Montalvan-Sanchez Eleazar E, Hernandez-Marrero Jessica, Norwood Dalton A, González-Pons María, Dominguez Ricardo L, Rodriguez Luz M, Richmond Ellen, Limburg Paul J, Cruz-Correa Marcia, Morgan Douglas R
Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.
Hospital de Occidente, Ministry of Health, Copan, Honduras.
Cancer Prev Res (Phila). 2024 Dec 3;17(12):549-555. doi: 10.1158/1940-6207.CAPR-23-0345.
Gastric adenocarcinoma (GAC) is the fourth leading global cause of cancer mortality and leading infection-associated cancer. High-incidence regions of GAC include Latin America and Eastern Asia. Immigrants from high-incidence regions maintain their GAC risk. GAC is a major U.S. cancer disparity, and its incidence rates are 2 to 10 times higher in non-White populations. Emerging guidelines recommend 3-year surveillance endoscopy for patients with high-risk gastric premalignant conditions (GPMC). Clinical trials of GPMC chemoprevention agents are lacking. We conducted a NCI Division of Cancer Prevention-funded, phase II placebo-controlled chemoprevention trial in patients with GPMCs (atrophic gastritis and intestinal metaplasia) with a highly bioavailable preparation of curcuminoids (Meriva). The trial sites in Puerto Rico and rural Honduras had important characteristics: (i) representative Caribbean and Mesoamerican populations, linked to large U.S. immigrant populations; (ii) high prevalence of Helicobacter pylori infection and GPMCs; (iii) the absence of turmeric and curcuminoids in local diets; and (iv) proven bidirectional collaboration with U.S. academic institutions. H. pylori-negative patients with GPMCs were randomized to the study drug (500 mg po bid) or placebo for 180 days (NCT02782949), with primary outcomes based upon histologic parameters. Principal study challenges included (i) an international regulatory environment; (ii) research infrastructure strengthening, particularly in Central America; (iii) participant recruitment in Honduras, wherein only 10% to 15% are H. pylori negative; (iv) the COVID-19 pandemic; and (v) natural disasters (three hurricanes). There were no losses to follow-up related to the pandemic or natural disasters. In conclusion, the south-south partnership provides a model for chemoprevention and translational studies in Latino populations with prevalent cancers, such as GAC.
胃腺癌（GAC）是全球第四大致癌死亡原因，也是主要的感染相关癌症。GAC的高发地区包括拉丁美洲和东亚。来自高发地区的移民仍保持其患GAC的风险。GAC是美国癌症差异的一个主要问题，其发病率在非白人人群中高出2至10倍。新出现的指南建议对高危胃前驱病变（GPMC）患者进行3年的监测性内镜检查。目前缺乏GPMC化学预防剂的临床试验。我们开展了一项由美国国立癌症研究所癌症预防司资助的II期安慰剂对照化学预防试验，研究对象为患有GPMC（萎缩性胃炎和肠化生）的患者，使用一种生物利用度高的姜黄素制剂（Meriva）。波多黎各和洪都拉斯农村的试验地点具有重要特点：（i）具有代表性的加勒比和中美洲人群，与大量美国移民人口相关；（ii）幽门螺杆菌感染和GPMC的高患病率；（iii）当地饮食中不存在姜黄和姜黄素；（iv）与美国学术机构有经过验证的双向合作。GPMC的幽门螺杆菌阴性患者被随机分为研究药物组（口服500毫克，每日两次）或安慰剂组，为期180天（NCT02782949），主要结局基于组织学参数。主要研究挑战包括：（i）国际监管环境；（ii）加强研究基础设施，特别是在中美洲；（iii）在洪都拉斯招募参与者，其中只有10%至15%为幽门螺杆菌阴性；（iv）新冠疫情；（v）自然灾害（三次飓风）。没有与疫情或自然灾害相关的失访情况。总之，南南伙伴关系为拉丁裔人群中常见癌症（如GAC）化学预防和平行转化研究提供了一个模式。
