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新辅助放化疗和食管切除术后肿瘤阳性切缘患者的辅助治疗。

Adjuvant Therapy for Patients with a Tumor-Positive Resection Margin After Neoadjuvant Chemoradiotherapy and Esophagectomy.

机构信息

Department of Surgery, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, The Netherlands.

Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.

出版信息

Ann Surg Oncol. 2024 Jun;31(6):3813-3818. doi: 10.1245/s10434-024-14912-x. Epub 2024 Jan 20.

Abstract

BACKGROUND

Approximately 4-9% of patients have a tumor-positive resection margin after neoadjuvant chemoradiotherapy (nCRT) and esophagectomy. Although it is associated with decreased survival, Western guidelines do not recommend adjuvant treatment.

OBJECTIVE

The aim of this study was to assess the proportion of patients who received adjuvant therapy, and to evaluate overall survival (OS) after esophagectomy in patients with a tumor-positive resection margin.

METHODS

Patients diagnosed with resectable (cT2-4a/cTxN0-3/NxM0) esophageal cancer between 2015 and 2022, and treated with nCRT followed by irradical esophagectomy, were selected from the Netherlands Cancer Registry. The primary outcome was the proportion of patients with a tumor-positive resection margin who started adjuvant treatment ≤16 weeks after esophagectomy, including chemotherapy/radiotherapy, immunotherapy, or targeted therapy. OS was calculated from the date of surgery until the date of death or last day of follow-up.

RESULTS

Overall, 376 patients were included in our study, of whom 357 were treated with nCRT. Of these 357 patients, 98.3% had a microscopically irradical resection and 1.7% had a macroscopically irradical resection. Approximately 72.3% of tumors showed a partial response (Mandard 2-3) and 11.8% showed little/no pathological response (Mandard 4-5) to nCRT. One of 357 patients underwent adjuvant chemoradiotherapy and 39 patients (61%) underwent adjuvant immunotherapy (nivolumab). The median and 5-year OS rate of all patients was 16.4 months (95% confidence interval 13.1-19.8) and 21%, respectively.

CONCLUSION

Real-world population-level data showed that no patients with a tumor-positive resection margin underwent adjuvant therapy following nCRT and esophagectomy prior to 2021. Interestingly, 61% of patients were treated with adjuvant nivolumab in 2021-2022. OS after irradical esophagectomy is poor and long-term data will explore the added value of nivolumab.

摘要

背景

在接受新辅助放化疗(nCRT)和食管切除术的患者中,约有 4-9%的患者存在肿瘤阳性切缘。尽管这与生存时间缩短有关,但西方指南不建议进行辅助治疗。

目的

本研究旨在评估接受辅助治疗的患者比例,并评估肿瘤阳性切缘的食管切除术后患者的总生存率(OS)。

方法

从荷兰癌症登记处中选择 2015 年至 2022 年间诊断为可切除(cT2-4a/cTxN0-3/NxM0)食管癌并接受 nCRT 联合根治性食管切除术的患者。主要结局是肿瘤阳性切缘患者在食管切除术后≤16 周内开始辅助治疗的比例,包括化疗/放疗、免疫治疗或靶向治疗。OS 从手术日期计算至死亡日期或最后一次随访日期。

结果

总体而言,本研究纳入了 376 例患者,其中 357 例接受 nCRT 治疗。这 357 例患者中,98.3%的患者为显微镜下不完全切除,1.7%的患者为肉眼下不完全切除。nCRT 后,约 72.3%的肿瘤显示部分缓解(Mandard 2-3),11.8%的肿瘤显示几乎无病理缓解(Mandard 4-5)。357 例患者中有 1 例接受辅助放化疗,39 例(61%)接受辅助免疫治疗(nivolumab)。所有患者的中位和 5 年 OS 率分别为 16.4 个月(95%置信区间 13.1-19.8)和 21%。

结论

真实世界的人群水平数据显示,在 2021 年之前,没有肿瘤阳性切缘的患者在 nCRT 和食管切除术后接受辅助治疗。有趣的是,2021-2022 年有 61%的患者接受了辅助 nivolumab 治疗。根治性食管切除术后的 OS 较差,长期数据将探索 nivolumab 的附加价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc16/11076321/f5572be614fc/10434_2024_14912_Fig1_HTML.jpg

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