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

Jing Guo, Aman Xu, Xiaowei Sun, Xuhui Zhao, Yabin Xia, Huamin Rao, Yaming Zhang, Rupeng Zhang, Li Chen, Tao Zhang, Gang Li, Hongtao Xu and Dazhi Xu ()
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Jing Guo: Fudan University Shanghai Cancer Center
Aman Xu: The First Affiliated Hospital of Anhui Medical University
Xiaowei Sun: Sun Yat-sen University Cancer Center, Guangzhou
Xuhui Zhao: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital)
Yabin Xia: The First Affiliated Hospital of Wannan Medical College
Huamin Rao: Jiangxi Provincial Cancer Hospital
Yaming Zhang: Anqing Municipal Hospital
Rupeng Zhang: Tianjin Medical University Cancer Institute and Hospital, Tianjin
Li Chen: The Second Affiliated Hospital of Zhejiang University School of Medicine
Tao Zhang: Yuebei People’s Hospital
Gang Li: Jiangsu Cancer Hospital
Hongtao Xu: Lishui Municipal Central Hospital
Dazhi Xu: Fudan University Shanghai Cancer Center

Nature Communications, 2021, vol. 12, issue 1, 1-7

Abstract: Abstract 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.

Date: 2021
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DOI: 10.1038/s41467-021-26778-8

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