主要病理反应作为接受新辅助化疗/化疗免疫治疗的食管鳞状细胞癌患者的预后替代指标：一项多中心队列研究。

Major pathologic response as a prognostic surrogate in esophageal squamous cell carcinoma patients receiving neoadjuvant chemotherapy/chemoimmunotherapy: A multi-center cohort study.

作者信息

Hong Zhinuan, Xie Shuhan, Xu Hui, Ke Sunkui, Liu Wenyi, Huang Shijie, Chen Shuchen, Xie Jinbiao, Xu Jinxin, Kang Mingqiang

机构信息

Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Cardio-Thoracic Surgery(Fujian Medical University), Fujian Province University, Fuzhou, China; Key Laboratory of Ministry of Education for Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Fujian Key Laboratory of Tumor Microbiology, Fujian Medical University, Fuzhou, China.

Department of Thoracic Surgery, Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.

出版信息

Eur J Surg Oncol. 2025 Feb;51(2):109500. doi: 10.1016/j.ejso.2024.109500. Epub 2024 Nov 24.

DOI:10.1016/j.ejso.2024.109500

PMID:39647444

Abstract

PURPOSE

To determine the prognostic and survival surrogate value of major pathologic response (MPR) in esophageal squamous cell carcinoma (ESCC) patients undergoing neoadjuvant chemotherapy/chemoimmunotherapy(nCT/nICT) and surgery.

METHOD

A retrospective multi-center study cohort study enrolled 305 ESCC patients who underwent neoadjuvant chemotherapy/chemoimmunotherapy followed by esophagectomy. Endpoints included recurrence-free survival (RFS), locoregional recurrence-free survival(L-RFS), distant metastasis-free survival(D-MFS), and recurrence patterns. The Cox regression analysis and Harrell's C-index were used to analyze survival differences and surrogate endpoints. The Kaplan-Meier method was used for the subgroup analysis in two subgroups(the patients receiving nICT and patients receiving nCT) and the prognostic value analysis of adjuvant therapy in non-MPR and MPR patients.

RESULT

Of the 305 patients, 105 achieved MPR, demonstrating a significantly improved RFS (P value < 0.001), L-RFS (P value < 0.001), and D-MFS (P value = 0.003). MPR was identified as an independent risk factor for RFS(HR:0.415, 95%CI:[0.227, 0.759], P value = 0.004) and demonstrated equal predictive capacity to be a surrogate of survival endpoints with T stage and N stage(Harrell's C-index: 0.613). In subgroup analysis, patients with MPR showed better survival outcomes in subgroups that received neoadjuvant chemoimmunotherapy (P value = 0.012) and neoadjuvant chemotherapy(P value < 0.001). Additionally, adjuvant therapy did not confer additional survival benefits to both MPR and non-MPR patients. Compared with patients who achieved MPR, non-MPR patients exhibited a higher recurrence rate, although the recurrence sites were similar between the two groups.

CONCLUSION

MPR can serve as an independent prognostic factor and a surrogate of survival endpoints in ESCC patients undergoing nCT/nICT. Besides, as a potential indicator for postoperative management, MPR can provide reference basis and evidence support in clinical practice.

摘要

目的

确定接受新辅助化疗/化疗免疫治疗（nCT/nICT）及手术的食管鳞状细胞癌（ESCC）患者中主要病理反应（MPR）的预后及生存替代价值。

方法

一项回顾性多中心队列研究纳入了305例行新辅助化疗/化疗免疫治疗后接受食管切除术的ESCC患者。终点包括无复发生存期（RFS）、局部区域无复发生存期（L-RFS）、远处转移无复发生存期（D-MFS）及复发模式。采用Cox回归分析和Harrell's C指数分析生存差异及替代终点。采用Kaplan-Meier法对两个亚组（接受nICT的患者和接受nCT的患者）进行亚组分析，以及对非MPR和MPR患者的辅助治疗预后价值进行分析。

结果

305例患者中，105例达到MPR，其RFS（P值<0.001）、L-RFS（P值<0.001）和D-MFS（P值=0.003）均显著改善。MPR被确定为RFS的独立危险因素（HR：0.415，95%CI：[0.227, 0.759]，P值=0.004），并且作为生存终点替代指标，其预测能力与T分期和N分期相当（Harrell's C指数：0.613）。在亚组分析中，MPR患者在接受新辅助化疗免疫治疗（P值=0.012）和新辅助化疗（P值<0.001）的亚组中显示出更好的生存结局。此外，辅助治疗对MPR和非MPR患者均未带来额外的生存获益。与达到MPR的患者相比，非MPR患者复发率更高，尽管两组复发部位相似。