Advanced

Effect of celecoxib on survival in patients with advanced non-small cell lung cancer: A double blind randomised clinical phase III trial (CYCLUS study) by the Swedish Lung Cancer Study Group

Koch, Andrea; Bergman, Bengt; Holmberg, Erik; Sederholm, Christer; Ek, Lars LU ; Kosieradzki, Jaroslaw LU ; Lamberg, Kristina; Thaning, Lars; Ydreborg, Sven-Olof and Sorenson, Sverre (2011) In European Journal of Cancer 47(10). p.1546-1555
Abstract
Background: Increased expression of cyclooxygenase-2 (COX-2) is common in non-small cell lung cancer (NSCLC) and has been associated with poor prognosis. Experimental and clinical phase II trials have indicated that the addition of the COX-2 inhibitor celecoxib to palliative chemotherapy might increase survival time in patients with advanced NSCLC. Methods: We performed a double-blind, placebo-controlled multicentre phase III trial at 13 centres in Sweden. Three hundred and nineteen patients with advanced NSCLC stage IIIB-IV and performance status 0-2 were randomised to receive celecoxib 400 mg b.i.d. or placebo in addition to palliative chemotherapy. The primary objective was to compare overall survival. Other end-points were quality of... (More)
Background: Increased expression of cyclooxygenase-2 (COX-2) is common in non-small cell lung cancer (NSCLC) and has been associated with poor prognosis. Experimental and clinical phase II trials have indicated that the addition of the COX-2 inhibitor celecoxib to palliative chemotherapy might increase survival time in patients with advanced NSCLC. Methods: We performed a double-blind, placebo-controlled multicentre phase III trial at 13 centres in Sweden. Three hundred and nineteen patients with advanced NSCLC stage IIIB-IV and performance status 0-2 were randomised to receive celecoxib 400 mg b.i.d. or placebo in addition to palliative chemotherapy. The primary objective was to compare overall survival. Other end-points were quality of life, progression-free survival, toxicity, cardiovascular events and biological markers. The trial is registered with ClinicalTrials.gov, No. NCT00300729. Findings: Three hundred and sixteen patients were included in the analysis, 158 in each treatment group. Median survival time was 8.5 months. There was no survival difference between the treatment arms. Small but not statistically significant differences in global quality of life and pain were seen favouring the celecoxib group. No increased incidence of cardiovascular events was observed in the celecoxib group. Interpretation: This study failed to demonstrate a survival benefit of the addition of celecoxib to palliative chemotherapy. (C) 2011 Elsevier Ltd. All rights reserved. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Non-small cell lung cancer, Cyclooxygenase-2 inhibitor, Celecoxib, Chemotherapy, Palliative treatment, Quality of life
in
European Journal of Cancer
volume
47
issue
10
pages
1546 - 1555
publisher
IFAC & Elsevier Ltd.
external identifiers
  • wos:000292946200015
  • scopus:79958788120
ISSN
1879-0852
DOI
10.1016/j.ejca.2011.03.035
language
English
LU publication?
yes
id
7d6e97cb-2729-4ec2-afa0-b8aecdc7c7c4 (old id 2092689)
date added to LUP
2011-09-02 08:34:16
date last changed
2017-11-19 03:18:17
@article{7d6e97cb-2729-4ec2-afa0-b8aecdc7c7c4,
  abstract     = {Background: Increased expression of cyclooxygenase-2 (COX-2) is common in non-small cell lung cancer (NSCLC) and has been associated with poor prognosis. Experimental and clinical phase II trials have indicated that the addition of the COX-2 inhibitor celecoxib to palliative chemotherapy might increase survival time in patients with advanced NSCLC. Methods: We performed a double-blind, placebo-controlled multicentre phase III trial at 13 centres in Sweden. Three hundred and nineteen patients with advanced NSCLC stage IIIB-IV and performance status 0-2 were randomised to receive celecoxib 400 mg b.i.d. or placebo in addition to palliative chemotherapy. The primary objective was to compare overall survival. Other end-points were quality of life, progression-free survival, toxicity, cardiovascular events and biological markers. The trial is registered with ClinicalTrials.gov, No. NCT00300729. Findings: Three hundred and sixteen patients were included in the analysis, 158 in each treatment group. Median survival time was 8.5 months. There was no survival difference between the treatment arms. Small but not statistically significant differences in global quality of life and pain were seen favouring the celecoxib group. No increased incidence of cardiovascular events was observed in the celecoxib group. Interpretation: This study failed to demonstrate a survival benefit of the addition of celecoxib to palliative chemotherapy. (C) 2011 Elsevier Ltd. All rights reserved.},
  author       = {Koch, Andrea and Bergman, Bengt and Holmberg, Erik and Sederholm, Christer and Ek, Lars and Kosieradzki, Jaroslaw and Lamberg, Kristina and Thaning, Lars and Ydreborg, Sven-Olof and Sorenson, Sverre},
  issn         = {1879-0852},
  keyword      = {Non-small cell lung cancer,Cyclooxygenase-2 inhibitor,Celecoxib,Chemotherapy,Palliative treatment,Quality of life},
  language     = {eng},
  number       = {10},
  pages        = {1546--1555},
  publisher    = {IFAC & Elsevier Ltd.},
  series       = {European Journal of Cancer},
  title        = {Effect of celecoxib on survival in patients with advanced non-small cell lung cancer: A double blind randomised clinical phase III trial (CYCLUS study) by the Swedish Lung Cancer Study Group},
  url          = {http://dx.doi.org/10.1016/j.ejca.2011.03.035},
  volume       = {47},
  year         = {2011},
}