检测食管鳞状细胞癌新辅助放化疗后的残留病灶：前瞻性多中心preSINO试验

Detecting residual disease after neoadjuvant chemoradiotherapy for oesophageal squamous cell carcinoma: The prospective multicentre preSINO trial.

作者信息

Yang Yang, Liu Zhichao, Wong Ian, Gao Xing, Zhang Hong, Liu Jun, Eyck Ben M, Shao Jinchen, Han Yuchen, van der Wilk Berend J, Chao Yinkai, Law Simon, Wijnhoven Bas P L, van Lanschot J Jan B, Li Zhigang

机构信息

Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Department of Surgery, LKS Faculty of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong, China.

出版信息

Br J Surg. 2025 Feb 1;112(2). doi: 10.1093/bjs/znaf004.

DOI:10.1093/bjs/znaf004

PMID:39937490

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11816269/

Abstract

BACKGROUND

Neoadjuvant chemoradiotherapy (nCRT) in patients with oesophageal squamous cell carcinoma (OSCC) may lead to clinical complete response (cCR). It is important to know the accuracy of clinical response evaluations (CREs) before advocating active surveillance instead of oesophagectomy.

METHODS

This was a prospective, multicentre study of patients with locally advanced OSCC. They received the first CRE (bite-on-bite biopsies) 4-6 weeks after nCRT. Patients with residual tumour underwent surgery. Patients with a cCR at CRE-1 underwent a second CRE 10-12 weeks after nCRT using PET-CT, bite-on-bite biopsies and endoscopic ultrasound fine-needle aspiration (EUS-FNA). All patients without distant metastases underwent surgery. Primary endpoint was the accuracy of CREs for detecting Tumour Regression Grade (TRG)3-4 or TRG1-2 with ypN+ residual tumour with a prespecified false-negative rate (FNR) of 19.5%. Circulating-tumour DNA (ctDNA) at CREs was performed for exploratory analysis.

RESULTS

In total 309 patients were included. Eighteen of 133 patients with TRG3-4 or TRG1-2 with ypN+ residual tumours were not detected by bite-on-bite biopsies and EUS-FNA (FNR: 13.5%). Sensitivity, specificity, negative predictive value and positive predictive value of detecting any residual tumour were 81.7%, 93.2%, 68.7% and 96.5% respectively. PET-CT detected interval distant metastases in 13 (4.9%) of 268 patients presurgically. After a minimum 12-month follow-up, systemic recurrence rates were 28.0% in patients with positive ctDNA at CREs and 5.3% in those with negative ctDNA.

CONCLUSIONS

Bite-on-bite biopsies and EUS-FNA were accurate in detecting residual disease after nCRT in OSCC. Positive ctDNA at CREs may indicate an increased risk of systemic metastases.

摘要

背景

食管鳞状细胞癌（OSCC）患者的新辅助放化疗（nCRT）可能导致临床完全缓解（cCR）。在提倡积极监测而非食管切除术之前，了解临床反应评估（CRE）的准确性很重要。

方法

这是一项针对局部晚期OSCC患者的前瞻性多中心研究。他们在nCRT后4-6周接受首次CRE（逐块活检）。有残留肿瘤的患者接受手术。在nCRT后10-12周，CRE-1达到cCR的患者使用PET-CT、逐块活检和内镜超声细针穿刺（EUS-FNA）进行第二次CRE。所有无远处转移的患者均接受手术。主要终点是CRE检测肿瘤退缩分级（TRG）3-4或TRG1-2以及ypN+残留肿瘤的准确性，预设假阴性率（FNR）为19.5%。在CRE时进行循环肿瘤DNA（ctDNA）检测以进行探索性分析。

结果

共纳入309例患者。133例TRG3-4或TRG1-2且有ypN+残留肿瘤的患者中，有18例未通过逐块活检和EUS-FNA检测到（FNR：13.5%）。检测任何残留肿瘤的敏感性、特异性、阴性预测值和阳性预测值分别为81.7%、93.2%、68.7%和96.5%。PET-CT在268例术前患者中检测到13例（4.9%）有间期远处转移。经过至少12个月的随访，CRE时ctDNA阳性的患者全身复发率为28.0%，ctDNA阴性的患者为5.3%。