Population Pharmacokinetic Model of Intravenous Busulfan in Hematopoietic Cell Transplantation: Systematic Review and Comparative Simulations
Background Busulfan is commonly used in the chemotherapy prior to hematopoietic cell transplantation (HCT). Busulfan has a narrow therapeutic window and a well-established exposure–response relationship with important clinical outcomes. Model-informed precision dosing (MIPD) based on population phar...
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| Veröffentlicht in: | Clinical pharmacokinetics 2023-07, Vol.62 (7), p.955-968 |
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| creator | Takahashi, Takuto Jaber, Mutaz M. Brown, Sarah J. Al-Kofahi, Mahmoud |
| description | Background
Busulfan is commonly used in the chemotherapy prior to hematopoietic cell transplantation (HCT). Busulfan has a narrow therapeutic window and a well-established exposure–response relationship with important clinical outcomes. Model-informed precision dosing (MIPD) based on population pharmacokinetic (popPK) models has been implemented in the clinical settings. We aimed to systematically review existing literature on popPK models of intravenous busulfan.
Methods
We systematically searched Ovid MEDLINE, EMBASE, Cochrane Library, Scopus, and Web of Science databases from inception to December 2022 to identify original popPK models (nonlinear mixed-effect modeling) of intravenous busulfan in HCT population. Model-predicted busulfan clearance (CL) was compared using US population data.
Results
Of the 44 eligible popPK studies published since 2002, 68% were developed predominantly in children, 20% in adults, and 11% in both children and adults. The majority of the models were described using first-order elimination or time-varying CL (69% and 26%, respectively). All but three included a body-size descriptor (e.g., body weight, body surface area). Other commonly included covariates were age (30%) and
GSTA1
variant (15%). Median between-subject and between-occasion variabilities of CL were 20% and 11%, respectively. Between-model variabilities in predicted median CL were |
| doi_str_mv | 10.1007/s40262-023-01275-x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2835272937</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2835272937</sourcerecordid><originalsourceid>FETCH-LOGICAL-c347t-f2795765566f9c18bcfdce6e9a3a5acc274980371ee38584e764c946bb3630933</originalsourceid><addsrcrecordid>eNp9kcFu1DAQhi0EokvhBTggH7kExnZsx9xgBbRSERUtZ8vrnYBLYgc7WdqH4J1xdxeOnEaa-ebX_PMT8pzBKwagX5cWuOINcNEA41o2tw_IijFtGma4ekhWIBhvpFHihDwp5QYAOg7wmJwI3TIJIFbk92WalsHNIUV6-d3l0fn0I0Scg6ef0hYHmnp6HufsdhjTUui7pSxD7yINkZ7h6OY0pbDH1zgM9Dq7WKbBxXmv-YZe3ZX5HqvAF9wF_EVd3NJ1GieXa3eH9CqMxwvKU_Kod0PBZ8d6Sr5-eH-9PmsuPn88X7-9aLxo9dz0XBuplZRK9cazbuP7rUeFxgknnfdct6YDoRmi6GTXolatN63abIQSYIQ4JS8PulNOPxcssx1D8fV-F7GatLwTkmtuhK4oP6A-p1Iy9nbKYXT5zjKw9zHYQwy2xmD3MdjbuvTiqL9sRtz-W_n79wqIA1DqKH7DbG_SkmP1_D_ZP35xlpM</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2835272937</pqid></control><display><type>article</type><title>Population Pharmacokinetic Model of Intravenous Busulfan in Hematopoietic Cell Transplantation: Systematic Review and Comparative Simulations</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Takahashi, Takuto ; Jaber, Mutaz M. ; Brown, Sarah J. ; Al-Kofahi, Mahmoud</creator><creatorcontrib>Takahashi, Takuto ; Jaber, Mutaz M. ; Brown, Sarah J. ; Al-Kofahi, Mahmoud</creatorcontrib><description>Background
Busulfan is commonly used in the chemotherapy prior to hematopoietic cell transplantation (HCT). Busulfan has a narrow therapeutic window and a well-established exposure–response relationship with important clinical outcomes. Model-informed precision dosing (MIPD) based on population pharmacokinetic (popPK) models has been implemented in the clinical settings. We aimed to systematically review existing literature on popPK models of intravenous busulfan.
Methods
We systematically searched Ovid MEDLINE, EMBASE, Cochrane Library, Scopus, and Web of Science databases from inception to December 2022 to identify original popPK models (nonlinear mixed-effect modeling) of intravenous busulfan in HCT population. Model-predicted busulfan clearance (CL) was compared using US population data.
