Annals of Oncology Advance Access originally published online on September 4, 2007
Annals of Oncology 2007 18(12):2000-2005; doi:10.1093/annonc/mdm379
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© 2007 European Society for Medical Oncology
gastrointestinal tumors |
A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5–FU2 + irinotecan or LV5–FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer
1 Department of Digestive Oncology, Institut Bergonié, Regional Cancer Center, Bordeaux
2 Centre Régional de Lutte contre le Cancer Val d'Aurelle-Paul Lamarque, Montpellier
3 Centre Eugène Marquis, Rennes
4 Centre Oscar Lambret, Lille
5 Clinique Francheville, Périgueux
6 Centre François Baclesse, Caen
7 Centre René Huguenin, Saint-Cloud
8 Fédération Nationale des Centres de Lutte Contre le Cancer, Paris, France
* Correspondence to: Dr Y. Bécouarn, Department of Digestive Oncology, Institut Bergonié, Regional Cancer Center, 229 cours de l'Argonne, 33076 Bordeaux Cedex, France. Tel: +33-5-56-33-33-33; Fax: +33-5-56-33-33-83; E-mail: becouarn{at}bergonie.org
Background: To assess activity and safety of an experimental combination of irinotecan and oxaliplatin (IRINOX) as first-line treatment in advanced colorectal cancer.
Patients and methods: In this randomized phase II trial, 80 patients were treated: arm A (IRINOX) in 40 patients received at day 1 oxaliplatin 85 mg/m2 and irinotecan 180 mg/m2 biweekly, standard arm B received a biweekly simplified folinic acid (FA) and fluorouracil (FU), FA 200 mg/m2 in a 2-h infusion and bolus injection of 5FU 400 mg/m2 on day 1, then a two 400 mg/m2 continuous infusion of FU on days 1 and 2 with either oxaliplatin 85 mg/m2 (20 patients) or irinotecan 180 mg/m2 (20 patients).
Results: Twenty-one partial responses (52.5%, median duration 7.2 months) were observed with the IRINOX arm and two complete and 20 partial responses (55%, median duration 6.4 months) with arm B. Median progression-free and overall survival times were 8.4 and 19 months, respectively, in the IRINOX arm and 8.1 and 20.4 months in arm B. Main grade 3/4 toxic effects were, respectively, neutropenia 42.5% and 32.5%; febrile neutropenia 10% and 5%; diarrhea 32.5% and 7.5%; vomiting 10.0% and 5%; neurosensory toxicity 17.5% and 7.5%.
Conclusion: The IRINOX arm has a manageable toxicity and is active.
Key words: advanced colorectal cancer, first-line treatment, FU, irinotecan, oxaliplatin
Received for publication June 4, 2007. Accepted for publication July 2, 2007.