Final Overall Survival: Fulvestrant 500 mg vs 250 mg in the Randomized CONFIRM Trial

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10286154" target="_blank" >RIV/00216208:11110/14:10286154 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1093/jnci/djt337" target="_blank" >http://dx.doi.org/10.1093/jnci/djt337</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1093/jnci/djt337" target="_blank" >10.1093/jnci/djt337</a>

Result language
angličtina
Original language name
Final Overall Survival: Fulvestrant 500 mg vs 250 mg in the Randomized CONFIRM Trial
Original language description
Background 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 analysisof OS was subsequently planned for when 75% of patients had died. Methods 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. Results In total, 736 women (median age = 61.0
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FD - Oncology and haematology
OECD FORD branch
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Publication year
2014
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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