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

Nature Communications

Huamin Rao¹  Jing Guo²  Dazhi Xu²  Xiaowei Sun³  Rupeng Zhang⁴  Aman Xu⁵  Tao Zhang⁶  Gang Li⁷  Hongtao Xu⁸  Xuhui Zhao⁹  Yabin Xia^1,10  Li Chen^1,11  Yaming Zhang^1,12 

[1] Department of Abdominal Surgery, Jiangxi Provincial Cancer Hospital, Nanchang, Jiangxi, China;Department of Gastric Surgery, Fudan University Shanghai Cancer Center, Shanghai, China;Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China;Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China;Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China;Department of Gastric Surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China;Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, HeFei, Anhui, China;Department of Gastrointestinal Surgery, Yuebei People’s Hospital, Shaoguan, Guangdong, China;Department of General Surgery, Jiangsu Cancer Hospital, Nanjing, Jiangsu, China;Department of General Surgery, Lishui Municipal Central Hospital, Lishui, Zhejiang, China;Department of General Surgery, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital), Hefei, Anhui, China;Department of General Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China;Department of General Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China;Department of Surgical Oncology, Anqing Municipal Hospital, Anqing, Anhui, China;

DOI  :  10.1038/s41467-021-26778-8

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY