Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol®-PM) in patients with solid tumors
The aim of this study was to determine the maximum tolerated dose (MTD) and the pharmacokinetic profile of Genexol-PM in Asian cancer patients. Patients (N=24) refractory to previous chemotherapy received Genexol-PM as an 1-h infusion on a weekly basis for 3 weeks followed by a resting week. The sta...
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| Veröffentlicht in: | Annals of oncology 2010-02, Vol.21 (2), p.382-388 |
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| container_title | Annals of oncology |
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| creator | Lim, W.T. Tan, E.H. Toh, C.K. Hee, S.W. Leong, S.S. Ang, P.C.S. Wong, N.S. Chowbay, B. |
| description | The aim of this study was to determine the maximum tolerated dose (MTD) and the pharmacokinetic profile of Genexol-PM in Asian cancer patients.
Patients (N=24) refractory to previous chemotherapy received Genexol-PM as an 1-h infusion on a weekly basis for 3 weeks followed by a resting week. The starting dose was 80 mg/m2 and the maximum administered dose was 200 mg/m2.
The majority of patients had lung, nasopharyngeal and breast cancers and in eleven patients (46%), taxane-based chemotherapy had previously failed. The MTD was defined at 180 mg/m2. The most common grade 3 non-hematologic adverse events in cycle 1 were fatigue (4%) and neuropathy (4%) occurring mainly at 200 mg/m2. Five (21%) patients had partial response, nine (38%) had stable disease and seven (29%) had disease progression. Five of 11 previously taxane-refractory patients showed clinical benefit to Genexol-PM. The pharmacokinetics of Genexol-PM displayed dose-proportionality, with both the maximum concentration (Cmax) and the area under the concentration-time curve from zero to infinity (AUC0–∞) increasing by approximately four- and threefold, respectively, as the dose of Genexol-PM was escalated from 80 to 200 mg/m2. The median total-body clearance of Genexol-PM for all patients was 43.9 l/h.
The weekly regimen of Genexol-PM was well tolerated and responses were observed in patients with refractory tumors, including patients who had failed taxane-based chemotherapy previously. |
| doi_str_mv | 10.1093/annonc/mdp315 |
| format | Article |
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Patients (N=24) refractory to previous chemotherapy received Genexol-PM as an 1-h infusion on a weekly basis for 3 weeks followed by a resting week. The starting dose was 80 mg/m2 and the maximum administered dose was 200 mg/m2.
The majority of patients had lung, nasopharyngeal and breast cancers and in eleven patients (46%), taxane-based chemotherapy had previously failed. The MTD was defined at 180 mg/m2. The most common grade 3 non-hematologic adverse events in cycle 1 were fatigue (4%) and neuropathy (4%) occurring mainly at 200 mg/m2. Five (21%) patients had partial response, nine (38%) had stable disease and seven (29%) had disease progression. Five of 11 previously taxane-refractory patients showed clinical benefit to Genexol-PM. The pharmacokinetics of Genexol-PM displayed dose-proportionality, with both the maximum concentration (Cmax) and the area under the concentration-time curve from zero to infinity (AUC0–∞) increasing by approximately four- and threefold, respectively, as the dose of Genexol-PM was escalated from 80 to 200 mg/m2. The median total-body clearance of Genexol-PM for all patients was 43.9 l/h.
The weekly regimen of Genexol-PM was well tolerated and responses were observed in patients with refractory tumors, including patients who had failed taxane-based chemotherapy previously.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdp315</identifier><identifier>PMID: 19633055</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adult ; Aged ; Antineoplastic agents ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - pharmacokinetics ; Asian ; Biological and medical sciences ; Chemistry, Pharmaceutical ; Drug Administration Schedule ; Female ; Genexol-PM ; Humans ; Liposomes - adverse effects ; Liposomes - pharmacokinetics ; Male ; Maximum Tolerated Dose ; Medical sciences ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Neoplasms - drug therapy ; Neoplasms - metabolism ; Neoplasms - pathology ; Paclitaxel - administration & dosage ; Paclitaxel - adverse effects ; Paclitaxel - pharmacokinetics ; pharmacokinetics ; Pharmacology. Drug treatments ; phase 1 ; Salvage Therapy ; Treatment Outcome ; Tumors ; weekly regime</subject><ispartof>Annals of oncology, 2010-02, Vol.21 (2), p.382-388</ispartof><rights>2009 European Society for Medical Oncology</rights><rights>The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org 2010</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3955-a7527860ad0d82778f523610ed1f4e1cdad425e24b2e708b491dd317b8b7933</citedby><cites>FETCH-LOGICAL-c3955-a7527860ad0d82778f523610ed1f4e1cdad425e24b2e708b491dd317b8b7933</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22536769$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19633055$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lim, W.T.</creatorcontrib><creatorcontrib>Tan, E.H.</creatorcontrib><creatorcontrib>Toh, C.K.</creatorcontrib><creatorcontrib>Hee, S.W.</creatorcontrib><creatorcontrib>Leong, S.S.</creatorcontrib><creatorcontrib>Ang, P.C.S.</creatorcontrib><creatorcontrib>Wong, N.S.</creatorcontrib><creatorcontrib>Chowbay, B.</creatorcontrib><title>Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol®-PM) in patients with solid tumors</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>The aim of this study was to determine the maximum tolerated dose (MTD) and the pharmacokinetic profile of Genexol-PM in Asian cancer patients.
