局部晚期胃癌术后预防性腹腔热化疗:一项II期试验的最终结果

IF 7 2区 医学 Q1 ONCOLOGY
Biao Fan, Hao Su, Lingqian Wang, Xin Ji, Yinan Zhang, Ziyu Jia, Ji Zhang, Zhaode Bu, Xiaojiang Wu
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引用次数: 0

摘要

目的:评价顺铂预防性腹腔热化疗(HIPEC)治疗局部晚期胃癌(LAGC)的疗效。方法:于2015年3月至2016年11月进行II期临床试验。连续50例LAGC患者随机分为两组:实验组(根治性胃切除术+ HIPEC顺铂+辅助化疗)和对照组(根治性胃切除术+辅助化疗)。生存率被密切监测。结果:所有患者5年总生存率(OS)为80.0%。实验组5年OS率低于对照组,分别为75.8%和88.2%,差异无统计学意义。此外,接受HIPEC或未接受HIPEC的患者的5年无复发生存率(RFS)分别为75.8%和88.2%。在多因素分析中,只有pT分期[危险比(RR)=7.079, P=0.018]与预后有显著相关性。两组最常见的复发方式均为腹膜复发。实验组腹膜复发率低于对照组,差异无统计学意义。结论:本试验清楚地表明,预防性HIPEC联合顺铂既不能降低腹膜复发的风险,也不能改善LAGC患者的预后。因此,HIPEC联合顺铂不推荐作为根治性胃切除术后LAGC腹膜复发的预防性治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Prophylactic hyperthermic intraperitoneal chemotherapy in patients with locally advanced gastric cancer after curative surgery: Final results of a phase II trial.

Objective: The trial was designed to evaluate the efficacy of prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin for patients with locally advanced gastric cancer (LAGC).

Methods: Between March 2015 and November 2016, a phase II clinical trial was performed. Fifty consecutive patients with LAGC were randomly assigned to two groups: the experimental group (radical gastrectomy + HIPEC with cisplatin + adjuvant chemotherapy) and the control group (radical gastrectomy + adjuvant chemotherapy). Survival rates were closely monitored.

Results: The 5-year overall survival (OS) rate of all patients was 80.0%. The 5-year OS rate in the experimental group was lower than that in the control group, at 75.8% and 88.2%, respectively, with no statistical significance. In addition, 5-year recurrence-free survival (RFS) rates of patients who underwent HIPEC or not were also 75.8% and 88.2%, respectively. In the multivariate analysis, only pT stage [risk ratio (RR)=7.079, P=0.018] was significantly associated with prognosis. The most common recurrence pattern was peritoneal recurrence in both groups. The experimental group had a lower incidence of peritoneal recurrence than the control group with no statistical significance.

Conclusions: This trial clearly revealed that prophylactic HIPEC with cisplatin neither decrease the risk of peritoneal recurrence nor improve the prognosis of patients with LAGC. Thus, HIPEC with cisplatin is not recommended as a prophylactic treatment for peritoneal recurrence of LAGC after radical gastrectomy.

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来源期刊
自引率
9.80%
发文量
1726
审稿时长
4.5 months
期刊介绍: Chinese Journal of Cancer Research (CJCR; Print ISSN: 1000-9604; Online ISSN:1993-0631) is published by AME Publishing Company in association with Chinese Anti-Cancer Association.It was launched in March 1995 as a quarterly publication and is now published bi-monthly since February 2013. CJCR is published bi-monthly in English, and is an international journal devoted to the life sciences and medical sciences. It publishes peer-reviewed original articles of basic investigations and clinical observations, reviews and brief communications providing a forum for the recent experimental and clinical advances in cancer research. This journal is indexed in Science Citation Index Expanded (SCIE), PubMed/PubMed Central (PMC), Scopus, SciSearch, Chemistry Abstracts (CA), the Excerpta Medica/EMBASE, Chinainfo, CNKI, CSCI, etc.
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