Phase II study of a 4-week capecitabine regimen in advanced or recurrent gastric cancer.

摘要: Our objective was to evaluate the efficacy and safety of capecitabine in chemotherapy-naive patients with unresectable advanced or metastatic gastric cancer. An open-label multicenter phase II study conducted for previously untreated Oral 828 mg/m 2 twice daily given on days 1-21 every 4 weeks. Baseline characteristics 60 enrolled were: male/female 49/11, median age 64 years (range 28-74), good performance status (ECOG 0-1) 98% 27 had prior gastrectomy (45%). A treatment cycles were administered 1-37). Five excluded from analysis because they did not meet eligibility criteria. The overall response rate (RR) evaluable patient population (n=55) 26% [95% confidence interval (95% CI) 15-39%] a further 29% stable disease. RR intent-to-treat (n=60) 23% Cl 13-36.0%). Median time progression 3.4 months 1.8-6.1) survival 10.0 6.4-13.6). most frequent grade 3/4 drug-related adverse event hand-foot syndrome (13%), but this readily managed by interruption dose reduction. No developed diarrhea, vomiting, leukopenia thrombocytopenia. We conclude that 4-week regimen showed promising activity well tolerated as first-line therapy advanced/ Further investigation is warranted.