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Moderately hypo-fractionated radiotherapy combined with S-1 in inoperable locally advanced esophageal squamous cell carcinoma: A prospective, single-arm phase II study (GASTO-1045)

PURPOSE: We launched this prospective phase II single-arm trial on the combination of moderately hypo-fractionated radiotherapy and S-1, to explore the safety and efficacy of the new potent regimen in inoperable locally advanced esophageal squamous carcinoma (LA-ESCC) patients. METHODS: Patients wit...

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Autores principales: Zhou, Rui, Luo, Guangyu, Guo, Suping, Wu, Yingjia, Luo, Qiaoting, Wang, Daquan, Chen, Naibin, Liu, Fangjie, Guo, Jinyu, Ye, Wenfeng, Qiu, Bo, Liu, Hui
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10036360/
https://www.ncbi.nlm.nih.gov/pubmed/36969023
http://dx.doi.org/10.3389/fonc.2023.1138304
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author Zhou, Rui
Luo, Guangyu
Guo, Suping
Wu, Yingjia
Luo, Qiaoting
Wang, Daquan
Chen, Naibin
Liu, Fangjie
Guo, Jinyu
Ye, Wenfeng
Qiu, Bo
Liu, Hui
author_facet Zhou, Rui
Luo, Guangyu
Guo, Suping
Wu, Yingjia
Luo, Qiaoting
Wang, Daquan
Chen, Naibin
Liu, Fangjie
Guo, Jinyu
Ye, Wenfeng
Qiu, Bo
Liu, Hui
author_sort Zhou, Rui
collection PubMed
description PURPOSE: We launched this prospective phase II single-arm trial on the combination of moderately hypo-fractionated radiotherapy and S-1, to explore the safety and efficacy of the new potent regimen in inoperable locally advanced esophageal squamous carcinoma (LA-ESCC) patients. METHODS: Patients with unresectable stage II-IVB LA-ESCC (UICC 2002, IVB only with metastatic celiac or supraclavicular lymph nodes) were included. Moderately hypofractionated radiotherapy (60Gy in 24 fractions) concurrent with S-1 was delivered. Meanwhile, gastrostomy tube placement by percutaneous endoscopic gastrostomy (PEG) was performed to provide nutritional support. Nutritional supplements were prescribed to meet requirements. The study outcomes included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), locoregional progression-free survival (LRPFS), distant metastasis-free survival (DMFS), failure pattern, toxicities, nutritional status and treatment compliance. Endoscopy was routinely performed during post-treatment follow-up. RESULTS: Fifty-eight patients were included with a median follow-up of 24.4 months. The median age was 63 years (range 49-83 years) and 42 patients (72.4%) had stage III or IV diseases. The ORR was 91.3% and the CR rate was 60.3%. The estimated 2-year PFS rate and 2-year OS rate was 44.2% (95% confidence interval (CI), 31.3-57.1%) and 71.4% (95% CI, 59.4-83.4%), respectively. Radiation-induced esophagitis was the most common non-hematologic toxicity and 5 patients (8.6%) developed grade≥3 esophagitis. While, with PEG nutrition support, the nutrition-related indicators presented a clear trend toward a gradual improvement. Treatment-related death was not observed. CONCLUSIONS: The moderately hypo-fractionated radiotherapy combined with S-1 showed promising loco-regional disease control and survival benefit in inoperable LA-ESCC patients. Meanwhile, favorable nutritional status and low incidence of severe radiation-induced esophagitis were observed with PEG nutritional support. Moreover, endoscopy examination contributed to the early detection of recurrent esophageal lesions and timely salvage treatment. The efficacy and toxicity of the combined regimen deserved further evaluation. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT03660449.
