A real-world study evaluating the safety and efficacy of envafolimab-containing regimens in the treatment of digestive adenocarcinoma patients
10.3969/j.issn.1672-2159.2024.07.005
- VernacularTitle: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
- Author:
Jiaxue WU
1
;
Jian ZHAO
;
Yusheng WANG
Author Information
1. 030001 山西医科大学
- Keywords:
Envafolimab;
Digestive adenocarcinoma;
Adverse event;
Safety;
PD-L1 inhibitor
- From:
Modern Interventional Diagnosis and Treatment in Gastroenterology
2024;29(7):778-783,788
- CountryChina
- Language:Chinese
-
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.