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

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).

SUBMITTER: Zhang X

PROVIDER: S-EPMC7060643 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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

Zhang Xiaobin X Eyck Ben M BM Yang Yang Y Liu Jun J Chao Yin-Kai YK Hou Ming-Mo MM Hung Tsung-Min TM Pang Qingsong Q Yu Zhen-Tao ZT Jiang Hongjing H Law Simon S Wong Ian I Lam Ka-On KO van der Wilk Berend J BJ van der Gaast Ate A Spaander Manon C W MCW Valkema Roelf R Lagarde Sjoerd M SM Wijnhoven Bas P L BPL van Lanschot J Jan B JJB Li Zhigang Z Li Zhigang Z

BMC cancer 20200306 1

<h4>Background</h4>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 eval ...[more]

PMID: 32143580

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Project description:BackgroundProgrammed death 1 (PD-1) inhibitor demonstrated durable antitumor activity in advanced esophageal squamous cell carcinoma (ESCC), but the clinical benefit of perioperative immunotherapy in ESCC remains unclear. This study evaluated the efficacy and safety of neoadjuvant chemoradiotherapy (nCRT) combined with the PD-1 inhibitor toripalimab in patients with resectable ESCC.MethodsFrom July 2020 to July 2022, 21 patients with histopathologically confirmed thoracic ESCC and clinical staged as cT1-4aN1-2M0/cT3-4aN0M0 were enrolled. Eligible patients received radiotherapy (23 fractions of 1.8 Gy, 5 fractions a week) with concurrent chemotherapy of paclitaxel/cisplatin (paclitaxel 45 mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 and two cycles of toripalimab 240 mg every 3 weeks after nCRT for neoadjuvant therapy before surgery, four cycles of toripalimab 240 mg every 3 weeks for adjuvant therapy after surgery. The primary endpoint was the major pathological response (MPR) rate. The secondary endpoints were safety and survival outcomes.ResultsA total of 21 patients were included, of whom 20 patients underwent surgery, 1 patient refused surgery and another patient was confirmed adenocarcinoma after surgery. The MPR and pathological complete response (pCR) rates were 78.9% (15/19) and 47.4% (9/19) for surgery ESCC patients. 21 patients (100.0%) had any-grade treatment-related adverse events, with the most common being lymphopenia (100.0%), leukopenia (85.7%), neutropenia (52.4%). 14 patients (66.7%) had adverse events of grade 3 with the most common being lymphopenia (66.7%). The maximum standardized uptake value and total lesion glycolysis of positron emission tomography/CT after neoadjuvant therapy well predicted the pathological response. The peripheral CD4+%, CD3+HLA-DR+/CD3+%, CD8+HLA-DR+/CD8+%, and IL-6 were significant differences between pCR and non-pCR groups at different times during neoadjuvant therapy. Three patients had tumor relapse and patients with MPR have longer disease-free survival than non-MPR patients.ConclusionsnCRT combined with perioperative toripalimab is effective and safe for locally advanced resectable ESCC. Long-term survival outcomes remain to be determined.Trial registration numberNCT04437212.

Project description:BackgroundEsophageal squamous cell carcinoma (ESCC) is an aggressive type of cancer, associated with poor prognosis. The development of an accurate and non-invasive method to evaluate the pathologic response of patients with ESCC to chemoradiotherapy remains a critical issue. Therefore, the aim of this study was to assess the importance of vascular permeability and texture parameters in predicting the response to neoadjuvant chemoradiotherapy (NACRT) in patients with ESCC.MethodsThis prospective analysis included patients with T1-T2 stage of ESCC, without either lymphatic or metastasis, and distant metastasis. All patients underwent surgery having received two rounds of NACRT. All patients underwent dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) twice, i.e., before the first NACRT and after the second NACRT. Patients were assessed for treatment response at 30 days after the second NACRT. Patients were divided into the complete response (CR) and partial response (PR) groups based on their responses to NACRT. Vascular permeability and texture parameters were extracted from the DCE-MRI scans. After assessing the diagnostic performance of individual parameters, a combined model with vascular permeability and texture parameters was generated to predict the response to NACRT.ResultsIn this study, the CR and PR groups included 16 patients each. The volume transfer constant (Ktrans), extracellular extravascular volume fraction (ve), and entropy values, as well as changes to each of these parameters, extracted from the second DCE-MRI scans, showed significant differences between the CR and PR groups. The area under the curve (AUC) of Ktrans, ve, and entropy values showed good diagnostic ability (0.813, 0.789, and 0.707, respectively). A logistic regression model combining Ktrans, ve, and entropy had significant diagnostic ability (AUC=0.977).ConclusionsThe use of a combined model with vascular permeability and texture parameters can improve post-NACRT prognostication in patients with ESCC.

Dataset Information

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

Publications

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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