新辅助免疫化疗治疗可切除食管癌的疗效和安全性研究。

0 MEDICINE, RESEARCH & EXPERIMENTAL
Xiaomin Wang, Bingxu Li, Zhiyong Zheng, Weijie Wang
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引用次数: 0

摘要

免疫抑制剂与化疗的结合重塑了食管癌(EC)的治疗格局。本研究旨在评估新辅助免疫化疗(nICT)方案对可切除食管癌患者的有效性和安全性。研究共纳入了99名符合条件的患者。研究收集了患者特征、nICT方案、手术方法、术后结果、与新辅助治疗和手术相关的不良事件(AEs)、总生存期(OS)和无病生存期(DFS)等数据。OS、DFS和安全性是主要终点。Cox回归分析用于确定总体人群的预后因素。此外,还进行了探索性研究,以评估血液免疫指标在预测肿瘤消退方面的临床价值。手术后,99.0%的患者实现了完全切除(R0)。根据美国癌症联合委员会(AJCC)/美国病理学家学会(CAP)的肿瘤回归分级(TRG)评估结果,完全或中度反应是最常见的结果(64.7%)。一年的OS和DFS率分别为91.6%和49.3%。21.2%的患者出现了与新辅助治疗相关的≥3级AE,其中胃肠道反应最为常见(16例,16.2%)。没有与治疗相关的死亡报告。10.1%的患者发生了≥3级的手术相关AE,其中最常见的是吻合口漏(6例,6.1%)。有几个因素与明显改善的OS相关,包括紫杉醇与铂联合化疗方案、使用腹腔镜或胸腔镜(左侧或右侧)的手术方式、最后一次治疗与手术之间的间隔时间≤34天,以及未发现阳性淋巴结。较高的 cT 分期与较差的 DFS 显著相关。血液免疫标记物,如中性粒细胞与淋巴细胞比值(NLR)和淋巴细胞与单核细胞比值(LMR)可预测EC患者的肿瘤消退情况。总之,nICT 在可切除的 EC 中表现出良好的有效性和安全性。与预后相关的是铂类化疗药物的选择,而非免疫抑制剂的类型。此外,最后一次使用nICT与手术之间的时间间隔较短(≤34天)也与预后的改善有关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Neoadjuvant immunochemotherapy for resectable esophageal cancer: A study on efficacy and safety.

The combination of immunosuppressants and chemotherapy has reshaped the treatment landscape for esophageal cancer (EC). This study aimed to evaluate the effectiveness and safety of a neoadjuvant immunochemotherapy (nICT) regimen in patients with resectable EC. A total of 99 eligible patients were included. Data on patient characteristics, nICT regimens, surgical approaches, postoperative outcomes, adverse events (AEs) related to neoadjuvant therapy and surgery, overall survival (OS), and disease-free survival (DFS) were collected. OS, DFS, and safety were the primary endpoints. Cox regression analysis was used to identify prognostic factors in the overall population. Additionally, exploratory research was conducted to assess the clinical value of blood immune indicators in predicting tumor regression. Following surgery, 99.0% of patients achieved complete resection (R0). After neoadjuvant therapy, the number of patients with stage T0N0 increased, with complete or moderate responses being the most common outcomes according to American Joint Committee on Cancer (AJCC)/ College of American Pathologists (CAP)-tumor regression grading (TRG) evaluations (64.7%). The one-year OS and DFS rates were 91.6% and 49.3%, respectively. Grade ≥3 AEs related to neoadjuvant therapy occurred in 21.2% of patients, with gastrointestinal reactions being the most frequent (16 cases, 16.2%). No treatment-related deaths were reported. Grade ≥3 surgery-related AEs occurred in 10.1% of patients, with anastomotic leakage being the most common (six cases, 6.1%). Several factors were associated with significantly improved OS, including chemotherapy regimens combining paclitaxel with platinum, surgical approaches using laparoscopy or thoracotomy (left or right), an interval of ≤34 days between the last treatment and surgery, and the absence of positive lymph node detection. Higher cT staging was significantly associated with worse DFS. Blood immune markers, such as the neutrophil-to-lymphocyte ratio (NLR) and lymphocyte-to-monocyte ratio (LMR) were found to predict tumor regression in EC patients. In summary, nICT demonstrated favorable effectiveness and safety in resectable EC. The choice of platinum-based chemotherapy agents, rather than the type of immunosuppressant, was associated with prognosis. Moreover, a shorter interval (≤34 days) between the final nICT administration and surgery was linked to improved outcomes.

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