Results
Of the 44 eligible popPK studies published since 2002, 68% were developed predominantly in children, 20% in adults, and 11% in both children and adults. The majority of the models were described using first-order elimination or time-varying CL (69% and 26%, respectively). All but three included a body-size descriptor (e.g., body weight, body surface area). Other commonly included covariates were age (30%) and
GSTA1
variant (15%). Median between-subject and between-occasion variabilities of CL were 20% and 11%, respectively. Between-model variabilities in predicted median CL were < 20% in all of the weight tiers (10–110 kg) in the simulation based on US population data.
Conclusion
Busulfan PK is commonly described using a first-order elimination or time-varying CL. A simple model with limited covariates were generally sufficient to attain relatively small unexplained variabilities. However, therapeutic drug monitoring may still be necessary to attain a narrow target exposure.</description><identifier>ISSN: 0312-5963</identifier><identifier>EISSN: 1179-1926</identifier><identifier>DOI: 10.1007/s40262-023-01275-x</identifier><identifier>PMID: 37415003</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Administration, Intravenous ; Adult ; Body Surface Area ; Busulfan - pharmacokinetics ; Child ; Drug Monitoring ; Hematopoietic Stem Cell Transplantation ; Humans ; Internal Medicine ; Medicine ; Medicine & Public Health ; Pharmacology/Toxicology ; Pharmacotherapy ; Systematic Review</subject><ispartof>Clinical pharmacokinetics, 2023-07, Vol.62 (7), p.955-968</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c347t-f2795765566f9c18bcfdce6e9a3a5acc274980371ee38584e764c946bb3630933</citedby><cites>FETCH-LOGICAL-c347t-f2795765566f9c18bcfdce6e9a3a5acc274980371ee38584e764c946bb3630933</cites><orcidid>0000-0001-8296-6412</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40262-023-01275-x$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40262-023-01275-x$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37415003$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Takahashi, Takuto</creatorcontrib><creatorcontrib>Jaber, Mutaz M.</creatorcontrib><creatorcontrib>Brown, Sarah J.</creatorcontrib><creatorcontrib>Al-Kofahi, Mahmoud</creatorcontrib><title>Population Pharmacokinetic Model of Intravenous Busulfan in Hematopoietic Cell Transplantation: Systematic Review and Comparative Simulations</title><title>Clinical pharmacokinetics</title><addtitle>Clin Pharmacokinet</addtitle><addtitle>Clin Pharmacokinet</addtitle><description>Background
Busulfan is commonly used in the chemotherapy prior to hematopoietic cell transplantation (HCT). Busulfan has a narrow therapeutic window and a well-established exposure–response relationship with important clinical outcomes. Model-informed precision dosing (MIPD) based on population pharmacokinetic (popPK) models has been implemented in the clinical settings. We aimed to systematically review existing literature on popPK models of intravenous busulfan.
Methods
We systematically searched Ovid MEDLINE, EMBASE, Cochrane Library, Scopus, and Web of Science databases from inception to December 2022 to identify original popPK models (nonlinear mixed-effect modeling) of intravenous busulfan in HCT population. Model-predicted busulfan clearance (CL) was compared using US population data.
Results
Of the 44 eligible popPK studies published since 2002, 68% were developed predominantly in children, 20% in adults, and 11% in both children and adults. The majority of the models were described using first-order elimination or time-varying CL (69% and 26%, respectively). All but three included a body-size descriptor (e.g., body weight, body surface area). Other commonly included covariates were age (30%) and
GSTA1
variant (15%). Median between-subject and between-occasion variabilities of CL were 20% and 11%, respectively. Between-model variabilities in predicted median CL were < 20% in all of the weight tiers (10–110 kg) in the simulation based on US population data.
