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Annals of Oncology 2006 17(3):443-449; doi:10.1093/annonc/mdj104
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© 2006 European Society for Medical Oncology

Randomised Phase III study of biweekly 24-h infusion of high-dose 5FU with folinic acid and oxaliplatin versus monthly plus 5-FU/folinic acid in first-line treatment of advanced colorectal cancer

G. A. P. Hospers1,*, M. Schaapveld2, J. W. R. Nortier3, J. Wils4, A. van Bochove5, R. S. de Jong6, G. J. Creemers7, Z. Erjavec8, D. J. de Gooyer9, P. H. Th. J. Slee10, C. J. H. Gerrits11, J. M. Smit12 and N. H. Mulder1

1 Department of Medical Oncology, University of Groningen and University Medical Center Groningen, Groningen; 2 Comprehensive Cancer Centre North-Netherlands, Groningen; 3 Department of Medical Oncology, Leiden University Medical Center, Leiden; 4 Department of Medical Oncology, Laurentius Hospital, Roermond; 5 Department of Internal Medicine, Zaans Medical Center, Zaandam; 6 Department of Oncology, Martini Hospital, Groningen; 7 Department of Internal Medicine, Catharina Hospital, Eindhoven; 8 Department of Internal Medicine, Delfzicht Hospital, Delfzijl; 9 Department of Internal Medicine, Franciscus Hospital, Roosendaal; 10 Department of Oncology, Sint Antonius Hospital, Nieuwegein; 11 Department of Internal Medicine, Twente Hospital, Hengelo; 12 Department of Internal Medicine, Gelre Hospital, Apeldoorn, The Netherlands

* Correspondence to: Dr. G. A. P. Hospers, Department of Medical Oncology, University Medical Center Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands. E-mail: g.a.p.hospers{at}int.umcg.nl

Background: A phase III study was started to compare oxaliplatin/5FU/LV in the first-line with bolus FU/LV in metastatic colorectal cancer.

Patients and methods: 302 patients were randomised and received bolus 5-FU 425 mg/m2 day 1–5, FA 20 mg/m2 day 1–5, q 4 wk or oxaliplatin 85 mg/m2, 2 h-infusion, FA 200 mg/m2, 1-h infusion. 5-FU 2600 mg/m2, 24-h infusion day 1, q 2 wk. The primary endpoint was response rate (RR).

Results: The median follow-up is 31.8 months, 90.4% of the patients have died. Confirmed RR, progression free survival (PFS; months) and median overall survival (OS; months) in 5FU/LV versus 5FU/LV/oxaliplatin were respectively 18.5% versus (vs) 33.8% (P = 0.004), 5.6 vs 6.7 (P = 0.016) and 13.3 vs 13.8 (P = 0.619). In the 5FU/LV/oxaliplatin arm less grade 3/4 toxicity was measured for diarrhoea, stomatitis, an increase in idiosyncratic side effects and neurosensory events compared with 5FU/LV. The quality of life (QOL) was equal in both arms. Second line treatment was given in 62% of the patients, crossover of 5FU/LV to 5FU/LV/oxaliplatin occurred in 14%.

Conclusions: Oxaliplatin in the first-line resulted in an increased RR and PFS with less grade 3/4 mucositis/diarrhoea compared with 5FU/LV alone. Idiosyncratic side effects deserve attention with oxaliplatin. Despite a low treatment cross over rate, OS in both groups was comparable.

Key words: advanced colorectal cancer, oxaliplatin, phase III study


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