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Article: Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study

TitleAccuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study
Authors
KeywordsAccuracy
Active surveillance
Esophageal cancer
Esophagectomy
Neoadjuvant chemoradiotherapy
Issue Date2020
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.biomedcentral.com/bmccancer/
Citation
BMC Cancer, 2020, v. 20, p. article no. 194 How to Cite?
AbstractBackground: After neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer, high pathologically complete response (pCR) rates are being achieved especially in patients with squamous cell carcinoma (SCC). An active surveillance strategy has been proposed for SCC patients with clinically complete response (cCR) after nCRT. To justify omitting surgical resection, patients with residual disease should be accurately identified. The aim of this study is to assess the accuracy of response evaluations after nCRT based on the preSANO trial, including positron emission tomography with computed tomography (PET-CT), endoscopy with bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) in patients with potentially curable esophageal SCC. Methods: Operable esophageal SCC patients who are planned to undergo nCRT according to the CROSS regimen and are planned to undergo surgery will be recruited from four Asian centers. Four to 6 weeks after completion of nCRT, patients will undergo a first clinical response evaluation (CRE-1) consisting of endoscopy with bite-on-bite biopsies. In patients without histological evidence of residual tumor (i.e. without positive biopsies), surgery will be postponed another 6 weeks. A second clinical response evaluation (CRE-2) will be performed 10-12 weeks after completion of nCRT, consisting of PET-CT, endoscopy with bite-on-bite biopsies and EUS with FNA. Immediately after CRE-2 all patients without evidence of distant metastases will undergo esophagectomy. Results of CRE-1 and CRE-2 as well as results of the three single diagnostic modalities will be correlated to pathological response in the resection specimen (gold standard) for calculation of sensitivity, specificity, negative predictive value and positive predictive value. Discussion: If the current study shows that major locoregional residual disease (> 10% residual carcinoma or any residual nodal disease) can be accurately (i.e. with sensitivity of 80.5%) detected in patients with esophageal SCC, a prospective trial will be conducted comparing active surveillance with standard esophagectomy in patients with a clinically complete response after nCRT (SINO trial). Trial registration: The preSINO trial has been registered at ClinicalTrials.gov as NCT03937362 (May 3, 2019). © 2020 The Author(s).
Persistent Identifierhttp://hdl.handle.net/10722/290552
ISSN
2021 Impact Factor: 4.638
2020 SCImago Journal Rankings: 1.358
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorZhang, X-
dc.contributor.authorEyck, BM-
dc.contributor.authorYang, Y-
dc.contributor.authorLiu, J-
dc.contributor.authorChao, YK-
dc.contributor.authorHou, MO-
dc.contributor.authorHung, TM-
dc.contributor.authorPang, Q-
dc.contributor.authorYu, ZT-
dc.contributor.authorJiang, H-
dc.contributor.authorLaw, S-
dc.contributor.authorWong, I-
dc.contributor.authorLam, KO-
dc.contributor.authorvan der Wilk, BJ-
dc.contributor.authorvan der Gaast, A-
dc.contributor.authorSpaander, MCW-
dc.contributor.authorValkema, R-
dc.contributor.authorLargarde, SM-
dc.contributor.authorWijnhoven, BPL-
dc.contributor.authorvan Lanschot, JJB-
dc.contributor.authorLi, Z-
dc.date.accessioned2020-11-02T05:43:52Z-
dc.date.available2020-11-02T05:43:52Z-
dc.date.issued2020-
dc.identifier.citationBMC Cancer, 2020, v. 20, p. article no. 194-
dc.identifier.issn1471-2407-
dc.identifier.urihttp://hdl.handle.net/10722/290552-
dc.description.abstractBackground: After neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer, high pathologically complete response (pCR) rates are being achieved especially in patients with squamous cell carcinoma (SCC). An active surveillance strategy has been proposed for SCC patients with clinically complete response (cCR) after nCRT. To justify omitting surgical resection, patients with residual disease should be accurately identified. The aim of this study is to assess the accuracy of response evaluations after nCRT based on the preSANO trial, including positron emission tomography with computed tomography (PET-CT), endoscopy with bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) in patients with potentially curable esophageal SCC. Methods: Operable esophageal SCC patients who are planned to undergo nCRT according to the CROSS regimen and are planned to undergo surgery will be recruited from four Asian centers. Four to 6 weeks after completion of nCRT, patients will undergo a first clinical response evaluation (CRE-1) consisting of endoscopy with bite-on-bite biopsies. In patients without histological evidence of residual tumor (i.e. without positive biopsies), surgery will be postponed another 6 weeks. A second clinical response evaluation (CRE-2) will be performed 10-12 weeks after completion of nCRT, consisting of PET-CT, endoscopy with bite-on-bite biopsies and EUS with FNA. Immediately after CRE-2 all patients without evidence of distant metastases will undergo esophagectomy. Results of CRE-1 and CRE-2 as well as results of the three single diagnostic modalities will be correlated to pathological response in the resection specimen (gold standard) for calculation of sensitivity, specificity, negative predictive value and positive predictive value. Discussion: If the current study shows that major locoregional residual disease (> 10% residual carcinoma or any residual nodal disease) can be accurately (i.e. with sensitivity of 80.5%) detected in patients with esophageal SCC, a prospective trial will be conducted comparing active surveillance with standard esophagectomy in patients with a clinically complete response after nCRT (SINO trial). Trial registration: The preSINO trial has been registered at ClinicalTrials.gov as NCT03937362 (May 3, 2019). © 2020 The Author(s).-
dc.languageeng-
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.biomedcentral.com/bmccancer/-
dc.relation.ispartofBMC Cancer-
dc.rightsBMC Cancer. Copyright © BioMed Central Ltd.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectAccuracy-
dc.subjectActive surveillance-
dc.subjectEsophageal cancer-
dc.subjectEsophagectomy-
dc.subjectNeoadjuvant chemoradiotherapy-
dc.titleAccuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study-
dc.typeArticle-
dc.identifier.emailLaw, S: slaw@hku.hk-
dc.identifier.emailWong, I: wongick@hku.hk-
dc.identifier.emailLam, KO: lamkaon@hku.hk-
dc.identifier.authorityLaw, S=rp00437-
dc.identifier.authorityWong, I=rp01480-
dc.identifier.authorityLam, KO=rp01501-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1186/s12885-020-6669-y-
dc.identifier.pmid32143580-
dc.identifier.pmcidPMC7060643-
dc.identifier.scopuseid_2-s2.0-85081528579-
dc.identifier.hkuros317874-
dc.identifier.volume20-
dc.identifier.spagearticle no. 194-
dc.identifier.epagearticle no. 194-
dc.identifier.isiWOS:000519053700004-
dc.publisher.placeUnited Kingdom-
dc.identifier.issnl1471-2407-

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