Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology
Comparisons of duration of response (DoR) and duration of clinical benefit (DoCB) within clinical trials are prone to biases. To address these biases, we used new methodology to prospectively analyze expected DoR and expected DoCB. Objective response rate and clinical benefit rate were calculated fo...
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creator | Garnett, Sally Anne Martin, Miguel Jerusalem, Guy Petruzelka, Lubos Torres, Roberto Bondarenko, Igor N. Khasanov, Rustem Verhoeven, Didier Pedrini, José L. Smirnova, Iva Lichinitser, Mikhail R. Pendergrass, Kelly Lindemann, Justin P. O. Di Leo, Angelo |
description | Comparisons of duration of response (DoR) and duration of clinical benefit (DoCB) within clinical trials are prone to biases. To address these biases, we used new methodology to prospectively analyze expected DoR and expected DoCB. Objective response rate and clinical benefit rate were calculated for fulvestrant 500 and 250 mg, and used to calculate expected DoR and expected DoCB for each dose group. The ratios for expected DoR and expected DoCB (expected DoR
500
/expected DoR
250
and expected DoCB
500
/expected DoCB
250
) were then calculated, thereby allowing statistical comparisons of these endpoints between each arm of the COmparisoN of Faslodex In Recurrent or Metastatic breast cancer (CONFIRM) trial. Expected DoRs for fulvestrant 500 and 250 mg were 3.2 and 3.6 months, respectively. The expected DoR ratio between fulvestrant 500 and 250 mg was not statistically significant (0.89; 95 % CI, 0.48–1.67,
P
= 0.724). The expected DoCBs for fulvestrant 500 and 250 mg were 9.8 and 7.2 months, respectively. The expected DoCB ratio showed that the expected DoCB for fulvestrant 500 mg was significantly improved compared with the expected DoCB for fulvestrant 250 mg (1.36; 95 % CI, 1.07–1.73,
P
= 0.013). Analysis of the expected DoR and expected DoCB showed fulvestrant 500 mg significantly increased expected DoCB compared with fulvestrant 250 mg in the CONFIRM trial. |
doi_str_mv | 10.1007/s10549-012-2395-8 |
format | Article |
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500
/expected DoR
250
and expected DoCB
500
/expected DoCB
250
) were then calculated, thereby allowing statistical comparisons of these endpoints between each arm of the COmparisoN of Faslodex In Recurrent or Metastatic breast cancer (CONFIRM) trial. Expected DoRs for fulvestrant 500 and 250 mg were 3.2 and 3.6 months, respectively. The expected DoR ratio between fulvestrant 500 and 250 mg was not statistically significant (0.89; 95 % CI, 0.48–1.67,
P
= 0.724). The expected DoCBs for fulvestrant 500 and 250 mg were 9.8 and 7.2 months, respectively. The expected DoCB ratio showed that the expected DoCB for fulvestrant 500 mg was significantly improved compared with the expected DoCB for fulvestrant 250 mg (1.36; 95 % CI, 1.07–1.73,
P
= 0.013). Analysis of the expected DoR and expected DoCB showed fulvestrant 500 mg significantly increased expected DoCB compared with fulvestrant 250 mg in the CONFIRM trial.</description><identifier>ISSN: 0167-6806</identifier><identifier>ISSN: 1573-7217</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-012-2395-8</identifier><identifier>PMID: 23378064</identifier><identifier>CODEN: BCTRD6</identifier><language>eng</language><publisher>Boston: Springer US</publisher><subject>advanced breast cancer ; Antimitotic agents ; Antineoplastic agents ; Antineoplastic Agents, Hormonal - administration & dosage ; Antineoplastic Agents, Hormonal - therapeutic use ; Breast Neoplasms - drug therapy ; Clinical Trial ; Clinical trials ; Comparative analysis ; comparison ; duration of clinical benefit ; duration of response ; Estradiol - administration & dosage ; Estradiol - analogs & derivatives ; Estradiol - therapeutic use ; Female ; Fulvestrant ; Human health sciences ; Humans ; Medicine ; Medicine & Public Health ; methodology ; Methods ; Oncologie ; Oncology ; Product development ; Sciences de la santé humaine ; Time Factors ; Treatment Outcome</subject><ispartof>Breast cancer research and treatment, 2013-02, Vol.138 (1), p.149-155</ispartof><rights>The Author(s) 2013</rights><rights>2014 INIST-CNRS</rights><rights>COPYRIGHT 2013 Springer</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c614t-57ddebb01cc2b3b138f7812413b2894ed40a99656bde4f3f868d444f06855e593</citedby><cites>FETCH-LOGICAL-c614t-57ddebb01cc2b3b138f7812413b2894ed40a99656bde4f3f868d444f06855e593</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10549-012-2395-8$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10549-012-2395-8$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27580023$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23378064$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Garnett, Sally Anne</creatorcontrib><creatorcontrib>Martin, Miguel</creatorcontrib><creatorcontrib>Jerusalem, Guy</creatorcontrib><creatorcontrib>Petruzelka, Lubos</creatorcontrib><creatorcontrib>Torres, Roberto</creatorcontrib><creatorcontrib>Bondarenko, Igor N.</creatorcontrib><creatorcontrib>Khasanov, Rustem</creatorcontrib><creatorcontrib>Verhoeven, Didier</creatorcontrib><creatorcontrib>Pedrini, José L.</creatorcontrib><creatorcontrib>Smirnova, Iva</creatorcontrib><creatorcontrib>Lichinitser, Mikhail R.</creatorcontrib><creatorcontrib>Pendergrass, Kelly</creatorcontrib><creatorcontrib>Lindemann, Justin P. O.</creatorcontrib><creatorcontrib>Di Leo, Angelo</creatorcontrib><title>Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><addtitle>Breast Cancer Res Treat</addtitle><description>Comparisons of duration of response (DoR) and duration of clinical benefit (DoCB) within clinical trials are prone to biases. To address these biases, we used new methodology to prospectively analyze expected DoR and expected DoCB. Objective response rate and clinical benefit rate were calculated for fulvestrant 500 and 250 mg, and used to calculate expected DoR and expected DoCB for each dose group. The ratios for expected DoR and expected DoCB (expected DoR
500
/expected DoR
250
and expected DoCB
500
/expected DoCB
250
) were then calculated, thereby allowing statistical comparisons of these endpoints between each arm of the COmparisoN of Faslodex In Recurrent or Metastatic breast cancer (CONFIRM) trial. Expected DoRs for fulvestrant 500 and 250 mg were 3.2 and 3.6 months, respectively. The expected DoR ratio between fulvestrant 500 and 250 mg was not statistically significant (0.89; 95 % CI, 0.48–1.67,
P
= 0.724). The expected DoCBs for fulvestrant 500 and 250 mg were 9.8 and 7.2 months, respectively. The expected DoCB ratio showed that the expected DoCB for fulvestrant 500 mg was significantly improved compared with the expected DoCB for fulvestrant 250 mg (1.36; 95 % CI, 1.07–1.73,
P
= 0.013). Analysis of the expected DoR and expected DoCB showed fulvestrant 500 mg significantly increased expected DoCB compared with fulvestrant 250 mg in the CONFIRM trial.</description><subject>advanced breast cancer</subject><subject>Antimitotic agents</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents, Hormonal - administration & dosage</subject><subject>Antineoplastic Agents, Hormonal - therapeutic use</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Clinical Trial</subject><subject>Clinical trials</subject><subject>Comparative analysis</subject><subject>comparison</subject><subject>duration of clinical benefit</subject><subject>duration of response</subject><subject>Estradiol - administration & dosage</subject><subject>Estradiol - analogs & derivatives</subject><subject>Estradiol - therapeutic use</subject><subject>Female</subject><subject>Fulvestrant</subject><subject>Human health sciences</subject><subject>Humans</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>methodology</subject><subject>Methods</subject><subject>Oncologie</subject><subject>Oncology</subject><subject>Product development</subject><subject>Sciences de la santé humaine</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0167-6806</issn><issn>1573-7217</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><recordid>eNp9kl9r1TAYxoso7jj9AN5IQBRvOvOnTVMvhHFwOpgORK9Dmr7tyUiTmrRn7KP4bU13zuYOiOQiIe_ved7w5smylwSfEIyr95HgsqhzTGhOWV3m4lG2ImXF8oqS6nG2woRXOReYH2XPYrzCGNcVrp9mR5SxKl0Xq-z32g-jCsb1qJ2Dmox3yHcoQBy9i4CUaw8K2hpntLKoAQedmdI-XQM41M12C3EKyk1oCqCmAdKpD34eIzIOTRtA68tvZ-ffv6a6UfYDUuNok9edtYNrNMC08a23vr95nj3plI3wYr8fZz_PPv1Yf8kvLj-fr08vcs1JMeVl1bbQNJhoTRvWECa6ShBaENZQURfQFljVNS9500LRsU5w0RZF0WEuyhLKmh1nH3e-49wM0Or07KCsHIMZVLiRXhl5WHFmI3u_lawUnBCWDNjOwBroQfrQGLmlt8Lb82x7qbRsQFLKhSRFRTlOqnf7tsH_mtPk5GCiBmuVAz9HSVgCCaOEJvT1Du2VBWlc59M79ILLU8YEZoJgnqiTf1BptTAY7ZffSvcHgrcPBBtQdtpEb-flP-IhSHagDj7GAN39cAiWSxDlLogyBVEuQZQiaV49nOq94i55CXizB1RMeepScLSJf7mqFBjTZbp0x8VxSSkEeeXn4FIi_tP9D3Dl9pw</recordid><startdate>20130201</startdate><enddate>20130201</enddate><creator>Garnett, Sally Anne</creator><creator>Martin, Miguel</creator><creator>Jerusalem, Guy</creator><creator>Petruzelka, Lubos</creator><creator>Torres, Roberto</creator><creator>Bondarenko, Igor N.</creator><creator>Khasanov, Rustem</creator><creator>Verhoeven, Didier</creator><creator>Pedrini, José L.</creator><creator>Smirnova, Iva</creator><creator>Lichinitser, Mikhail R.</creator><creator>Pendergrass, Kelly</creator><creator>Lindemann, Justin P. O.</creator><creator>Di Leo, Angelo</creator><general>Springer US</general><general>Springer</general><general>Kluwer Academic Publishers</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>7X8</scope><scope>Q33</scope><scope>5PM</scope></search><sort><creationdate>20130201</creationdate><title>Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology</title><author>Garnett, Sally Anne ; Martin, Miguel ; Jerusalem, Guy ; Petruzelka, Lubos ; Torres, Roberto ; Bondarenko, Igor N. ; Khasanov, Rustem ; Verhoeven, Didier ; Pedrini, José L. ; Smirnova, Iva ; Lichinitser, Mikhail R. ; Pendergrass, Kelly ; Lindemann, Justin P. O. ; Di Leo, Angelo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c614t-57ddebb01cc2b3b138f7812413b2894ed40a99656bde4f3f868d444f06855e593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>advanced breast cancer</topic><topic>Antimitotic agents</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents, Hormonal - administration & dosage</topic><topic>Antineoplastic Agents, Hormonal - therapeutic use</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Clinical Trial</topic><topic>Clinical trials</topic><topic>Comparative analysis</topic><topic>comparison</topic><topic>duration of clinical benefit</topic><topic>duration of response</topic><topic>Estradiol - administration & dosage</topic><topic>Estradiol - analogs & derivatives</topic><topic>Estradiol - therapeutic use</topic><topic>Female</topic><topic>Fulvestrant</topic><topic>Human health sciences</topic><topic>Humans</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>methodology</topic><topic>Methods</topic><topic>Oncologie</topic><topic>Oncology</topic><topic>Product development</topic><topic>Sciences de la santé humaine</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Garnett, Sally Anne</creatorcontrib><creatorcontrib>Martin, Miguel</creatorcontrib><creatorcontrib>Jerusalem, Guy</creatorcontrib><creatorcontrib>Petruzelka, Lubos</creatorcontrib><creatorcontrib>Torres, Roberto</creatorcontrib><creatorcontrib>Bondarenko, Igor N.