Clinical pharmacology of cytarabine in patients with acute myeloid leukemia: a Cancer and Leukemia Group B study

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

doi:10.1007/BF00686192

Clinical pharmacology of cytarabine in patients with acute myeloid leukemia: a Cancer and Leukemia Group B study

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

Medicine - Hematology, Oncology, Transplant

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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) μM 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.

Original language	English (US)
Pages (from-to)	425-430
Number of pages	6
Journal	Cancer chemotherapy and pharmacology
Volume	36
Issue number	5
DOIs	https://doi.org/10.1007/BF00686192
State	Published - Sep 1995

Keywords

Cytarabine
Leukemia

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10.1007/BF00686192

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Fleming, R. A., Capizzi, R. L., Rosner, G. L., Oliver, L. K., Smith, S. J., Schiffer, C. A., Silver, R. T., Peterson, B. A., Weiss, R. B., Omura, G. A., Mayer, R. J., Van Echo, D. A., Bloomfield, C. D., & Schilsky, R. L. (1995). Clinical pharmacology of cytarabine in patients with acute myeloid leukemia: a Cancer and Leukemia Group B study. Cancer chemotherapy and pharmacology, 36(5), 425-430. https://doi.org/10.1007/BF00686192

Fleming, RA, Capizzi, RL, Rosner, GL, Oliver, LK, Smith, SJ, Schiffer, CA, Silver, RT, Peterson, BA, Weiss, RB, Omura, GA, Mayer, RJ, Van Echo, DA, Bloomfield, CD & Schilsky, RL 1995, 'Clinical pharmacology of cytarabine in patients with acute myeloid leukemia: a Cancer and Leukemia Group B study', Cancer chemotherapy and pharmacology, vol. 36, no. 5, pp. 425-430. https://doi.org/10.1007/BF00686192

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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) μM 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.",

keywords = "Cytarabine, Leukemia",

author = "Fleming, {Ronald A.} and Capizzi, {Robert L.} and Rosner, {Gary L.} and Oliver, {Lawrence K.} and Smith, {Stephen J.} and Schiffer, {Charles A.} and Silver, {Richard T.} and Peterson, {Bruce A} and Weiss, {Raymond B.} and Omura, {George A.} and Mayer, {Robert J.} and {Van Echo}, {David A.} and Bloomfield, {Clara D.} and Schilsky, {Richard L.}",

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T1 - Clinical pharmacology of cytarabine in patients with acute myeloid leukemia

T2 - a Cancer and Leukemia Group B study

AU - Fleming, Ronald A.

AU - Capizzi, Robert L.

AU - Rosner, Gary L.

AU - Oliver, Lawrence K.

AU - Smith, Stephen J.

AU - Schiffer, Charles A.

AU - Silver, Richard T.

AU - Peterson, Bruce A

AU - Weiss, Raymond B.

AU - Omura, George A.

AU - Mayer, Robert J.

AU - Van Echo, David A.

AU - Bloomfield, Clara D.

AU - Schilsky, Richard L.

PY - 1995/9

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N2 - 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) μM 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.

AB - 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) μM 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.

KW - Cytarabine

KW - Leukemia

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Clinical pharmacology of cytarabine in patients with acute myeloid leukemia: a Cancer and Leukemia Group B study

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