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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Veröffentlicht in:Breast cancer research and treatment 2013-02, Vol.138 (1), p.149-155
Hauptverfasser: 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
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container_end_page 155
container_issue 1
container_start_page 149
container_title Breast cancer research and treatment
container_volume 138
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
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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). 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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). 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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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