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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| Affiliation: | (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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