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
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
Affiliations
Andreas L. Petzer
Central European Leukemia Study Group (CELSG), Internal Medicine V, Hematology and Oncology, Medical University Innsbruck, Innsbruck, Austria;Internal Medicine I, Hematology and Medical Oncology; Krankenhaus Barmherzige Schwestern Linz, Linz, Austria
Dominic Fong
Central European Leukemia Study Group (CELSG), Internal Medicine V, Hematology and Oncology, Medical University Innsbruck, Innsbruck, Austria
Thomas Lion
CCRI Children's Cancer Research Institute/LabDia Labordiagnostik, Vienna, Austria
Irina Dyagil
Department of Hematology, RC Radiation Medicine, Kiev, Ukraine
Zvenyslava Masliak
Institute of Blood Pathology and Transfusion Medicine, Lviv, Ukraine
Andrija Bogdanovic
Clinical Center of Serbia, Institut za Haematologiju, Belgrad, Serbia and Montenegro
Laimonas Griskevicius
Clinics of Internal, Family Medicine and Oncology, Medical Faculty, Vilnius University, Hospital Santariskiu Clinics, Vilnius, Lithuania
Sandra Lejniece
National Center of Hematology, Riga, Latvia
Stefan Goranov
University Hospital for Active Treatment “St. George”, Plovdiv, Bulgaria
Liana Gercheva
University Hospital for Active Treatment “St. Marina”, Varna, Bulgaria
Aleksandar Stojanovic
Clinic for Hematology, National Clinical Center Skopje, Skopje, Macedonia
Dontcho Peytchev
National Center of Hematology and Transfusiology, Sofia, Bulgaria
Nikolay Tzvetkov
University Hospital for Active Treatment, Pleven, Bulgaria
Rasa Griniute
Kaunas University Hospital, Kaunas, Lithuania
Atanas Stanchev
Alexandrovska University Hospital, Sofia, Bulgaria
Thomas Grubinger
Department of Medical Statistics, Informatics and Health Economics, Medical University Innsbruck
Marthin Kwakkelstein
Novartis, Basel, Switzerland
Peter Schuld
Novartis, Nurnberg, Germany, Bonn, Germany
Guenther Gastl
Central European Leukemia Study Group (CELSG), Internal Medicine V, Hematology and Oncology, Medical University Innsbruck, Innsbruck, Austria
Dominik Wolf
Central European Leukemia Study Group (CELSG), Internal Medicine V, Hematology and Oncology, Medical University Innsbruck, Innsbruck, Austria;University Hospital Bonn, Department of Hematology/Oncology, Bonn, Germany
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
