PMID- 21212157
OWN - NLM
STAT- MEDLINE
DCOM- 20111128
LR  - 20200913
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 22
IP  - 6
DP  - 2011 Jun
TI  - 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.
PG  - 1374-1381
LID - S0923-7534(19)38488-1 [pii]
LID - 10.1093/annonc/mdq618 [doi]
AB  - 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. CONCLUSION: 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.
FAU - Reck, M
AU  - Reck M
AD  - Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Hamburg. 
      Electronic address: dr.martin.reck@web.de.
FAU - Kaiser, R
AU  - Kaiser R
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.
FAU - Eschbach, C
AU  - Eschbach C
AD  - Department of Pneumology, Asklepios Hospitals Harburg, Hamburg, Germany.
FAU - Stefanic, M
AU  - Stefanic M
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.
FAU - Love, J
AU  - Love J
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.
FAU - Gatzemeier, U
AU  - Gatzemeier U
AD  - Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Hamburg.
FAU - Stopfer, P
AU  - Stopfer P
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach.
FAU - von Pawel, J
AU  - von Pawel J
AD  - Department of Pneumology, Asklepios Hospitals Harburg, Hamburg, Germany.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20110106
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Indoles)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.1 (Protein-Tyrosine Kinases)
RN  - G6HRD2P839 (nintedanib)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Indoles/administration & dosage/adverse effects/pharmacokinetics/*therapeutic use
MH  - Lung Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Protein Kinase Inhibitors/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Protein-Tyrosine Kinases/antagonists & inhibitors
MH  - Recurrence
MH  - Treatment Outcome
EDAT- 2011/01/08 06:00
MHDA- 2011/12/13 00:00
CRDT- 2011/01/08 06:00
PHST- 2011/01/08 06:00 [entrez]
PHST- 2011/01/08 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
AID - S0923-7534(19)38488-1 [pii]
AID - 10.1093/annonc/mdq618 [doi]
PST - ppublish
SO  - Ann Oncol. 2011 Jun;22(6):1374-1381. doi: 10.1093/annonc/mdq618. Epub 2011 Jan 6.