结直肠癌术中预防性腹腔灌注化疗联合洛铂：一项前瞻性、随机、对照、多中心研究

IF 7 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMC Medicine Pub Date : 2025-06-06 DOI:10.1186/s12916-025-04180-1

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

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引用次数: 0

摘要

背景：大肠癌根治性手术后腹膜转移（PM）是导致治疗失败的重要原因。术中腹腔灌注化疗可能是预防结直肠癌患者术后PM的有效方法。本研究旨在探讨洛铂术中预防性腹腔灌注化疗治疗结直肠癌的安全性和可行性。方法：2017年12月12日至2019年10月17日，从中国25家医院招募720名符合条件的T4或N +临床TNM期结直肠癌患者。符合条件的患者按1:1的比例随机分为仅行结直肠癌切除术（对照组）或术中切除结直肠癌并腹腔灌注化疗联合洛铂（洛铂组）。该试验的主要终点是手术后PM的发生率，次要终点包括安全性、总生存期（OS）时间、无复发生存期（RFS）时间、腹膜无复发生存期（PRFS）时间和肝转移率。结果：纳入全分析集（FAS）的716例患者中，洛铂组352例，对照组364例。在FAS人群中，术中加入洛铂预防性腹腔灌注化疗可降低3年PM的主要终点率（3.56% vs 8.75%, P = 0.0053）。3年OS组间无显著差异（93.2% vs 90.4%, P = 0.1660）。洛铂组3年RFS率（88.1% vs 81.6%, 0.0146）和3年PRFS率（96.6% vs 91.5%, P = 0.0053）均显著高于对照组。两组在安全组（SS）人群中不良事件（ae）的发生率（69.77% vs 64.75%）或严重程度（ae）方面无统计学差异。结论：术中启动洛铂预防性腹腔灌注化疗可降低结直肠癌患者3年PM率，同时改善3年RFS和PRFS。治疗耐受性良好，安全性与对照组相当。试验注册：中国临床试验注册中心，ChiCTR1800014617。

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Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study.

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.

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来源期刊

BMC Medicine 医学-医学：内科

CiteScore

13.10

自引率

1.10%

发文量

435

审稿时长

4-8 weeks

期刊介绍： BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.