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Annals of Oncology Advance Access published online on January 21, 2008
Annals of Oncology, doi:10.1093/annonc/mdm588
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© 2008 European Society for Medical Oncology. For Permissions, please email: journals.permissions@oxfordjournals.org

A randomized phase III multicenter trial comparing irinotecan in combination with the Nordic bolus 5-FU and folinic acid schedule or the bolus/infused de Gramont schedule (Lv5FU2) in patients with metastatic colorectal cancer

B. Glimelius1,2,*, H. Sørbye3, L. Balteskard4, P. Byström2, P. Pfeiffer5, K. Tveit6, R. Heikkilä7, N. Keldsen8, M. Albertsson9, H. Starkhammar10, H. Garmo11 and Å. Berglund1

1 Department of Oncology, Radiology and Clinical Immunology, Uppsala University Hospital, Uppsala
2 Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden
3 Department of Oncology, Haukeland University Hospital, Bergen
4 Department of Oncology, University Hospital, Tromsö, Norway
5 Department of Oncology, University Hospital, Odense, Denmark
6 Department of Oncology, Ullevål University Hospital, Oslo
7 Department of Hemato-Oncology, Stavanger University Hospital, Stavanger, Norway
8 Department of Oncology, Central Hospital, Herning, Denmark
9 Department of Oncology, University Hospital, Malmö
10 Department of Oncology, University Hospital, Linköping
11 Regional Oncologic Center, Uppsala, Sweden

* Correspondence to: Dr B. Glimelius, Department of Oncology, Radiology and Clinical Immunology, Uppsala University Hospital, SE-751 85 Uppsala, Sweden. Tel: +46-18-611-55-13; Fax: +46-18-611-10-27; E-mail: bengt.glimelius{at}onkologi.uu.se

Background: To compare irinotecan with the Nordic 5-fluorouracil (5-FU) and folinic acid (FA) bolus schedule [irinotecan 180 mg/m2 on day 1, 5-FU 500 mg/m2 and FA 60 mg/m2 on day 1 and 2 (FLIRI)] or the Lv5FU2 schedule [irinotecan 180 mg/m2 on day 1, FA 200 mg/m2, 5-FU bolus 400 mg/m2 and infused 5-FU 600 mg/m2 on day 1 and 2 (Lv5FU2-IRI)] due to uncertainties about how to administrate 5-FU with irinotecan.

Patients and methods: Patients (n = 567) with metastatic colorectal cancer were randomly assigned to receive FLIRI or Lv5FU2-IRI. Primary end point was progression-free survival (PFS).

Results: Patient characteristics were well balanced. PFS did not differ between groups (median 9 months, P = 0.22). Overall survival (OS) was also similar (median 19 months, P = 0.9). Fewer objective responses were seen in the FLIRI group (35% versus 49%, P = 0.001) but the metastatic resection rate did not differ (4% versus 6%, P = 0.3). Grade 3/4 neutropenia (11% versus 5%, P = 0.01) and grade 2 alopecia (18% versus 9%, P = 0.002) were more common in the FLIRI group. The 60-day mortality was 2.4% versus 2.1%.

Conclusions: Irinotecan with the bolus Nordic schedule (FLIRI) is a convenient treatment with PFS and OS comparable to irinotecan with the Lv5FU2 schedule. Neutropenia and alopecia are more prevalent, but both regimens are equally well tolerated.

chemotherapy, colorectal cancer, irinotecan, randomized trial, 5-fluorouracil

Received for publication September 11, 2007. Revision received November 12, 2007. Accepted for publication December 5, 2007.


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