Efficacy and safety of capecitabine as maintenance therapy after capecitabine-based combination chemotherapy for patients with advanced esophagogastric junction adenocarcinoma

OBJECTIVE: The aim of the present study was to investigate the efficacy and safety of single-agent capecitabine therapy after capecitabine-based combination chemotherapy for patients with advanced adenocarcinoma of the esophagogastric junction (EGJ). PATIENTS AND METHODS: Seventy-two patients with pathologically proven advanced EGJ adenocarcinoma underwent 2-6 cycles of capecitabine-based first-line combination chemotherapy between January 2010 and October 2014. When initial disease control had been achieved, 60 patients were randomly assigned to receive the capecitabine treatment (oral capecitabine 1,250 mg/m(2) twice daily on days 114 every 3 weeks) to see whether it is involved in maintenance regimen or not, while 12 patients were excluded. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and major adverse events were monitored. RESULTS: The median PFS was 11.0 months (95% confidence interval [CI], 0-23.2 months) and OS was 17.0 months (95% CI, 2.1-31.9 months) for the maintenance group. In contrast, median PFS was 7.0 months (95% CI, 5.8-8.2 months) and OS was 11.0 months (95% CI, 2.07-31.9 months) for the control group. Compared to controls, patients who received capecitabine maintenance therapy showed significantly prolonged PFS and OS. The capecitabine-related adverse events included leukopenia, anemia, and thrombocytopenia, hand-foot syndrome, nausea/vomiting, neuropathy, and liver dysfunction. Treatment-related adverse events were tolerable, and there were no significant differences in the prevalence of adverse events between patients who received maintenance therapy and controls. CONCLUSIONS: Our finding shows that single-agent capecitabine maintenance therapy was effective, well-tolerated and safe after first-line capecitabine-based combination chemotherapy in patients with advanced EGJ adenocarcinoma.