国际肿瘤学杂志

国际肿瘤学杂志››2024,Vol. 51››Issue (10): 620-626.doi:10.3760/cma.j.cn371439-20240410-00104

• 论著 •上一篇下一篇

替雷利珠单抗联合化疗在可切除食管癌新辅助治疗中的疗效及安全性评价

吴琴1, 吴栋1, 谢健龙1, 罗钦辉1, 劳良玲2, 曾宇斌1, 林立尧1()

  1. 1广东医科大学附属医院胸外科，湛江 524001
    2广东医科大学附属医院门诊部，湛江 524001
  • 收稿日期:2024-04-10修回日期:2024-07-25出版日期:2024-10-08发布日期:2024-12-04
  • 通讯作者:林立尧 E-mail:linliyao061@163.com
  • 基金资助:
    广东省医学科学技术研究基金(B2022007);湛江市科技计划(2022A01194)

Evaluation of efficacy and safety of tislelizumab combined with chemotherapy in neoadjuvant treatment for resectable esophageal cancer

Wu Qin1, Wu Dong1, Xie Jianlong1, Luo Qinhui1, Lao Liangling2, Zeng Yubin1, Lin Liyao1()

  1. 1Department of Thoracic Surgery， Affiliated Hospital of Guangdong Medical University， Zhanjiang 524001， China
    2Department of Out-patient， Affiliated Hospital of Guangdong Medical University， Zhanjiang 524001， China
  • Received:2024-04-10Revised:2024-07-25Online:2024-10-08Published:2024-12-04
  • Contact:Lin Liyao E-mail:linliyao061@163.com
  • Supported by:
    Guangdong Medical Science and Technology Research Fund Project(B2022007);Zhanjiang Science and Technology Plan Project(2022A01194)

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摘要：

目的分析替雷利珠单抗联合新辅助化疗治疗可切除食管鳞状细胞癌（ESCC）的近期疗效和安全性。方法收集2021年4月至2023年10月于广东医科大学附属医院胸外科行新辅助治疗后联合外科手术切除的56例ESCC患者的临床资料，根据术前新辅助治疗方式的不同分为新辅助化疗联合免疫治疗（化免）组（n=24）和新辅助化疗（化疗）组（n=32），对比两组患者术后肿瘤退缩分级、客观缓解率（ORR）、疾病控制率（DCR）、病理完全缓解（pCR）率、主要病理缓解（MPR）率、R0切除率、围手术期指标以及安全性。结果化免组患者肿瘤退缩分级优于化疗组，差异有统计学意义（Z=9.39，P=0.025）。化免组ORR为75.00%（18/24）、DCR为91.67%（22/24），化疗组ORR为46.88%（15/32）、DCR为65.62%（21/32），差异均有统计学意义（χ2=4.48，P=0.034；χ2=5.21，P=0.022）。化免组的R0切除率为87.50%（21/24），高于化疗组的59.38%（19/32），差异具有统计学意义（χ2=5.31，P=0.021）。化免组pCR率为29.17%（7/24）、MPR率为54.17%（13/24），化疗组pCR率为6.25%（2/32）、MPR率为28.12%（9/32），pCR率差异无统计学意义（χ2=3.78，P=0.052），MPR率差异有统计学意义（χ2=3.89，P=0.048）。化免组新辅助治疗结束至手术开始的间隔时间为（42.71±8.29）d、化疗组为（42.25±8.03）d，化免组患者术中出血量为（215.54±57.85）ml、化疗组为（229.65±57.74）ml，化免组患者手术时间为（293.52±37.50）min、化疗组为（295.31±37.66）min，化免组患者术后住院时间为（17.90±3.49）d、化疗组为（18.42±3.82）d，差异均无统计学意义（t=0.21，P=0.835；t=0.90，P=0.370；t=0.18，P=0.861；t=0.52，P=0.603）。在术后并发症方面，两组患者术后并发症总发生率差异无统计学意义[62.50%（15/24）比84.38%（27/32），χ2=0.59，P=0.440]。两组患者出现的主要药物不良反应包括白细胞计数降低、恶心呕吐、肝功能不全、皮肤瘙痒、甲状腺功能减退等，多为1~2级，3级共3例，无4级不良反应发生；化免组不良反应总发生率为62.50%（15/24），化疗组不良反应总发生率为65.62%（21/32），差异无统计学意义（χ2=0.06，P=0.809）。结论对于可切除ESCC的术前新辅助治疗，替雷利珠单抗联合化疗较单一化疗方案近期疗效更优，安全性良好，可改善手术疗效。

