Japanese Journal of Clinical Oncology Advance Access published online on September 22, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp114
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© The Author (2009). Published by Oxford University Press. All rights reserved
A Phase II Study of Irinotecan and Capecitabine for Patients with Unresectable Liver-only Metastases from Colorectal Cancer
1 Department of General Surgery, Ruijin Hospital, School of Medicine of Shanghai Jiaotong University, Shanghai
2 Department of General Surgery, Affiliated Hospital of Nantong University, Nantong, China
3 Pacific Cancer Centre, Singapore, Singapore
For reprints and all correspondence: Ren Zhao, Department of General Surgery, Ruijin Hospital, School of Medicine of Shanghai Jiaotong University, No. 197, Ruijin Er Road, Shanghai 200035, China. E-mail: drren.zhao{at}gmail.com
Received May 23, 2009; accepted August 10, 2009
Objective: To assess the resectability rate of patients with initially unresectable liver-only metastases from colorectal cancer (CRC) after treatment with irinotecan/capecitabine.
Methods: Patients received irinotecan (240 mg/m2) as a 30 min intravenous infusion on day 1 and capecitabine (1000 mg/m2) orally bid for 14 days beginning on day 2. Treatment was repeated every 3 weeks. The protocol encouraged two to four cycles of irinotecan/capecitabine after recovery from surgery.
Results: Between May 2004 and February 2007, 48 patients entered in the study. Forty-seven (97.9%) of the 48 patients were assessable for response. The overall response rate before surgery was 56.3% (95% CI, 42.3–70.3%) in the treated population, including 2 non-confirmed complete response (CR), 18 partial responses (PR) and 7 non-confirmed PR. Twenty-three (47.9%) of 29 patients with tumor shrinkage proceeded to surgical intervention. Twenty of the 23 patients had a complete resection (S-CR). With a median follow-up time of 32 months (range, 24–38 months), the overall median time to progression and overall survival for all patients were 16.7 months (95% CI, 10.0–23.4 months) and 27.5 months (95% CI, 23.6–31.4 months) for all patients. The 1- 2- and 3-year overall survival estimates were 79.2% (95% CI, 67.7–90.7%), 60.4% (95% CI, 46.6–74.3%) and 29.2% (95% CI, 16.3–42.0%), respectively. Grade 3 diarrhea occurred in eight (17.0%) patients. The most common Grade 3/4 hematological adverse event was neutropenia in 8.5% of the patients. There were no treatment-related deaths during this study.
Conclusions: Irinotecan/capecitabine appears to be a safe and very effective regimen in selected patients with unresectable liver metastases from CRC, but who are treated with a curative intent.
Key Words: colorectal cancer • liver metastases • irinotecan • capecitabine