Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with
fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive
advanced breast cancer.
Author(s): Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R,
Verhoeven D, Pedrini JL, Smirnova I, Lichinitser MR, Pendergrass K, Garnett S,
Lindemann JP, Sapunar F, Martin M.
Affiliation(s): Sandro Pitigliani Medical Oncology Unit, Hospital of Prato, Prato, Italy.
adileo@usl4.toscana.it
Publication date & source: 2010, J Clin Oncol. , 28(30):4594-600
PURPOSE: We compared fulvestrant 500 mg regimen with the approved dose of
fulvestrant 250 mg per month for treatment of postmenopausal women with estrogen
receptor-positive advanced breast cancer who experienced progression after prior
endocrine therapy.
PATIENTS AND METHODS: Comparison of Faslodex in Recurrent or Metastatic Breast
Cancer (CONFIRM) is a double-blind, parallel-group, multicenter, phase III study.
Patients were randomly assigned to fulvestrant 500 mg (500 mg intramuscularly
[IM] on day 0, then 500 mg IM on days 14 and 28 and every 28 days thereafter) or
250 mg every 28 days. Primary end point was progression-free survival (PFS).
Secondary end points included objective response rate, clinical benefit rate
(CBR), duration of clinical benefit (DoCB), overall survival (OS), and quality of
life (QOL).
RESULTS: PFS was significantly longer for fulvestrant 500 mg (n = 362) than 250
mg (n = 374) (hazard ratio [HR] = 0.80; 95% CI, 0.68 to 0.94; P = .006),
corresponding to a 20% reduction in risk of progression. Objective response rate
was similar for fulvestrant 500 mg and 250 mg (9.1% v 10.2%, respectively). CBR
was 45.6% for fulvestrant 500 mg and 39.6% for fulvestrant 250 mg. DoCB and OS
were 16.6 and 25.1 months, respectively, for the 500-mg group, whereas DoCB and
OS were 13.9 and 22.8 months, respectively, in the 250-mg group. Fulvestrant 500
mg was well tolerated with no dose-dependent adverse events. QOL was similar for
both arms.
CONCLUSION: Fulvestrant 500 mg was associated with a statistically significant
increase in PFS and not associated with increased toxicity, corresponding to a
clinically meaningful improvement in benefit versus risk compared with
fulvestrant 250 mg.
Erratum in
J Clin Oncol. 2011 Jun 1;29(16):2293.
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