Conclusion
Busulfan PK is commonly described using a first-order elimination or time-varying CL. A simple model with limited covariates were generally sufficient to attain relatively small unexplained variabilities. However, therapeutic drug monitoring may still be necessary to attain a narrow target exposure.</description><subject>Administration, Intravenous</subject><subject>Adult</subject><subject>Body Surface Area</subject><subject>Busulfan - pharmacokinetics</subject><subject>Child</subject><subject>Drug Monitoring</subject><subject>Hematopoietic Stem Cell Transplantation</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Systematic Review</subject><issn>0312-5963</issn><issn>1179-1926</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcFu1DAQhi0EokvhBTggH7kExnZsx9xgBbRSERUtZ8vrnYBLYgc7WdqH4J1xdxeOnEaa-ebX_PMT8pzBKwagX5cWuOINcNEA41o2tw_IijFtGma4ekhWIBhvpFHihDwp5QYAOg7wmJwI3TIJIFbk92WalsHNIUV6-d3l0fn0I0Scg6ef0hYHmnp6HufsdhjTUui7pSxD7yINkZ7h6OY0pbDH1zgM9Dq7WKbBxXmv-YZe3ZX5HqvAF9wF_EVd3NJ1GieXa3eH9CqMxwvKU_Kod0PBZ8d6Sr5-eH-9PmsuPn88X7-9aLxo9dz0XBuplZRK9cazbuP7rUeFxgknnfdct6YDoRmi6GTXolatN63abIQSYIQ4JS8PulNOPxcssx1D8fV-F7GatLwTkmtuhK4oP6A-p1Iy9nbKYXT5zjKw9zHYQwy2xmD3MdjbuvTiqL9sRtz-W_n79wqIA1DqKH7DbG_SkmP1_D_ZP35xlpM</recordid><startdate>20230701</startdate><enddate>20230701</enddate><creator>Takahashi, Takuto</creator><creator>Jaber, Mutaz M.</creator><creator>Brown, Sarah J.</creator><creator>Al-Kofahi, Mahmoud</creator><general>Springer International Publishing</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8296-6412</orcidid></search><sort><creationdate>20230701</creationdate><title>Population Pharmacokinetic Model of Intravenous Busulfan in Hematopoietic Cell Transplantation: Systematic Review and Comparative Simulations</title><author>Takahashi, Takuto ; Jaber, Mutaz M. ; Brown, Sarah J. ; Al-Kofahi, Mahmoud</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c347t-f2795765566f9c18bcfdce6e9a3a5acc274980371ee38584e764c946bb3630933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Administration, Intravenous</topic><topic>Adult</topic><topic>Body Surface Area</topic><topic>Busulfan - pharmacokinetics</topic><topic>Child</topic><topic>Drug Monitoring</topic><topic>Hematopoietic Stem Cell Transplantation</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Systematic Review</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Takahashi, Takuto</creatorcontrib><creatorcontrib>Jaber, Mutaz M.</creatorcontrib><creatorcontrib>Brown, Sarah J.</creatorcontrib><creatorcontrib>Al-Kofahi, Mahmoud</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical pharmacokinetics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Takahashi, Takuto</au><au>Jaber, Mutaz M.</au><au>Brown, Sarah J.</au><au>Al-Kofahi, Mahmoud</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Population Pharmacokinetic Model of Intravenous Busulfan in Hematopoietic Cell Transplantation: Systematic Review and Comparative Simulations</atitle><jtitle>Clinical pharmacokinetics</jtitle><stitle>Clin Pharmacokinet</stitle><addtitle>Clin Pharmacokinet</addtitle><date>2023-07-01</date><risdate>2023</risdate><volume>62</volume><issue>7</issue><spage>955</spage><epage>968</epage><pages>955-968</pages><issn>0312-5963</issn><eissn>1179-1926</eissn><abstract>Background
Busulfan is commonly used in the chemotherapy prior to hematopoietic cell transplantation (HCT). Busulfan has a narrow therapeutic window and a well-established exposure–response relationship with important clinical outcomes. Model-informed precision dosing (MIPD) based on population pharmacokinetic (popPK) models has been implemented in the clinical settings. We aimed to systematically review existing literature on popPK models of intravenous busulfan.
Methods
We systematically searched Ovid MEDLINE, EMBASE, Cochrane Library, Scopus, and Web of Science databases from inception to December 2022 to identify original popPK models (nonlinear mixed-effect modeling) of intravenous busulfan in HCT population. Model-predicted busulfan clearance (CL) was compared using US population data.
Results
Of the 44 eligible popPK studies published since 2002, 68% were developed predominantly in children, 20% in adults, and 11% in both children and adults. The majority of the models were described using first-order elimination or time-varying CL (69% and 26%, respectively). All but three included a body-size descriptor (e.g., body weight, body surface area). Other commonly included covariates were age (30%) and
GSTA1
variant (15%). Median between-subject and between-occasion variabilities of CL were 20% and 11%, respectively. Between-model variabilities in predicted median CL were < 20% in all of the weight tiers (10–110 kg) in the simulation based on US population data.
Conclusion
Busulfan PK is commonly described using a first-order elimination or time-varying CL. A simple model with limited covariates were generally sufficient to attain relatively small unexplained variabilities. However, therapeutic drug monitoring may still be necessary to attain a narrow target exposure.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>37415003</pmid><doi>10.1007/s40262-023-01275-x</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0001-8296-6412</orcidid></addata></record> |
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| subjects | Administration, Intravenous Adult Body Surface Area Busulfan - pharmacokinetics Child Drug Monitoring Hematopoietic Stem Cell Transplantation Humans Internal Medicine Medicine Medicine & Public Health Pharmacology/Toxicology Pharmacotherapy Systematic Review |
| title | Population Pharmacokinetic Model of Intravenous Busulfan in Hematopoietic Cell Transplantation: Systematic Review and Comparative Simulations |
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