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Clinical Trial
. 2013 Feb;138(1):149-55.
doi: 10.1007/s10549-012-2395-8. Epub 2013 Feb 3.

Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology

Sally Anne Garnett  1 , Miguel Martin, Guy Jerusalem, Lubos Petruzelka, Roberto Torres, Igor N Bondarenko, Rustem Khasanov, Didier Verhoeven, José L Pedrini, Iva Smirnova, Mikhail R Lichinitser, Kelly Pendergrass, Justin P O Lindemann, Angelo Di Leo
Affiliations
Clinical Trial

Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology

Sally Anne Garnett et al. Breast Cancer Res Treat. 2013 Feb.

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 DoR500/expected DoR250 and expected DoCB500/expected DoCB250) 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.

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Figures

Fig. 1
Fig. 1
Duration of response from date of randomization for patients with an objective response (evaluable for all randomized patients with measurable disease at baseline). Patients with a best objective response of complete response or partial response are included
Fig. 2
Fig. 2
Duration of clinical benefit in patients with clinical benefit (evaluable for all randomized patients). Patients with a best objective response of complete response, partial response, or stable disease of ≥24 weeks' duration are included
See this image and copyright information in PMC

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