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Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial
PURPOSE: The efficacy of neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) remains controversial. In this trial, we compared the survival and safety of NCRT plus surgery with surgery alone in patients with locally advanced ESCC. PATIENTS...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Society of Clinical Oncology
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145832/ https://www.ncbi.nlm.nih.gov/pubmed/30089078 http://dx.doi.org/10.1200/JCO.2018.79.1483 |
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author | Yang, Hong Liu, Hui Chen, Yuping Zhu, Chengchu Fang, Wentao Yu, Zhentao Mao, Weimin Xiang, Jiaqing Han, Yongtao Chen, Zhijian Yang, Haihua Wang, Jiaming Pang, Qingsong Zheng, Xiao Yang, Huanjun Li, Tao Lordick, Florian D’Journo, Xavier Benoit Cerfolio, Robert J. Korst, Robert J. Novoa, Nuria M. Swanson, Scott J. Brunelli, Alessandro Ismail, Mahmoud Fernando, Hiran C. Zhang, Xu Li, Qun Wang, Geng Chen, Baofu Mao, Teng Kong, Min Guo, Xufeng Lin, Ting Liu, Mengzhong Fu, Jianhua |
author_facet | Yang, Hong Liu, Hui Chen, Yuping Zhu, Chengchu Fang, Wentao Yu, Zhentao Mao, Weimin Xiang, Jiaqing Han, Yongtao Chen, Zhijian Yang, Haihua Wang, Jiaming Pang, Qingsong Zheng, Xiao Yang, Huanjun Li, Tao Lordick, Florian D’Journo, Xavier Benoit Cerfolio, Robert J. Korst, Robert J. Novoa, Nuria M. Swanson, Scott J. Brunelli, Alessandro Ismail, Mahmoud Fernando, Hiran C. Zhang, Xu Li, Qun Wang, Geng Chen, Baofu Mao, Teng Kong, Min Guo, Xufeng Lin, Ting Liu, Mengzhong Fu, Jianhua |
author_sort | Yang, Hong |
collection | PubMed |
description | PURPOSE: The efficacy of neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) remains controversial. In this trial, we compared the survival and safety of NCRT plus surgery with surgery alone in patients with locally advanced ESCC. PATIENTS AND METHODS: From June 2007 to December 2014, 451 patients with potentially resectable thoracic ESCC, clinically staged as T1-4N1M0/T4N0M0, were randomly allocated to NCRT plus surgery (group CRT; n = 224) and surgery alone (group S; n = 227). In group CRT, patients received vinorelbine 25 mg/m(2) intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m(2) IV day 1, or 25 mg/m(2) IV on days 1 to 4 every 3 weeks for two cycles, with a total concurrent radiation dose of 40.0 Gy administered in 20 fractions of 2.0 Gy on 5 days per week. In both groups, patients underwent McKeown or Ivor Lewis esophagectomy. The primary end point was overall survival. RESULTS: The pathologic complete response rate was 43.2% in group CRT. Compared with group S, group CRT had a higher R0 resection rate (98.4% v 91.2%; P = .002), a better median overall survival (100.1 months v 66.5 months; hazard ratio, 0.71; 95% CI, 0.53 to 0.96; P = .025), and a prolonged disease-free survival (100.1 months v 41.7 months; hazard ratio, 0.58; 95% CI, 0.43 to 0.78; P < .001). Leukopenia (48.9%) and neutropenia (45.7%) were the most common grade 3 or 4 adverse events during chemoradiotherapy. Incidences of postoperative complications were similar between groups, with the exception of arrhythmia (group CRT: 13% v group S: 4.0%; P = .001). Peritreatment mortality was 2.2% in group CRT versus 0.4% in group S (P = .212). CONCLUSION: This trial shows that NCRT plus surgery improves survival over surgery alone among patients with locally advanced ESCC, with acceptable and manageable adverse events. |
format | Online Article Text |
id | pubmed-6145832 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | American Society of Clinical Oncology |
record_format | MEDLINE/PubMed |
