Jiacong Liu, Ziheng Wu, Shihong Zhou, Wang Lv, Yiqing Wang, Pinghui Xia, Linhai Zhu, Jian Hu
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This study aims to analyze the clinical outcomes and long-term survival of neoadjuvant immunochemotherapy for locally advanced ESCC, and explore the feasibility of using major pathological response (MPR) as a surrogate endpoint.</p><p><strong>Methods: </strong>This real-world retrospective study consecutively included eligible patients with stage II-IVA locally advanced ESCC who received neoadjuvant immunochemotherapy and surgery between 2019 and 2022 at the Department of Thoracic Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine.</p><p><strong>Results: </strong>This study collected a total of 166 patients, and ultimately included 126 patients after screening. The objective response rate (ORR) was 69.8% (88/126). The incidence of grade 3-4 adverse events (AEs) was 13.5% (17/126). MPR was observed in 49 (38.9%) patients, and 24 (19.0%) patients achieved a complete pathological response (pCR). The median progression-free survival (PFS) was 31.7 months and the 3-year PFS rate was 56.3%. The median overall survival (OS) was not reached and the 3-year OS rate was 70.6%. The median PFS of the non-MPR group was 25.0 months, with the MPR group not achieved (hazard ratio [HR], 2.503; 95% CI 1.359-4.610; P = 0.0022). The median OS in the non-MPR group was 31.7 months and not reached in the MPR group (HR, 3.607; 95% CI 1.576-8.254; P = 0.0012). MPR is an independent prognostic factor affecting OS (HR, 2.522; 95% CI 1.018-6.401; P = 0.046).</p><p><strong>Conclusions: </strong>Neoadjuvant immunochemotherapy is safe and effective for locally advanced ESCC, and can result in certain survival benefits. 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The median progression-free survival (PFS) was 31.7 months and the 3-year PFS rate was 56.3%. The median overall survival (OS) was not reached and the 3-year OS rate was 70.6%. The median PFS of the non-MPR group was 25.0 months, with the MPR group not achieved (hazard ratio [HR], 2.503; 95% CI 1.359-4.610; P = 0.0022). The median OS in the non-MPR group was 31.7 months and not reached in the MPR group (HR, 3.607; 95% CI 1.576-8.254; P = 0.0012). MPR is an independent prognostic factor affecting OS (HR, 2.522; 95% CI 1.018-6.401; P = 0.046).</p><p><strong>Conclusions: </strong>Neoadjuvant immunochemotherapy is safe and effective for locally advanced ESCC, and can result in certain survival benefits. 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引用次数: 0
摘要
背景：新辅助免疫化疗有望成为局部晚期食管鳞状细胞癌（ESCC）的标准治疗模式。本研究旨在分析局部晚期ESCC新辅助免疫化疗的临床结局和长期生存，探讨以主要病理反应（major pathology response， MPR）作为替代终点的可行性。方法：本真实世界回顾性研究连续纳入2019年至2022年在浙江大学医学院第一附属医院胸外科接受新辅助免疫化疗和手术的ii期- iva期局部晚期ESCC患者。结果：本研究共收集了166例患者，经筛选最终纳入126例患者。客观有效率为69.8%（88/126）。3-4级不良事件（ae）发生率为13.5%（17/126）。49例（38.9%）患者出现MPR， 24例（19.0%）患者达到完全病理反应（pCR）。中位无进展生存期（PFS）为31.7个月，3年PFS率为56.3%。中位总生存期（OS）未达到，3年OS率为70.6%。非MPR组的中位PFS为25.0个月，MPR组未实现(风险比[HR]， 2.503；95% ci 1.359-4.610；p = 0.0022)。非MPR组的中位总生存期为31.7个月，MPR组未达到总生存期(HR, 3.607；95% ci 1.576-8.254；p = 0.0012)。MPR是影响OS的独立预后因素(HR, 2.522；95% ci 1.018-6.401；p = 0.046)。结论：新辅助免疫化疗治疗局部晚期ESCC安全有效，并可获得一定的生存获益。MPR可以作为预测长期OS的替代终点。
Neoadjuvant immunochemotherapy for locally advanced esophageal squamous cell carcinoma in real-world practice: an analysis of the clinical outcomes and long-term survival, and the feasibility of using major pathological response as a surrogate endpoint.
Background: Neoadjuvant immunochemotherapy is expected to become the standard treatment mode for locally advanced esophageal squamous cell carcinoma (ESCC). This study aims to analyze the clinical outcomes and long-term survival of neoadjuvant immunochemotherapy for locally advanced ESCC, and explore the feasibility of using major pathological response (MPR) as a surrogate endpoint.
Methods: This real-world retrospective study consecutively included eligible patients with stage II-IVA locally advanced ESCC who received neoadjuvant immunochemotherapy and surgery between 2019 and 2022 at the Department of Thoracic Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine.
Results: This study collected a total of 166 patients, and ultimately included 126 patients after screening. The objective response rate (ORR) was 69.8% (88/126). The incidence of grade 3-4 adverse events (AEs) was 13.5% (17/126). MPR was observed in 49 (38.9%) patients, and 24 (19.0%) patients achieved a complete pathological response (pCR). The median progression-free survival (PFS) was 31.7 months and the 3-year PFS rate was 56.3%. The median overall survival (OS) was not reached and the 3-year OS rate was 70.6%. The median PFS of the non-MPR group was 25.0 months, with the MPR group not achieved (hazard ratio [HR], 2.503; 95% CI 1.359-4.610; P = 0.0022). The median OS in the non-MPR group was 31.7 months and not reached in the MPR group (HR, 3.607; 95% CI 1.576-8.254; P = 0.0012). MPR is an independent prognostic factor affecting OS (HR, 2.522; 95% CI 1.018-6.401; P = 0.046).
Conclusions: Neoadjuvant immunochemotherapy is safe and effective for locally advanced ESCC, and can result in certain survival benefits. MPR can serve as a surrogate endpoint for predicting long-term OS.
期刊介绍：
European Journal of Medical Research publishes translational and clinical research of international interest across all medical disciplines, enabling clinicians and other researchers to learn about developments and innovations within these disciplines and across the boundaries between disciplines. The journal publishes high quality research and reviews and aims to ensure that the results of all well-conducted research are published, regardless of their outcome.
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