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Association of creatine kinase and skin toxicity in phase I trials of anticancer agents
Background: We investigated the association between skin rash and plasma creatine kinase (CK) levels in oncology phase I trials. Methods: We analysed data from 295 patients treated at our institution within 25 phase I trials which included CK measurements in the protocol. Trials involved drugs targe...
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| Published in: | British journal of cancer 2012-11, Vol.107 (11), p.1797-1800 |
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| Main Authors: | , , , , , , , , , , , |
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| container_end_page | 1800 |
| container_issue | 11 |
| container_start_page | 1797 |
| container_title | British journal of cancer |
| container_volume | 107 |
| creator | Moreno Garcia, V Thavasu, P Blanco Codesido, M Molife, L R Vitfell Pedersen, J Puglisi, M Basu, B Shah, K Iqbal, J de Bono, J S Kaye, S B Banerji, U |
| description | Background:
We investigated the association between skin rash and plasma creatine kinase (CK) levels in oncology phase I trials.
Methods:
We analysed data from 295 patients treated at our institution within 25 phase I trials which included CK measurements in the protocol. Trials involved drugs targeting EGFR/HER2, m-TOR, VEGFR, SRC/ABL, aurora kinase, BRAF/MEK, PARP, CDK, A5B1 integrin, as well as oncolytic viruses and vascular disrupting agents.
Results:
Creatine kinase measurements were available for 278 patients. The highest levels of plasma CK during the trial were seen among patients with Grade (G) 2/3 rash (median 249 U l
−1
) compared with G1 (median 81 U l
−1
) and no rash (median 55 U l
−1
) (
P |
| doi_str_mv | 10.1038/bjc.2012.482 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3504946</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1492634247</sourcerecordid><originalsourceid>FETCH-LOGICAL-c579t-9d69aa5db5c5bdecddea63e4730e59e3cfbec4495622786267e4c0f77e9c77c13</originalsourceid><addsrcrecordid>eNptkc1rFDEYxoNY7Lp68ywBETw4a74zuRRK8aNQ6EXxGDKZd7ZZZ5M1mRX735th19pKT3nD83s_H4ReUbKihLcfuo1fMULZSrTsCVpQyVlDW6afogUhRDfEMHKKnpeyqV9DWv0MnTJOjGkJW6Dv56UkH9wUUsRpwD5DjSPgHyG6AtjFHpca4yn9Dj5Mt7jGu5tZusRTDm4sc5qLU_AuesjYrSFO5QU6GaoGL4_vEn379PHrxZfm6vrz5cX5VeOlNlNjemWck30nvex68H0PTnEQmhOQBrgfOvBCGKkY061iSoPwZNAajNfaU75EZ4e6u323hd7X3tmNdpfD1uVbm1ywD5UYbuw6_bJcEmGEqgXeHQvk9HMPZbLbUDyMo4uQ9sVSYZjigtWRlujNf-gm7XOs61lKddvOx52p9wfK51RKhuFuGErs7JitjtnZMVsdq_jr-wvcwX8tqsDbI-CKd-OQ65lD-ccpxYQ0pnLNgStVimvI96Z7rPEfY5-ugg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1178890877</pqid></control><display><type>article</type><title>Association of creatine kinase and skin toxicity in phase I trials of anticancer agents</title><source>PubMed</source><creator>Moreno Garcia, V ; Thavasu, P ; Blanco Codesido, M ; Molife, L R ; Vitfell Pedersen, J ; Puglisi, M ; Basu, B ; Shah, K ; Iqbal, J ; de Bono, J S ; Kaye, S B ; Banerji, U</creator><creatorcontrib>Moreno Garcia, V ; Thavasu, P ; Blanco Codesido, M ; Molife, L R ; Vitfell Pedersen, J ; Puglisi, M ; Basu, B ; Shah, K ; Iqbal, J ; de Bono, J S ; Kaye, S B ; Banerji, U</creatorcontrib><description>Background:
We investigated the association between skin rash and plasma creatine kinase (CK) levels in oncology phase I trials.
Methods:
We analysed data from 295 patients treated at our institution within 25 phase I trials which included CK measurements in the protocol. Trials involved drugs targeting EGFR/HER2, m-TOR, VEGFR, SRC/ABL, aurora kinase, BRAF/MEK, PARP, CDK, A5B1 integrin, as well as oncolytic viruses and vascular disrupting agents.
