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Annals of Oncology Advance Access originally published online on January 21, 2008
Annals of Oncology 2008 19(5):909-914; doi:10.1093/annonc/mdm588
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

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.

Key words: 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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