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Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer.
Choi, Il Ju; Kook, Myeong-Cherl; Kim, Young-Il; Cho, Soo-Jeong; Lee, Jong Yeul; Kim, Chan Gyoo; Park, Boram; Nam, Byung-Ho.
Afiliação
  • Choi IJ; From the Center for Gastric Cancer (I.J.C., M.-C.K., Y.-I.K., S.-J.C., J.Y.L., C.G.K.) and the Biometrics Research Branch, Research Institute (B.P., B.-H.N.), National Cancer Center, Goyang, South Korea.
  • Kook MC; From the Center for Gastric Cancer (I.J.C., M.-C.K., Y.-I.K., S.-J.C., J.Y.L., C.G.K.) and the Biometrics Research Branch, Research Institute (B.P., B.-H.N.), National Cancer Center, Goyang, South Korea.
  • Kim YI; From the Center for Gastric Cancer (I.J.C., M.-C.K., Y.-I.K., S.-J.C., J.Y.L., C.G.K.) and the Biometrics Research Branch, Research Institute (B.P., B.-H.N.), National Cancer Center, Goyang, South Korea.
  • Cho SJ; From the Center for Gastric Cancer (I.J.C., M.-C.K., Y.-I.K., S.-J.C., J.Y.L., C.G.K.) and the Biometrics Research Branch, Research Institute (B.P., B.-H.N.), National Cancer Center, Goyang, South Korea.
  • Lee JY; From the Center for Gastric Cancer (I.J.C., M.-C.K., Y.-I.K., S.-J.C., J.Y.L., C.G.K.) and the Biometrics Research Branch, Research Institute (B.P., B.-H.N.), National Cancer Center, Goyang, South Korea.
  • Kim CG; From the Center for Gastric Cancer (I.J.C., M.-C.K., Y.-I.K., S.-J.C., J.Y.L., C.G.K.) and the Biometrics Research Branch, Research Institute (B.P., B.-H.N.), National Cancer Center, Goyang, South Korea.
  • Park B; From the Center for Gastric Cancer (I.J.C., M.-C.K., Y.-I.K., S.-J.C., J.Y.L., C.G.K.) and the Biometrics Research Branch, Research Institute (B.P., B.-H.N.), National Cancer Center, Goyang, South Korea.
  • Nam BH; From the Center for Gastric Cancer (I.J.C., M.-C.K., Y.-I.K., S.-J.C., J.Y.L., C.G.K.) and the Biometrics Research Branch, Research Institute (B.P., B.-H.N.), National Cancer Center, Goyang, South Korea.
N Engl J Med ; 378(12): 1085-1095, 2018 Mar 22.
Article em En | MEDLINE | ID: mdl-29562147
ABSTRACT

BACKGROUND:

Patients with early gastric cancers that are limited to gastric mucosa or submucosa usually have an advanced loss of mucosal glandular tissue (glandular atrophy) and are at high risk for subsequent (metachronous) development of new gastric cancer. The long-term effects of treatment to eradicate Helicobacter pylori on histologic improvement and the prevention of metachronous gastric cancer remain unclear.

METHODS:

In this prospective, double-blind, placebo-controlled, randomized trial, we assigned 470 patients who had undergone endoscopic resection of early gastric cancer or high-grade adenoma to receive either H. pylori eradication therapy with antibiotics or placebo. Two primary outcomes were the incidence of metachronous gastric cancer detected on endoscopy performed at the 1-year follow-up or later and improvement from baseline in the grade of glandular atrophy in the gastric corpus lesser curvature at the 3-year follow-up.

RESULTS:

A total of 396 patients were included in the modified intention-to-treat analysis population (194 in the treatment group and 202 in placebo group). During a median follow-up of 5.9 years, metachronous gastric cancer developed in 14 patients (7.2%) in the treatment group and in 27 patients (13.4%) in the placebo group (hazard ratio in the treatment group, 0.50; 95% confidence interval, 0.26 to 0.94; P=0.03). Among the 327 patients in the subgroup that underwent histologic analysis, improvement from baseline in the atrophy grade at the gastric corpus lesser curvature was observed in 48.4% of the patients in the treatment group and in 15.0% of those in the placebo group (P<0.001). There were no serious adverse events; mild adverse events were more common in the treatment group (42.0% vs. 10.2%, P<0.001).

CONCLUSIONS:

Patients with early gastric cancer who received H. pylori treatment had lower rates of metachronous gastric cancer and more improvement from baseline in the grade of gastric corpus atrophy than patients who received placebo. (Funded by the National Cancer Center, South Korea; ClinicalTrials.gov number, NCT02407119 .).
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Gástricas / Helicobacter pylori / Infecções por Helicobacter / Claritromicina / Amoxicilina / Antibacterianos / Recidiva Local de Neoplasia Tipo de estudo: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Gástricas / Helicobacter pylori / Infecções por Helicobacter / Claritromicina / Amoxicilina / Antibacterianos / Recidiva Local de Neoplasia Tipo de estudo: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2018 Tipo de documento: Article