Patients (N=24) refractory to previous chemotherapy received Genexol-PM as an 1-h infusion on a weekly basis for 3 weeks followed by a resting week. The starting dose was 80 mg/m2 and the maximum administered dose was 200 mg/m2.
The majority of patients had lung, nasopharyngeal and breast cancers and in eleven patients (46%), taxane-based chemotherapy had previously failed. The MTD was defined at 180 mg/m2. The most common grade 3 non-hematologic adverse events in cycle 1 were fatigue (4%) and neuropathy (4%) occurring mainly at 200 mg/m2. Five (21%) patients had partial response, nine (38%) had stable disease and seven (29%) had disease progression. Five of 11 previously taxane-refractory patients showed clinical benefit to Genexol-PM. The pharmacokinetics of Genexol-PM displayed dose-proportionality, with both the maximum concentration (Cmax) and the area under the concentration-time curve from zero to infinity (AUC0–∞) increasing by approximately four- and threefold, respectively, as the dose of Genexol-PM was escalated from 80 to 200 mg/m2. The median total-body clearance of Genexol-PM for all patients was 43.9 l/h.
The weekly regimen of Genexol-PM was well tolerated and responses were observed in patients with refractory tumors, including patients who had failed taxane-based chemotherapy previously.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - pharmacokinetics</subject><subject>Asian</subject><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Genexol-PM</subject><subject>Humans</subject><subject>Liposomes - adverse effects</subject><subject>Liposomes - pharmacokinetics</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Neoplasms - drug therapy</subject><subject>Neoplasms - metabolism</subject><subject>Neoplasms - pathology</subject><subject>Paclitaxel - administration & dosage</subject><subject>Paclitaxel - adverse effects</subject><subject>Paclitaxel - pharmacokinetics</subject><subject>pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>phase 1</subject><subject>Salvage Therapy</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>weekly regime</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0UGP1CAUwPHGaNxx9ejVcDGuh7pQSilHHdfZTda4RmOMF0LhNYNDSwW6M_Ol_BB-MmvarCdjOHD55T3yJ8ueEvyKYEHPVd_7Xp93ZqCE3ctWhFUir3FJ7mcrLAqac0bLk-xRjN8xxpUoxMPshIiKUszYKtvfbFUEdIWGrQqd0n5ne0hWo5hGc0S-RQrtAXbuiJwdfPSdcmhQ2tmkDuBQ60M3OpWs79HZBno4ePfrZ37z_iWy_QSThT5FtLdpi6J31qA0dj7Ex9mDVrkIT5b7NPv07uLz-jK__rC5Wr--zjUVjOWKs4LXFVYGm7rgvG5ZQSuCwZC2BKKNMmXBoCibAjium1IQYyjhTd1wQelp9mKeOgT_Y4SYZGejBudUD36MklMqyulUk8xnqYOPMUArh2A7FY6SYPkntJxDyzn05J8tk8emA_NXL2Un8HwBKmrl2qB6beOdKwpGK16JyZ3Nzo_Df3cub7QxweEOq7CTFaecycuv3-R6w99i8fGN_DJ5PnuYAt9aCDLq6Ts0GBtAJ2m8_cem3-5Vusw</recordid><startdate>201002</startdate><enddate>201002</enddate><creator>Lim, W.T.</creator><creator>Tan, E.H.</creator><creator>Toh, C.K.</creator><creator>Hee, S.W.</creator><creator>Leong, S.S.</creator><creator>Ang, P.C.S.</creator><creator>Wong, N.S.</creator><creator>Chowbay, B.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</scope><scope>BSCLL</scope><scope>IQODW</scope><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></search><sort><creationdate>201002</creationdate><title>Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol®-PM) in patients with solid tumors</title><author>Lim, W.T. ; Tan, E.H. ; Toh, C.K. ; Hee, S.W. ; Leong, S.S. ; Ang, P.C.S. ; Wong, N.S. ; Chowbay, B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3955-a7527860ad0d82778f523610ed1f4e1cdad425e24b2e708b491dd317b8b7933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - pharmacokinetics</topic><topic>Asian</topic><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Genexol-PM</topic><topic>Humans</topic><topic>Liposomes - adverse effects</topic><topic>Liposomes - pharmacokinetics</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Neoplasms - drug therapy</topic><topic>Neoplasms - metabolism</topic><topic>Neoplasms - pathology</topic><topic>Paclitaxel - administration & dosage</topic><topic>Paclitaxel - adverse effects</topic><topic>Paclitaxel - pharmacokinetics</topic><topic>pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>phase 1</topic><topic>Salvage Therapy</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>weekly regime</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lim, W.T.