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Statements

Subject Item
n2:RIV%2F00216208%3A11120%2F14%3A43907526%21RIV14-MSM-11120___
rdf:type
skos:Concept n9:Vysledek
dcterms:description
Effective maintenance therapies after chemoradiotherapy for lung cancer are lacking. Our aim was to investigate whether the MUC1 antigen-specific cancer immunotherapy tecemotide improves survival in patients with stage III unresectable non-small-cell lung cancer when given as maintenance therapy after chemoradiation.The phase 3 START trial was an international, randomised, double-blind trial that recruited patients with unresectable stage III non-small-cell lung cancer who had completed chemoradiotherapy within the 4—12 week window before randomisation and received confirmation of stable disease or objective response. Patients were stratified by stage (IIIA vs IIIB), response to chemoradiotherapy (stable disease vs objective response), delivery of chemoradiotherapy (concurrent vs sequential), and region using block randomisation, and were randomly assigned (2:1, double-blind) by a central interactive voice randomisation system to either tecemotide or placebo. Injections of tecemotide (806 μg lipopeptide) or placebo were given every week for 8 weeks, and then every 6 weeks until disease progression or withdrawal. Cyclophosphamide 300 mg/m2 (before tecemotide) or saline (before placebo) was given once before the first study drug administration. The primary endpoint was overall survival in a modified intention-to-treat population. Effective maintenance therapies after chemoradiotherapy for lung cancer are lacking. Our aim was to investigate whether the MUC1 antigen-specific cancer immunotherapy tecemotide improves survival in patients with stage III unresectable non-small-cell lung cancer when given as maintenance therapy after chemoradiation.The phase 3 START trial was an international, randomised, double-blind trial that recruited patients with unresectable stage III non-small-cell lung cancer who had completed chemoradiotherapy within the 4—12 week window before randomisation and received confirmation of stable disease or objective response. Patients were stratified by stage (IIIA vs IIIB), response to chemoradiotherapy (stable disease vs objective response), delivery of chemoradiotherapy (concurrent vs sequential), and region using block randomisation, and were randomly assigned (2:1, double-blind) by a central interactive voice randomisation system to either tecemotide or placebo. Injections of tecemotide (806 μg lipopeptide) or placebo were given every week for 8 weeks, and then every 6 weeks until disease progression or withdrawal. Cyclophosphamide 300 mg/m2 (before tecemotide) or saline (before placebo) was given once before the first study drug administration. The primary endpoint was overall survival in a modified intention-to-treat population.
dcterms:title
Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial
skos:prefLabel
Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial
skos:notation
RIV/00216208:11120/14:43907526!RIV14-MSM-11120___
n9:predkladatel
n10:orjk%3A11120
n3:aktivita
n11:N
n3:aktivity
N
n3:cisloPeriodika
1
n3:dodaniDat
n16:2014
n3:domaciTvurceVysledku
n17:2838869
n3:druhVysledku
n13:J
n3:duvernostUdaju
n15:S
n3:entitaPredkladatele
n5:predkladatel
n3:idSjednocenehoVysledku
49417
n3:idVysledku
RIV/00216208:11120/14:43907526
n3:jazykVysledku
n4:eng
n3:klicovaSlova
trial.; START; The; cancer; lung; cell; non-small; III; stage; for; chemo-radiotherapy; after; therapy; maintenance; placebo; versus; L-BLP25; Tecemotide
n3:klicoveSlovo
n6:The n6:START n6:maintenance n6:trial. n6:Tecemotide n6:cancer n6:cell n6:placebo n6:chemo-radiotherapy n6:versus n6:lung n6:therapy n6:stage n6:L-BLP25 n6:non-small n6:for n6:III n6:after
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[BED71DB3F038]
n3:nazevZdroje
Lancet Oncology
n3:obor
n12:FD
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
22
n3:rokUplatneniVysledku
n16:2014
n3:svazekPeriodika
15
n3:tvurceVysledku
Havel, Libor
n3:wos
000329135300032
s:issn
1470-2045
s:numberOfPages
10
n18:organizacniJednotka
11120