The effect of different doses of cyclosporin A on the systemic exposure of orally administered paclitaxel
The objective of this study was to define the minimally effective dose of cyclosporin A (CsA) that would result in a maximal increase of the systemic exposure to oral paclitaxel. Six evaluable patients participated in this randomized cross-over study in which they received at two occasions two doses...
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| Veröffentlicht in: | Anti-cancer drugs 2001-04, Vol.12 (4), p.351-358 |
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| creator | Malingré, Mirte M Beijnen, Jos H Rosing, Hilde Koopman, Franciska J van Tellingen, Olaf Duchin, Ken ten Bokkel Huinink, Wim W Swart, Martha Lieverst, Jan Schellens, Jan HM |
| description | The objective of this study was to define the minimally effective dose of cyclosporin A (CsA) that would result in a maximal increase of the systemic exposure to oral paclitaxel. Six evaluable patients participated in this randomized cross-over study in which they received at two occasions two doses of 90 mg/m oral paclitaxel 7 h apart in combination with 10 or 5 mg/kg CsA. Dose reduction of CsA from 10 to 5 mg/kg resulted in a statistically significant decrease in the area under the plasma concentration-time curve (AUC) and time above the threshold concentrations of 0.1 μM (T>0.1 μM) of oral paclitaxel. The mean (±SD) AUC and T>0.1 μM values of oral paclitaxel with CsA 10 mg/kg were 4.29±0.88 μM·h and 12.0±2.1 h, respectively. With CsA 5 mg/kg these values were 2.75±0.63 μM·h and 7.0±2.1 h, respectively (p = 0.028 for both parameters). In conclusion, dose reduction of CsA from 10 to 5 mg/kg resulted in a significant decrease in the AUC and T>0.1 μM values of oral paclitaxel. Because CsA 10 mg/kg resulted in similar paclitaxel AUC and T>0.1 μM values compared to CsA 15 mg/kg (data which we have published previously), the minimally effective dose of CsA is determined at 10 mg/kg. |
| doi_str_mv | 10.1097/00001813-200104000-00008 |
| format | Article |
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Six evaluable patients participated in this randomized cross-over study in which they received at two occasions two doses of 90 mg/m oral paclitaxel 7 h apart in combination with 10 or 5 mg/kg CsA. Dose reduction of CsA from 10 to 5 mg/kg resulted in a statistically significant decrease in the area under the plasma concentration-time curve (AUC) and time above the threshold concentrations of 0.1 μM (T>0.1 μM) of oral paclitaxel. The mean (±SD) AUC and T>0.1 μM values of oral paclitaxel with CsA 10 mg/kg were 4.29±0.88 μM·h and 12.0±2.1 h, respectively. With CsA 5 mg/kg these values were 2.75±0.63 μM·h and 7.0±2.1 h, respectively (p = 0.028 for both parameters). In conclusion, dose reduction of CsA from 10 to 5 mg/kg resulted in a significant decrease in the AUC and T>0.1 μM values of oral paclitaxel. Because CsA 10 mg/kg resulted in similar paclitaxel AUC and T>0.1 μM values compared to CsA 15 mg/kg (data which we have published previously), the minimally effective dose of CsA is determined at 10 mg/kg.</description><identifier>ISSN: 0959-4973</identifier><identifier>EISSN: 1473-5741</identifier><identifier>DOI: 10.1097/00001813-200104000-00008</identifier><identifier>PMID: 11335792</identifier><language>eng</language><publisher>England: Lippincott Williams & Wilkins, Inc</publisher><subject>Adenocarcinoma - drug therapy ; Administration, Oral ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics ; Antineoplastic Combined Chemotherapy Protocols - toxicity ; Area Under Curve ; Breast Neoplasms - drug therapy ; Carcinoma, Small Cell - drug therapy ; Cyclosporine - administration & dosage ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Gastrointestinal Diseases - chemically induced ; Hematologic Diseases - chemically induced ; Humans ; Infusions, Intravenous ; Lung Neoplasms - drug therapy ; Male ; Middle Aged ; Neoplasms - drug therapy ; Neoplasms - pathology ; Paclitaxel - administration & dosage ; Premedication ; Stomach Neoplasms - drug therapy ; Uterine Cervical Neoplasms - drug therapy ; Uterine Neoplasms - drug therapy</subject><ispartof>Anti-cancer drugs, 2001-04, Vol.12 (4), p.351-358</ispartof><rights>2001 Lippincott Williams & Wilkins, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3568-e4d1bdecfc039f681fb3531ea84e0838552746d0498afc6121c32d156068ce3f3</citedby><cites>FETCH-LOGICAL-c3568-e4d1bdecfc039f681fb3531ea84e0838552746d0498afc6121c32d156068ce3f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27922,27923</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11335792$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Malingré, Mirte M</creatorcontrib><creatorcontrib>Beijnen, Jos H</creatorcontrib><creatorcontrib>Rosing, Hilde</creatorcontrib><creatorcontrib>Koopman, Franciska J</creatorcontrib><creatorcontrib>van Tellingen, Olaf</creatorcontrib><creatorcontrib>Duchin, Ken</creatorcontrib><creatorcontrib>ten Bokkel Huinink, Wim W</creatorcontrib><creatorcontrib>Swart, Martha</creatorcontrib><creatorcontrib>Lieverst, Jan</creatorcontrib><creatorcontrib>Schellens, Jan HM</creatorcontrib><title>The effect of different doses of cyclosporin A on the systemic exposure of orally administered paclitaxel</title><title>Anti-cancer drugs</title><addtitle>Anticancer Drugs</addtitle><description>The objective of this study was to define the minimally effective dose of cyclosporin A (CsA) that would result in a maximal increase of the systemic exposure to oral paclitaxel. Six evaluable patients participated in this randomized cross-over study in which they received at two occasions two doses of 90 mg/m oral paclitaxel 7 h apart in combination with 10 or 5 mg/kg CsA. Dose reduction of CsA from 10 to 5 mg/kg resulted in a statistically significant decrease in the area under the plasma concentration-time curve (AUC) and time above the threshold concentrations of 0.1 μM (T>0.1 μM) of oral paclitaxel. The mean (±SD) AUC and T>0.1 μM values of oral paclitaxel with CsA 10 mg/kg were 4.29±0.88 μM·h and 12.0±2.1 h, respectively. With CsA 5 mg/kg these values were 2.75±0.63 μM·h and 7.0±2.1 h, respectively (p = 0.028 for both parameters). In conclusion, dose reduction of CsA from 10 to 5 mg/kg resulted in a significant decrease in the AUC and T>0.1 μM values of oral paclitaxel. Because CsA 10 mg/kg resulted in similar paclitaxel AUC and T>0.1 μM values compared to CsA 15 mg/kg (data which we have published previously), the minimally effective dose of CsA is determined at 10 mg/kg.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Administration, Oral</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics</subject><subject>Antineoplastic Combined Chemotherapy Protocols - toxicity</subject><subject>Area Under Curve</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Carcinoma, Small Cell - drug therapy</subject><subject>Cyclosporine - administration & dosage</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Gastrointestinal Diseases - chemically induced</subject><subject>Hematologic Diseases - chemically induced</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasms - drug therapy</subject><subject>Neoplasms - pathology</subject><subject>Paclitaxel - administration & dosage</subject><subject>Premedication</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Uterine Cervical Neoplasms - drug therapy</subject><subject>Uterine Neoplasms - drug therapy</subject><issn>0959-4973</issn><issn>1473-5741</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1UctOwzAQtBCIlsIvIP9AwI6dxDlWFS-pEpdyjlx7rRqcOLJTtfl7HMrjxF52d3ZmpZ1FCFNyR0ld3ZMUVFCW5SkTnrpsgsQZmlNesayoOD1Hc1IXdcbris3QVYzviZFwdolmlDJWVHU-R3azAwzGgBqwN1jbVAboBqx9hDhBalTOx94H2-El9h0ekiKOcYDWKgzH3sd9gInpg3RuxFK3trNpHkDjXipnB3kEd40ujHQRbr7zAr09PmxWz9n69elltVxnihWlyIBrutWgjCKsNqWgZssKRkEKDkQwURR5xUtNeC2kUSXNqWK5pkVJSqGAGbZA4rRXBR9jANP0wbYyjA0lzeRe8-Ne8-veFySS9PYk7ffbFvSf8NuuROAnwsG7dF_8cPsDhGYH0g275r-vsE9dhHsQ</recordid><startdate>200104</startdate><enddate>200104</enddate><creator>Malingré, Mirte M</creator><creator>Beijnen, Jos H</creator><creator>Rosing, Hilde</creator><creator>Koopman, Franciska J</creator><creator>van Tellingen, Olaf</creator><creator>Duchin, Ken</creator><creator>ten Bokkel Huinink, Wim W</creator><creator>Swart, Martha</creator><creator>Lieverst, Jan</creator><creator>Schellens, Jan HM</creator><general>Lippincott Williams & Wilkins, Inc</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></search><sort><creationdate>200104</creationdate><title>The effect of different doses of cyclosporin A on the systemic exposure of orally administered paclitaxel</title><author>Malingré, Mirte M ; Beijnen, Jos H ; Rosing, Hilde ; Koopman, Franciska J ; van Tellingen, Olaf ; Duchin, Ken ; ten Bokkel Huinink, Wim W ; Swart, Martha ; Lieverst, Jan ; Schellens, Jan