Trends in the Use and Role of Biomarkers in Phase I Oncology Trials
Purpose: There has been interest in using biomarkers that aid the evaluation of new anticancer agents. We evaluated trends in the use of biomarkers and their contribution to the main goals of phase I trials. Experimental Design: We did a systematic review of abstracts submitted to the American Socie...
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| Veröffentlicht in: | Clinical cancer research 2007-11, Vol.13 (22), p.6719-6726 |
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| container_title | Clinical cancer research |
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| creator | Goulart, Bernardo H L Clark, Jeffrey W Pien, Homer H Roberts, Thomas G Finkelstein, Stan N Chabner, Bruce A |
| description | Purpose: There has been interest in using biomarkers that aid the evaluation of new anticancer agents. We evaluated trends in the
use of biomarkers and their contribution to the main goals of phase I trials.
Experimental Design: We did a systematic review of abstracts submitted to the American Society of Clinical Oncology annual meeting from 1991 to
2002 and the publications related to these abstracts. We analyzed the use of biomarkers and their contribution to published
phase I trials.
Results: Twenty percent of American Society of Clinical Oncology phase I abstracts (503 of 2458) from 1991 to 2002 included biomarkers.
This proportion increased over time (14% in 1991 compared with 26% in 2002; P < 0.02). Independent predictors of the use of biomarkers included National Cancer Institute sponsorship, submission in the
time period of 1999 to 2002, adult population, and drug family (biological agents). Biomarkers supported dose selection for
phase II studies in 11 of 87 of the trials (13%) emanating from these abstracts. However, the primary determinants of phase
II dose and schedule were toxicity and/or efficacy in all but one of these 87 trials (1%). Biomarker studies provided evidence
supporting the proposed mechanism of action in 34 of 87 of the published trials (39%).
Conclusions: The use of biomarkers in phase I trials has increased over the period from 1991 to 2002. To date, biomarker utilization has
made a limited and primarily supportive contribution to dose selection, the primary end point of phase I studies. Additional
studies are needed to determine what type of biomarker information is most valuable to evaluate in phase I trials. |
| doi_str_mv | 10.1158/1078-0432.CCR-06-2860 |
| format | Article |
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use of biomarkers and their contribution to the main goals of phase I trials.
Experimental Design: We did a systematic review of abstracts submitted to the American Society of Clinical Oncology annual meeting from 1991 to
2002 and the publications related to these abstracts. We analyzed the use of biomarkers and their contribution to published
phase I trials.
Results: Twenty percent of American Society of Clinical Oncology phase I abstracts (503 of 2458) from 1991 to 2002 included biomarkers.
This proportion increased over time (14% in 1991 compared with 26% in 2002; P < 0.02). Independent predictors of the use of biomarkers included National Cancer Institute sponsorship, submission in the
time period of 1999 to 2002, adult population, and drug family (biological agents). Biomarkers supported dose selection for
phase II studies in 11 of 87 of the trials (13%) emanating from these abstracts. However, the primary determinants of phase
II dose and schedule were toxicity and/or efficacy in all but one of these 87 trials (1%). Biomarker studies provided evidence
supporting the proposed mechanism of action in 34 of 87 of the published trials (39%).
Conclusions: The use of biomarkers in phase I trials has increased over the period from 1991 to 2002. To date, biomarker utilization has
made a limited and primarily supportive contribution to dose selection, the primary end point of phase I studies. Additional
studies are needed to determine what type of biomarker information is most valuable to evaluate in phase I trials.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.CCR-06-2860</identifier><identifier>PMID: 18006773</identifier><language>eng</language><publisher>United States: American Association for Cancer Research</publisher><subject>biomarkers ; Biomarkers, Tumor - analysis ; Biomarkers, Tumor - metabolism ; cancer ; clinical trials ; Clinical Trials, Phase I as Topic ; end points ; Humans ; Neoplasms - drug therapy ; phase I</subject><ispartof>Clinical cancer research, 2007-11, Vol.13 (22), p.6719-6726</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c485t-36b73f6c1fa399d1573f55876a52b9dc3804158831e042a7e158323925f42a083</citedby><cites>FETCH-LOGICAL-c485t-36b73f6c1fa399d1573f55876a52b9dc3804158831e042a7e158323925f42a083</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3342,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18006773$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Goulart, Bernardo H L</creatorcontrib><creatorcontrib>Clark, Jeffrey W</creatorcontrib><creatorcontrib>Pien, Homer H</creatorcontrib><creatorcontrib>Roberts, Thomas G</creatorcontrib><creatorcontrib>Finkelstein, Stan N</creatorcontrib><creatorcontrib>Chabner, Bruce A</creatorcontrib><title>Trends in the Use and Role of Biomarkers in Phase I Oncology Trials</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>Purpose: There has been interest in using biomarkers that aid the evaluation of new anticancer agents. We evaluated trends in the
use of biomarkers and their contribution to the main goals of phase I trials.
Experimental Design: We did a systematic review of abstracts submitted to the American Society of Clinical Oncology annual meeting from 1991 to
2002 and the publications related to these abstracts. We analyzed the use of biomarkers and their contribution to published
phase I trials.
Results: Twenty percent of American Society of Clinical Oncology phase I abstracts (503 of 2458) from 1991 to 2002 included biomarkers.
This proportion increased over time (14% in 1991 compared with 26% in 2002; P < 0.02). Independent predictors of the use of biomarkers included National Cancer Institute sponsorship, submission in the
time period of 1999 to 2002, adult population, and drug family (biological agents). Biomarkers supported dose selection for
phase II studies in 11 of 87 of the trials (13%) emanating from these abstracts. However, the primary determinants of phase
II dose and schedule were toxicity and/or efficacy in all but one of these 87 trials (1%). Biomarker studies provided evidence
supporting the proposed mechanism of action in 34 of 87 of the published trials (39%).
