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 Blood, 1 March 2008, Vol. 111, No. 5, pp. 2581-2588.
Prepublished online as a Blood First Edition Paper on January 2, 2008; DOI 10.1182/blood-2007-08-107482.

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CLINICAL TRIALS AND OBSERVATIONS

Dose-finding study of imatinib in combination with intravenous cytarabine: feasibility in newly diagnosed patients with chronic myeloid leukemia

Wendy Deenik1, Bronno van der Holt1, Gregor E. G. Verhoef2, Willem M. Smit3, Marie J. Kersten4, Hanneke C. Kluin-Nelemans5, Leo F. Verdonck6, Augustin Ferrant7, Anton V. M. B. Schattenberg8, Jeroen J. W. M. Janssen9, Pieter Sonneveld1, Marinus van Marwijk Kooy10, Shulamit Wittebol11, Roelof Willemze12, Pierre W. Wijermans13, Petra H. M. Westveer1, H. Berna Beverloo1, Peter Valk1, Bob Löwenberg1, Gert J. Ossenkoppele9, and Jan J. Cornelissen1

1 Erasmus University Medical Center, Rotterdam, The Netherlands; 2 University Hospital Gasthuisberg, Leuven, Belgium; 3 Medical Spectrum Twente, Enschede, The Netherlands; 4 Academic Medical Center, Amsterdam, The Netherlands; 5 University Medical Center Groningen, Groningen, The Netherlands; 6 University Medical Center Utrecht, Utrecht, The Netherlands; 7 University Hospital St-Luc, Brussels, Belgium; 8 Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands; 9 Vrije Universiteit Medical Center, Amsterdam, The Netherlands; 10 Isala Clinic-Sophia, Zwolle, The Netherlands; and 11 Meander Medical Center, Amersfoort, The Netherlands; 12 Leiden University Medical Center, Leiden, The Netherlands; and 13 Haga Hospital, The Hague, The Netherlands

The HOVON cooperative study group performed a feasibility study of escalated imatinib and intravenous cytarabine in 165 patients with early chronic-phase chronic myeloid leukemia (CML). Patients received 2 cycles of intravenous cytarabine (200 mg/m2 or 1000 mg/m2 days 1-7) in conjunction with imatinib (200 mg, 400 mg, 600 mg, or 800 mg), according to predefined, successive dose levels. All dose levels proved feasible. Seven dose-limiting toxicities (DLTs) were observed in 302 cycles of chemotherapy, which were caused by streptococcal bacteremia in 5 cases. Intermediate-dose cytarabine (1000 mg/m2) prolonged time to neutrophil recovery and platelet recovery compared with a standard dose (200 mg/m2). High-dose imatinib (600 mg or 800 mg) extended the time to platelet recovery compared with a standard dose (400 mg). More infectious complications common toxicity criteria (CTC) grade 3 or 4 were observed after intermediate-dose cytarabine compared with a standard-dose of cytarabine. Early response data after combination therapy included a complete cytogenetic response in 48% and a major molecular response in 30% of patients, which increased to 46% major molecular responses at 1 year, including 13% complete molecular responses. We conclude that combination therapy of escalating dosages of imatinib and cytarabine is feasible. This study was registered at www.kankerbestrijding.nl as no. CKTO-2001-03.


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T. P. Hughes, S. Branford, D. L. White, J. Reynolds, R. Koelmeyer, J. F. Seymour, K. Taylor, C. Arthur, A. Schwarer, J. Morton, et al.
Impact of early dose intensity on cytogenetic and molecular responses in chronic- phase CML patients receiving 600 mg/day of imatinib as initial therapy
Blood, November 15, 2008; 112(10): 3965 - 3973.
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