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Annals of Oncology Advance Access originally published online on April 11, 2008
Annals of Oncology 2008 19(8):1470-1476; doi:10.1093/annonc/mdn161
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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

urogenital tumors

First-line bevacizumab combined with reduced dose interferon-{alpha}2a is active in patients with metastatic renal cell carcinoma

B. Melichar1,*, P. Koralewski2, A. Ravaud3, A. Pluzanska4, S. Bracarda5, C. Szczylik6, C. Chevreau7, M. Filipek8, R. Delva9, E. Sevin10, S. Négrier11, J. McKendrick12, A. Santoro13, P. Pisa14 and B. Escudier15

1 Charles University Medical School and Teaching Hospital, Hradec Králové, Czech Republic
2 Szpital im. Rydygiera, Krakow, Poland
3 Department of Medical Oncology and Radiotherapy, Hôpital Saint André, CHU Bordeaux, Bordeaux, France
4 Klinika Chemioterapii AM, Lodz, Poland
5 Department of Medical Oncology, Azienda Ospedaliera, Perugia, Italy
6 Oncology Clinic, Wojskowy Instytut Medyczny, Warsaw, Poland
7 Department of Medical Oncology, Institut Claudius-Regaud, Toulouse Cedex, France
8 Szpital Wojewodzki im. Sw. Lukasz, Tarnow, Poland
9 Department of Medical Oncology, Centre Paul Papin, Angers
10 Centre Régional François Baclesse de Lutte contre le Cancer, Caen
11 Department of Medical Oncology, Centre Léon Bérard, Lyon, France
12 Department of Medical Oncology, Box Hill Hospital, Box Hill, Australia
13 Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Italy
14 F. Hoffmann-La Roche Ltd, Basel, Switzerland
15 Department of Medicine, Institut Gustave Roussy, Villejuif, France

* Correspondence to: Dr B. Melichar, Department of Oncology and Radiotherapy, Charles University Medical School and Teaching Hospital Hradec Kra' love, Sokolská 581, Building 23, 500 05 Hradec Králové, Czech Republic. Tel: +420-495-834-574; Fax: +420-495-832-081; E-mail: melichar{at}fnhk.cz

Background: In patients with untreated metastatic renal cell carcinoma (mRCC), progression-free survival (PFS) was longer with bevacizumab + interferon (IFN)-{alpha} than IFN + placebo (AVOREN trial). In this hypothesis-generating study, subgroup analysis was carried out to determine the effect of IFN dose reduction.

Patients and methods: A total of 649 patients received IFN 9 MIU s.c. three times weekly plus bevacizumab 10 mg/kg or placebo every 2 weeks until disease progression. The IFN dose was reduced to 6 or 3 MIU with the development of IFN-attributed toxicity. Differences between treatment arms in PFS, response rate and tolerability were analysed in the reduced-dose group.

Results: IFN dose was reduced in 131 patients in the bevacizumab + IFN arm and 97 patients in the IFN + placebo arm during the trial. PFS rates in the bevacizumab + reduced-dose IFN group were comparable with the total population (Kaplan–Meier estimates of event-free rate at 1 year: 0.524 versus 0.427). Bevacizumab + reduced-dose IFN was well tolerated, with substantial decreases in the rate of adverse events following dose reduction.

Conclusion: This retrospective subgroup analysis suggests that the dose of IFN can be reduced to manage side-effects while maintaining efficacy in patients with mRCC receiving bevacizumab + IFN.

Key words: antiangiogenic therapy, bevacizumab, interferon-{alpha}, renal cell carcinoma, vascular endothelial growth factor (VEGF)

Received for publication January 14, 2008. Revision received March 10, 2008. Accepted for publication March 17, 2008.


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