spelling | pubmed-61458322018-09-25 Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial Yang, Hong Liu, Hui Chen, Yuping Zhu, Chengchu Fang, Wentao Yu, Zhentao Mao, Weimin Xiang, Jiaqing Han, Yongtao Chen, Zhijian Yang, Haihua Wang, Jiaming Pang, Qingsong Zheng, Xiao Yang, Huanjun Li, Tao Lordick, Florian D’Journo, Xavier Benoit Cerfolio, Robert J. Korst, Robert J. Novoa, Nuria M. Swanson, Scott J. Brunelli, Alessandro Ismail, Mahmoud Fernando, Hiran C. Zhang, Xu Li, Qun Wang, Geng Chen, Baofu Mao, Teng Kong, Min Guo, Xufeng Lin, Ting Liu, Mengzhong Fu, Jianhua J Clin Oncol ORIGINAL REPORTS PURPOSE: The efficacy of neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) remains controversial. In this trial, we compared the survival and safety of NCRT plus surgery with surgery alone in patients with locally advanced ESCC. PATIENTS AND METHODS: From June 2007 to December 2014, 451 patients with potentially resectable thoracic ESCC, clinically staged as T1-4N1M0/T4N0M0, were randomly allocated to NCRT plus surgery (group CRT; n = 224) and surgery alone (group S; n = 227). In group CRT, patients received vinorelbine 25 mg/m(2) intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m(2) IV day 1, or 25 mg/m(2) IV on days 1 to 4 every 3 weeks for two cycles, with a total concurrent radiation dose of 40.0 Gy administered in 20 fractions of 2.0 Gy on 5 days per week. In both groups, patients underwent McKeown or Ivor Lewis esophagectomy. The primary end point was overall survival. RESULTS: The pathologic complete response rate was 43.2% in group CRT. Compared with group S, group CRT had a higher R0 resection rate (98.4% v 91.2%; P = .002), a better median overall survival (100.1 months v 66.5 months; hazard ratio, 0.71; 95% CI, 0.53 to 0.96; P = .025), and a prolonged disease-free survival (100.1 months v 41.7 months; hazard ratio, 0.58; 95% CI, 0.43 to 0.78; P < .001). Leukopenia (48.9%) and neutropenia (45.7%) were the most common grade 3 or 4 adverse events during chemoradiotherapy. Incidences of postoperative complications were similar between groups, with the exception of arrhythmia (group CRT: 13% v group S: 4.0%; P = .001). Peritreatment mortality was 2.2% in group CRT versus 0.4% in group S (P = .212). CONCLUSION: This trial shows that NCRT plus surgery improves survival over surgery alone among patients with locally advanced ESCC, with acceptable and manageable adverse events. American Society of Clinical Oncology 2018-09-20 2018-08-08 /pmc/articles/PMC6145832/ /pubmed/30089078 http://dx.doi.org/10.1200/JCO.2018.79.1483 Text en © 2018 by American Society of Clinical Oncology http://creativecommons.org/licenses/by/4.0/ Licensed under the Creative Commons Attribution 4.0 License: http://creativecommons.org/licenses/by/4.0/ |
spellingShingle | ORIGINAL REPORTS Yang, Hong Liu, Hui Chen, Yuping Zhu, Chengchu Fang, Wentao Yu, Zhentao Mao, Weimin Xiang, Jiaqing Han, Yongtao Chen, Zhijian Yang, Haihua Wang, Jiaming Pang, Qingsong Zheng, Xiao Yang, Huanjun Li, Tao Lordick, Florian D’Journo, Xavier Benoit Cerfolio, Robert J. Korst, Robert J. Novoa, Nuria M. Swanson, Scott J. Brunelli, Alessandro Ismail, Mahmoud Fernando, Hiran C. Zhang, Xu Li, Qun Wang, Geng Chen, Baofu Mao, Teng Kong, Min Guo, Xufeng Lin, Ting Liu, Mengzhong Fu, Jianhua Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial |
title | Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial |
title_full | Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial |
title_fullStr | Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial |
title_full_unstemmed | Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial |
title_short | Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial |
title_sort | neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of the esophagus (neocrtec5010): a phase iii multicenter, randomized, open-label clinical trial |
topic | ORIGINAL REPORTS |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145832/ https://www.ncbi.nlm.nih.gov/pubmed/30089078 http://dx.doi.org/10.1200/JCO.2018.79.1483 |
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