Results:
Creatine kinase measurements were available for 278 patients. The highest levels of plasma CK during the trial were seen among patients with Grade (G) 2/3 rash (median 249 U l
−1
) compared with G1 (median 81 U l
−1
) and no rash (median 55 U l
−1
) (
P
<0.001). There was a significant reduction in CK after the rash resolved (mean 264.2
vs
100.1;
P
=0.012) in 25 patients, where serial CK values were available.
In vitro
exposure of human keratinocytes to EGFR, MEK and a PI3Kinase/m-TOR inhibitor led to the increased expression of CK-brain and not CK-muscle or mitochondrial-CK.
Conclusion:
Plasma CK elevation is associated with development of skin rash caused by novel anticancer agents. This should be studied further to characterise different isoforms as this will change the way we report adverse events in oncology phase I clinical trials.</description><identifier>ISSN: 0007-0920</identifier><identifier>EISSN: 1532-1827</identifier><identifier>DOI: 10.1038/bjc.2012.482</identifier><identifier>PMID: 23099802</identifier><identifier>CODEN: BJCAAI</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>631/45/607/1172 ; 692/1807/1812 ; 692/308/2779/109/1940 ; 692/699/67/1059 ; Antineoplastic Agents - adverse effects ; Antitumor agents ; Biological and medical sciences ; Biomedical and Life Sciences ; Biomedicine ; Brain research ; Cancer Research ; Clinical Study ; Clinical trials ; Clinical Trials, Phase I as Topic ; Creatine Kinase - blood ; Dermatology ; Drug Resistance ; Epidemiology ; Exanthema - blood ; Exanthema - chemically induced ; Humans ; Keratinocytes - enzymology ; Medical research ; Medical sciences ; Molecular Medicine ; Oncology ; Plasma ; Retrospective Studies ; Skin involvement in other diseases. Miscellaneous. General aspects ; Toxicity ; Tumors</subject><ispartof>British journal of cancer, 2012-11, Vol.107 (11), p.1797-1800</ispartof><rights>The Author(s) 2012</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Nature Publishing Group Nov 20, 2012</rights><rights>Copyright © 2012 Cancer Research UK 2012 Cancer Research UK</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c579t-9d69aa5db5c5bdecddea63e4730e59e3cfbec4495622786267e4c0f77e9c77c13</citedby><cites>FETCH-LOGICAL-c579t-9d69aa5db5c5bdecddea63e4730e59e3cfbec4495622786267e4c0f77e9c77c13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3504946/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3504946/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27922,27923,53789,53791</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26624599$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23099802$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Moreno Garcia, V</creatorcontrib><creatorcontrib>Thavasu, P</creatorcontrib><creatorcontrib>Blanco Codesido, M</creatorcontrib><creatorcontrib>Molife, L R</creatorcontrib><creatorcontrib>Vitfell Pedersen, J</creatorcontrib><creatorcontrib>Puglisi, M</creatorcontrib><creatorcontrib>Basu, B</creatorcontrib><creatorcontrib>Shah, K</creatorcontrib><creatorcontrib>Iqbal, J</creatorcontrib><creatorcontrib>de Bono, J S</creatorcontrib><creatorcontrib>Kaye, S B</creatorcontrib><creatorcontrib>Banerji, U</creatorcontrib><title>Association of creatine kinase and skin toxicity in phase I trials of anticancer agents</title><title>British journal of cancer</title><addtitle>Br J Cancer</addtitle><addtitle>Br J Cancer</addtitle><description>Background:
We investigated the association between skin rash and plasma creatine kinase (CK) levels in oncology phase I trials.
Methods:
We analysed data from 295 patients treated at our institution within 25 phase I trials which included CK measurements in the protocol. Trials involved drugs targeting EGFR/HER2, m-TOR, VEGFR, SRC/ABL, aurora kinase, BRAF/MEK, PARP, CDK, A5B1 integrin, as well as oncolytic viruses and vascular disrupting agents.
Results:
Creatine kinase measurements were available for 278 patients. The highest levels of plasma CK during the trial were seen among patients with Grade (G) 2/3 rash (median 249 U l
−1
) compared with G1 (median 81 U l
−1
) and no rash (median 55 U l
−1
) (
P
<0.001). There was a significant reduction in CK after the rash resolved (mean 264.2
vs
100.1;
P
=0.012) in 25 patients, where serial CK values were available.
