Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy
Background: The oncology community usually perceives phase I oncology trials as associated with poor or limited benefits and substantial risks. There is scarce data concerning outcome and survival of patients enrolled in current phase I oncology trials. Patients and methods: We reviewed all phase I...
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| Veröffentlicht in: | Annals of oncology 2008-04, Vol.19 (4), p.787-792 |
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| container_title | Annals of oncology |
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| creator | Italiano, A. Massard, C. Bahleda, R. Vataire, A.-L. Deutsch, E. Magné, N. Pignon, J.-P. Vassal, G. Armand, J.-P. Soria, J.-C. |
| description | Background: The oncology community usually perceives phase I oncology trials as associated with poor or limited benefits and substantial risks. There is scarce data concerning outcome and survival of patients enrolled in current phase I oncology trials. Patients and methods: We reviewed all phase I oncology trials conducted by investigators from the Adult Phase I Unit at Institut Gustave Roussy from 2003 to 2006. We report data concerning patient demographics, treatment outcome, toxicity, survival and type of care after trial exit. Results: We analyzed 10 trials involving 180 participants. The overall response rate was 7.2%. Disease control (objective response plus stable disease) was achieved in 48.2% of patients. The rate of toxic death was 0.5%. In all, 38% of patients had at least one episode of grade 3 or 4 toxic events. The median progression-free survival and the median overall survival (OS) were 2.3 and 8.7 months, respectively. On multivariate analysis, a time between diagnosis of disease and inclusion in the phase I trial ≥24 months and evidence of disease control were statistically significant predictors of improved OS. Conclusion: Current phase I oncology trials are safe and are associated with clinical benefit in a substantial proportion of patients. |
| doi_str_mv | 10.1093/annonc/mdm548 |
| format | Article |
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There is scarce data concerning outcome and survival of patients enrolled in current phase I oncology trials. Patients and methods: We reviewed all phase I oncology trials conducted by investigators from the Adult Phase I Unit at Institut Gustave Roussy from 2003 to 2006. We report data concerning patient demographics, treatment outcome, toxicity, survival and type of care after trial exit. Results: We analyzed 10 trials involving 180 participants. The overall response rate was 7.2%. Disease control (objective response plus stable disease) was achieved in 48.2% of patients. The rate of toxic death was 0.5%. In all, 38% of patients had at least one episode of grade 3 or 4 toxic events. The median progression-free survival and the median overall survival (OS) were 2.3 and 8.7 months, respectively. On multivariate analysis, a time between diagnosis of disease and inclusion in the phase I trial ≥24 months and evidence of disease control were statistically significant predictors of improved OS. Conclusion: Current phase I oncology trials are safe and are associated with clinical benefit in a substantial proportion of patients.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdm548</identifier><identifier>PMID: 18042834</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Adult ; Aged ; Aged, 80 and over ; anticancer drugs ; Antineoplastic agents ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - pharmacokinetics ; Antineoplastic Agents - pharmacology ; Antineoplastic Agents - therapeutic use ; Antineoplastic Agents, Hormonal - therapeutic use ; Biological and medical sciences ; Clinical Trials, Phase I as Topic ; Disease-Free Survival ; early clinical trials ; Female ; France - epidemiology ; Humans ; Immunotherapy ; Kaplan-Meier Estimate ; Male ; Medical sciences ; Middle Aged ; Multivariate Analysis ; Neoplasms - drug therapy ; Neoplasms - immunology ; Neoplasms - mortality ; Neoplasms - radiotherapy ; Neoplasms - therapy ; oncology ; Pharmacology. Drug treatments ; phase I trials ; targeted therapies ; Treatment Outcome</subject><ispartof>Annals of oncology, 2008-04, Vol.19 (4), p.787-792</ispartof><rights>The Author 2007. 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 2008</rights><rights>2008 INIST-CNRS</rights><rights>The Author 2007. 