[替利单抗联合新辅助化疗局部进展期胃癌围手术期的短期疗效及安全性结局]。

Q3 Medicine
Y W Chen, Y H Gao, Y S Zhao, X D Zhao, L Li, H Cui, H Zhang, C X Long, Z Qiao
{"title":"[替利单抗联合新辅助化疗局部进展期胃癌围手术期的短期疗效及安全性结局]。","authors":"Y W Chen, Y H Gao, Y S Zhao, X D Zhao, L Li, H Cui, H Zhang, C X Long, Z Qiao","doi":"10.3760/cma.j.cn441530-20250304-00081","DOIUrl":null,"url":null,"abstract":"<p><p><b>Objective:</b> In this study, we aimed to investigate the short-term efficacy and safety of perioperative administration of the PD-1 inhibitor tislelizumab combined with the SOX regimen (oxaliplatin plus S-1) in patients with locally advanced gastric cancer, and to identify factors influencing therapeutic outcomes. <b>Methods:</b> In this retrospective cohort study, we analyzed clinical data of 166 patients who had undergone perioperative therapy and D2 radical gastrectomy in the Department of General Surgery, First Medical Center of Chinese PLA General Hospital between September 2021 and September 2023. The cohort comprised 140 men and 26 women, of median age 62 years (range: 30-75). The patients were allocated to two groups: 62 receiving tislelizumab plus SOX (combination therapy group), and 104 SOX alone (chemotherapy-only group). Primary outcomes included pathological complete response rate, treatment-related adverse events, and complications of surgery. Secondary outcomes comprised major pathological response rate, tumor regression grade (Grades 1-2 denoting favorable response, Grade 3 moderate, and Grades 4-5 poor response), R0 resection rate, and short-term survival outcomes (1-year disease-free and overall survivals). Risk factors associated with pCR in the combination group were also analyzed. <b>Results:</b> The combination therapy group exhibited significantly higher rates of pCR (25.8% vs. 8.7%, χ<sup>2</sup>=8.93, <i>P</i>=0.003) and Grade 1 tumor regression (25.8% vs. 16.3%, χ<sup>2</sup>=15.32, <i>P</i>=0.001) than the chemotherapy-only group. There were no statistically significant differences in major pathological response rates (41.9% vs. 39.4%), R0 resection rates (96.8% vs. 97.1%,), treatment- related adverse events (48.4% vs. 42.3%,), surgical complications (9.7% vs. 12.5%), 1-year disease-free survival (82.3% vs. 78.8%), or 1-year overall survival (93.5% vs. 91.3%), There were no statistically significant differences (all <i>P</i>>0.05). Multivariate logistic analysis identified neural invasion as an independent risk factor for reduced pCR in the combination group (OR=0.10, 95%CI:0.01-0.85,<i>P</i>=0.035). <b>Conclusions:</b> Perioperative tislelizumab combined with SOX chemotherapy improves pathological response rates in patients with locally advanced gastric cancer and has favorable short-term efficacy and safety profiles. Neural invasion may diminish the therapeutic efficacy of immunotherapy.</p>","PeriodicalId":23959,"journal":{"name":"中华胃肠外科杂志","volume":"28 5","pages":"536-543"},"PeriodicalIF":0.0000,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Short-term effects and safety outcomes of the combination of tislelizumab and neoadjuvant chemotherapy in the perioperative treatment of locally advanced gastric cancer].\",\"authors\":\"Y W Chen, Y H Gao, Y S Zhao, X D Zhao, L Li, H Cui, H Zhang, C X Long, Z Qiao\",\"doi\":\"10.3760/cma.j.cn441530-20250304-00081\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Objective:</b> In this study, we aimed to investigate the short-term efficacy and safety of perioperative administration of the PD-1 inhibitor tislelizumab combined with the SOX regimen (oxaliplatin plus S-1) in patients with locally advanced gastric cancer, and to identify factors influencing therapeutic outcomes. <b>Methods:</b> In this retrospective cohort study, we analyzed clinical data of 166 patients who had undergone perioperative therapy and D2 radical gastrectomy in the Department of General Surgery, First Medical Center of Chinese PLA General Hospital between September 2021 and September 2023. The cohort comprised 140 men and 26 women, of median age 62 years (range: 30-75). The patients were allocated to two groups: 62 receiving tislelizumab plus SOX (combination therapy group), and 104 SOX alone (chemotherapy-only group). Primary outcomes included pathological complete response rate, treatment-related adverse events, and complications of surgery. Secondary outcomes comprised major pathological response rate, tumor regression grade (Grades 1-2 denoting favorable response, Grade 3 moderate, and Grades 4-5 poor response), R0 resection rate, and short-term survival outcomes (1-year disease-free and overall survivals). Risk factors associated with pCR in the combination group were also analyzed. <b>Results:</b> The combination therapy group exhibited significantly higher rates of pCR (25.8% vs. 8.7%, χ<sup>2</sup>=8.93, <i>P</i>=0.003) and Grade 1 tumor regression (25.8% vs. 16.3%, χ<sup>2</sup>=15.32, <i>P</i>=0.001) than the chemotherapy-only group. There were no statistically significant differences in major pathological response rates (41.9% vs. 39.4%), R0 resection rates (96.8% vs. 97.1%,), treatment- related adverse events (48.4% vs. 42.3%,), surgical complications (9.7% vs. 12.5%), 1-year disease-free survival (82.3% vs. 78.8%), or 1-year overall survival (93.5% vs. 91.3%), There were no statistically significant differences (all <i>P</i>>0.05). Multivariate logistic analysis identified neural invasion as an independent risk factor for reduced pCR in the combination group (OR=0.10, 95%CI:0.01-0.85,<i>P</i>=0.035). <b>Conclusions:</b> Perioperative tislelizumab combined with SOX chemotherapy improves pathological response rates in patients with locally advanced gastric cancer and has favorable short-term efficacy and safety profiles. Neural invasion may diminish the therapeutic efficacy of immunotherapy.</p>\",\"PeriodicalId\":23959,\"journal\":{\"name\":\"中华胃肠外科杂志\",\"volume\":\"28 5\",\"pages\":\"536-543\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-05-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中华胃肠外科杂志\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3760/cma.j.cn441530-20250304-00081\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中华胃肠外科杂志","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3760/cma.j.cn441530-20250304-00081","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

