High fludarabine exposure and relationship with treatment-related mortality after nonmyeloablative hematopoietic cell transplantation

Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell transplantation (HCT) recipients and exposure-response relationships remain undefined. The objective of this study was to evaluate the association betwe...

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Published inBone marrow transplantation (Basingstoke) Vol. 46; no. 1; pp. 20 - 26
Main Authors Long-Boyle, J R, Green, K G, Brunstein, C G, Cao, Q, Rogosheske, J, Weisdorf, D J, Miller, J S, Wagner, J E, McGlave, P B, Jacobson, P A
Format Journal Article
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Published London Nature Publishing Group UK 01.01.2011
Nature Publishing Group
Subjects
631/154/436/1729
692/700/565/545/576/1955
Adult
Aged
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Biological and medical sciences
Bone marrow transplantation
Bone marrow, stem cells transplantation. Graft versus host reaction
Cancer
Care and treatment
Cell Biology
Complications and side effects
Data processing
Dosage and administration
Dose-response effects
Drug Monitoring
Female
Fludarabine
Graft Survival - drug effects
Graft vs Host Disease - epidemiology
Graft-versus-host reaction
Hematology
Hematopoietic Stem Cell Transplantation - mortality
Hematopoietic stem cells
Hemopoiesis
Humans
Immunosuppressive Agents - administration & dosage
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Immunosuppressive Agents - blood
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Internal Medicine
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Medical sciences
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original-article
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Renal insufficiency
Renal Insufficiency - complications
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Risk Factors
Stem cell transplantation
Stem Cells
Survival Analysis
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Transfusions. Complications. Transfusion reactions. Cell and gene therapy
Transplantation
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Vidarabine - analogs & derivatives
Vidarabine - blood
Vidarabine Phosphate - adverse effects
Vidarabine Phosphate - analogs & derivatives
Vidarabine Phosphate - pharmacokinetics
Vidarabine Phosphate - therapeutic use
Young Adult
United States
fludarabine
pharmacokinetics
nonmyeloablative
TRM
F-ara-A
Antineoplastic agent
Purine nucleotide
Hematology
Stem cell
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Nucleotide analog
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Abstract Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell transplantation (HCT) recipients and exposure-response relationships remain undefined. The objective of this study was to evaluate the association between plasma F-ara-A exposure, the systemically circulating moiety of fludarabine, and engraftment, acute GVHD, TRM and OS after HCT. The preparative regimen consisted of CY 50 mg/kg/day i.v. day –6; plus fludarabine 30–40 mg/m 2 /day i.v. on days –6 to –2 and TBI 200 cGy on day –1. F-ara-A pharmacokinetics were carried out with the first dose of fludarabine in 87 adult patients. Median (range) F-ara-A area-under-the-curve (AUC (0−∞) ) was 5.0 μg h/mL (2.0–11.0), clearance 15.3 L/h (6.2–36.6), C min 55 ng/mL (17–166) and concentration on day zero 16.0 ng/mL (0.1–144.1). Despite dose reductions, patients with renal insufficiency had higher F-ara-A exposures. There was strong association between high plasma concentrations of F-ara-A and increased risk of TRM and reduced OS. Patients with an AUC (0−∞) greater than 6.5 μg h/mL had 4.56 greater risk of TRM and significantly lower OS. These data suggest that clinical strategies are needed to optimize dosing of fludarabine to prevent overexposure and toxicity in HCT.
AbstractList Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell transplantation (HCT) recipients and exposure-response relationships remain undefined. The objective of this study was to evaluate the association between plasma F-ara-A exposure, the systemically circulating moiety of fludarabine, and engraftment, acute GVHD, TRM and OS after HCT. The preparative regimen consisted of CY 50mg/kg/day i.v. day -6; plus fludarabine 30-40 mg/[m.sup.2]/day i.v. on days -6 to -2 and TBI 200 cGy on day -1. F-ara-A pharmacokinetics were carried out with the first dose of fludarabine in 87 adult patients. Median (range) F-ara-A area-under-the-curve ([AUC.sub.(0-[infinity]])) was 5.0 [micro]g h/mL (2.0-11.0), clearance 15.3L/h (6.2-36.6), [C.sub.min] 55 [micro]g/mL (17-166) and concentration on [day.sub.zero] 16.0 ng/mL (0.1-144.1). Despite dose reductions, patients with renal insufficiency had higher F-ara-A exposures. There was strong association between high plasma concentrations of F-ara-A and increased risk of TRM and reduced OS. Patients with an [AUC.sub.(0-[infinity])] greater than 6.5 [micro]g h/mL had 4.56 greater risk of TRM and significantly lower OS. These data suggest that clinical strategies are needed to optimize dosing of fludarabine to prevent overexposure and toxicity in HCT. Bone Marrow Transplantation (2011) 46, 20-26; doi: 10.1038/bmt.2010.53; published online 12 April 2010 Keywords: fludarabine; F-ara-A; nonmyeloablative; TRM; pharmacokinetics
Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell transplantation (HCT) recipients and exposure-response relationships remain undefined. The objective of this study was to evaluate the association between plasma F-ara-A exposure, the systemically circulating moiety of fludarabine, and engraftment, acute GVHD, TRM and OS after HCT. The preparative regimen consisted of CY 50 mg/kg/day i.v. day -6; plus fludarabine 30-40 mg/m²/day i.v. on days -6 to -2 and TBI 200 cGy on day -1. F-ara-A pharmacokinetics were carried out with the first dose of fludarabine in 87 adult patients. Median (range) F-ara-A area-under-the-curve (AUC((0-∞))) was 5.0 μg h/mL (2.0-11.0), clearance 15.3 L/h (6.2-36.6), C(min) 55 ng/mL (17-166) and concentration on day(zero) 16.0 ng/mL (0.1-144.1). Despite dose reductions, patients with renal insufficiency had higher F-ara-A exposures. There was strong association between high plasma concentrations of F-ara-A and increased risk of TRM and reduced OS. Patients with an AUC((0-∞)) greater than 6.5 μg h/mL had 4.56 greater risk of TRM and significantly lower OS. These data suggest that clinical strategies are needed to optimize dosing of fludarabine to prevent overexposure and toxicity in HCT.
Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell transplantation (HCT) recipients and exposure-response relationships remain undefined. The objective of this study was to evaluate the association between plasma F-ara-A exposure, the systemically circulating moiety of fludarabine, and engraftment, acute GVHD, TRM and OS after HCT. The preparative regimen consisted of CY 50mg/kg/day i.v. day -6; plus fludarabine 30-40mg/m super(2)/day i.v. on days -6 to -2 and TBI 200cGy on day -1. F-ara-A pharmacokinetics were carried out with the first dose of fludarabine in 87 adult patients. Median (range) F-ara-A area-under-the-curve (AUC sub((0- infinity ))) was 5.0 mu gh/mL (2.0-11.0), clearance 15.3L/h (6.2-36.6), C sub(min) 55ng/mL (17-166) and concentration on day sub(zero) 16.0ng/mL (0.1-144.1). Despite dose reductions, patients with renal insufficiency had higher F-ara-A exposures. There was strong association between high plasma concentrations of F-ara-A and increased risk of TRM and reduced OS. Patients with an AUC sub((0- infinity )) greater than 6.5 mu gh/mL had 4.56 greater risk of TRM and significantly lower OS. These data suggest that clinical strategies are needed to optimize dosing of fludarabine to prevent overexposure and toxicity in HCT.
Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell transplantation (HCT) recipients and exposure-response relationships remain undefined. Our objective of this study was to evaluate the association between plasma F-ara-A exposure, the systemically circulating moiety of fludarabine, and engraftment, acute graft vs host disease (GVHD), treatment-related mortality (TRM) and survival after HCT. The preparative regimen consisted of cyclophosphamide 50 mg/kg/day i.v. day −6; plus fludarabine 30-40 mg/m 2 /day i.v. on days −6 to −2 and TBI 200 cGy on day −1. F-ara-A pharmacokinetics were performed with the first dose of fludarabine in 87 adult patients. Median (range) F-ara-A AUC (0-∞) was 5.0 ug*hr/mL (2.0-11.0), clearance 15.3 L/hour (6.2-36.6), C min 55 ng/mL (17-166), and concentration on day zero 16.0 ng/mL (0.1-144.1). Despite dose reductions, patients with renal insufficiency had higher F-ara-A exposures. There was strong association between high plasma concentrations of F-ara-A and increased risk of TRM and reduced overall survival. Patients with an AUC (0-∞) greater than 6.5 ug*hr/mL had 4.56 greater risk of TRM and significantly lower survival. These data suggest that clinical strategies are needed to optimize dosing of fludarabine to prevent overexposure and toxicity in HCT.
Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell transplantation (HCT) recipients and exposure-response relationships remain undefined. The objective of this study was to evaluate the association between plasma F-ara-A exposure, the systemically circulating moiety of fludarabine, and engraftment, acute GVHD, TRM and OS after HCT. The preparative regimen consisted of CY 50 mg/kg/day i.v. day –6; plus fludarabine 30–40 mg/m 2 /day i.v. on days –6 to –2 and TBI 200 cGy on day –1. F-ara-A pharmacokinetics were carried out with the first dose of fludarabine in 87 adult patients. Median (range) F-ara-A area-under-the-curve (AUC (0−∞) ) was 5.0 μg h/mL (2.0–11.0), clearance 15.3 L/h (6.2–36.6), C min 55 ng/mL (17–166) and concentration on day zero 16.0 ng/mL (0.1–144.1). Despite dose reductions, patients with renal insufficiency had higher F-ara-A exposures. There was strong association between high plasma concentrations of F-ara-A and increased risk of TRM and reduced OS. Patients with an AUC (0−∞) greater than 6.5 μg h/mL had 4.56 greater risk of TRM and significantly lower OS. These data suggest that clinical strategies are needed to optimize dosing of fludarabine to prevent overexposure and toxicity in HCT.
Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell transplantation (HCT) recipients and exposure-response relationships remain undefined. The objective of this study was to evaluate the association between plasma F-ara-A exposure, the systemically circulating moiety of fludarabine, and engraftment, acute GVHD, TRM and OS after HCT. The preparative regimen consisted of CY 50mg/kg/day i.v. day -6; plus fludarabine 30-40 mg/[m.sup.2]/day i.v. on days -6 to -2 and TBI 200 cGy on day -1. F-ara-A pharmacokinetics were carried out with the first dose of fludarabine in 87 adult patients. Median (range) F-ara-A area-under-the-curve ([AUC.sub.(0-[infinity]])) was 5.0 [micro]g h/mL (2.0-11.0), clearance 15.3L/h (6.2-36.6), [C.sub.min] 55 [micro]g/mL (17-166) and concentration on [day.sub.zero] 16.0 ng/mL (0.1-144.1). Despite dose reductions, patients with renal insufficiency had higher F-ara-A exposures. There was strong association between high plasma concentrations of F-ara-A and increased risk of TRM and reduced OS. Patients with an [AUC.sub.(0-[infinity])] greater than 6.5 [micro]g h/mL had 4.56 greater risk of TRM and significantly lower OS. These data suggest that clinical strategies are needed to optimize dosing of fludarabine to prevent overexposure and toxicity in HCT.
Audience Academic
Author Miller, J S
Cao, Q
Long-Boyle, J R
Rogosheske, J
Brunstein, C G
Weisdorf, D J
McGlave, P B
Jacobson, P A
Wagner, J E
Green, K G
AuthorAffiliation 1 Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, MN
4 Biostatistic Core, Masonic Cancer Center, University of Minnesota, Minneapolis, MN
3 Division of Hematology, Oncology, Transplantation, University of Minnesota, Minneapolis, MN
2 Department of Pharmacy, University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota, MN
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IsDoiOpenAccess true
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Issue 1
Keywords fludarabine
pharmacokinetics
nonmyeloablative
TRM
F-ara-A
Antineoplastic agent
Purine nucleotide
Hematology
Stem cell
Mortality
Hematopoietic cell
Exposure
Nucleotide analog
Non myeloablative treatment
Fludarabine
Treatment
Antimetabolic
Graft
Fluorine Organic compounds
Pharmacokinetics
Language English
License CC BY 4.0
Users may view, print, copy, download and text and data- mine the content in such documents, for the purposes of academic research, subject always to the full Conditions of use: http://www.nature.com/authors/editorial_policies/license.html#terms
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content type line 23
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PublicationSubtitle Official journal of the European Society for Blood and Marrow Transplantation
PublicationTitle Bone marrow transplantation (Basingstoke)
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Snippet Despite its common use in nonmyeloablative preparative regimens, the pharmacokinetics of fludarabine are poorly characterized in hematopoietic cell...
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SubjectTerms 631/154/436/1729
692/700/565/545/576/1955
Adult
Aged
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Biological and medical sciences
Bone marrow transplantation
Bone marrow, stem cells transplantation. Graft versus host reaction
Cancer
Care and treatment
Cell Biology
Complications and side effects
Data processing
Dosage and administration
Dose-response effects
Drug Monitoring
Female
Fludarabine
Graft Survival - drug effects
Graft vs Host Disease - epidemiology
Graft-versus-host reaction
Hematology
Hematopoietic Stem Cell Transplantation - mortality
Hematopoietic stem cells
Hemopoiesis
Humans
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - adverse effects
Immunosuppressive Agents - blood
Immunosuppressive Agents - pharmacokinetics
Incidence
Internal Medicine
Male
Medical sciences
Medicine
Medicine & Public Health
Metabolic Clearance Rate
Middle Aged
Mortality
Neutrophil Infiltration - drug effects
original-article
Patient outcomes
Pharmacokinetics
Prodrugs - adverse effects
Prodrugs - pharmacokinetics
Prodrugs - therapeutic use
Public Health
Renal insufficiency
Renal Insufficiency - complications
Renal Insufficiency - metabolism
Risk Factors
Stem cell transplantation
Stem Cells
Survival Analysis
Toxicity
Transfusions. Complications. Transfusion reactions. Cell and gene therapy
Transplantation
Transplantation Conditioning
Vidarabine - analogs & derivatives
Vidarabine - blood
Vidarabine Phosphate - adverse effects
Vidarabine Phosphate - analogs & derivatives
Vidarabine Phosphate - pharmacokinetics
Vidarabine Phosphate - therapeutic use
Young Adult
Title High fludarabine exposure and relationship with treatment-related mortality after nonmyeloablative hematopoietic cell transplantation
URI http://dx.doi.org/10.1038/bmt.2010.53
https://link.springer.com/article/10.1038/bmt.2010.53
https://www.ncbi.nlm.nih.gov/pubmed/20383215
https://www.proquest.com/docview/835132288
https://search.proquest.com/docview/1038592257
https://pubmed.ncbi.nlm.nih.gov/PMC2904846
Volume 46
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