Abstract: Objective To investigate the efficacy and adverse effect of DCF regimen with subsequent S-1 maintenance
chemotherapy in patients with advanced gastric cancer (AGC). Methods Sixty AGC patients without disease progression after
4 to 6 cycles of DCF regimen as the first-line chemotherapy were randomized into maintenance group and control group (30
patients each). The patients in the maintenance group received maintenance chemotherapy with S-1 (40 mg/m2, twice daily for
14 days; 21 days for a treatment cycle) until disease progression or with intolerant toxicity, and those in the control group
received optimal supportive care. Results The response rate (CR+PR) was 33.3% in the maintenance group, significantly higher
than that in the control group (3.33%, P<0.05), and the disease control rate (CR+PR+SD) also differed significantly between the
two groups (73.3% vs 46.7%, P<0.05). The median time to progression was 7.9 months in the maintenance group and 6.8
months in the control group, with median overall survival time of 13.8 and 11.7 months, respectively (P>0.05). The most
common adverse effect in the maintenance group included nausea, vomiting, leucocytopenia, and hand-foot syndrome; no
death occurred in relation to the therapy. Conclusions S-1 maintenance chemotherapy, with a tolerable toxicity profile, can
improve the RR, DCR and median time to progression in AGC patients who respond to DCF regimen, but its efficacy still
awaits further evaluation.