</creatorcontrib><creatorcontrib>Tan, E.H.</creatorcontrib><creatorcontrib>Toh, C.K.</creatorcontrib><creatorcontrib>Hee, S.W.</creatorcontrib><creatorcontrib>Leong, S.S.</creatorcontrib><creatorcontrib>Ang, P.C.S.</creatorcontrib><creatorcontrib>Wong, N.S.</creatorcontrib><creatorcontrib>Chowbay, B.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Istex</collection><collection>Pascal-Francis</collection><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>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lim, W.T.</au><au>Tan, E.H.</au><au>Toh, C.K.</au><au>Hee, S.W.</au><au>Leong, S.S.</au><au>Ang, P.C.S.</au><au>Wong, N.S.</au><au>Chowbay, B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol®-PM) in patients with solid tumors</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2010-02</date><risdate>2010</risdate><volume>21</volume><issue>2</issue><spage>382</spage><epage>388</epage><pages>382-388</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>The aim of this study was to determine the maximum tolerated dose (MTD) and the pharmacokinetic profile of Genexol-PM in Asian cancer patients.
Patients (N=24) refractory to previous chemotherapy received Genexol-PM as an 1-h infusion on a weekly basis for 3 weeks followed by a resting week. The starting dose was 80 mg/m2 and the maximum administered dose was 200 mg/m2.
The majority of patients had lung, nasopharyngeal and breast cancers and in eleven patients (46%), taxane-based chemotherapy had previously failed. The MTD was defined at 180 mg/m2. The most common grade 3 non-hematologic adverse events in cycle 1 were fatigue (4%) and neuropathy (4%) occurring mainly at 200 mg/m2. Five (21%) patients had partial response, nine (38%) had stable disease and seven (29%) had disease progression. Five of 11 previously taxane-refractory patients showed clinical benefit to Genexol-PM. The pharmacokinetics of Genexol-PM displayed dose-proportionality, with both the maximum concentration (Cmax) and the area under the concentration-time curve from zero to infinity (AUC0–∞) increasing by approximately four- and threefold, respectively, as the dose of Genexol-PM was escalated from 80 to 200 mg/m2. The median total-body clearance of Genexol-PM for all patients was 43.9 l/h.
The weekly regimen of Genexol-PM was well tolerated and responses were observed in patients with refractory tumors, including patients who had failed taxane-based chemotherapy previously.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>19633055</pmid><doi>10.1093/annonc/mdp315</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0923-7534 |
| ispartof | Annals of oncology, 2010-02, Vol.21 (2), p.382-388 |
| issn | 0923-7534 1569-8041 |
| language | eng |
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| source | MEDLINE; Alma/SFX Local Collection; EZB Electronic Journals Library |
| subjects | Adult Aged Antineoplastic agents Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Antineoplastic Agents - pharmacokinetics Asian Biological and medical sciences Chemistry, Pharmaceutical Drug Administration Schedule Female Genexol-PM Humans Liposomes - adverse effects Liposomes - pharmacokinetics Male Maximum Tolerated Dose Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Neoplasms - drug therapy Neoplasms - metabolism Neoplasms - pathology Paclitaxel - administration & dosage Paclitaxel - adverse effects Paclitaxel - pharmacokinetics pharmacokinetics Pharmacology. Drug treatments phase 1 Salvage Therapy Treatment Outcome Tumors weekly regime |
| title | Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol®-PM) in patients with solid tumors |
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