OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
OBJECTIVE: 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. METHODS: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. RESULTS: 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. CONCLUSION: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.
Authors: M Martin-Richard; R Gallego; C Pericay; J Garcia Foncillas; B Queralt; E Casado; J Barriuso; V Iranzo; I Juez; L Visa; E Saigi; A Barnadas; X Garcia-Albeniz; J Maurel Journal: Invest New Drugs Date: 2013-12 Impact factor: 3.850