In vitro
exposure of human keratinocytes to EGFR, MEK and a PI3Kinase/m-TOR inhibitor led to the increased expression of CK-brain and not CK-muscle or mitochondrial-CK.
Conclusion:
Plasma CK elevation is associated with development of skin rash caused by novel anticancer agents. This should be studied further to characterise different isoforms as this will change the way we report adverse events in oncology phase I clinical trials.</description><subject>631/45/607/1172</subject><subject>692/1807/1812</subject><subject>692/308/2779/109/1940</subject><subject>692/699/67/1059</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antitumor agents</subject><subject>Biological and medical sciences</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Brain research</subject><subject>Cancer Research</subject><subject>Clinical Study</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase I as Topic</subject><subject>Creatine Kinase - blood</subject><subject>Dermatology</subject><subject>Drug Resistance</subject><subject>Epidemiology</subject><subject>Exanthema - blood</subject><subject>Exanthema - chemically induced</subject><subject>Humans</subject><subject>Keratinocytes - enzymology</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Molecular Medicine</subject><subject>Oncology</subject><subject>Plasma</subject><subject>Retrospective Studies</subject><subject>Skin involvement in other diseases. Miscellaneous. General aspects</subject><subject>Toxicity</subject><subject>Tumors</subject><issn>0007-0920</issn><issn>1532-1827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><recordid>eNptkc1rFDEYxoNY7Lp68ywBETw4a74zuRRK8aNQ6EXxGDKZd7ZZZ5M1mRX735th19pKT3nD83s_H4ReUbKihLcfuo1fMULZSrTsCVpQyVlDW6afogUhRDfEMHKKnpeyqV9DWv0MnTJOjGkJW6Dv56UkH9wUUsRpwD5DjSPgHyG6AtjFHpca4yn9Dj5Mt7jGu5tZusRTDm4sc5qLU_AuesjYrSFO5QU6GaoGL4_vEn379PHrxZfm6vrz5cX5VeOlNlNjemWck30nvex68H0PTnEQmhOQBrgfOvBCGKkY061iSoPwZNAajNfaU75EZ4e6u323hd7X3tmNdpfD1uVbm1ywD5UYbuw6_bJcEmGEqgXeHQvk9HMPZbLbUDyMo4uQ9sVSYZjigtWRlujNf-gm7XOs61lKddvOx52p9wfK51RKhuFuGErs7JitjtnZMVsdq_jr-wvcwX8tqsDbI-CKd-OQ65lD-ccpxYQ0pnLNgStVimvI96Z7rPEfY5-ugg</recordid><startdate>20121120</startdate><enddate>20121120</enddate><creator>Moreno Garcia, V</creator><creator>Thavasu, P</creator><creator>Blanco Codesido, M</creator><creator>Molife, L R</creator><creator>Vitfell Pedersen, J</creator><creator>Puglisi, M</creator><creator>Basu, B</creator><creator>Shah, K</creator><creator>Iqbal, J</creator><creator>de Bono, J S</creator><creator>Kaye, S B</creator><creator>Banerji, U</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>C6C</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>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7QO</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>20121120</creationdate><title>Association of creatine kinase and skin toxicity in phase I trials of anticancer agents</title><author>Moreno Garcia, V ; Thavasu, P ; Blanco Codesido, M ; Molife, L R ; Vitfell Pedersen, J ; Puglisi, M ; Basu, B ; Shah, K ; Iqbal, J ; de Bono, J S ; Kaye, S B ; Banerji, U</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c579t-9d69aa5db5c5bdecddea63e4730e59e3cfbec4495622786267e4c0f77e9c77c13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>631/45/607/1172</topic><topic>692/1807/1812</topic><topic>692/308/2779/109/1940</topic><topic>692/699/67/1059</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antitumor agents</topic><topic>Biological and medical sciences</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Brain research</topic><topic>Cancer Research</topic><topic>Clinical Study</topic><topic>Clinical trials</topic><topic>Clinical Trials, Phase I as Topic</topic><topic>Creatine Kinase - blood</topic><topic>Dermatology</topic><topic>Drug Resistance</topic><topic>Epidemiology</topic><topic>Exanthema - blood</topic><topic>Exanthema - chemically induced</topic><topic>Humans</topic><topic>Keratinocytes - enzymology</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Molecular Medicine</topic><topic>Oncology</topic><topic>Plasma</topic><topic>Retrospective Studies</topic><topic>Skin involvement in other diseases. Miscellaneous. General