关键词:食管肿瘤,免疫疗法,替雷利珠单抗,新辅助化疗

Abstract:

ObjectiveTo analyze the short-term efficacy and safety of tislelizumab combined with neoadjuvant chemotherapy in the treatment of resectable esophageal squamous cell carcinoma （ESCC）.MethodsThe clinical data of 56 patients with ESCC who received neoadjuvant therapy combined with surgical resection in the Department of Thoracic Surgery， Affiliated Hospital of Guangdong Medical University from April 2021 to October 2023 were collected. According to the different preoperative neoadjuvant therapy methods， the patients were divided into neoadjuvant chemotherapy combined with immunotherapy group （chemoimmunization group，n=24） and neoadjuvant chemotherapy group （chemotherapy group，n=32）. The postoperative tumor regression grade， objective response rate （ORR）， disease control rate （DCR）， pathological complete response （pCR） rate， major pathological remssion （MPR） rate， R0 resection rate， perioperative indicators， and security were compared between the two groups.ResultsIn chemoimmunization group， the tumor regression grade was better than that in chemotherapy group， with a statistically significant difference （Z=9.39，P=0.025）. The ORR and the DCR were 75.00% （18/24） and 91.67% （22/24） in chemoimmunization group， and 46.88% （15/32） and 65.62% （21/32） in chemotherapy group， with statistically significant differences （χ2=4.48，P=0.034；χ2=5.21，P=0.022）. The R0 resection rate was 87.50% （21/24） in chemoimmunization group， which was higher than that of the chemotherapy group [59.38% （19/32）]， with a statistically significant difference （χ2=5.31，P=0.021）. The pCR rate and MPR rate were 29.17% （7/24） and 54.17% （13/24） in chemoimmunization group， and 6.25% （2/32） and 28.12% （9/32） in chemotherapy group， there was no statistically significant difference in pCR rate （χ2=3.78，P=0.052）， but there was a statistically significant difference in MPR rate （χ2=3.89，P=0.048）. The interval between the end of neoadjuvant treatment and the start of surgery was （42.71±8.29） days in chemoimmunization group， and （42.25±8.03） days in chemotherapy group. The intraoperative blood loss of patients was （215.54±57.85） ml in chemoimmunization group， and （229.65±57.74） ml in chemotherapy group. The operation time of patients was （293.52±37.50） minutes in chemoimmunization group， and （295.31±37.66） minutes in chemotherapy group. The postoperative hospitalization time of patients was （17.90±3.49） days in chemoimmunization group， and （18.42±3.82） days in chemotherapy group， all with no statistically significant differences （t=0.21，P=0.835；t=0.90，P=0.370；t=0.18，P=0.861；t=0.52，P=0.603）. In terms of postoperative complications， there was no statistically significant difference in the total incidence of postoperative complications between the two groups [62.50% （15/24）vs.84.38% （27/32），χ2=0.59，P=0.440]. The main adverse drug reactions in the two groups included decreased white blood cell count， nausea and vomiting， liver dysfunction， pruritus， hypothyroidism，etc. Most of them were grade 1-2， 3 cases were grade 3， and no grade 4 adverse reactions occurred. The total incidence of adverse reactions was 62.50% （15/24） in chemoimmunization group， and 65.62% （21/32） in chemotherapy group， with no statistically significant difference （χ2=0.06，P=0.809）.ConclusionFor the preoperative neoadjuvant therapy of resectable ESCC， the combination of tislelizumab and chemotherapy has better short-term efficacy and better safety than the single chemotherapy scheme， which can improve the surgical efficacy.

Key words:Esophageal neoplasms,Immunotherapy,Tislelizumab,Neoadjuvant chemotherapy