title: Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology.
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.
authors: AstraZeneca Pharmaceuticals, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK. sally.garnett@astrazeneca.com
authors: Sally Anne
authors: SA
authors: Garnett
authors: Miguel
authors: M
authors: Martin
authors: Guy
authors: G
authors: Jerusalem
authors: Lubos
authors: L
authors: Petruzelka
authors: Roberto
authors: R
authors: Torres
authors: Igor N
authors: IN
authors: Bondarenko
authors: Rustem
authors: R
authors: Khasanov
authors: Didier
authors: D
authors: Verhoeven
authors: José L
authors: JL
authors: Pedrini
authors: Iva
authors: I
authors: Smirnova
authors: Mikhail R
authors: MR
authors: Lichinitser
authors: Kelly
authors: K
authors: Pendergrass
authors: Justin P O
authors: JP
authors: Lindemann
authors: Angelo
authors: A
authors: Di Leo
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D000077267:Fulvestrant; D006801:Humans; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D000077267:Fulvestrant; D004958:Estradiol
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