OBJECTIVES : To review the published literature on the efficacy and safety of pharmacological interventions for the treatment of adults with advanced or metastatic gastric cancer.

METHODS : A systematic search of published literature was performed using Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials (CENTRAL) from database inception to June 2018. Conference (ASCO, ESMO, and JSMO) and bibliographic searches were also performed. Randomized clinical trials (RCTs) reporting efficacy and safety outcomes in first-line maintenance (patients randomized after response to first-line systemic therapy) or second-line setting were included in the review. The quality assessment of RCTs was carried out using the National Institute for Health and Care Excellence (NICE) checklist.

RESULTS : Of the 8,624 screened citations, 17 studies (first-line maintenance, 6; second-line, 11) published between 2002 and 2018 met the inclusion criteria (sample size, 40-665 patients). The ECOG performance status of the majority of included patients was between 0 and 1. From the start of the maintenance phase, the median overall survival (mOS) and progression-free survival (mPFS) duration ranged from 5.8 to 17.0 months and 2.7 to 11.0 months, respectively. Longer mOS and mPFS were observed with chemotherapy vs best supportive care (BSC) in the first-line maintenance studies. Among the second-line studies, mOS ranged from 2.4 to 13.9 months, and mPFS ranged from 1.5 to 4.6 months. A significantly higher mOS was observed with ramucirumab (5.2 vs 3.8 months; p=0.05), irinotecan (4.0 vs 2.4 months; p=0.01), and taxanes (5.3 vs 3.8 months; p=0.01) vs BSC.

CONCLUSIONS : RCTs assessing chemotherapeutic/biologic agents report an incremental survival benefit compared with BSC after first-line chemotherapy. A continued need remains for effective, and novel therapies to help improve outcomes in advanced or metastatic gastric cancer.