Chemoradiation versus Oesophagectomy for Locally Advanced Oesophageal Cancer in Chinese Patients: Study Protocol for a Randomized Controlled Trial

Abstract Background: Surgery is the gold standard treatment for local advanced disease, while definitive concurrent chemoradiotherapy (DCRT) is recommended for those who are medically unable to tolerate major surgery or medically fit patients who decline surgery. The primary aim of this trial is to compare the outcomes in Chinese oesophageal squamous cell cancer patients with locally advanced resectable disease who have received either surgery or DCRT. Methods/design: One hundred ninety-six patients with T1bN+M0 or T2-4aN0-2M0 oesophageal squamous cell cancer will be randomized to the DCRT group or the surgery group. In the DCRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50 Gy/25 fractions and basic chemotherapy with 5-fluorouracil (5-FU) regimens. In the surgery group, patients will receive neoadjuvant chemoradiotherapy (NCRT) and standard oesophagectomy. Five years of follow-up will be scheduled for patients. The primary endpoints are 2-year/5-year overall survival; the secondary endpoints are 2-year/5-year progression-free survival, treatment-related adverse events and the patients’ quality of life. The main evaluation methods include oesophagoscopy, endoscopic ultrasonography and biopsy, oesophageal barium meal, CT, PET-CT, blood tests, and questionnaires. Discussion: The preponderant oesophageal cancer pathology type is dramatically different in western Caucasian and Asian oesophageal cancer patients: Caucasian patients present with 80% adenocarcinomas, and Asians patients present with 95% squamous cell carcinomas. This phenomenon needs more in-depth studies to elucidate the differences in these populations. Based on the results of this study, we will show whether DCRT will benefit patients more than oesophagectomy. It will contribute more evidence to the management of oesophageal squamous cell cancer. Trial registration: ClinicalTrials.gov identifier NCT02972372; registered on November 26, 2016；the URL of the trial registry record: https://clinicaltrials.gov/ct2/show/NCT02972372?term=shegan+gao&rank=1

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Radiomics Signature Facilitates Organ-Saving Strategy in Patients With Esophageal Squamous Cell Cancer Receiving Neoadjuvant Chemoradiotherapy

Frontiers in Oncology ◽

10.3389/fonc.2020.615167 ◽

2021 ◽

Vol 10 ◽

Author(s):

Yue Li ◽

Jun Liu ◽

Hong-xuan Li ◽

Xu-wei Cai ◽

Zhi-gang Li ◽

...

Keyword(s):

Squamous Cell ◽

Squamous Cell Cancer ◽

Cell Cancer ◽

Locally Advanced ◽

Neoadjuvant Chemoradiotherapy ◽

Esophageal Squamous Cell Cancer ◽

Clinical Model ◽

Clinical Variables ◽

Treatment Plans ◽

Radiomics Signature

After neoadjuvant chemoradiotherapy (NCRT) in locally advanced esophageal squamous cell cancer (ESCC), roughly 40% of the patients may achieve pathologic complete response (pCR). Those patients may benefit from organ-saving strategy if the probability of pCR could be correctly identified before esophagectomy. A reliable approach to predict pathological response allows future studies to investigate individualized treatment plans.MethodAll eligible patients treated in our center from June 2012 to June 2019 were retrospectively collected. Radiomics features extracted from pre-/post-NCRT CT images were selected by univariate logistic and LASSO regression. A radiomics signature (RS) developed with selected features was combined with clinical variables to construct RS+clinical model with multivariate logistic regression, which was internally validated by bootstrapping. Performance and clinical usefulness of RS+clinical model were assessed by receiver operating characteristic (ROC) curves and decision curve analysis, respectively.ResultsAmong the 121 eligible patients, 51 achieved pCR (42.1%) after NCRT. Eighteen radiomics features were selected and incorporated into RS. The RS+clinical model has improved prediction performance for pCR compared with the clinical model (corrected area under the ROC curve, 0.84 vs. 0.70). At the 60% probability threshold cutoff (i.e., the patient would opt for observation if his probability of pCR was >60%), net 13% surgeries could be avoided by RS+clinical model, equivalent to implementing organ-saving strategy in 31.37% of the 51 true-pCR cases.ConclusionThe model built with CT radiomics features and clinical variables shows the potential of predicting pCR after NCRT; it provides significant clinical benefit in identifying qualified patients to receive individualized organ-saving treatment plans.

