High-dose imatinib induction followed by standard-dose maintenance in pre-treated chronic phase chronic myeloid leukemia patients – final analysis of a randomized, multicenter, phase III trial

oleh: Andreas L. Petzer, Dominic Fong, Thomas Lion, Irina Dyagil, Zvenyslava Masliak, Andrija Bogdanovic, Laimonas Griskevicius, Sandra Lejniece, Stefan Goranov, Liana Gercheva, Aleksandar Stojanovic, Dontcho Peytchev, Nikolay Tzvetkov, Rasa Griniute, Atanas Stanchev, Thomas Grubinger, Marthin Kwakkelstein, Peter Schuld, Guenther Gastl, Dominik Wolf

Format: Article
Diterbitkan: Ferrata Storti Foundation 2012-10-01

Deskripsi

Background Previous data suggest that the response of chronic myeloid leukemia cells to imatinib is dose-dependent. The potential benefit of initial dose intensification of imatinib in pre-treated patients with chronic phase chronic myeloid leukemia remains unknown.Design and Methods Two hundred and twenty-seven pre-treated patients with chronic myeloid leukemia in chronic phase were randomly assigned to continuous treatment with a standard dose of imatinib (400 mg/day; n=113) or to 6 months of high-dose induction with imatinib (800 mg/day) followed by a standard dose of imatinib as maintenance therapy (n=114).Results The rates of major and complete cytogenetic responses were significantly higher in the high-dose arm than in the standard-dose arm at both 3 and 6 months (major cytogenetic responses: 36.8% versus 21.2%, P=0.01 and 50.0% versus 34.5%, P=0.018; complete cytogenetic responses: 22.8% versus 6.2%, P