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Blood, 15 December 2003, Vol. 102, No. 13, pp. 4298-4305.
Prepublished online as a Blood First Edition Paper on August 21, 2003; DOI 10.1182/blood-2003-04-1010.
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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Results of a prospective phase 2 study combining imatinib mesylate and cytarabine for the treatment of Philadelphia-positive patients with chronic myelogenous leukemia in chronic phase
Martine Gardembas,
Philippe Rousselot,
Michel Tulliez,
Magda Vigier,
Agnès Buzyn,
Françoise Rigal-Huguet,
Laurence Legros,
Mauricette Michallet,
Christian Berthou,
Nathalie Cheron,
Frederic Maloisel,
François-Xavier Mahon,
Thierry Facon,
Patrice Berthaud,
Joëlle Guilhot, and
François Guilhot, for the CML French Group (FI LMC)
From the Department of Oncology-Hematology and Cell Therapy, Centre Hospitalier Universitaire (CHU) la Milétrie, Poitiers, France, and Division of Hematology of the University Hospital of Angers, St Louis, Paris, Créteil, Nantes, Necker, Paris, Toulouse, Nice, Lyon, Brest, St Antoine, Paris, Strasbourg, Bordeaux, Lille, and Novartis Pharma Rueil-Malmaisen, France.
In chronic myelogenous leukemia (CML) imatinib mesylate has been shown to selectively inhibit the tyrosine kinase domain of the oncogenic bcr-abl fusion protein. Using this agent alone high rates of cytogenetic responses were recorded. However, several mechanisms of resistance have been described. In vitro studies examining the effects of imatinib mesylate plus cytarabine have shown synergistic antiproliferative effects of this combination. Thus, the CML French Group decided to perform a phase 2 trial testing a combination of imatinib mesylate and low-dose cytarabine in 30 previously untreated patients in chronic phase. Treatment was administered on 28-day cycles. Patients were treated continuously with imatinib mesylate orally at a dose of 400 mg daily. Cytarabine was given on days 15 to 28 of each cycle at an initial dose of 20 mg/m2/d via subcutaneous injection. Adverse events were frequently observed with grade 3 or 4 hematologic toxicities and nonhematologic toxicities in 53% (n = 16) and 23% (n = 7) of patients, respectively. The cumulative incidence of complete cytogenetic response (CCR) at 12 months was 83% and at 6 months 100% of the patients achieved complete hematologic response (CHR). We concluded that the combination was safe and promising given the rates of response. (Blood. 2003;102:4298-4305)
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