J Gastric Cancer.  2017 Jun;17(2):120-131. 10.5230/jgc.2017.17.e15.

Effect of a Proton Pump Inhibitor on Tumor Bleeding Prevention in Unresectable Gastric Cancer Patients: a Double-Blind, Randomized, Placebo-Controlled Trial

• Kim YI
• Kim MJ
• Park SR
• Kim HK
• Cho SJ
• Lee JY
• Kim CG
• Kim GH
• Park MI
• Nam BH
• Park YI
• Choi IJ

• KMID: 2383735
• DOI: http://doi.org/10.5230/jgc.2017.17.e15

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).

Keyword

Proton pump inhibitors; Stomach neoplasms; Hemorrhage; Primary prevention; Drug therapy

MeSH Terms

Drug Therapy
Follow-Up Studies
Hemorrhage*
Humans
Incidence
Lansoprazole
Primary Prevention
Prospective Studies
Proton Pump Inhibitors
Proton Pumps*
Protons*
Stomach Neoplasms*
Proton Pump Inhibitors
Proton Pumps
Protons

Figure

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  Fig. 1 CONSORT diagram of this study. CONSORT = Consolidated Standards of Reporting Trials; ECOG = Eastern Cooperative Oncology Group; PPI = proton pump inhibitor.

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  Fig. 2 Cumulative incidence rates of tumor bleeding in lansoprazole and placebo groups.

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  Fig. 3 OS in the lansoprazole and placebo groups. OS = overall survival.

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