</creatorcontrib><creatorcontrib>Khasanov, Rustem</creatorcontrib><creatorcontrib>Verhoeven, Didier</creatorcontrib><creatorcontrib>Pedrini, José L.</creatorcontrib><creatorcontrib>Smirnova, Iva</creatorcontrib><creatorcontrib>Lichinitser, Mikhail R.</creatorcontrib><creatorcontrib>Pendergrass, Kelly</creatorcontrib><creatorcontrib>Lindemann, Justin P. O.</creatorcontrib><creatorcontrib>Di Leo, Angelo</creatorcontrib><collection>Springer Nature OA Free Journals</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><collection>Université de Liège - Open Repository and Bibliography (ORBI)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Garnett, Sally Anne</au><au>Martin, Miguel</au><au>Jerusalem, Guy</au><au>Petruzelka, Lubos</au><au>Torres, Roberto</au><au>Bondarenko, Igor N.</au><au>Khasanov, Rustem</au><au>Verhoeven, Didier</au><au>Pedrini, José L.</au><au>Smirnova, Iva</au><au>Lichinitser, Mikhail R.</au><au>Pendergrass, Kelly</au><au>Lindemann, Justin P. O.</au><au>Di Leo, Angelo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology</atitle><jtitle>Breast cancer research and treatment</jtitle><stitle>Breast Cancer Res Treat</stitle><addtitle>Breast Cancer Res Treat</addtitle><date>2013-02-01</date><risdate>2013</risdate><volume>138</volume><issue>1</issue><spage>149</spage><epage>155</epage><pages>149-155</pages><issn>0167-6806</issn><issn>1573-7217</issn><eissn>1573-7217</eissn><coden>BCTRD6</coden><abstract>Comparisons of duration of response (DoR) and duration of clinical benefit (DoCB) within clinical trials are prone to biases. To address these biases, we used new methodology to prospectively analyze expected DoR and expected DoCB. Objective response rate and clinical benefit rate were calculated for fulvestrant 500 and 250 mg, and used to calculate expected DoR and expected DoCB for each dose group. The ratios for expected DoR and expected DoCB (expected DoR
500
/expected DoR
250
and expected DoCB
500
/expected DoCB
250
) were then calculated, thereby allowing statistical comparisons of these endpoints between each arm of the COmparisoN of Faslodex In Recurrent or Metastatic breast cancer (CONFIRM) trial. Expected DoRs for fulvestrant 500 and 250 mg were 3.2 and 3.6 months, respectively. The expected DoR ratio between fulvestrant 500 and 250 mg was not statistically significant (0.89; 95 % CI, 0.48–1.67,
P
= 0.724). The expected DoCBs for fulvestrant 500 and 250 mg were 9.8 and 7.2 months, respectively. The expected DoCB ratio showed that the expected DoCB for fulvestrant 500 mg was significantly improved compared with the expected DoCB for fulvestrant 250 mg (1.36; 95 % CI, 1.07–1.73,
P
= 0.013). Analysis of the expected DoR and expected DoCB showed fulvestrant 500 mg significantly increased expected DoCB compared with fulvestrant 250 mg in the CONFIRM trial.</abstract><cop>Boston</cop><pub>Springer US</pub><pmid>23378064</pmid><doi>10.1007/s10549-012-2395-8</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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subjects | advanced breast cancer Antimitotic agents Antineoplastic agents Antineoplastic Agents, Hormonal - administration & dosage Antineoplastic Agents, Hormonal - therapeutic use Breast Neoplasms - drug therapy Clinical Trial Clinical trials Comparative analysis comparison duration of clinical benefit duration of response Estradiol - administration & dosage Estradiol - analogs & derivatives Estradiol - therapeutic use Female Fulvestrant Human health sciences Humans Medicine Medicine & Public Health methodology Methods Oncologie Oncology Product development Sciences de la santé humaine Time Factors Treatment Outcome |
title | Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology |
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