摘要

目的:本研究旨在探讨PD-1抑制剂tislelizumab联合SOX方案(奥沙利铂+ S-1)围手术期治疗局部晚期胃癌患者的短期疗效和安全性,并探讨影响治疗结果的因素。方法:回顾性队列研究,分析解放军总医院第一医疗中心普外科2021年9月至2023年9月期间接受围手术期治疗及D2根治性胃切除术的166例患者的临床资料。该队列包括140名男性和26名女性,中位年龄62岁(范围:30-75岁)。患者被分为两组:62例接受tislelizumab + SOX(联合治疗组),104例单独接受SOX(化疗组)。主要结局包括病理完全缓解率、治疗相关不良事件和手术并发症。次要结局包括主要病理反应率、肿瘤消退等级(1-2级为良好反应,3级为中等反应,4-5级为不良反应)、R0切除率和短期生存结局(1年无病生存和总生存)。同时分析联合用药组pCR相关的危险因素。结果:联合治疗组的pCR率(25.8%比8.7%,χ2=8.93, P=0.003)和1级肿瘤消退率(25.8%比16.3%,χ2=15.32, P=0.001)均显著高于单纯化疗组。两组主要病理反应率(41.9%比39.4%)、R0切除率(96.8%比97.1%)、治疗相关不良事件(48.4%比42.3%)、手术并发症(9.7%比12.5%)、1年无病生存率(82.3%比78.8%)、1年总生存率(93.5%比91.3%)差异均无统计学意义(P < 0.05)。多因素logistic分析发现,神经侵犯是联合用药组pCR降低的独立危险因素(OR=0.10, 95%CI:0.01-0.85,P=0.035)。结论:围手术期tislelizumab联合SOX化疗可提高局部晚期胃癌患者的病理反应率,具有良好的短期疗效和安全性。神经侵犯可能降低免疫治疗的疗效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Short-term effects and safety outcomes of the combination of tislelizumab and neoadjuvant chemotherapy in the perioperative treatment of locally advanced gastric cancer].

Objective: In this study, we aimed to investigate the short-term efficacy and safety of perioperative administration of the PD-1 inhibitor tislelizumab combined with the SOX regimen (oxaliplatin plus S-1) in patients with locally advanced gastric cancer, and to identify factors influencing therapeutic outcomes. Methods: In this retrospective cohort study, we analyzed clinical data of 166 patients who had undergone perioperative therapy and D2 radical gastrectomy in the Department of General Surgery, First Medical Center of Chinese PLA General Hospital between September 2021 and September 2023. The cohort comprised 140 men and 26 women, of median age 62 years (range: 30-75). The patients were allocated to two groups: 62 receiving tislelizumab plus SOX (combination therapy group), and 104 SOX alone (chemotherapy-only group). Primary outcomes included pathological complete response rate, treatment-related adverse events, and complications of surgery. Secondary outcomes comprised major pathological response rate, tumor regression grade (Grades 1-2 denoting favorable response, Grade 3 moderate, and Grades 4-5 poor response), R0 resection rate, and short-term survival outcomes (1-year disease-free and overall survivals). Risk factors associated with pCR in the combination group were also analyzed. Results: The combination therapy group exhibited significantly higher rates of pCR (25.8% vs. 8.7%, χ2=8.93, P=0.003) and Grade 1 tumor regression (25.8% vs. 16.3%, χ2=15.32, P=0.001) than the chemotherapy-only group. There were no statistically significant differences in major pathological response rates (41.9% vs. 39.4%), R0 resection rates (96.8% vs. 97.1%,), treatment- related adverse events (48.4% vs. 42.3%,), surgical complications (9.7% vs. 12.5%), 1-year disease-free survival (82.3% vs. 78.8%), or 1-year overall survival (93.5% vs. 91.3%), There were no statistically significant differences (all P>0.05). Multivariate logistic analysis identified neural invasion as an independent risk factor for reduced pCR in the combination group (OR=0.10, 95%CI:0.01-0.85,P=0.035). Conclusions: Perioperative tislelizumab combined with SOX chemotherapy improves pathological response rates in patients with locally advanced gastric cancer and has favorable short-term efficacy and safety profiles. Neural invasion may diminish the therapeutic efficacy of immunotherapy.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
中华胃肠外科杂志
中华胃肠外科杂志 Medicine-Medicine (all)
CiteScore
1.00
自引率
0.00%
发文量
6776
期刊介绍:
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信