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Randomised, double-blind trial of carboplatin and paclitaxel with daily oral cediranib or placebo in patients with advanced non-small cell lung cancer: NCIC Clinical Trials Group study BR29.
Laurie, S A; Solomon, B J; Seymour, L; Ellis, P M; Goss, G D; Shepherd, F A; Boyer, M J; Arnold, A M; Clingan, P; Laberge, F; Fenton, D; Hirsh, V; Zukin, M; Stockler, M R; Lee, C W; Chen, E X; Montenegro, A; Ding, K; Bradbury, P A.
Afiliación
  • Laurie SA; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia. Electronic address: slaurie@toh.on.ca.
  • Solomon BJ; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Seymour L; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Ellis PM; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Goss GD; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Shepherd FA; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Boyer MJ; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Arnold AM; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Clingan P; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Laberge F; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Fenton D; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Hirsh V; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Zukin M; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Stockler MR; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Lee CW; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Chen EX; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Montenegro A; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Ding K; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
  • Bradbury PA; The NCIC Clinical Trials Group, Kingston, Ontario, Canada; The Australasian Lung Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.
Eur J Cancer ; 50(4): 706-12, 2014 Mar.
Article en En | MEDLINE | ID: mdl-24360368
ABSTRACT

INTRODUCTION:

This randomised double-blind placebo-controlled study evaluated the addition of cediranib, an inhibitor of vascular endothelial growth factor receptors 1-3, to standard carboplatin/paclitaxel chemotherapy in advanced non-small cell lung cancer.

METHODS:

Eligible patients received paclitaxel (200mg/m(2)) and carboplatin (area under the concentration time curve 6) intravenously every 3 weeks. Daily oral cediranib/placebo 20mg was commenced day 1 of cycle 1 and continued as monotherapy after completion of 4-6 cycles of chemotherapy. The primary end-point of the study was overall survival (OS). The trial would continue to full accrual if an interim analysis (IA) for progression-free survival (PFS), performed after 170 events of progression or death in the first 260 randomised patients, revealed a hazard ratio (HR) for PFS of ⩽ 0.70.

RESULTS:

The trial was halted for futility at the IA (HR for PFS 0.89, 95% confidence interval [CI] 0.66-1.20, p = 0.45). A final analysis was performed on all 306 enrolled patients. The addition of cediranib increased response rate ([RR] 52% versus 34%, p = 0.001) but did not significantly improve PFS (HR 0.91, 95% CI 0.71-1.18, p = 0.49) or OS (HR 0.94, 95% CI 0.69-1.30, p=0.72). Cediranib patients had more grade 3 hypertension, diarrhoea and anorexia.

CONCLUSIONS:

The addition of cediranib 20mg daily to carboplatin/paclitaxel chemotherapy increased RR and toxicity, but not survival.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Quinazolinas / Protocolos de Quimioterapia Combinada Antineoplásica / Carboplatino / Paclitaxel / Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Cancer Año: 2014 Tipo del documento: Article
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Quinazolinas / Protocolos de Quimioterapia Combinada Antineoplásica / Carboplatino / Paclitaxel / Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Cancer Año: 2014 Tipo del documento: Article