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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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

Název v anglickém jazyce

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

Popis výsledku anglicky

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

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

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Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2014

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of the National Cancer Institute

ISSN

0027-8874

e-ISSN

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Svazek periodika

106

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

7

Strana od-do

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Kód UT WoS článku

000331891900010

EID výsledku v databázi Scopus

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