G‐CSF Priming,clofarabine, and high dose cytarabine (GCLAC) for upfront treatment of acute myeloid leukemia,advanced myelodysplastic syndrome or advanced myeloproliferative neoplasm |
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| Authors: | Pamela S Becker Bruno C Medeiros Anthony S Stein Megan Othus Frederick R Appelbaum Stephen J Forman Bart L Scott Paul C Hendrie Kelda M Gardner John M Pagel Roland B Walter Cynthia Parks Brent L Wood Janis L Abkowitz Elihu H Estey |
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| Institution: | 1. Division of Hematology, Department of Medicine, University of Washington, Seattle, Washington;2. Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;3. Division of Hematology, Department of Medicine, Stanford School of Medicine, Palo Alto, California;4. Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California;5. Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;6. Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington;7. Department of Laboratory Medicine, University of Washington, Seattle, Washington |
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| Abstract: | Prior study of the combination of clofarabine and high dose cytarabine with granulocyte colony‐stimulating factor (G‐CSF) priming (GCLAC) in relapsed or refractory acute myeloid leukemia resulted in a 46% rate of complete remission despite unfavorable risk cytogenetics. A multivariate analysis demonstrated that the remission rate and survival with GCLAC were superior to FLAG (fludarabine, cytarabine, G‐CSF) in the relapsed setting. We therefore initiated a study of the GCLAC regimen in the upfront setting in a multicenter trial. The objectives were to evaluate the rates of complete remission (CR), overall and relapse‐free survival (OS and RFS), and toxicity of GCLAC. Clofarabine was administered at 30 mg m?2 day?1 × 5 and cytarabine at 2 g m?2 day?1 × 5 after G‐CSF priming in 50 newly‐diagnosed patients ages 18–64 with AML or advanced myelodysplastic syndrome (MDS) or advanced myeloproliferative neoplasm (MPN). Responses were assessed in the different cytogenetic risk groups and in patients with antecedent hematologic disorder. The overall CR rate was 76% (95% confidence interval CI] 64–88%) and the CR + CRp (CR with incomplete platelet count recovery) was 82% (95% CI 71–93%). The CR rate was 100% for patients with favorable, 84% for those with intermediate, and 62% for those with unfavorable risk cytogenetics. For patients with an antecedent hematologic disorder (AHD), the CR rate was 65%, compared to 85% for those without an AHD. The 60 day mortality was 2%. Thus, front line GCLAC is a well‐tolerated, effective induction regimen for AML and advanced myelodysplastic or myeloproliferative disorders. Am. J. Hematol. 90:295–300, 2015. © 2014 Wiley Periodicals, Inc. |
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