Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): a prospective multicenter diagnostic cohort study
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Published:2020-03-06
Issue:1
Volume:20
Page:
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ISSN:1471-2407
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Container-title:BMC Cancer
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language:en
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Short-container-title:BMC Cancer
Author:
Zhang Xiaobin, Eyck Ben M., Yang Yang, Liu Jun, Chao Yin-Kai, Hou Ming-Mo, Hung Tsung-Min, Pang Qingsong, Yu Zhen-Tao, Jiang Hongjing, Law Simon, Wong Ian, Lam Ka-On, van der Wilk Berend J., van der Gaast Ate, Spaander Manon C. W., Valkema Roelf, Lagarde Sjoerd M., Wijnhoven Bas P. L., van Lanschot J. Jan B., Li ZhigangORCID
Abstract
Abstract
Background
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).
Funder
Shanghai Chest Hospital
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
Reference35 articles.
1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424. 2. Eyck BM, van der Wilk BJ, Lagarde SM, Wijnhoven BPL, Valkema R, Spaander MCW, et al. Neoadjuvant chemoradiotherapy for resectable oesophageal cancer. Best Pract Res Clin Gastroenterol. 2018;36–37:37–44. https://doi.org/10.1016/j.bpg.2018.11.007. 3. Shapiro J, van Lanschot JJB, Hulshof M, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, et al. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015;16(9):1090–8. 4. van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, et al. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012;366(22):2074–84. 5. van der Wilk BJ, Eyck BM, Spaander MCW, Valkema R, Lagarde SM, Wijnhoven BPL, et al. Towards an organ-sparing approach for locally advanced esophageal Cancer. Dig Surg. 2018 Sep;18:1–8.
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