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</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c489t-5b587facb7e37efa9a0ef978f00cf64bea01dd740aeacbe0f8a505836436da883</citedby><cites>FETCH-LOGICAL-c489t-5b587facb7e37efa9a0ef978f00cf64bea01dd740aeacbe0f8a505836436da883</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,27933,27934</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20227373$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18042834$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Italiano, A.</creatorcontrib><creatorcontrib>Massard, C.</creatorcontrib><creatorcontrib>Bahleda, R.</creatorcontrib><creatorcontrib>Vataire, A.-L.</creatorcontrib><creatorcontrib>Deutsch, E.</creatorcontrib><creatorcontrib>Magné, N.</creatorcontrib><creatorcontrib>Pignon, J.-P.</creatorcontrib><creatorcontrib>Vassal, G.</creatorcontrib><creatorcontrib>Armand, J.-P.</creatorcontrib><creatorcontrib>Soria, J.-C.</creatorcontrib><title>Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Background: The oncology community usually perceives phase I oncology trials as associated with poor or limited benefits and substantial risks. There is scarce data concerning outcome and survival of patients enrolled in current phase I oncology trials. Patients and methods: We reviewed all phase I oncology trials conducted by investigators from the Adult Phase I Unit at Institut Gustave Roussy from 2003 to 2006. We report data concerning patient demographics, treatment outcome, toxicity, survival and type of care after trial exit. Results: We analyzed 10 trials involving 180 participants. The overall response rate was 7.2%. Disease control (objective response plus stable disease) was achieved in 48.2% of patients. The rate of toxic death was 0.5%. In all, 38% of patients had at least one episode of grade 3 or 4 toxic events. The median progression-free survival and the median overall survival (OS) were 2.3 and 8.7 months, respectively. On multivariate analysis, a time between diagnosis of disease and inclusion in the phase I trial ≥24 months and evidence of disease control were statistically significant predictors of improved OS. Conclusion: Current phase I oncology trials are safe and are associated with clinical benefit in a substantial proportion of patients.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>anticancer drugs</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - pharmacokinetics</subject><subject>Antineoplastic Agents - pharmacology</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Antineoplastic Agents, Hormonal - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Clinical Trials, Phase I as Topic</subject><subject>Disease-Free Survival</subject><subject>early clinical trials</subject><subject>Female</subject><subject>France - epidemiology</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multivariate Analysis</subject><subject>Neoplasms - drug therapy</subject><subject>Neoplasms - immunology</subject><subject>Neoplasms - mortality</subject><subject>Neoplasms - radiotherapy</subject><subject>Neoplasms - therapy</subject><subject>oncology</subject><subject>Pharmacology. Drug treatments</subject><subject>phase I trials</subject><subject>targeted therapies</subject><subject>Treatment Outcome</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0c2L1DAYBvAgijuOHr1KEBQvdfPRpu1RFnd3dEGQ8YO5hHfSRLO2SU3Swbn6l5uhZQUvHsJ7yC9PXngQekrJa0pafg7OeafOh26oyuYeWtFKtEVDSnofrUjLeFFXvDxDj2K8JYSIlrUP0RnNgDW8XKHf26AhDdol7Kek_KAxuA7HKRzsAXpsHR4hJKvsCC5F7A0ev0PUeIPzt7733444BQt9xApCsLo75WAT_IAZIRwnf5oCQ8IbF5NN-fZqigkOGn_0U4zHx-iBye_1k2Wu0afLt9uL6-Lmw9Xm4s1NocqmTUW1r5ragNrXmtfaQAtEm7ZuDCHKiHKvgdCuq0sCOiNNTAMVqRouSi46aBq-Ri_n3DH4n5OOSQ42Kt334HReRDLKSlG1dYbP_4G3fgou7yZpKwTjNJ81Kmakgo8xaCPHYAcIR0mJPDUj52bk3Ez2z5bQaT_o7q9eqsjgxQIgKuhNAKdsvHOMMFbzmmf3anZ-Gv_757KjjUn_usMQfkiRsyp5_XUnL9_tvuw-v99Kwf8AOsi3BQ</recordid><startdate>20080401</startdate><enddate>20080401</enddate><creator>Italiano, A.</creator><creator>Massard, C.</creator><creator>Bahleda, R.</creator><creator>Vataire, A.-L.</creator><creator>Deutsch, E.</creator><creator>Magné, N.</creator><creator>Pignon, J.-P.</creator><creator>Vassal, G.</creator><creator>Armand, J.-P.</creator><creator>Soria, J.-C.</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><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>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>20080401</creationdate><title>Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy</title><author>Italiano, A. ; Massard, C. ; Bahleda, R. ; Vataire, A.