Clinical pharmacology of cytarabine in patients with acute myeloid leukemia: a Cancer and Leukemia Group B study |
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| Authors: | Ronald A Fleming Robert L Capizzi Gary L Rosner Lawrence K Oliver Stephen J Smith Charles A Schiffer Richard T Silver Bruce A Peterson Raymond B Weiss George A Omura Robert J Mayer David A Van Echo Clara D Bloomfield Richard L Schilsky |
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| Institution: | (1) Medical Center Boulevard, Comprehensive Cancer Center of Wake Forest University, 27157-1082 Winston-Salem, NC, USA;(2) Duke University Medical Center, Durham, NC, USA;(3) The Upjohn Company, Kalamazoo, MI, USA;(4) University of Maryland Cancer Center, Baltimore, MD, USA;(5) The New York Hospital, New York, NY, USA;(6) University of Minnesota Medical School, Minneapolis, MN, USA;(7) Walter Reed Army Medical Center, Washington DC, USA;(8) The University of Alabama at Birmingham, Birmingham, AL, USA;(9) Dana-Farber Cancer Institute, Boston, MA, USA;(10) Roswell Park Cancer Institute, Buffalo, NY, USA;(11) Cancer Research Center, University of Chicago, Chicago, IL, USA;(12) Present address: US Bioscience, West Conshohocken, PA, USA |
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| Abstract: | The pharmacokinetics of cytarabine (ara-C) were determined in 265 patients with acute myeloid leukemia (AML) receiving ara-C (200 mg/m2 per day for 7 days as a continuous infusion) and daunorubicin during induction therapy. The mean (standard deviation) ara-C concentration at steady-state (Css) and systemic clearance (Cl) were 0.30 (0.13)  M and 134 (71) l/h per m2 respectively. Males had a significantly faster ara-C Cl (139 vs 131 l/h per m2,P=0.025) than females. Significant correlations were noted between ara-C Cl and the pretreatment, peripheral white blood cell count (P=0.005) and pretreatment blast count (P=0.020). No significant differences in ara-C Css or Cl were noted in patients achieving complete remission compared with those failing therapy (P=0.315,P=0.344, respectively). No significant correlations were observed between ara-C pharmacokinetic parameters and several indices of patient toxicity. Our findings indicate that variability in ara-C disposition in plasma at this dosage level does not correlate with remission status or toxicity in patients with AML receiving initial induction therapy with ara-C and daunorubicin.This study was supported in part by grants from the National Cancer Institute (CA-03927, CA-37027, CA-59518, CA-47577, CA-32291, CA-07968, CA-16450, CA-16450, CA-26806, CA-47545, CA-12197, and CA-41287), the Upjohn Company, and the Coleman Leukemia Research Fund |
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| Keywords: | Cytarabine Leukemia |
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