1. ¹Royal Free and University College Medical School, UCL, London, UK
2. ²ICRF Clinical Centre, Cookridge Hospital, Leeds, UK
3. ³Christie Hospital, Manchester, UK

Correspondence: Dr JA Ledermann, Cancer Research UK and UCL Cancer Trials Centre, Department of Oncology, UCL, Stephenson House, 158-160 North Gower Street, London NW1 2ND, UK. E-mail: j.ledermann@ctc.ucl.ac.uk

⁴Current address: Kent Cancer Services, Maidstone Hospital, Kent, UK

Received 24 April 2002; Revised 9 August 2002; Accepted 9 September 2002.

Abstract

We investigated the activity of irinotecan given with a more convenient modified bimonthly de Gramont regimen of bolus and infusional 5-fluorouracil [IrMdG] in advanced or metastatic colorectal cancer in the first and second line setting. Irinotecan 180 mg m^-2 was infused over 90 min. L-folinic acid 175 mg or d,l folinic acid 350 mg was given over 2 h followed by a bolus of 5-fluorouracil (400 mg m^-2) and a 46 h continuous infusion of 5-fluorouracil (2.4–2.8 g m^-2). Forty-six previously untreated patients (Group A) and 36 who had received 5-fluorouracil for metastatic disease (Group B) were recruited. Seventy-eight patients were evaluable for response. A partial response was seen in 13 out of 43 (30% [95%CI 28.1–31.9%]) in Group A and 8/35 (23% [95% CI 17.9–28.1%]) in Group B. 40% (95%CI 38.1–41.9%) of Group A and 26% (95% CI 20.9–31.1%) of Group B patients achieved disease stabilisation. The median progression free survival from the start of this treatment was 7 months (95% CI 4.4–9.6 months) in Group A and 5 months (95% CI 2.8–7.2 months) in Group B. Median overall survival was 14 months (95% CI 9.0–18.9) in Group A and 11 months (95% CI 5.9–16.1) in Group B. Grade 3–4 toxicity in both treatment groups were similar; leucopenia 17% and diarrhoea 7–8%. Grade 3–4 mucositis was not seen and severe alopecia affected only three patients. IrMdG is an active and well-tolerated regimen for both the first and second line treatment of advanced colorectal cancer.