现代消化及介入诊疗2024,Vol.29Issue(7) :778-783,788.DOI:10.3969/j.issn.1672-2159.2024.07.005

真实世界中含恩沃利单抗方案治疗消化道腺癌患者的安全性及疗效研究

A real-world study evaluating the safety and efficacy of envafolimab-containing regimens in the treatment of digestive adenocarcinoma patients

武稼雪 赵健 王育生
现代消化及介入诊疗2024,Vol.29Issue(7) :778-783,788.DOI:10.3969/j.issn.1672-2159.2024.07.005

真实世界中含恩沃利单抗方案治疗消化道腺癌患者的安全性及疗效研究

A real-world study evaluating the safety and efficacy of envafolimab-containing regimens in the treatment of digestive adenocarcinoma patients

武稼雪 1赵健 2王育生3
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作者信息

  • 1. 030001 山西医科大学
  • 2. 030013 山西省肿瘤医院
  • 3. 030001 山西医科大学第一医院
  • 折叠

摘要

目的 回顾性分析真实世界中含恩沃利单抗的治疗方案治疗消化道腺癌的安全性和有效性数据.方法 回顾性收集2021年12月至2023年7月在山西省肿瘤医院接受含恩沃利单抗方案治疗的35例消化道腺癌患者的治疗信息.应用IBM SPSS Statistics 27统计学软件分析数据,对定量数据用均数±标准差或中位数表示,定性数据用频率和百分比表示,通过Kaplan-Meier(KM)法分析生存状况,使用GraphPad Prism 9.5.1制作图像.结果 108例患者中,35例符合入组标准.24(68.6%)例发生1~3级不良事件(AE),无4、5级AE发生.免疫治疗可能相关不良事件发生率为31.4%.总体不良事件发生的中位时间为4.8个月.35例患者中有23例至少接受了一次疗效评估,5例达到部分缓解(PR),15例达到病情稳定(SD),无患者达到完全缓解(CR),客观缓解率(ORR)为21.7%,疾病控制率(DCR)为87.0%.在6例错配修复蛋白缺失/微卫星高度不稳定性(dMMR/MSI-H)病变患者中,ORR为50%,DCR为100%.在17例错配修复功能完整/微卫星稳定(pMMR/MSS)病变患者中,ORR为11.8%,DCR为82.4%.结论 真实世界中含恩沃利单抗的方案治疗消化道腺癌显示出良好的安全性,同时具有较好的疗效.

Abstract

Objective To retrospectively analyze the safety and efficacy data of envafolimab-containing treatment regimens for digestive adenocarcinoma in the real world.Methods Treatment information of 35 patients with digestive adenocarcinoma who received envafolimab-containing regimens at Shanxi Provincial Cancer Hospital from December 2021 to July 2023 was retrospectively collected.Data were analyzed using IBM SPSS Statistics 27.Descriptive statistics were used to present quantitative data as mean±standard deviation or median,and qualitative data as frequency and percentage.Survival status was analyzed using the Kaplan-Meier(KM)method,and graphs were created using GraphPad Prism 9.5.1.Results Among 108 patients,35 met the inclusion criteria.Twenty-four(68.6%)experienced grade 1-3 adverse events(AEs),with no grade 4 or 5 AEs.The incidence rate of immune-related AEs was 31.4%.The median time to overall AE occurrence was 4.8 months.Twenty-three of the 35 patients underwent at least one efficacy evaluation,with 5 achieving partial response(PR)and 15 achieving stable disease(SD).No patients achieved complete response(CR).The objective response rate(ORR)was 21.7%,and the disease control rate(DCR)was 87.0%.Among the six patients with deficient mismatch repair/microsatellite instability-high(dMMR/MSI-H)lesions,the ORR was 50%,and the DCR was 100%.Among the 17 patients with proficient mismatch repair/microsatellite stable(pMMR/MSS)lesions,the ORR was 11.8%,and the DCR was 82.4%.Conclusion Envafolimab-containing regimens demonstrate good safety and favorable efficacy in the real-world treatment of digestive adenocarcinoma.

关键词

恩沃利单抗/消化道腺癌/不良事件(AE)/安全性/PD-L1抑制剂

Key words

Envafolimab/Digestive adenocarcinoma/Adverse event/Safety/PD-L1 inhibitor

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基金项目

山西省卫生健康委员会项目(2022025)

出版年

2024
现代消化及介入诊疗
广东省医学学术交流中心

现代消化及介入诊疗

CSTPCD
影响因子:1.019
ISSN:1672-2159
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