Pegylated Recombinant Interferon Alpha-2B Vs Recombinant Interferon
Leukemia (2004) 18, 309–315 & 2004 Nature Publishing Group All rights reserved 0887-6924/04 $25.00 www.nature.com/leu Pegylated recombinant interferon alpha-2b vs recombinant interferon alpha-2b for the initial treatment of chronic-phase chronic myelogenous leukemia: a phase III study M Michallet1, F Maloisel2, M Delain3, A Hellmann4, A Rosas5, RT Silver6 and C Tendler7, for the PEG-Intron CML Study Group8 1Hoˆpital Edouard Herriot, Lyon, France; 2Hoˆpital Hautepierre, Strasbourg, France; 3Hoˆpital Bretonneau, Tours, France; 4Medical University of Gdansk, Gdansk, Poland; 5Centro Mexico Nacional La Raza Instituto Mexicano del Seguro Social, Mexico City, Mexico; 6New York Presbyterian Hospital-Weill Cornell Medical Center, New York, NY, USA; and 7Schering-Plough, Kenilworth, NJ, USA Recombinant interferon alpha-2b (rIFN-a2b) is an effective A pegylated form of recombinant interferon alpha-2b (rIFN- therapy for chronic-phase chronic myelogenous leukemia a2b), PEG Introns (Schering-Plough Corporation, Kenilworth, (CML). Polyethylene glycol-modified rIFN-a2b is a novel for- mulation with a serum half-life (B40 h) compatible with once- NJ, USA), was developed, which contains a single polyethylene weekly dosing. This open-label, noninferiority trial randomized glycol moiety (12 000 Da average molecular weight). Pegylated 344 newly diagnosed CML patients: 171 received subcutaneous rIFN-a2b exhibits decreased clearance, increased area under the pegylated rIFN-a2b (6 lg/kg/week); 173 received rIFN-a2b (5 curve, and a significantly longer half-life (B10-fold greater) than 2 million International Units/m /day). Primary efficacy end point rIFN-a2b, and is compatible with weekly dosing.9 An increased was the 12-month major cytogenetic response (MCR) rate area under the curve in combination with prolonged tumor ( 35% Philadelphia chromosome-positive cells).
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