Ⅲ-ⅣA ESCC can significantly improve the prognosis of patients with good safety.

Key words: Esophageal squamous cell carcinoma, Chemoradiotherapy, Immune checkpoint inhibitors