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 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.
  
  
  CONCLUSIONS
  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.affiliation: Asklepios Fachkliniken, Robert-Koch-Allee 2, 82131 München-Gauting, Germany. Electronic address: j.pawel@asklepios.com.
authors.forename: Joachim
authors.initials: J
authors.lastname: von Pawel
authors.affiliation: Cancer Research Center, Kashirskoe Shosse 24, Moscow 115478, Russian Federation.
authors.forename: Vera
authors.initials: V
authors.lastname: Gorbounova
authors.affiliation: LungenClinic Grosshansdorf, Member of German Center for Lung Research (DZL), Woehrendamm 80, 22927 Grosshansdorf, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Reck
authors.affiliation: Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology Department of Lung Cancer and Chest Tumors, Roentgen Str 5, Warsaw 02-781, Poland.
authors.forename: Dariusz M
authors.initials: DM
authors.lastname: Kowalski
authors.affiliation: Sanofi, Chilly-Mazarin 91385, France.
authors.forename: Aurore
authors.initials: A
authors.lastname: Allard
authors.affiliation: Sanofi, Vitry-sur-Seine 94403, France.
authors.forename: Mustapha
authors.initials: M
authors.lastname: Chadjaa
authors.affiliation: Sanofi, Vitry-sur-Seine 94403, France.
authors.forename: Augustin
authors.initials: A
authors.lastname: Rey
authors.affiliation: Institut de Cancérologie de l'Ouest, Boulevard Jacques Monod, 44805 Nantes, Saint Herblain Cedex, France.
authors.forename: Jaafar
authors.initials: J
authors.lastname: Bennouna
authors.affiliation: IRCCS AOU San Martino IST, Istituto Nazionale per la Ricerca sul Cancro, Largo R. Benzi 10, 16132 Genova, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Grossi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D010984:Platinum / Q000008:administration & dosage; D012694:Serine / Q000008:administration & dosage / Q000031:analogs & derivatives; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D012694:Serine; D010984:Platinum; C400245:AC 7700
keywords: Non-small cell lung cancer (NSCLC); Ombrabulin; Phase 2; Platinum; Taxane