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新辅助信迪利单抗联合化疗治疗可切除胃食管交界腺癌的短期疗效和安全性

The short-term efficacy and safety of neoadjuvant Sintilimab combined with chemotherapy for resectable gastroesophageal junction adenocarcinoma.

作者信息

Chen Liji, Zhang Shifa, Ma Hongmei, Zhong Kaize, Yang Dongbao, Sun Jiuhe, Liu Hongfeng, Song Ru, Cai Haibo

机构信息

Jining Medical University, Jining, Shandong, 272000, P.R. China.

Department of Thoracic Surgery, Jining NO. 1 People's Hospital, Jining, Shandong, 272000, P. R. China.

出版信息

Langenbecks Arch Surg. 2024 Dec 12;410(1):5. doi: 10.1007/s00423-024-03576-6.

Abstract

INTRODUCTION

To explore whether neoadjuvant Sintilimab is suitable for patients with gastroesophageal junction (GEJ) adenocarcinoma, we designed this study to evaluate the short-term efficacy and safety of neoadjuvant Sintilimab in combination with chemotherapy for resectable GEJ adenocarcinoma.

METHODS

We retrospectively collected data on patients with GEJ adenocarcinoma who underwent surgery after receiving neoadjuvant immunotherapy combined with chemotherapy at Jining First People's Hospital between October 2020 and October 2023. The primary endpoint was complete pathological response (pCR) rate; secondary endpoints: major pathological response (MPR) rate, neoadjuvant therapy-related adverse events (AES), the safety of surgery, Postoperative Complications, and overall survival (OS).

RESULTS

24 eligible patients were enrolled in the study and achieved a pCR rate of 16.7%. The treatment-related AES was manageable. The median time interval between the end of neoadjuvant therapy and surgery was 35 days (28-81 days), R0 resection rate was 100%. The most common postoperative complications in the study were pneumonia (n = 11, 45.8%). Median follow-up was 13.5(interquartile range: 8.00, 25.50) months, Kaplan-Meier survival analysis showed median OS was not reached.

CONCLUSIONS

It was safe and effective for resectable GEJ adenocarcinoma to undergo neoadjuvant Sintilimab combined with chemotherapy followed by surgery, and long-term efficacy needs to be confirmed by further follow-up.

摘要

引言

为探讨新辅助信迪利单抗是否适用于胃食管交界(GEJ)腺癌患者,我们设计了本研究,以评估新辅助信迪利单抗联合化疗用于可切除GEJ腺癌的短期疗效和安全性。

方法

我们回顾性收集了2020年10月至2023年10月在济宁市第一人民医院接受新辅助免疫治疗联合化疗后接受手术的GEJ腺癌患者的数据。主要终点是完全病理缓解(pCR)率;次要终点:主要病理缓解(MPR)率、新辅助治疗相关不良事件(AEs)、手术安全性、术后并发症和总生存期(OS)。

结果

24例符合条件的患者纳入研究,pCR率为16.7%。治疗相关的AEs可控。新辅助治疗结束至手术的中位时间间隔为35天(28 - 81天),R0切除率为100%。研究中最常见的术后并发症是肺炎(n = 11,45.8%)。中位随访时间为13.5(四分位间距:8.00,25.50)个月,Kaplan-Meier生存分析显示未达到中位OS。

结论

新辅助信迪利单抗联合化疗后行手术治疗可切除GEJ腺癌安全有效,长期疗效需进一步随访确认。

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