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Annals of Oncology Advance Access originally published online on September 6, 2007
Annals of Oncology 2007 18(11):1810-1816; doi:10.1093/annonc/mdm347
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© 2007 European Society for Medical Oncology

gastrointestinal tumors

Capecitabine plus oxaliplatin and irinotecan regimen every other week: a phase I/II study in first-line treatment of metastatic colorectal cancer

E. Bajetta*, L. Celio, E. Ferrario, M. Di Bartolomeo, A. Denaro, K. Dotti, M. Mancin, R. Bajetta, A. Colombo and S. Pusceddu

1 Medical Oncology Unit 2, Fondazione IRCCS ‘Istituto Nazionale Tumori’, Milan, Italy

* Correspondence to: Dr E. Bajetta, Medical Oncology Unit 2, Fondazione IRCCS ‘Istituto Nazionale Tumori’, Via G. Venezian 1, 20133 Milano, Italy. Tel: +39 02 23902500; Fax: +39 02 23902149; E-mail: emilio.bajetta{at}istitutotumori.mi.it

Background: A phase I/II study was performed to determine the safety and activity of a capecitabine plus oxaliplatin and irinotecan (COI) regimen using capecitabine concurrently with oxaliplatin and irinotecan in previously untreated patients with metastatic colorectal cancer.

Patients and methods: Patients received irinotecan on day 1, oxaliplatin (85 mg/m2) on day 2 and capecitabine (1000 mg/m2 orally twice daily) on days 2–6 of a biweekly schedule. Three dose levels ranging from 150 to 180 mg/m2 were explored for irinotecan in sequential cohorts of three to six patients. Once the recommended dose was determined, a total of 28 eligible patients were planned at this dose level.

Results: Thirty-eight patients received a median of six cycles. The recommended phase II dose of irinotecan was 180 mg/m2. Toxicity was manageable: the most common severe toxicities were diarrhoea (24%) and nausea (16%). Of 27 assessable patients treated at the recommended dose, 17 achieved a partial response (overall response rate (ORR) 63%; 95% confidece interval (CI), 44 to 78%), with eight patients undergoing liver metastasectomy. Estimated progression-free survival and overall median survival were 8.5 and 23.5 months, respectively.

Conclusions: Biweekly COI is feasible and active. Tolerability and ease of administration make the regimen well suited for downsizing hepatic colorectal metastases before curative surgery.

Key words: colorectal cancer, capecitabine, irinotecan, oxaliplatin, triplet regimen

Received for publication April 26, 2007. Revision received May 24, 2007. Accepted for publication May 29, 2007.


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