Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study
Abstract Background Peritoneal metastasis (PM) after radical surgery is an important cause of treatment failure in colorectal cancer (CRC). Intraoperative intraperitoneal perfusion chemotherapy may be an effective method for preventing postoperative PM in patients with CRC. This study aimed to explo...
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2025-06-01
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| author | Hao Su Rui Zhang Yunfeng Li Yanke Li Wei Pei Zhigang Jie Zhimin Liu Meijin Huang Jing Zhuang Qian Jiang Ming Xie Guiying Wang Wenbin Zhang Ming Liu Jiansi Chen Zejun Wang Kang Wang Xinghong Zhang Guoxin Li Xiangfu Zeng Xinxiang Li Xuejun Sun Ju Wang Dongzhu Zeng Changlong Zhuang Haitao Zhou Xishan Wang |
| author_facet | Hao Su Rui Zhang Yunfeng Li Yanke Li Wei Pei Zhigang Jie Zhimin Liu Meijin Huang Jing Zhuang Qian Jiang Ming Xie Guiying Wang Wenbin Zhang Ming Liu Jiansi Chen Zejun Wang Kang Wang Xinghong Zhang Guoxin Li Xiangfu Zeng Xinxiang Li Xuejun Sun Ju Wang Dongzhu Zeng Changlong Zhuang Haitao Zhou Xishan Wang |
| author_sort | Hao Su |
| collection | DOAJ |
| description | Abstract Background Peritoneal metastasis (PM) after radical surgery is an important cause of treatment failure in colorectal cancer (CRC). Intraoperative intraperitoneal perfusion chemotherapy may be an effective method for preventing postoperative PM in patients with CRC. This study aimed to explore the safety and feasibility of intraoperatively preventive intraperitoneal perfusion chemotherapy using lobaplatin for CRC. Methods Between 12 December 2017 and 17 October 2019, 720 eligible CRC patients with T4 or N + clinical TNM stage were recruited from 25 hospitals in China. Eligible patients were randomised in a 1:1 ratio to undergo resection of CRC only (control group) or resection of CRC with intraperitoneal perfusion chemotherapy with lobaplatin intraoperatively (lobaplatin group). The primary endpoint of this trial was the rate of PM after surgery, while secondary endpoints included safety, overall survival (OS) time, recurrence-free survival (RFS) time, peritoneal recurrence-free survival (PRFS) time, and the rate of liver metastasis. Results Of 716 patients included in the full analysis set (FAS), 352 were assigned to the lobaplatin group and 364 to the control group. In the FAS population, adding intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin decreased the primary end point rate of 3-year PM (3.56% vs 8.75%, P = 0.0053). There was no significant difference in the 3-year OS between the groups (93.2% vs 90.4%, P = 0.1660). The 3-year RFS rate (88.1% vs 81.6%, 0.0146) and 3-year PRFS rate (96.6% vs 91.5%, P = 0.0053) were significantly higher in the lobaplatin group than the control group. There were no statistically significant differences between the two groups in the incidence (69.77% vs 64.75%) or severity of adverse events (AEs) in the safety set (SS) population. Conclusions Initiation of intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin reduced the 3-year PM rate in CRC patients while improving both 3-year RFS and PRFS. The treatment was well tolerated, and the safety findings were comparable with those of the control group. Trial registration Chinese Clinical Trial Registry, ChiCTR1800014617. |
| format | Article |
| id | doaj-art-6a09986b25ef45c99c1936cd8b27f2b3 |
| institution | DOAJ |
| issn | 1741-7015 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
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| series | BMC Medicine |
| spelling | doaj-art-6a09986b25ef45c99c1936cd8b27f2b32025-08-20T03:10:37ZengBMCBMC Medicine1741-70152025-06-0123111110.1186/s12916-025-04180-1Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre studyHao Su0Rui Zhang1Yunfeng Li2Yanke Li3Wei Pei4Zhigang Jie5Zhimin Liu6Meijin Huang7Jing Zhuang8Qian Jiang9Ming Xie10Guiying Wang11Wenbin Zhang12Ming Liu13Jiansi Chen14Zejun Wang15Kang Wang16Xinghong Zhang17Guoxin Li18Xiangfu Zeng19Xinxiang Li20Xuejun Sun21Ju Wang22Dongzhu Zeng23Changlong Zhuang24Haitao Zhou25Xishan Wang26Department of Gastrointestinal Surgery, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & InstituteDepartment of Colorectal Surgery, Cancer Hospital of China Medical University, Cancer Hospital of Dalian University of Technology, Liaoning Cancer Hospital & InsitituteDepartment of Colorectal Surgery, Yunnan Cancer HospitalDepartment of Anus and Intestine Surgery, First Affiliated Hospital of China Medical UniversityDepartment of Colorectal Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical CollegeDepartment of Colorectal Surgery, the First Affiliated Hospital of Nanchang UniversityDepartment of Laparoscopic Comprehensive Surgery, Zibo Central HospitalDepartment of Colon and Rectum Surgery, Sixth Affiliated Hospital of Sun Yat-Sen UniversityDepartment of General Surgery, Henan Cancer HospitalDepartment of General Surgery, Jiangsu Cancer HospitalDepartment of Gastrointestinal Surgery, Afiliated Hospital of Zunyi Medical UniversityThe Second Department of Surgery, The Fourth Hospital of Hebei Medical UniversityGastrointestinal Tumor Surgery, the First Affiliated Hospital of Xinjiang Medical UniversityDepartment of General Surgery, The Fourth Hospital of HARBIN Medical UniversityDepartment of Gastrointestinal Surgery, Guangxi Medical University Cancer HospitalDepartment of Gastrointestinal Surgery, Cancer Hospital Affiliated to Guizhou Medical UniversityDepartment of Gastrointestinal Surgery, Sichuan Provincial People’s HospitalDepartment of Gastrointestinal Surgery, Heilongjiang Agricultural Reclamation General HospitalCancer Center, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine, Tsinghua UniversityDepartment of General Surgery, First Affiliated Hospital of Gannan Medical UniversityDepartment of Colorectal Surgery, Fudan University Shanghai Cancer CenterDepartment of General Surgery, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Gastrointestinal Surgery, Inner Mongolia Autonomous Region People’s HospitalDepartment of General Surgery, The Third Affiliated Hospital of Chongqing Medical UniversityHainan Changan International Pharmaceutical Co., Ltd.Department of Colorectal Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical CollegeDepartment of Colorectal Surgery, National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical CollegeAbstract Background Peritoneal metastasis (PM) after radical surgery is an important cause of treatment failure in colorectal cancer (CRC). Intraoperative intraperitoneal perfusion chemotherapy may be an effective method for preventing postoperative PM in patients with CRC. This study aimed to explore the safety and feasibility of intraoperatively preventive intraperitoneal perfusion chemotherapy using lobaplatin for CRC. Methods Between 12 December 2017 and 17 October 2019, 720 eligible CRC patients with T4 or N + clinical TNM stage were recruited from 25 hospitals in China. Eligible patients were randomised in a 1:1 ratio to undergo resection of CRC only (control group) or resection of CRC with intraperitoneal perfusion chemotherapy with lobaplatin intraoperatively (lobaplatin group). The primary endpoint of this trial was the rate of PM after surgery, while secondary endpoints included safety, overall survival (OS) time, recurrence-free survival (RFS) time, peritoneal recurrence-free survival (PRFS) time, and the rate of liver metastasis. Results Of 716 patients included in the full analysis set (FAS), 352 were assigned to the lobaplatin group and 364 to the control group. In the FAS population, adding intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin decreased the primary end point rate of 3-year PM (3.56% vs 8.75%, P = 0.0053). There was no significant difference in the 3-year OS between the groups (93.2% vs 90.4%, P = 0.1660). The 3-year RFS rate (88.1% vs 81.6%, 0.0146) and 3-year PRFS rate (96.6% vs 91.5%, P = 0.0053) were significantly higher in the lobaplatin group than the control group. There were no statistically significant differences between the two groups in the incidence (69.77% vs 64.75%) or severity of adverse events (AEs) in the safety set (SS) population. Conclusions Initiation of intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin reduced the 3-year PM rate in CRC patients while improving both 3-year RFS and PRFS. The treatment was well tolerated, and the safety findings were comparable with those of the control group. Trial registration Chinese Clinical Trial Registry, ChiCTR1800014617.https://doi.org/10.1186/s12916-025-04180-1Peritoneal metastasesColorectal cancerIntraperitoneal perfusion chemotherapyRecurrence-free survival |
| spellingShingle | Hao Su Rui Zhang Yunfeng Li Yanke Li Wei Pei Zhigang Jie Zhimin Liu Meijin Huang Jing Zhuang Qian Jiang Ming Xie Guiying Wang Wenbin Zhang Ming Liu Jiansi Chen Zejun Wang Kang Wang Xinghong Zhang Guoxin Li Xiangfu Zeng Xinxiang Li Xuejun Sun Ju Wang Dongzhu Zeng Changlong Zhuang Haitao Zhou Xishan Wang Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study BMC Medicine Peritoneal metastases Colorectal cancer Intraperitoneal perfusion chemotherapy Recurrence-free survival |
| title | Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study |
| title_full | Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study |
| title_fullStr | Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study |
| title_full_unstemmed | Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study |
| title_short | Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study |
| title_sort | intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer a prospective randomised controlled multicentre study |
| topic | Peritoneal metastases Colorectal cancer Intraperitoneal perfusion chemotherapy Recurrence-free survival |
| url | https://doi.org/10.1186/s12916-025-04180-1 |
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