DISRUPT: A randomised phase 2 trial of ombrabulin (AVE8062) plus a taxane-platinum regimen as first-line therapy for metastatic non-small cell lung cancer

Joachim von Pawel, Vera Gorbounova, Martin Reck, Dariusz M. Kowalski, Aurore Allard, Mustapha Chadjaa, Augustin Rey, Jaafar Bennouna, Francesco Grossi

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Background: DISRUPT evaluated whether adding the vascular-disrupting agent ombrabulin to a taxane-platinum doublet in the first-line setting improved progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC). Methods: Patients were randomised to ombrabulin 35mg/m2 or placebo followed by a taxane-platinum regimen every 3 weeks. Results: Overall, 176 patients were randomised. After 124 events, median PFS was not significantly improved with ombrabulin vs placebo (5.65 vs 5.45 months; HR 0.948; 60% CI 0.813-1.106; one-sided P= 0.39). The two groups showed similar overall survival (median 11.0 months in both groups), objective response rate (32% ombrabulin; 31% placebo) and safety profiles. Conclusion: This study did not meet its primary endpoint of improving PFS by adding ombrabulin to a taxane-platinum regimen for first-line treatment of metastatic NSCLC.

Original languageEnglish
Pages (from-to)224-229
Number of pages6
JournalLung Cancer
Volume85
Issue number2
DOIs
Publication statusPublished - 2014

Fingerprint

Platinum
Non-Small Cell Lung Carcinoma
Disease-Free Survival
Placebos
Therapeutics
Blood Vessels
AC 7700
taxane
Safety
Survival

Keywords

  • Non-small cell lung cancer (NSCLC)
  • Ombrabulin
  • Phase 2
  • Platinum
  • Taxane

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research
  • Medicine(all)

Cite this

DISRUPT : A randomised phase 2 trial of ombrabulin (AVE8062) plus a taxane-platinum regimen as first-line therapy for metastatic non-small cell lung cancer. / von Pawel, Joachim; Gorbounova, Vera; Reck, Martin; Kowalski, Dariusz M.; Allard, Aurore; Chadjaa, Mustapha; Rey, Augustin; Bennouna, Jaafar; Grossi, Francesco.

In: Lung Cancer, Vol. 85, No. 2, 2014, p. 224-229.

Research output: Contribution to journalArticle

von Pawel, Joachim ; Gorbounova, Vera ; Reck, Martin ; Kowalski, Dariusz M. ; Allard, Aurore ; Chadjaa, Mustapha ; Rey, Augustin ; Bennouna, Jaafar ; Grossi, Francesco. / DISRUPT : A randomised phase 2 trial of ombrabulin (AVE8062) plus a taxane-platinum regimen as first-line therapy for metastatic non-small cell lung cancer. In: Lung Cancer. 2014 ; Vol. 85, No. 2. pp. 224-229.
@article{d7b0b8c5a21d484fb6c34402e9d88917,
title = "DISRUPT: A randomised phase 2 trial of ombrabulin (AVE8062) plus a taxane-platinum regimen as first-line therapy for metastatic non-small cell lung cancer",
abstract = "Background: DISRUPT evaluated whether adding the vascular-disrupting agent ombrabulin to a taxane-platinum doublet in the first-line setting improved progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC). Methods: Patients were randomised to ombrabulin 35mg/m2 or placebo followed by a taxane-platinum regimen every 3 weeks. Results: Overall, 176 patients were randomised. After 124 events, median PFS was not significantly improved with ombrabulin vs placebo (5.65 vs 5.45 months; HR 0.948; 60{\%} CI 0.813-1.106; one-sided P= 0.39). The two groups showed similar overall survival (median 11.0 months in both groups), objective response rate (32{\%} ombrabulin; 31{\%} placebo) and safety profiles. Conclusion: This study did not meet its primary endpoint of improving PFS by adding ombrabulin to a taxane-platinum regimen for first-line treatment of metastatic NSCLC.",
keywords = "Non-small cell lung cancer (NSCLC), Ombrabulin, Phase 2, Platinum, Taxane",
author = "{von Pawel}, Joachim and Vera Gorbounova and Martin Reck and Kowalski, {Dariusz M.} and Aurore Allard and Mustapha Chadjaa and Augustin Rey and Jaafar Bennouna and Francesco Grossi",
year = "2014",
doi = "10.1016/j.lungcan.2014.05.013",
language = "English",
volume = "85",
pages = "224--229",
journal = "Lung Cancer",
issn = "0169-5002",
publisher = "Elsevier Ireland Ltd",
number = "2",

}

TY - JOUR

T1 - DISRUPT

T2 - A randomised phase 2 trial of ombrabulin (AVE8062) plus a taxane-platinum regimen as first-line therapy for metastatic non-small cell lung cancer

AU - von Pawel, Joachim

AU - Gorbounova, Vera

AU - Reck, Martin

AU - Kowalski, Dariusz M.

AU - Allard, Aurore

AU - Chadjaa, Mustapha

AU - Rey, Augustin

AU - Bennouna, Jaafar

AU - Grossi, Francesco

PY - 2014

Y1 - 2014

N2 - Background: DISRUPT evaluated whether adding the vascular-disrupting agent ombrabulin to a taxane-platinum doublet in the first-line setting improved progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC). Methods: Patients were randomised to ombrabulin 35mg/m2 or placebo followed by a taxane-platinum regimen every 3 weeks. Results: Overall, 176 patients were randomised. After 124 events, median PFS was not significantly improved with ombrabulin vs placebo (5.65 vs 5.45 months; HR 0.948; 60% CI 0.813-1.106; one-sided P= 0.39). The two groups showed similar overall survival (median 11.0 months in both groups), objective response rate (32% ombrabulin; 31% placebo) and safety profiles. Conclusion: This study did not meet its primary endpoint of improving PFS by adding ombrabulin to a taxane-platinum regimen for first-line treatment of metastatic NSCLC.

AB - Background: DISRUPT evaluated whether adding the vascular-disrupting agent ombrabulin to a taxane-platinum doublet in the first-line setting improved progression-free survival (PFS) in patients with metastatic non-small cell lung cancer (NSCLC). Methods: Patients were randomised to ombrabulin 35mg/m2 or placebo followed by a taxane-platinum regimen every 3 weeks. Results: Overall, 176 patients were randomised. After 124 events, median PFS was not significantly improved with ombrabulin vs placebo (5.65 vs 5.45 months; HR 0.948; 60% CI 0.813-1.106; one-sided P= 0.39). The two groups showed similar overall survival (median 11.0 months in both groups), objective response rate (32% ombrabulin; 31% placebo) and safety profiles. Conclusion: This study did not meet its primary endpoint of improving PFS by adding ombrabulin to a taxane-platinum regimen for first-line treatment of metastatic NSCLC.

KW - Non-small cell lung cancer (NSCLC)

KW - Ombrabulin

KW - Phase 2

KW - Platinum

KW - Taxane

UR - http://www.scopus.com/inward/record.url?scp=84904102075&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84904102075&partnerID=8YFLogxK

U2 - 10.1016/j.lungcan.2014.05.013

DO - 10.1016/j.lungcan.2014.05.013

M3 - Article

C2 - 24888230

AN - SCOPUS:84904102075

VL - 85

SP - 224

EP - 229

JO - Lung Cancer

JF - Lung Cancer

SN - 0169-5002

IS - 2

ER -