新辅助免疫治疗食管鳞癌的疗效、安全性和预后模型。

Efficacy, safety, and prognostic modeling in neoadjuvant immunotherapy for esophageal squamous cell carcinoma.

机构信息

Department of Thoracic Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

出版信息

Int Immunopharmacol. 2024 Dec 5;142(Pt A):112845. doi: 10.1016/j.intimp.2024.112845. Epub 2024 Aug 30.

DOI:10.1016/j.intimp.2024.112845

PMID:39216114

Abstract

OBJECTIVE

To evaluate the safety and efficacy of neoadjuvant immunotherapy in patients with esophageal squamous cell carcinoma (ESCC) and construct a prognostic model.

METHODS

Clinical data were retrospectively collected from patients with locally advanced ESCC who received neoadjuvant immunotherapy and chemotherapy. The primary endpoints were major pathologic remission rate and disease-free survival, and secondary endpoints were treatment-related adverse events and perioperative complications. Correlates affecting pathological response were analyzed using univariate and multivariate logistic regression, survival-related variables were screened by Boruta and least absolute shrinkage and selection operator Cox regression analysis. A nomogram was constructed and utilized to test the predictive efficacy of the treatment with receiver operating characteristic curve and decision curve analysis.

RESULTS

A total of 181 patients were enrolled, of whom 119 (66 %) patients received 3-4 cycles of treatment. Treatment-related adverse events occurred in 65.2 % of the patients, with 13.3 % experiencing severe complications. Major pathological remission rate was achieved in 68 (37.6 %) patients, with no significant difference between the treatment cycle groups (P=0.925). The nomogram included pathologic TNM stage, lymphovascular invasion, post-treatment and post-surgery albumin levels, and post-treatment systemic immune-inflammation index. One-year disease-free survival area under the curve was 0.86 (95 %CI, 0.75-0.97) in the derivation cohort and 0.75 (95 %CI, 0.50-0.99) in the validation cohort, with good calibration performance.

CONCLUSIONS

Pathological staging combined with albumin level and systemic immune-inflammation index could be a superior predictor of survival prognosis in ESCC patients receiving neoadjuvant immunotherapy. The findings of this study yield new evidence regarding the efficacy and safety of neoadjuvant immunotherapy in ESCC and provide a tool for identifying patients at risk of recurrence.

摘要

目的

评估新辅助免疫治疗在食管鳞癌（ESCC）患者中的安全性和有效性，并构建预后模型。

方法

回顾性收集接受新辅助免疫联合化疗的局部晚期 ESCC 患者的临床资料。主要终点为主要病理缓解率和无病生存期，次要终点为治疗相关不良事件和围手术期并发症。采用单因素和多因素逻辑回归分析影响病理反应的相关因素，通过 Boruta 和最小绝对收缩和选择算子 Cox 回归分析筛选与生存相关的变量。构建并利用列线图和受试者工作特征曲线、决策曲线分析检验治疗的预测效能。

结果

共纳入 181 例患者，其中 119 例（66%）患者接受了 3-4 个周期的治疗。65.2%的患者发生治疗相关不良事件，其中 13.3%的患者发生严重并发症。68 例（37.6%）患者达到主要病理缓解，治疗周期组间差异无统计学意义（P=0.925）。列线图包括病理 TNM 分期、脉管侵犯、治疗后和术后白蛋白水平、治疗后系统免疫炎症指数。在推导队列中，1 年无病生存率曲线下面积为 0.86（95%CI，0.75-0.97），验证队列中为 0.75（95%CI，0.50-0.99），具有良好的校准性能。