Conclusions: The use of biomarkers in phase I trials has increased over the period from 1991 to 2002. To date, biomarker utilization has
made a limited and primarily supportive contribution to dose selection, the primary end point of phase I studies. Additional
studies are needed to determine what type of biomarker information is most valuable to evaluate in phase I trials.</description><subject>biomarkers</subject><subject>Biomarkers, Tumor - analysis</subject><subject>Biomarkers, Tumor - metabolism</subject><subject>cancer</subject><subject>clinical trials</subject><subject>Clinical Trials, Phase I as Topic</subject><subject>end points</subject><subject>Humans</subject><subject>Neoplasms - drug therapy</subject><subject>phase I</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkF1LwzAUhoMobk5_gpIrwYtqvpteavFjMJiM7Tpk6ela7dqZbMj-vambeHXOS55zwnkQuqbknlKpHyhJdUIEZ_d5PkuISphW5AQNqZRpwpmSp7H_YwboIoQPQqigRJyjAdWEqDTlQ5TPPbRFwHWLtxXgRQBs2wLPugZwV-Knultb_wn-l3ivbHwf42nruqZb7fHc17YJl-isjAWujnWEFi_P8_wtmUxfx_njJHFCy23C1TLlpXK0tDzLCipjklKnykq2zArHNRHxMs0pEMFsCjFwxjMmyxiJ5iN0e9i78d3XDsLWrOvgoGlsC90uGEaZEEqoCMoD6HwXgofSbHwd79gbSkxvz_RmTG_GRHuGKNPbi3M3xw92yzUU_1NHXRG4OwBVvaq-aw_G2daB9xDAelcZyg1jRqU04z9DH3Xf</recordid><startdate>20071115</startdate><enddate>20071115</enddate><creator>Goulart, Bernardo H L</creator><creator>Clark, Jeffrey W</creator><creator>Pien, Homer H</creator><creator>Roberts, Thomas G</creator><creator>Finkelstein, Stan N</creator><creator>Chabner, Bruce A</creator><general>American Association for Cancer Research</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>7U7</scope><scope>C1K</scope></search><sort><creationdate>20071115</creationdate><title>Trends in the Use and Role of Biomarkers in Phase I Oncology Trials</title><author>Goulart, Bernardo H L ; Clark, Jeffrey W ; Pien, Homer H ; Roberts, Thomas G ; Finkelstein, Stan N ; Chabner, Bruce A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c485t-36b73f6c1fa399d1573f55876a52b9dc3804158831e042a7e158323925f42a083</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>biomarkers</topic><topic>Biomarkers, Tumor - analysis</topic><topic>Biomarkers, Tumor - metabolism</topic><topic>cancer</topic><topic>clinical trials</topic><topic>Clinical Trials, Phase I as Topic</topic><topic>end points</topic><topic>Humans</topic><topic>Neoplasms - drug therapy</topic><topic>phase I</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Goulart, Bernardo H L</creatorcontrib><creatorcontrib>Clark, Jeffrey W</creatorcontrib><creatorcontrib>Pien, Homer H</creatorcontrib><creatorcontrib>Roberts, Thomas G</creatorcontrib><creatorcontrib>Finkelstein, Stan N</creatorcontrib><creatorcontrib>Chabner, Bruce A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Goulart, Bernardo H L</au><au>Clark, Jeffrey W</au><au>Pien, Homer H</au><au>Roberts, Thomas G</au><au>Finkelstein, Stan N</au><au>Chabner, Bruce A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Trends in the Use and Role of Biomarkers in Phase I Oncology Trials</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2007-11-15</date><risdate>2007</risdate><volume>13</volume><issue>22</issue><spage>6719</spage><epage>6726</epage><pages>6719-6726</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>Purpose: There has been interest in using biomarkers that aid the evaluation of new anticancer agents. We evaluated trends in the
use of biomarkers and their contribution to the main goals of phase I trials.
Experimental Design: We did a systematic review of abstracts submitted to the American Society of Clinical Oncology annual meeting from 1991 to
2002 and the publications related to these abstracts. We analyzed the use of biomarkers and their contribution to published
phase I trials.
Results: Twenty percent of American Society of Clinical Oncology phase I abstracts (503 of 2458) from 1991 to 2002 included biomarkers.
This proportion increased over time (14% in 1991 compared with 26% in 2002; P < 0.02). Independent predictors of the use of biomarkers included National Cancer Institute sponsorship, submission in the
time period of 1999 to 2002, adult population, and drug family (biological agents). Biomarkers supported dose selection for
phase II studies in 11 of 87 of the trials (13%) emanating from these abstracts. However, the primary determinants of phase
II dose and schedule were toxicity and/or efficacy in all but one of these 87 trials (1%). Biomarker studies provided evidence
supporting the proposed mechanism of action in 34 of 87 of the published trials (39%).
Conclusions: The use of biomarkers in phase I trials has increased over the period from 1991 to 2002. To date, biomarker utilization has
made a limited and primarily supportive contribution to dose selection, the primary end point of phase I studies. Additional
studies are needed to determine what type of biomarker information is most valuable to evaluate in phase I trials.</abstract><cop>United States</cop><pub>American Association for Cancer Research</pub><pmid>18006773</pmid><doi>10.1158/1078-0432.CCR-06-2860</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; American Association for Cancer Research; Alma/SFX Local Collection |
| subjects | biomarkers Biomarkers, Tumor - analysis Biomarkers, Tumor - metabolism cancer clinical trials Clinical Trials, Phase I as Topic end points Humans Neoplasms - drug therapy phase I |
| title | Trends in the Use and Role of Biomarkers in Phase I Oncology Trials |
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