Capecitabine and doxorubicin combination chemotherapy as salvage therapy in pretreated advanced gastric cancer.

PURPOSE: The aim of this study was to evaluate the activity and the safety of a combination regimen of capecitabine and doxorubicin as salvage chemotherapy in advanced gastric cancer patients who had undergone one or two prior chemotherapy regimens. METHODS: Patients received capecitabine, 2,500 mg/m(2)/day PO for 14 days (D1-14) and doxorubicin, 30 mg/m(2) IV on day 1 every 3 weeks until disease progression. The response was evaluated according to RECIST criteria, and the toxicity was evaluated by NCI-CTC (version 2.0). RESULTS: Forty-five patients were enrolled. Twenty-six patients were treated as second-line chemotherapy and the remaining patients as third-line chemotherapy. A total of 152 cycles of chemotherapy (median 2, range 1-12) were administered. Median dose intensities of capecitabine and doxorubicin were 11,326 and 9.6 mg/m(2)/week, respectively. The overall response rate was 6.7% (95% CI, 4.1-12.5%) and the disease control rate was 46.7% (95% CI, 28.6-87.1%) according to an intent-to-treat analysis. The median progression-free survival was 11.3 weeks (95% CI, 5.6-16.7 weeks). The median overall survival was 29.1 weeks (95% CI, 18.3-39.9 weeks) with one-year survival rate of 24%. Severe (grade III/IV) hematologic and non-hematologic toxicity was uncommon and included nausea/vomiting in five (11.1%), neutropenia in two (4.4%), anemia in one (2.2%), and hand-foot syndrome in one patient (2.2%). CONCLUSIONS: The combination of capecitabine and doxorubicin is a feasible salvage regimen in advanced pre-treated gastric cancerope