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J Natl Cancer Inst. 2014 Jan;106(1):djt337. doi: 10.1093/jnci/djt337. Epub 2013 Dec 7.

Final overall survival: fulvestrant 500 mg vs 250 mg in the randomized CONFIRM trial.

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Affiliations of authors: "Sandra Pitigliani" Medical Oncology Unit, Hospital of Prato, Prato, Italy (ADL, LM); Medical Oncology, Centre Hospitalier Universitaire Sart Tilman and Liège University, Liège, Belgium (GJ); Department of Oncology, First Faculty of Medicine of Charles University, Prague, Czech Republic (LP); Clinical Oncology, Instituto Nacional del Cáncer, Santiago, Chile (RT); Dnipropetrovsk Municipal Clinical Hospital, Dnipropetrovsk, Ukraine (INB); Republican Clinical Oncological Center, Kazan, Russia (RK); AZ Klina, Brasschaat, Belgium (DV); Mastology, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil (JLP); Thoracal Department, Medical Radiological Science Center, Obninsk, Russia (IS); Chemotherapy and Combined Therapy, Russian Cancer Research Centre, Moscow, Russia (MRL); Medical Oncology, Kansas City Cancer Center, Kansas City, MO USA (KP); AstraZeneca Pharmaceuticals, Macclesfield, UK (SG, YR); Medical Oncology Service, Instituto de Investigacion Sanitaria, Hospital Universitario Gregorio Maranon, Universidad Complutense, Madrid, Spain (MM).



At the time of the initial analysis of overall survival (OS) for the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer (CONFIRM) randomized, double-blind, phase III trial, approximately 50% of patients had died. A final analysis of OS was subsequently planned for when 75% of patients had died.


Patients were randomly assigned 1:1 to fulvestrant 500 mg administered as two 5-mL intramuscular injections on days 0, 14, and 28 and every 28 (±3) days thereafter or fulvestrant 250 mg administered as two 5-mL intramuscular injections (one fulvestrant and one placebo [identical in appearance to study drug]) on days 0, 14 (two placebo injections only), and 28 and every 28 (±3) days thereafter. OS was analyzed using an unadjusted log-rank test. No adjustments were made for multiplicity. Serious adverse events (SAEs) and best response to subsequent therapy were also reported. All statistical tests were two-sided.


In total, 736 women (median age = 61.0 years) were randomly assigned to fulvestrant 500 mg (n = 362) or 250 mg (n = 374). At the final survival analysis, 554 of 736 (75.3%) patients had died. Median OS was 26.4 months for fulvestrant 500 mg and 22.3 months for 250 mg (hazard ratio = 0.81; 95% confidence interval = 0.69-0.96; nominal P = .02). There were no clinically important differences in SAE profiles between the treatment groups; no clustering of SAEs could be detected in either treatment group. Type of first subsequent therapy and objective responses to first subsequent therapy were well balanced between the two treatment groups.


In patients with locally advanced or metastatic estrogen receptor-positive breast cancer, fulvestrant 500 mg is associated with a 19% reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250 mg. Fulvestrant 500 mg was well tolerated, and no new safety concerns were identified.

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