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 35 mg/m(2) 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.

• Authors: Joachim von Pawel, Vera Gorbounova, Martin Reck, Dariusz M Kowalski, Aurore Allard, Mustapha Chadjaa, Augustin Rey, Jaafar Bennouna, Francesco Grossi, DISRUPT Investigators
• Journal: Lung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 85 Issue 2 Pg. 224-9 (Aug 2014) ISSN: 1872-8332 [Electronic] Ireland
• PMID: 24888230 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Chemical References

• Bridged-Ring Compounds
• Taxoids
• taxane
• Serine
• Platinum
• AC 7700

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bridged-Ring Compounds (administration & dosage)
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, pathology)
• Female
• Humans
• Lung Neoplasms (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Neoplasm Metastasis
• Neoplasm Recurrence, Local
• Platinum (administration & dosage)
• Serine (administration & dosage, analogs & derivatives)
• Taxoids (administration & dosage)
• Treatment Outcome