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608 RADIOMICS MODEL FACILITATES ORGAN-SAVING STRATEGY IN PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CANCER RECEIVING NEOADJUVANT CHEMORADIOTHERAPY

Diseases of the Esophagus ◽

10.1093/dote/doab052.608 ◽

2021 ◽

Vol 34 (Supplement_1) ◽

Author(s):

Yue Li

Keyword(s):

Squamous Cell ◽

Squamous Cell Cancer ◽

Cell Cancer ◽

Locally Advanced ◽

Neoadjuvant Chemoradiotherapy ◽

Esophageal Squamous Cell Cancer ◽

Minimum Diameter ◽

Clinical Model ◽

Clinical Variables ◽

Treatment Plans

Abstract After neoadjuvant chemoradiotherapy(NCRT) in locally advanced esophageal squamous cell cancer(ESCC), roughly 40% of the patients may achieve pathologic complete response (pCR) of the primary tumor. Those patients may benefit from organ-saving strategy if the probability of pCR could be correctly identified before esophagectomy. A reliable approach to predict pathological response allows future studies to investigate individualized treatment plans. We aim to establish a CT-based radiomics model to predict tumor response to NCRT. Methods 121 patients with ESCC who underwent NCRT followed by esophagectomy were retrospectively collected. Radiomics features extracted from pre−/post-NCRT CT images were selected by univariate logistic (p < 0.157) and LASSO regression. A radiomics signature(RS) developed with selected features was combined with 4 clinical variables, including percentage of tumor thickness reduction, tumor adventitia type, tumor minimum diameter on post-NCRT esophagogram and age, to construct RS + clinical model with multivariate logistic regression which was internally validated by bootstrapping. Performance and clinical usefulness of RS + clinical model were assessed by receiver operating characteristic(ROC) curves and decision curve analysis, respectively, comparing with the model of clinical variables alone. Results Among the 121 patients, 51 achieved pCR(42%) after NCRT. 16 radiomics features were selected and incorporated into RS. The RS + clinical model has improved prediction performance for pCR compared with the clinical model(corrected area under the ROC curve,0.843 vs. 0.700). At the 60% probability threshold cutoff(i.e., the patient would opt for observation if his probability of pCR was >60%), net 12% surgeries could be avoided by RS + clinical model without an increase in the number of missed residual diseases, equivalent to implementing organ-saving strategy in 29.4% of the 51 true-pCR cases. Conclusion The model built with CT radiomics features and clinical variables shows the potential of predicting pCR after NCRT; it provides significant clinical benefit in identifying qualified patients to receive individualized organ-saving treatment plans.

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Low cardiac dose and neutrophil-to-lymphocyte ratio predict overall survival in inoperable esophageal squamous cell cancer patients after chemoradiotherapy

Scientific Reports ◽

10.1038/s41598-021-86019-2 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yu-Chieh Ho ◽

Yuan-Chun Lai ◽

Hsuan-Yu Lin ◽

Ming-Hui Ko ◽

Sheng-Hung Wang ◽

...

Keyword(s):

Overall Survival ◽

Cancer Patients ◽

Squamous Cell ◽

Squamous Cell Cancer ◽

Performance Status ◽

Cell Cancer ◽

Esophageal Squamous Cell Cancer ◽

Lymphocyte Ratio ◽

Cardiac Dose

AbstractWe aimed to determine the prognostic significance of cardiac dose and hematological immunity parameters in esophageal cancer patients after concurrent chemoradiotherapy (CCRT). During 2010–2015, we identified 101 newly diagnosed esophageal squamous cell cancer patients who had completed definitive CCRT. Patients' clinical, dosimetric, and hematological data, including absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio (NLR), at baseline, during, and post-CCRT were analyzed. Cox proportional hazards were calculated to identify potential risk factors for overall survival (OS). Median OS was 13 months (95% confidence interval [CI]: 10.38–15.63). Univariate analysis revealed that male sex, poor performance status, advanced nodal stage, higher percentage of heart receiving 10 Gy (heart V10), and higher NLR (baseline and follow-up) were significantly associated with worse OS. In multivariate analysis, performance status (ECOG 0 & 1 vs. 2; hazard ratio [HR] 3.12, 95% CI 1.30–7.48), heart V10 (> 84% vs. ≤ 84%; HR 2.24, 95% CI 1.26–3.95), baseline NLR (> 3.56 vs. ≤ 3.56; HR 2.36, 95% CI 1.39–4.00), and follow-up NLR (> 7.4 vs. ≤ 7.4; HR 1.95, 95% CI 1.12–3.41) correlated with worse OS. Volume of low cardiac dose and NLR (baseline and follow-up) were associated with worse patient survival.

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