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Annals of Oncology 13:1868-1873, 2002
© 2002 European Society for Medical Oncology

Original Paper

Irinotecan combined with bolus 5-fluorouracil and folinic acid Nordic schedule as first-line therapy in advanced colorectal cancer

B. Glimelius1,2,+, R. Ristamäki3, M. Kjaer4, P. Pfeiffer5, T. Skovsgaard6, K. M. Tveit7, T. Linné8, J. E. Frödin2, B. Boussard9, D. Oulid-Aïssa9 and S. Pyrhönen3

1 Department of Oncology, Radiology and Clinical Immunology, Uppsala University Hospital, Uppsala; 2 Radiumhemmet, Karolinska Hospital, Stockholm, Sweden; 3 Turku University Central Hospital, Turku, Finland; 4 Department of Oncology, Aalborg Hospital, Aalborg; 5 Odense University Hospital, Onkologisk Afdeling R, Odense; 6 Department of Oncology, KAS Herlev, Herlev, Denmark; 7 Ullevaal University Hospital, Oslo, Norway; 8 Department of Oncology, Central Hospital, Sweden; 9 Global Medical Affairs Oncology, Aventis Pharma, Aron, Antony cedex, France

Received 27 May 2002; accepted 17 June 2002

Background:

This multicentre phase II study evaluated the efficacy and safety of irinotecan combined with the Nordic schedule of 5-fluorouracil (5-FU) and folinic acid (FA) as first-line therapy in patients with advanced colorectal cancer.

Patients and methods:

Seventy-four patients with measurable disease and a WHO performance status of 2 or less were treated with irinotecan 210 mg/m2 as a 30–90 min intravenous infusion on day 1, followed by 5-FU 500 mg/m2 and FA 60 mg/m2 bolus on days 1 and 2, every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was the objective response rate.

Results:

Twenty-nine out of 68 evaluable patients achieved a complete (n = 7) or partial (n = 22) response, leading to an overall response rate of 43% [95% confidence interval (CI) 31% to 55%]. The median duration of response was 10 months. The estimated median time to progression and survival were 6.4 months (95% CI 5.4–9.0) and 15.6 months (95% CI 13.3–19.0), respectively, in the intention-to-treat population. A total of 860 cycles were administered to 74 patients. Neutropenia was the main adverse event with grade 3–4 toxicity in 66% of patients and 17.5% of cycles. Grade 3–4 non-haematological toxicities were infrequent and included diarrhoea in 16% of patients and 2% of cycles and nausea/vomiting in 10% of patients and 1% of cycles.

Conclusions:

Irinotecan combined with the bolus Nordic schedule of 5-FU/FA is active in advanced colorectal cancer with an easily managed safety profile which ensures good schedule compliance. The low incidence of grade 3–4 non-haematological toxicity justifies the further evaluation of this combination in the context of randomised clinical trials.

Key words: chemotherapy, colorectal cancer, irinotecan, Nordic schedule


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