Effect of a Proton Pump Inhibitor on Tumor Bleeding Prevention in Unresectable Gastric Cancer Patients: a Double-Blind, Randomized, Placebo-Controlled Trial.
- Author:
Young Il KIM
1
;
Mi Jung KIM
;
Sook Ryun PARK
;
Hark Kyun KIM
;
Soo Jeong CHO
;
Jong Yeul LEE
;
Chan Gyoo KIM
;
Gwang Ha KIM
;
Moo In PARK
;
Byung Ho NAM
;
Young Iee PARK
;
Il Ju CHOI
Author Information
- Publication Type:Randomized Controlled Trial ; Original Article
- Keywords: Proton pump inhibitors; Stomach neoplasms; Hemorrhage; Primary prevention; Drug therapy
- MeSH: Drug Therapy; Follow-Up Studies; Hemorrhage*; Humans; Incidence; Lansoprazole; Primary Prevention; Prospective Studies; Proton Pump Inhibitors; Proton Pumps*; Protons*; Stomach Neoplasms*
- From:Journal of Gastric Cancer 2017;17(2):120-131
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. MATERIALS AND METHODS: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). RESULTS: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. CONCLUSIONS: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).