-L. ; Deutsch, E. ; Magné, N. ; Pignon, J.-P. ; Vassal, G. ; Armand, J.-P. ; Soria, J.-C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c489t-5b587facb7e37efa9a0ef978f00cf64bea01dd740aeacbe0f8a505836436da883</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>anticancer drugs</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - pharmacokinetics</topic><topic>Antineoplastic Agents - pharmacology</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Antineoplastic Agents, Hormonal - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Clinical Trials, Phase I as Topic</topic><topic>Disease-Free Survival</topic><topic>early clinical trials</topic><topic>Female</topic><topic>France - epidemiology</topic><topic>Humans</topic><topic>Immunotherapy</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multivariate Analysis</topic><topic>Neoplasms - drug therapy</topic><topic>Neoplasms - immunology</topic><topic>Neoplasms - mortality</topic><topic>Neoplasms - radiotherapy</topic><topic>Neoplasms - therapy</topic><topic>oncology</topic><topic>Pharmacology. Drug treatments</topic><topic>phase I trials</topic><topic>targeted therapies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Italiano, A.</creatorcontrib><creatorcontrib>Massard, C.</creatorcontrib><creatorcontrib>Bahleda, R.</creatorcontrib><creatorcontrib>Vataire, A.-L.</creatorcontrib><creatorcontrib>Deutsch, E.</creatorcontrib><creatorcontrib>Magné, N.</creatorcontrib><creatorcontrib>Pignon, J.-P.</creatorcontrib><creatorcontrib>Vassal, G.</creatorcontrib><creatorcontrib>Armand, J.-P.</creatorcontrib><creatorcontrib>Soria, J.-C.</creatorcontrib><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>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Italiano, A.</au><au>Massard, C.</au><au>Bahleda, R.</au><au>Vataire, A.-L.</au><au>Deutsch, E.</au><au>Magné, N.</au><au>Pignon, J.-P.</au><au>Vassal, G.</au><au>Armand, J.-P.</au><au>Soria, J.-C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2008-04-01</date><risdate>2008</risdate><volume>19</volume><issue>4</issue><spage>787</spage><epage>792</epage><pages>787-792</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Background: The oncology community usually perceives phase I oncology trials as associated with poor or limited benefits and substantial risks. There is scarce data concerning outcome and survival of patients enrolled in current phase I oncology trials. Patients and methods: We reviewed all phase I oncology trials conducted by investigators from the Adult Phase I Unit at Institut Gustave Roussy from 2003 to 2006. We report data concerning patient demographics, treatment outcome, toxicity, survival and type of care after trial exit. Results: We analyzed 10 trials involving 180 participants. The overall response rate was 7.2%. Disease control (objective response plus stable disease) was achieved in 48.2% of patients. The rate of toxic death was 0.5%. In all, 38% of patients had at least one episode of grade 3 or 4 toxic events. The median progression-free survival and the median overall survival (OS) were 2.3 and 8.7 months, respectively. On multivariate analysis, a time between diagnosis of disease and inclusion in the phase I trial ≥24 months and evidence of disease control were statistically significant predictors of improved OS. Conclusion: Current phase I oncology trials are safe and are associated with clinical benefit in a substantial proportion of patients.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>18042834</pmid><doi>10.1093/annonc/mdm548</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Aged, 80 and over anticancer drugs Antineoplastic agents Antineoplastic Agents - adverse effects Antineoplastic Agents - pharmacokinetics Antineoplastic Agents - pharmacology Antineoplastic Agents - therapeutic use Antineoplastic Agents, Hormonal - therapeutic use Biological and medical sciences Clinical Trials, Phase I as Topic Disease-Free Survival early clinical trials Female France - epidemiology Humans Immunotherapy Kaplan-Meier Estimate Male Medical sciences Middle Aged Multivariate Analysis Neoplasms - drug therapy Neoplasms - immunology Neoplasms - mortality Neoplasms - radiotherapy Neoplasms - therapy oncology Pharmacology. Drug treatments phase I trials targeted therapies Treatment Outcome |
| title | Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy |
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