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新辅助信迪利单抗联合化疗治疗局部晚期可切除食管鳞状细胞癌的中期随访结果

Mid-term follow-up results of neoadjuvant sintilimab combined with chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.

作者信息

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

机构信息

Department of Thoracic Surgery, Jining No. 1 People's Hospital, Jining, Shandong, China.

Institute of Thoracic Surgery, Jining Institute of Medical Sciences, Jining, Shandong, China.

出版信息

Front Immunol. 2024 Dec 4;15:1453176. doi: 10.3389/fimmu.2024.1453176. eCollection 2024.

Abstract

BACKGROUND

The study was conducted in order to investigate whether neoadjuvant immunotherapy combined with chemotherapy can bring survival benefits to patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) in the real world.

METHODS

We retrospectively analysed patients with locally advanced resectable ESCC who underwent surgery at the Jining First People's Hospital from April 2020 to April 2022. Based on their medical history, the enrolled patients were divided into a neoadjuvant immunochemotherapy plus surgery group (nICT group) and a surgery-only group (S group). Primary endpoints were the two-year overall survival (OS) and disease-free survival (DFS) rates. Secondary endpoints were the safety and efficacy of neoadjuvant immunochemotherapy for patients with locally advanced esophageal cancer, and compared the surgery and postoperative outcomes between the two groups.

RESULTS

A total of 47 patients in the nICT group and 73 patients in the S group were included for further analysis, the stage of the nICT group was more advanced than that of the S group. In the group nICT, 8 patients (17%) achieved the complete pathological response (pCR), 29 patients (61.7%) achieved major pathological response (MPR), including 6 patients (12.8%) with a primary tumor achieving pCR but had residual tumor cells in the lymph nodes (pT0N+), and the treatment-related AES was manageable. The surgery and postoperative outcomes were comparable in both groups. The two-year OS and DFS rates for the nICT group were 91.5% and 85.5% respectively, while those for the S group were 71.2% and 68.5%, and Kaplan-Meier survival analysis and log-rank test revealed significant differences in DFS and OS between the two groups. Patients who achieved MPR in the nICT group showed better DFS and OS, while the Three-cycle subgroup did not exhibit any survival benefit compared to the Two-cycle subgroup.

CONCLUSIONS

Neoadjuvant sintilimab combined with chemotherapy has promising efficacy and safety in the treatment of locally advanced resectable ESCC. The treatment modality has the potential to become a standard therapy for locally advanced resectable ESCC.

摘要

背景

本研究旨在探讨新辅助免疫治疗联合化疗能否在现实世界中为局部晚期可切除食管鳞状细胞癌(ESCC)患者带来生存获益。

方法

我们回顾性分析了2020年4月至2022年4月在济宁市第一人民医院接受手术的局部晚期可切除ESCC患者。根据病史,将纳入的患者分为新辅助免疫化疗加手术组(nICT组)和单纯手术组(S组)。主要终点是两年总生存率(OS)和无病生存率(DFS)。次要终点是新辅助免疫化疗对局部晚期食管癌患者的安全性和疗效,并比较两组的手术及术后结果。

结果

nICT组共47例患者,S组共73例患者纳入进一步分析,nICT组的分期比S组更晚。在nICT组中,8例患者(17%)达到完全病理缓解(pCR),29例患者(61.7%)达到主要病理缓解(MPR),其中6例患者(12.8%)原发肿瘤达到pCR但淋巴结有残留肿瘤细胞(pT0N+),且治疗相关不良事件可管理。两组的手术及术后结果具有可比性。nICT组的两年OS率和DFS率分别为91.5%和85.5%,而S组分别为71.2%和68.5%,Kaplan-Meier生存分析和对数秩检验显示两组在DFS和OS方面存在显著差异。nICT组中达到MPR的患者DFS和OS更好,而三周期亚组与两周期亚组相比未显示出任何生存获益。

结论

新辅助信迪利单抗联合化疗在治疗局部晚期可切除ESCC方面具有有前景的疗效和安全性。该治疗方式有可能成为局部晚期可切除ESCC的标准治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cb28/11652524/00f396118780/fimmu-15-1453176-g001.jpg

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