信迪利单抗联合化疗在局部进展期胃癌新辅助治疗中的疗效及安全性分析  被引量:1

Efficacy and safety of sindilizumab combined with chemotherapy in neoadjuvant treatment of locally progressive gastric cancer

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作  者:邓忠权 陈德振 朱海强 吴佳明 DENG Zhongquan;CHEN Dezhen;ZHU Haiqiang;WU Jiaming(Zhejiang University of Traditional Chinese Medicine,Zhejiang Hangzhou 310053,China;Jiaxing First Hospital(Affiliated Hospital of Jiaxing University),Zhejiang Jiaxing 314000,China)

机构地区:[1]浙江中医药大学,浙江杭州310053 [2]嘉兴市第一医院(嘉兴大学附属医院),浙江嘉兴314000

出  处:《现代肿瘤医学》2025年第4期628-635,共8页Journal of Modern Oncology

基  金:浙江省医药卫生科技计划项目(编号:2024KY431)。

摘  要:目的:探究奥沙利铂+卡培他滨(XELOX)化疗方案联合PD-1抑制剂信迪利单抗在局部进展期胃癌新辅助治疗中的近期疗效及安全性。方法:收集2020年09月至2023年09月于嘉兴市第一医院胃肠外科行新辅助治疗的74例局部进展期胃癌患者的临床病理资料,依据新辅助治疗方案的不同,将接受XELOX化疗方案的患者设为对照组(n=38),在对照组的基础上联合免疫治疗PD-1抑制剂信迪利单抗设为观察组(n=36),探究新辅助PD-1免疫治疗联合化疗与单独新辅助化疗的病理完全缓解(pathological complete remission,pCR)率,主要病理缓解(major pathological remission,MPR)率,客观缓解率(objective remission rate,ORR),不良反应发生情况等。结果:观察组的病理完全缓解率高于对照组[27.8%(10/36)vs 7.9%(3/38)];观察组主要病理缓解率高于对照组[47.2%(17/36)vs 23.7%(9/38)];两组经过新辅助治疗3个周期后,观察组ORR高于对照组[52.8%(19/36)vs 26.3%(10/38)],两组pCR率(χ^(2)=5.05,P=0.025)、MPR率(χ^(2)=4.49,P=0.034)、ORR(χ^(2)=5.43,P=0.020)差异具有统计学意义。两组患者主要的不良反应包括血液系统毒性、胃肠道反应(腹泻、恶心、呕吐)、肝肾功能损害、皮肤损害、肺炎、甲状腺功能减退等,其中3至4级不良反应均不足15%。结论:对于局部进展期胃癌的术前新辅助治疗,在XELOX化疗方案的基础上联合使用信迪利单抗具有较好的近期疗效及安全性。Objective:To examine the recent efficacy and safety of capecitabine+oxaliplatin(XELOX)combined with PD-1 inhibitor sindilizumab in locally progressive gastric neoadjuvant therapy.Methods:The clinicopathological data of 74 cases of locally progressive gastric cancer treated with neoadjuvant therapy in the Department of Gastrointestinal Surgery of Jiaxing No.1 Hospital from September 2020 to September 2023 were collected.Based on the different neoadjuvant treatment protocols,the patients receiving XELOX protocol were set up as the control group(n=38),and the combination of the PD-1 inhibitor sindilizumab with XELOX was set as the observation group(n=36).In the observation group(n=36),the pathological complete remission(PCR)rate,major pathological remission(MPR)rate,objective remission rate(ORR),and the occurrence of adverse reactions associated with neoadjuvant PD-1 immunotherapy in combination with chemotherapy and neoadjuvant chemotherapy alone were investigated.Results:The pathological complete remission rate of the observation group was higher than that of the control group[27.8%(10/36)vs 7.9%(3/38)],as was the major pathological remission rate[47.2%(17/36)vs 23.7%(9/38)].The ORR of the observation group was higher than that of the control group after three cycles of neoadjuvant therapy in both groups[52.8%(19/36)vs 26.3%(10/38)].Furthermore,the differences in PCR rate,MPR rate,and ORR between the two groups were statistically significant.The Chi-squared test yielded statistically significant results for the following variables:MPR rate(χ^(2)=4.49,P=0.034),ORR(χ^(2)=5.43,P=0.020),and PCR rate(χ^(2)=5.05,P=0.025)between the two groups.The most common adverse reactions in both groups were hematological toxicity,gastrointestinal reactions(diarrhea,nausea,vomiting),liver and renal function impairment,skin damage,pneumonia,hypothyroidism,and so forth.Of these,less than 15%were grade 3 to 4 adverse reactions.Conclusion:For preoperative neoadjuvant treatment of locally progressive gastric cancer.The combination of

关 键 词:局部进展期胃癌 信迪利单抗 新辅助治疗 

分 类 号:R735.2[医药卫生—肿瘤]

 

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