Cargando…

Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer

Whether extensive intraoperative peritoneal lavage (EIPL) after gastrectomy is beneficial to patients with locally advanced gastric cancer (AGC) is not clear. This phase 3, multicenter, parallel-group, prospective randomized study (NCT02745509) recruits patients between April 2016 and November 2017....

Descripción completa

Detalles Bibliográficos
Autores principales: Guo, Jing, Xu, Aman, Sun, Xiaowei, Zhao, Xuhui, Xia, Yabin, Rao, Huamin, Zhang, Yaming, Zhang, Rupeng, Chen, Li, Zhang, Tao, Li, Gang, Xu, Hongtao, Xu, Dazhi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8594430/
https://www.ncbi.nlm.nih.gov/pubmed/34782599
http://dx.doi.org/10.1038/s41467-021-26778-8
_version_ 1784599993279053824
author Guo, Jing
Xu, Aman
Sun, Xiaowei
Zhao, Xuhui
Xia, Yabin
Rao, Huamin
Zhang, Yaming
Zhang, Rupeng
Chen, Li
Zhang, Tao
Li, Gang
Xu, Hongtao
Xu, Dazhi
author_facet Guo, Jing
Xu, Aman
Sun, Xiaowei
Zhao, Xuhui
Xia, Yabin
Rao, Huamin
Zhang, Yaming
Zhang, Rupeng
Chen, Li
Zhang, Tao
Li, Gang
Xu, Hongtao
Xu, Dazhi
author_sort Guo, Jing
collection PubMed
description Whether extensive intraoperative peritoneal lavage (EIPL) after gastrectomy is beneficial to patients with locally advanced gastric cancer (AGC) is not clear. This phase 3, multicenter, parallel-group, prospective randomized study (NCT02745509) recruits patients between April 2016 and November 2017. Eligible patients who had been histologically proven AGC with T3/4NxM0 stage are randomly assigned (1:1) to either surgery alone or surgery plus EIPL. The results of the two groups are analyzed in the intent-to-treat population. A total of 662 patients with AGC (329 patients in the surgery alone group, and 333 in the surgery plus EIPL group) are included in the study. The primary endpoint is 3-year overall survival (OS). The secondary endpoints include 3-year disease free survival (DFS), 3-year peritoneal recurrence-free survival (reported in this manuscript) and 30-day postoperative complication and mortality (previously reported). The trial meets pre-specified endpoints. Estimated 3-year OS rates are 68.5% in the surgery alone group and 70.6% in the surgery plus EIPL group (log-rank p = 0.77). 3-year DFS rates are 61.2% in the surgery alone group and 66.0% in the surgery plus EIPL group (log-rank p = 0.24). The pattern of disease recurrence is similar in the two groups. In conclusion, EIPL does not improve the 3-year survival rate in AGC patients.
format Online
Article
Text
id pubmed-8594430
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Nature Publishing Group UK
record_format MEDLINE/PubMed
spelling pubmed-85944302021-11-19 Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer Guo, Jing Xu, Aman Sun, Xiaowei Zhao, Xuhui Xia, Yabin Rao, Huamin Zhang, Yaming Zhang, Rupeng Chen, Li Zhang, Tao Li, Gang Xu, Hongtao Xu, Dazhi Nat Commun Article Whether extensive intraoperative peritoneal lavage (EIPL) after gastrectomy is beneficial to patients with locally advanced gastric cancer (AGC) is not clear. This phase 3, multicenter, parallel-group, prospective randomized study (NCT02745509) recruits patients between April 2016 and November 2017. Eligible patients who had been histologically proven AGC with T3/4NxM0 stage are randomly assigned (1:1) to either surgery alone or surgery plus EIPL. The results of the two groups are analyzed in the intent-to-treat population. A total of 662 patients with AGC (329 patients in the surgery alone group, and 333 in the surgery plus EIPL group) are included in the study. The primary endpoint is 3-year overall survival (OS). The secondary endpoints include 3-year disease free survival (DFS), 3-year peritoneal recurrence-free survival (reported in this manuscript) and 30-day postoperative complication and mortality (previously reported). The trial meets pre-specified endpoints. Estimated 3-year OS rates are 68.5% in the surgery alone group and 70.6% in the surgery plus EIPL group (log-rank p = 0.77). 3-year DFS rates are 61.2% in the surgery alone group and 66.0% in the surgery plus EIPL group (log-rank p = 0.24). The pattern of disease recurrence is similar in the two groups. In conclusion, EIPL does not improve the 3-year survival rate in AGC patients. Nature Publishing Group UK 2021-11-15 /pmc/articles/PMC8594430/ /pubmed/34782599 http://dx.doi.org/10.1038/s41467-021-26778-8 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Guo, Jing
Xu, Aman
Sun, Xiaowei
Zhao, Xuhui
Xia, Yabin
Rao, Huamin
Zhang, Yaming
Zhang, Rupeng
Chen, Li
Zhang, Tao
Li, Gang
Xu, Hongtao
Xu, Dazhi
Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer
title Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer
title_full Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer
title_fullStr Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer
title_full_unstemmed Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer
title_short Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer
title_sort three-year outcomes of the randomized phase iii seiplus trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8594430/
https://www.ncbi.nlm.nih.gov/pubmed/34782599
http://dx.doi.org/10.1038/s41467-021-26778-8
work_keys_str_mv AT guojing threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT xuaman threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT sunxiaowei threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT zhaoxuhui threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT xiayabin threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT raohuamin threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT zhangyaming threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT zhangrupeng threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT chenli threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT zhangtao threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT ligang threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT xuhongtao threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer
AT xudazhi threeyearoutcomesoftherandomizedphaseiiiseiplustrialofextensiveintraoperativeperitoneallavageforlocallyadvancedgastriccancer