Haematologica (Jun 2010)

High-dose imatinib improves cytogenetic and molecular remissions in patients with pretreated Philadelphia-positive, BCR-ABL-positive chronic phase chronic myeloid leukemia: first results from the randomized CELSG phase III CML 11 “ISTAHIT” study

  • Andreas L. Petzer,
  • Dominik Wolf,
  • 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,
  • Radka Oucheva,
  • Hanno Ulmer,
  • Marthin Kwakkelstein,
  • Francesca Rancati,
  • Guenther Gastl

DOI
https://doi.org/10.3324/haematol.2009.013979
Journal volume & issue
Vol. 95, no. 6

Abstract

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Background Imatinib 400 mg/day is the standard treatment for patients with chronic phase chronic myeloid leukemia. Recent reports suggested higher and more rapid cytogenetic and molecular responses with higher doses of imatinib.Design and Methods In this prospective international, multicenter phase III study, 227 patients with pre-treated Philadelphia chromosome-positive, BCR-ABL-positive chronic myeloid leukemia were randomized to a standard-dose imatinib arm (400 mg/day) or a high-dose imatinib arm (800 mg/day for 6 months followed by 400 mg/day as maintenance therapy). In this planned interim analysis hematologic, cytogenetic and molecular responses as well as toxicity were evaluated.Results Compared to the standard-dose, high-dose imatinib led to higher rates of major and complete cytogenetic responses at both 3 months (major: 21% versus 37%, P=0.01; complete: 6% versus 25%, P