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spelling pubmed-100363602023-03-25 Moderately hypo-fractionated radiotherapy combined with S-1 in inoperable locally advanced esophageal squamous cell carcinoma: A prospective, single-arm phase II study (GASTO-1045) Zhou, Rui Luo, Guangyu Guo, Suping Wu, Yingjia Luo, Qiaoting Wang, Daquan Chen, Naibin Liu, Fangjie Guo, Jinyu Ye, Wenfeng Qiu, Bo Liu, Hui Front Oncol Oncology PURPOSE: We launched this prospective phase II single-arm trial on the combination of moderately hypo-fractionated radiotherapy and S-1, to explore the safety and efficacy of the new potent regimen in inoperable locally advanced esophageal squamous carcinoma (LA-ESCC) patients. METHODS: Patients with unresectable stage II-IVB LA-ESCC (UICC 2002, IVB only with metastatic celiac or supraclavicular lymph nodes) were included. Moderately hypofractionated radiotherapy (60Gy in 24 fractions) concurrent with S-1 was delivered. Meanwhile, gastrostomy tube placement by percutaneous endoscopic gastrostomy (PEG) was performed to provide nutritional support. Nutritional supplements were prescribed to meet requirements. The study outcomes included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), locoregional progression-free survival (LRPFS), distant metastasis-free survival (DMFS), failure pattern, toxicities, nutritional status and treatment compliance. Endoscopy was routinely performed during post-treatment follow-up. RESULTS: Fifty-eight patients were included with a median follow-up of 24.4 months. The median age was 63 years (range 49-83 years) and 42 patients (72.4%) had stage III or IV diseases. The ORR was 91.3% and the CR rate was 60.3%. The estimated 2-year PFS rate and 2-year OS rate was 44.2% (95% confidence interval (CI), 31.3-57.1%) and 71.4% (95% CI, 59.4-83.4%), respectively. Radiation-induced esophagitis was the most common non-hematologic toxicity and 5 patients (8.6%) developed grade≥3 esophagitis. While, with PEG nutrition support, the nutrition-related indicators presented a clear trend toward a gradual improvement. Treatment-related death was not observed. CONCLUSIONS: The moderately hypo-fractionated radiotherapy combined with S-1 showed promising loco-regional disease control and survival benefit in inoperable LA-ESCC patients. Meanwhile, favorable nutritional status and low incidence of severe radiation-induced esophagitis were observed with PEG nutritional support. Moreover, endoscopy examination contributed to the early detection of recurrent esophageal lesions and timely salvage treatment. The efficacy and toxicity of the combined regimen deserved further evaluation. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT03660449. Frontiers Media S.A. 2023-03-10 /pmc/articles/PMC10036360/ /pubmed/36969023 http://dx.doi.org/10.3389/fonc.2023.1138304 Text en Copyright © 2023 Zhou, Luo, Guo, Wu, Luo, Wang, Chen, Liu, Guo, Ye, Qiu and Liu https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Zhou, Rui
Luo, Guangyu
Guo, Suping
Wu, Yingjia
Luo, Qiaoting
Wang, Daquan
Chen, Naibin
Liu, Fangjie
Guo, Jinyu
Ye, Wenfeng
Qiu, Bo
Liu, Hui
Moderately hypo-fractionated radiotherapy combined with S-1 in inoperable locally advanced esophageal squamous cell carcinoma: A prospective, single-arm phase II study (GASTO-1045)
title Moderately hypo-fractionated radiotherapy combined with S-1 in inoperable locally advanced esophageal squamous cell carcinoma: A prospective, single-arm phase II study (GASTO-1045)
title_full Moderately hypo-fractionated radiotherapy combined with S-1 in inoperable locally advanced esophageal squamous cell carcinoma: A prospective, single-arm phase II study (GASTO-1045)
title_fullStr Moderately hypo-fractionated radiotherapy combined with S-1 in inoperable locally advanced esophageal squamous cell carcinoma: A prospective, single-arm phase II study (GASTO-1045)
title_full_unstemmed Moderately hypo-fractionated radiotherapy combined with S-1 in inoperable locally advanced esophageal squamous cell carcinoma: A prospective, single-arm phase II study (GASTO-1045)
title_short Moderately hypo-fractionated radiotherapy combined with S-1 in inoperable locally advanced esophageal squamous cell carcinoma: A prospective, single-arm phase II study (GASTO-1045)
title_sort moderately hypo-fractionated radiotherapy combined with s-1 in inoperable locally advanced esophageal squamous cell carcinoma: a prospective, single-arm phase ii study (gasto-1045)
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10036360/
https://www.ncbi.nlm.nih.gov/pubmed/36969023
http://dx.doi.org/10.3389/fonc.2023.1138304
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