Irinotecan Plus Capecitabine as a Second-line Treatment after Failure of 5-Fluorouracil and Platinum in Patients with Advanced Gastric Cancer

This Phase II study was conducted to evaluate the effects of irinotecan plus capecitabine in patients with advanced gastric cancer (AGC) who had received a first-line therapy of 5-fluorouracil/platinum regimen. Patients received capecitabine 1000 mg/m(2) b.i.d. on days 1-14 followed by a 7-day rest period, and irinotecan 100 mg/m(2) was administered through a 90 min intravenous infusion on days 1 and 8, based on a 3-week cycle. Forty-six (95.8%) of the 48 patients were assessable for response. Thirteen cases of partial response were confirmed, response rate of 27.1% (95% CI, 14.5-39.7%). The median follow-up period was 25.2 months. The median time to progression and overall survival for all patients were 4.1 months (95% CI, 3.4-4.8 months) and 7.6 months (95% CI, 5.1-10.1 months). Grade 3 diarrhea and hand-foot syndrome occurred in eight (17.4%) and two (4.3%) patients, respectively. The most common Grade 3/4 hematological adverse event was neutropenia in four (8.7%) patients. There were no treatment-related deaths during this study. Irinotecan plus capecitabine was a relatively active and tolerable regimen as a second-line chemotherapy for AGC. Further investigation of this regimen is warranted, including the addition of new biological agents such as bevacizumab or cetuximab to improve the salvage regimen.