HM</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3568-e4d1bdecfc039f681fb3531ea84e0838552746d0498afc6121c32d156068ce3f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Administration, Oral</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics</topic><topic>Antineoplastic Combined Chemotherapy Protocols - toxicity</topic><topic>Area Under Curve</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Carcinoma, Small Cell - drug therapy</topic><topic>Cyclosporine - administration & dosage</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Gastrointestinal Diseases - chemically induced</topic><topic>Hematologic Diseases - chemically induced</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasms - drug therapy</topic><topic>Neoplasms - pathology</topic><topic>Paclitaxel - administration & dosage</topic><topic>Premedication</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Uterine Cervical Neoplasms - drug therapy</topic><topic>Uterine Neoplasms - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Malingré, Mirte M</creatorcontrib><creatorcontrib>Beijnen, Jos H</creatorcontrib><creatorcontrib>Rosing, Hilde</creatorcontrib><creatorcontrib>Koopman, Franciska J</creatorcontrib><creatorcontrib>van Tellingen, Olaf</creatorcontrib><creatorcontrib>Duchin, Ken</creatorcontrib><creatorcontrib>ten Bokkel Huinink, Wim W</creatorcontrib><creatorcontrib>Swart, Martha</creatorcontrib><creatorcontrib>Lieverst, Jan</creatorcontrib><creatorcontrib>Schellens, Jan HM</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Anti-cancer drugs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Malingré, Mirte M</au><au>Beijnen, Jos H</au><au>Rosing, Hilde</au><au>Koopman, Franciska J</au><au>van Tellingen, Olaf</au><au>Duchin, Ken</au><au>ten Bokkel Huinink, Wim W</au><au>Swart, Martha</au><au>Lieverst, Jan</au><au>Schellens, Jan HM</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The effect of different doses of cyclosporin A on the systemic exposure of orally administered paclitaxel</atitle><jtitle>Anti-cancer drugs</jtitle><addtitle>Anticancer Drugs</addtitle><date>2001-04</date><risdate>2001</risdate><volume>12</volume><issue>4</issue><spage>351</spage><epage>358</epage><pages>351-358</pages><issn>0959-4973</issn><eissn>1473-5741</eissn><abstract>The objective of this study was to define the minimally effective dose of cyclosporin A (CsA) that would result in a maximal increase of the systemic exposure to oral paclitaxel. Six evaluable patients participated in this randomized cross-over study in which they received at two occasions two doses of 90 mg/m oral paclitaxel 7 h apart in combination with 10 or 5 mg/kg CsA. Dose reduction of CsA from 10 to 5 mg/kg resulted in a statistically significant decrease in the area under the plasma concentration-time curve (AUC) and time above the threshold concentrations of 0.1 μM (T>0.1 μM) of oral paclitaxel. The mean (±SD) AUC and T>0.1 μM values of oral paclitaxel with CsA 10 mg/kg were 4.29±0.88 μM·h and 12.0±2.1 h, respectively. With CsA 5 mg/kg these values were 2.75±0.63 μM·h and 7.0±2.1 h, respectively (p = 0.028 for both parameters). In conclusion, dose reduction of CsA from 10 to 5 mg/kg resulted in a significant decrease in the AUC and T>0.1 μM values of oral paclitaxel. Because CsA 10 mg/kg resulted in similar paclitaxel AUC and T>0.1 μM values compared to CsA 15 mg/kg (data which we have published previously), the minimally effective dose of CsA is determined at 10 mg/kg.</abstract><cop>England</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>11335792</pmid><doi>10.1097/00001813-200104000-00008</doi><tpages>8</tpages></addata></record> |
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| subjects | Adenocarcinoma - drug therapy Administration, Oral Adult Aged Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics Antineoplastic Combined Chemotherapy Protocols - toxicity Area Under Curve Breast Neoplasms - drug therapy Carcinoma, Small Cell - drug therapy Cyclosporine - administration & dosage Dose-Response Relationship, Drug Drug Administration Schedule Female Gastrointestinal Diseases - chemically induced Hematologic Diseases - chemically induced Humans Infusions, Intravenous Lung Neoplasms - drug therapy Male Middle Aged Neoplasms - drug therapy Neoplasms - pathology Paclitaxel - administration & dosage Premedication Stomach Neoplasms - drug therapy Uterine Cervical Neoplasms - drug therapy Uterine Neoplasms - drug therapy |
| title | The effect of different doses of cyclosporin A on the systemic exposure of orally administered paclitaxel |
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