国际肿瘤学杂志

国际肿瘤学杂志 ›› 2024, Vol. 51 ›› Issue (4): 210-216.doi: 10.3760/cma.j.cn371439-20230811-00035

• 论著 • 上一篇    下一篇

信迪利单抗与替雷利珠单抗在进展期食管鳞状细胞癌新辅助治疗中的疗效及安全性对比

杨毫, 施贵冬, 张程城, 张跃, 张力文, 付茂勇()   

  1. 川北医学院附属医院胸外科，南充 637000
  • 收稿日期:2023-08-11 修回日期:2023-12-14 出版日期:2024-04-08 发布日期:2024-05-10
  • 通讯作者: 付茂勇，Email：fumaoyongmd@163.com
  • 基金资助:
    南充市市校科教战略合作专项课题(22SXQT0095)

Comparison of efficacy and safety between sintilimab and tislelizumab in neoadjuvant therapy for advanced esophageal squamous cell carcinoma

Yang Hao, Shi Guidong, Zhang Chengcheng, Zhang Yue, Zhang Liwen, Fu Maoyong()   

  1. Department of Thoracic Surgery， Affiliated Hospital of North Sichuan Medical College， Nanchong 637000， China
  • Received:2023-08-11 Revised:2023-12-14 Online:2024-04-08 Published:2024-05-10
  • Contact: Fu Maoyong， Email：fumaoyongmd@163.com
  • Supported by:
    Nanchong City School Science and Education Strategic Cooperation Special Project(22SXQT0095)

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摘要：

目的 分析对比信迪利单抗与替雷利珠单抗在进展期食管鳞状细胞癌新辅助治疗中的近期疗效与安全性。方法 收集2021年1月至2022年10月于川北医学院附属医院胸外科行新辅助化疗（紫杉醇+奈达铂）联合免疫治疗的95例食管鳞状细胞癌患者的临床资料。依据使用免疫药物的不同，将其分为信迪利单抗组（n=58）及替雷利珠单抗组（n=37），对比两组新辅助治疗后客观缓解率（ORR）、不良反应发生情况、R0切除率、病理完全缓解（pCR）率等。结果 新辅助治疗2周期后，信迪利单抗组与替雷利珠单抗组具有类似的ORR[72.4%（42/58）比56.8%（21/37），χ2=2.48，P=0.115]。两组患者主要不良反应包括消化道反应（恶心、呕吐、腹泻）、血液系统毒性反应、甲状腺功能降低、脱发、肝肾功能损害、肺炎等，其中3级不良反应发生率均不足15%，无4级不良反应发生；信迪利单抗组甲状腺功能降低发生率明显高于替雷利珠单抗组[56.9%（33/58）比16.2%（6/37）]，差异具有统计学意义（χ2=15.45，P<0.001）。两组患者手术切除情况（χ2=1.26，P=0.661）、pCR率[31.0%（18/58）比32.4%（12/37），χ2=0.02，P=0.886]差异均无统计学意义。在术后并发症方面，两组患者术后均出现了部分肺部感染及吻合口瘘，但发生率均较低[19.0%（11/58）比24.3%（9/37），3.4%（2/58）比2.7%（1/37）]，差异均无统计学意义（χ2=0.39，P=0.532；χ2<0.01，P>0.999）。结论 对于进展期食管鳞状细胞癌的术前新辅助治疗，在化疗的基础上使用信迪利单抗或替雷利珠单抗均具有较好的近期疗效及安全性；使用信迪利单抗时需重视监测甲状腺功能。

关键词: 免疫疗法, 食道鳞癌, 药物相关性副作用和不良反应, 近期疗效

Abstract:

Objective To analyze and compare the short-term efficacy and safety of sintilimab and tislelizumab in neoadjuvant therapy for advanced esophageal squamous cell carcinoma. Methods The clinical data of 95 patients with esophageal squamous cell carcinoma who received neoadjuvant chemotherapy （paclitaxel + nedaplatin） combined with immunotherapy in the Department of Thoracic Surgery of the Affiliated Hospital of North Sichuan Medical College from January 2021 to October 2022 were collected. According to the different use of immune drugs， they were divided into the sintilimab group （n=58） and the tislelizumab group （n=37）. The objective remission rate （ORR）， adverse reactions， R0 resection rate， pathological complete response （pCR） rate， etc. were analyzed and compared between the two groups after neoadjuvant therapy. Results After 2 cycles of neoadjuvant therapy， the sintilimab group and the tislelizumab group had a similar ORR [72.4% （42/58） vs. 56.8% （21/37）， χ2=2.48， P=0.115]. The main adverse reactions of the two groups of patients included gastrointestinal reactions （nausea， vomiting， diarrhea）， hematological toxicity， hypothyroidism， alopecia， liver and kidney dysfunction， pneumonia， etc. The incidence of grade 3 adverse reactions was less than 15%， with no grade 4 adverse reactions. The incidence of hypothyroidism in the sintilimab group was significantly higher than that in the tislelizumab group [56.9% （33/58） vs. 16.2% （6/37）]， with a statistically significant difference （χ2=15.45， P<0.001）； There was no statistically significant difference in surgical resection （χ2=1.26， P=0.661） and pCR rate [31.0% （18/58） vs. 32.4% （12/37）， χ2=0.02， P=0.886] between the two groups of patients. In terms of postoperative complications， both groups of patients experienced partial pulmonary infections and anastomotic fistulas， but the incidence was relatively low [19.0% （11/58） vs. 24.3% （9/37）， 3.4% （2/58） vs. 2.7% （1/37）]， with no statistically significant difference （χ2=0.39， P=0.532； χ2<0.01， P>0.999）. Conclusion For preoperative neoadjuvant therapy of advanced esophageal squamous cell carcinoma， the use of either sintilimab or tislelizumab in addition to chemotherapy has good short-term efficacy and safety. Thyroid function should be monitored carefully when using sintilimab.

Key words: Immunotherapy, Esophageal squamous cell carcinoma, Drug-related side effects and adverse reactions, Short-term efficacy