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Japanese Journal of Clinical Oncology

Year: 2009  |  Volume: 39  |  Issue: 12  |  Page No.: 791 - 796

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

Q Sun, M Hang, W Xu, W Mao, X Hang, M Li and J. Zhang

Abstract

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/m2 b.i.d. on days 1–14 followed by a 7-day rest period, and irinotecan 100 mg/m2 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.

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