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Japanese Journal of Clinical Oncology Advance Access published online on October 1, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp116
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© The Author (2009). Published by Oxford University Press. All rights reserved

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

Qing Sun1, Meng Hang1, Wei Xu1, Weidong Mao2, Xiaosheng Hang3, Maoquan Li4 and Jiaxing Zhang4

1 Department of Medical Oncology, Wuxi 2nd People's Hospital, Nanjing Medical University
2 Department of Medical Oncology, Jiangyin People's Hospital, Medical School of Nantong University
3 Department of Medical Oncology, Wuxi Cancer Hospital, Medical School of Suzhou University, Jiangsu
4 Radiology Clinical Center, Shanghai Tenth People's Hospital of Tongji University, Shanghai, PR China

For reprints and all correspondence: Maoquan Li, Radiology Clinical Center, Shanghai Tenth People's Hospital of Tongji University, No. 301, Yanchang Rd, Shanghai 200072, PR China. E-mail: drmaoquan.li.md{at}gmail.com

Received June 24, 2009; accepted August 10, 2009

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.

Key Words: advanced gastric cancer • second-line chemotherapy • irinotecan • capecitabine


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