胃癌家族史和治疗。

Family History of Gastric Cancer and Treatment.

机构信息

From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.

出版信息

N Engl J Med. 2020 Jan 30;382(5):427-436. doi: 10.1056/NEJMoa1909666.

DOI:10.1056/NEJMoa1909666

PMID:31995688

Abstract

BACKGROUND

infection and a family history of gastric cancer are the main risk factors for gastric cancer. Whether treatment to eradicate can reduce the risk of gastric cancer in persons with a family history of gastric cancer in first-degree relatives is unknown.

METHODS

In this single-center, double-blind, placebo-controlled trial, we screened 3100 first-degree relatives of patients with gastric cancer. We randomly assigned 1838 participants with infection to receive either eradication therapy (lansoprazole [30 mg], amoxicillin [1000 mg], and clarithromycin [500 mg], each taken twice daily for 7 days) or placebo. The primary outcome was development of gastric cancer. A prespecified secondary outcome was development of gastric cancer according to eradication status, assessed during the follow-up period.

RESULTS

A total of 1676 participants were included in the modified intention-to-treat population for the analysis of the primary outcome (832 in the treatment group and 844 in the placebo group). During a median follow-up of 9.2 years, gastric cancer developed in 10 participants (1.2%) in the treatment group and in 23 (2.7%) in the placebo group (hazard ratio, 0.45; 95% confidence interval [CI], 0.21 to 0.94; P = 0.03 by log-rank test). Among the 10 participants in the treatment group in whom gastric cancer developed, 5 (50.0%) had persistent infection. Gastric cancer developed in 0.8% of participants (5 of 608) in whom infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70). Adverse events were mild and were more common in the treatment group than in the placebo group (53.0% vs. 19.1%; P<0.001).

CONCLUSIONS

Among persons with infection who had a family history of gastric cancer in first-degree relatives, eradication treatment reduced the risk of gastric cancer. (Funded by the National Cancer Center, South Korea; ClinicalTrials.gov number, NCT01678027.).

摘要

背景

感染和胃癌家族史是胃癌的主要危险因素。在一级亲属中有胃癌家族史的人群中，治疗根除是否能降低胃癌风险尚不清楚。

方法

在这项单中心、双盲、安慰剂对照试验中，我们对 3100 名胃癌患者的一级亲属进行了筛查。我们将 1838 名感染参与者随机分配接受根除治疗（兰索拉唑[30mg]、阿莫西林[1000mg]和克拉霉素[500mg]，每日两次，共 7 天）或安慰剂。主要结局是发展为胃癌。预先指定的次要结局是根据根除状态评估的随访期间胃癌的发展。

结果

共有 1676 名参与者被纳入主要结局的改良意向治疗人群进行分析（治疗组 832 名，安慰剂组 844 名）。中位随访 9.2 年后，治疗组中有 10 名（1.2%）参与者发生胃癌，安慰剂组中有 23 名（2.7%）参与者发生胃癌（风险比，0.45；95%置信区间[CI]，0.21 至 0.94；对数秩检验 P=0.03）。在治疗组中发生胃癌的 10 名参与者中，5 名（50.0%）持续感染。在感染根除的 608 名参与者中，有 0.8%（5 名）发生胃癌，在持续感染的 979 名参与者中，有 2.9%（28 名）发生胃癌（风险比，0.27；95%CI，0.10 至 0.70）。不良事件轻微，且治疗组比安慰剂组更常见（53.0%比 19.1%；P<0.001）。