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Received:November 18, 2024 Published Online:January 20, 2025
Received:November 18, 2024 Published Online:January 20, 2025
中文摘要: 目的 探讨对局部进展期胃癌采用信迪利单抗联合奥沙利铂+卡培他滨（CapeOX）行新辅助治疗的短期疗效及安全性。
方法 回顾性分析河北北方学院附属第一医院2019年1月至2020年12月51例局部进展期胃癌行新辅助治疗患者的临床资料，采用信迪利单抗联合CapeOX化疗的24例为试验组，采用CapeOX化疗的27例为对照组，后经评估均行开腹或腹腔镜胃癌根治术。对两组患者进行病理肿瘤降期、肿瘤退缩分级（TRG）、病理完全缓解率（pCR）、主要病理学缓解率(MPR)评价，观察不良反应。
结果 试验组T分期总降期率和MPR高于对照组，但差异无统计学意义(62.50%vs40.74%，χ2 2.407，P=0.121； 25.00%vs3.70%，χ2 3.231，P=0.072)；N分期总降期率显著高于对照组(75.00%vs37.03%，χ2 7.396，P=0.007)。试验组TRG评定优于对照组(Z=2.444，P=0.015)，其中试验组达pCR（TRG 0级）4例，对照组0例。两组均未出现4级不良反应，各不良反应发生率差异均无统计学意义(P＞0.05)。试验组的免疫相关不良反应发生率不高，且均为1~2级，经对症支持治疗后好转。
结论 信迪利单抗联合CapeOX化疗对局部进展期胃癌患者行新辅助治疗，可降低肿瘤局部N分期，优化术后病理TRG，有利于提高患者的短期疗效，且安全可控。
Abstract:Objective To investigate the short-term efficacy and safety of sintilimab combined with oxaliplatin and capecitabine(CapeOX) chemotherapy as neoadjuvant therapy for locally advanced gastric cancer.
Methods From January 2019 to December 2020, 51 patients with locally advanced gastric cancer undergoing neoadjuvant therapy in the First Affiliated Hospital of Hebei North University were retrospectively analyzed. Twenty-four patients treated with sintilimab combined with CapeOX chemotherapy were the experimental group, and 27 patients treated with CapeOX chemotherapy were the control group. After evaluation, all patients underwent open or laparoscopic radical gastrectomy. Pathological tumor downstaging, tumor regression grade (TRG), pathological complete response rate (pCR) and major pathological response rate (MPR) were evaluated in the two groups, and adverse reactions were observed.
Results The total downstaging rate of T stage and MPR in experimental group were higher than those in control group, but with no statistically significant difference (62.50%vs 40.74%,χ2= 2.407,P= 0.121; 25.00%vs 3.70%,χ2 3.231,P=0.072), while the total downstaging rate of N stage was significantly higher than that of control group (75.00%vs 37.03%,χ2 7.396,P=0.007). The experimental group surpassed the control group in evaluation of TRG (Z=2.444,P=0.015), among which 4 cases in the experimental group reached pCR(TRG 0 grade) and 0 case in the control group. There were no grade 4 adverse reactions occurred, and no significant difference was found in the incidence of adverse reactions between the two groups (P＞0.05). The incidence of immune-related adverse reactions in the experimental group was not high, and all of them were grade 1-2, which improved after symptomatic and supportive treatment.
Conclusion Sintilimab combined with CapeOX chemotherapy as neoadjuvant therapy for patients with locally advanced gastric cancer can reduce the local tumor N stage, optimize the postoperative pathological TRG, which is conducive to improving the short-term efficacy of patients, and is safe and controllable.
keywords: Oxaliplatin Capecitabine Sintilimab Neoadjuvant therapy Locally advanced gastric cancer Short-term efficacy Adverse reactions
文章编号： 中图分类号：R735.2 文献标志码：A
基金项目:河北省医学科学研究课题（20200502）；张家口市科学技术局项目（2322042D）
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