Yang Yang, Zhichao Liu, Ian Wong, Xing Gao, Hong Zhang, Jun Liu, Ben M Eyck, Jinchen Shao, Yuchen Han, Berend J van der Wilk, Yinkai Chao, Simon Law, Bas P L Wijnhoven, J Jan B van Lanschot, Zhigang Li
{"title":"Detecting residual disease after neoadjuvant chemoradiotherapy for oesophageal squamous cell carcinoma: The prospective multicentre preSINO trial.","authors":"Yang Yang, Zhichao Liu, Ian Wong, Xing Gao, Hong Zhang, Jun Liu, Ben M Eyck, Jinchen Shao, Yuchen Han, Berend J van der Wilk, Yinkai Chao, Simon Law, Bas P L Wijnhoven, J Jan B van Lanschot, Zhigang Li","doi":"10.1093/bjs/znaf004","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 2","pages":""},"PeriodicalIF":8.6000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11816269/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjs/znaf004","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍：
The British Journal of Surgery (BJS), incorporating the European Journal of Surgery, stands as Europe's leading peer-reviewed surgical journal. It serves as an invaluable platform for presenting high-quality clinical and laboratory-based research across a wide range of surgical topics. In addition to providing a comprehensive coverage of traditional surgical practices, BJS also showcases emerging areas in the field, such as minimally invasive therapy and interventional radiology.
While the journal appeals to general surgeons, it also holds relevance for specialty surgeons and professionals working in closely related fields. By presenting cutting-edge research and advancements, BJS aims to revolutionize the way surgical knowledge is shared and contribute to the ongoing progress of the surgical community.
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