title: A phase II double-blind study to investigate efficacy and safety of two doses of the triple angiokinase inhibitor BIBF 1120 in patients with relapsed advanced non-small-cell lung cancer.
abstract: BACKGROUND
  To assess the efficacy, safety, tolerability and pharmacokinetics of BIBF 1120 in patients with stage IIIB/IV non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with locally advanced or metastatic relapsed NSCLC in whom first- or second-line platinum-based chemotherapy failed were randomly allocated to daily 250 mg BIBF 1120 b.i.d. or 150 mg BIBF 1120 b.i.d. Primary end points were progression-free survival (PFS) and objective tumour response (RECIST). Incidence and severity of adverse events (AEs) were reported.
  
  
  RESULTS
  Seventy-three patients received BIBF 1120. Median PFS was 6.9 weeks, with no significant difference between treatment arms. Median overall survival (OS) was 21.9 weeks. Eastern Cooperative Oncology Group (ECOG) 0-1 patients (n = 56) had a median PFS of 11.6 weeks and a median OS of 37.7 weeks. Tumour stabilisation was achieved in 46% of patients (ECOG 0-1 patients: 59%), with one confirmed partial response (250 mg b.i.d.). Most commonly reported drug-related AEs were nausea (57.5%), diarrhoea (47.9%), vomiting (42.5%), anorexia (28.8%), abdominal pain (13.7%) and reversible alanine transaminase (13.7%) and aspartate aminotransferase elevations (9.6%). BIBF 1120 displayed dose-linear pharmacokinetic characteristics.
  
  
  CONCLUSIONS
  Continuous treatment with BIBF 1120 was well tolerated, with no difference in efficacy between treatment arms. PFS and objective response with single-agent treatment in advanced disease warrants further exploration.
authors.affiliation: Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Hamburg. Electronic address: dr.martin.reck@web.de.
authors.forename: M
authors.initials: M
authors.lastname: Reck
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.
authors.forename: R
authors.initials: R
authors.lastname: Kaiser
authors.affiliation: Department of Pneumology, Asklepios Hospitals Harburg, Hamburg, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Eschbach
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.
authors.forename: M
authors.initials: M
authors.lastname: Stefanic
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.
authors.forename: J
authors.initials: J
authors.lastname: Love
authors.affiliation: Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Hamburg.
authors.forename: U
authors.initials: U
authors.lastname: Gatzemeier
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.
authors.forename: P
authors.initials: P
authors.lastname: Stopfer
authors.affiliation: Department of Pneumology, Asklepios Hospitals Harburg, Hamburg, Germany.
authors.forename: J
authors.initials: J
authors.lastname: von Pawel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D007211:Indoles; D047428:Protein Kinase Inhibitors; D011505:Protein-Tyrosine Kinases; C530716:nintedanib