A phase II study of irinotecan and capecitabine for patients with unresectable liver-only metastases from colorectal cancer.
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/m(2)) as a 30 min intravenous infusion on day 1 and capecitabine (1000 mg/m(2)) 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.
Department of General Surgery, Ruijin Hospital, School of Medicine of Shanghai Jiaotong University, No. 197, Ruijin Er Road, Shanghai 200035, China. drren.zhao@gmail.com
Ren
R
Zhao
Jianwei
J
Zhu
Xiaopin
X
Ji
Jianhua
J
Cai
Fangjun
F
Wan
Qing
Q
Li
Baoliang
B
Zhong
Steven
S
Tucker
Daoyuan
D
Wang
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged
D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin