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Annals of Oncology Advance Access published online on April 7, 2005
Annals of Oncology, doi:10.1093/annonc/mdi154
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© 2005 European Society for Medical Oncology
Received November 6, 2004
Revised December 22, 2004
Accepted December 27, 2004

Original article

Oxaliplatin combined with irinotecan and 5-fluorouracil/leucovorin (OCFL) in metastatic colorectal cancer: a phase I-II study

Y. Seium 1, R. Stupp 2, T. Ruhstaller 3, P. Gervaz 4, G. Mentha 4, M. Philippe 4, A. Allal 5, C. Trembleau 1, J. Bauer 2, R. Morant 6, and A. D. Roth 1*

1 Oncosurgery, Geneva University Hospital, Geneva St. Gallen, Switzerland
2 University Hospital (CHUV), Multidisciplinary Oncology Center, Lausanne, Switzerland
3 Kantonspital St. Gallen, Division of Oncology, Department of Medicine C, St. Gallen, Switzerland
4 Services of Visceral Surgery, Geneva University Hospital, Geneva St. Gallen, Switzerland
5 Department of Radiooncology, Geneva University Hospital, Geneva, Switzerland
6 Zetup Clinic, St. Gallen, Switzerland

* To whom correspondence should be addressed.
A. D. Roth, E-mail: Arnaud.Roth{at}sim.hcuge.ch


  Abstract

Background: A phase I-II multicenter trial was conducted to define the maximal tolerated dose and describe the activity of an OCFL combination using oxaliplatin (OHP), irinotecan (CPT-11) and 5-fluorouracil (FU)/leucovorin (LV) in metastatic colorectal cancer (CRC).

Patients and methods: CRC patients not pretreated with palliative chemotherapy, with performance status ≤1 and adequate haematological, kidney and liver function, were eligible. Treatment consisted in weekly 24-h infusion 5-FU (2300 mg/m2)/LV (30 mg) and alternating OHP (70-85 mg/m2, days 1 and 15) and CPT-11 (80-140 mg/m2, days 8 and 22) repeated every 5 weeks. OHP and CPT-11 were escalated in cohorts of three to six patients.

Results: Thirty patients received a median of five cycles. Dose-limiting toxicity occurred at dose level 3, and the recommended dose was OHP 70 mg/m2, CPT-11 100 mg/m2, LV 30 mg and 5-FU 2300 mg/m2/24 h. Grade ≥3 toxicities were diarrhea 23%, neutropenia 20%, fatigue 7%, and neurologic 7%. Two febrile neutropenia episodes (one fatal) were recorded. Among 28 patients with measurable disease (90%), we observed two complete and 20 partial responses; overall RR was 78% (95% CI, 59% to 92%). Median time to progression and overall survival were 9.5 and 25.4 months, respectively. Seven patients underwent liver metastases resection.

Conclusion: OCFL is an overall well tolerated regimen with very high efficacy, which makes it most suitable for tumour control before surgery of metastatic disease.

Keywords: colorectal cancer; irinotecan; oxaliplatin; triplet regimen.
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