aspects</topic><topic>Toxicity</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Moreno Garcia, V</creatorcontrib><creatorcontrib>Thavasu, P</creatorcontrib><creatorcontrib>Blanco Codesido, M</creatorcontrib><creatorcontrib>Molife, L R</creatorcontrib><creatorcontrib>Vitfell Pedersen, J</creatorcontrib><creatorcontrib>Puglisi, M</creatorcontrib><creatorcontrib>Basu, B</creatorcontrib><creatorcontrib>Shah, K</creatorcontrib><creatorcontrib>Iqbal, J</creatorcontrib><creatorcontrib>de Bono, J S</creatorcontrib><creatorcontrib>Kaye, S B</creatorcontrib><creatorcontrib>Banerji, U</creatorcontrib><collection>SpringerOpen (Open Access)</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>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>ProQuest - Health & Medical Complete保健、医学与药学数据库</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection (Proquest) (PQ_SDU_P3)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Biotechnology Research Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Moreno Garcia, V</au><au>Thavasu, P</au><au>Blanco Codesido, M</au><au>Molife, L R</au><au>Vitfell Pedersen, J</au><au>Puglisi, M</au><au>Basu, B</au><au>Shah, K</au><au>Iqbal, J</au><au>de Bono, J S</au><au>Kaye, S B</au><au>Banerji, U</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Association of creatine kinase and skin toxicity in phase I trials of anticancer agents</atitle><jtitle>British journal of cancer</jtitle><stitle>Br J Cancer</stitle><addtitle>Br J Cancer</addtitle><date>2012-11-20</date><risdate>2012</risdate><volume>107</volume><issue>11</issue><spage>1797</spage><epage>1800</epage><pages>1797-1800</pages><issn>0007-0920</issn><eissn>1532-1827</eissn><coden>BJCAAI</coden><abstract>Background:
We investigated the association between skin rash and plasma creatine kinase (CK) levels in oncology phase I trials.
Methods:
We analysed data from 295 patients treated at our institution within 25 phase I trials which included CK measurements in the protocol. Trials involved drugs targeting EGFR/HER2, m-TOR, VEGFR, SRC/ABL, aurora kinase, BRAF/MEK, PARP, CDK, A5B1 integrin, as well as oncolytic viruses and vascular disrupting agents.
Results:
Creatine kinase measurements were available for 278 patients. The highest levels of plasma CK during the trial were seen among patients with Grade (G) 2/3 rash (median 249 U l
−1
) compared with G1 (median 81 U l
−1
) and no rash (median 55 U l
−1
) (
P
<0.001). There was a significant reduction in CK after the rash resolved (mean 264.2
vs
100.1;
P
=0.012) in 25 patients, where serial CK values were available.
In vitro
exposure of human keratinocytes to EGFR, MEK and a PI3Kinase/m-TOR inhibitor led to the increased expression of CK-brain and not CK-muscle or mitochondrial-CK.
Conclusion:
Plasma CK elevation is associated with development of skin rash caused by novel anticancer agents. This should be studied further to characterise different isoforms as this will change the way we report adverse events in oncology phase I clinical trials.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>23099802</pmid><doi>10.1038/bjc.2012.482</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0007-0920 |
| ispartof | British journal of cancer, 2012-11, Vol.107 (11), p.1797-1800 |
| issn | 0007-0920 1532-1827 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3504946 |
| source | PubMed |
| subjects | 631/45/607/1172 692/1807/1812 692/308/2779/109/1940 692/699/67/1059 Antineoplastic Agents - adverse effects Antitumor agents Biological and medical sciences Biomedical and Life Sciences Biomedicine Brain research Cancer Research Clinical Study Clinical trials Clinical Trials, Phase I as Topic Creatine Kinase - blood Dermatology Drug Resistance Epidemiology Exanthema - blood Exanthema - chemically induced Humans Keratinocytes - enzymology Medical research Medical sciences Molecular Medicine Oncology Plasma Retrospective Studies Skin involvement in other diseases. Miscellaneous. General aspects Toxicity Tumors |
| title | Association of creatine kinase and skin toxicity in phase I trials of anticancer agents |
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