PMID- 26448178
OWN - NLM
STAT- MEDLINE
DCOM- 20160128
LR  - 20190108
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Print)
IS  - 0007-0920 (Linking)
VI  - 113
IP  - 8
DP  - 2015 Oct 20
TI  - A randomised, phase II study of nintedanib or sunitinib in previously untreated 
      patients with advanced renal cell cancer: 3-year results.
PG  - 1140-7
LID - 10.1038/bjc.2015.313 [doi]
AB  - BACKGROUND: This exploratory study evaluated the safety/efficacy of nintedanib or 
      sunitinib as first-line therapy in patients with advanced renal cell carcinoma 
      (RCC). METHODS: Ninety-six patients were randomised (2:1) to either nintedanib 
      (200 mg twice daily) or sunitinib (50 mg kg(-1) once daily (4 weeks on treatment; 
      2 weeks off)). Primary endpoint was progression-free survival (PFS) at 9 months. 
      P-values reported are descriptive only; the study was not powered for such 
      comparisons. RESULTS: Progression-free survival at 9 months was comparable 
      between nintedanib and sunitinib (43.1% vs 45.2%, respectively; P=0.85). Median 
      PFS was 8.4 months in each group (hazard ratio (HR), 1.12; 95% confidence 
      interval (CI): 0.70-1.80; P=0.64). Median overall survival was 20.4 and 21.2 
      months for nintedanib and sunitinib, respectively (HR, 0.92; 95% CI: 0.54-1.56; 
      P=0.76). Overall incidence of any grade adverse events (AEs) was comparable 
      (90.6% vs 93.8%); AEs grade ⩾ 3 were lower with nintedanib than sunitinib (48.4% 
      vs 59.4%). Nintedanib was associated with lower incidences of some AEs typical of 
      antiangiogenic tyrosine kinase inhibitors (TKIs): hypertension, hypothyroidism, 
      hand-foot syndrome, cardiac disorders and haematological abnormalities. 
      CONCLUSIONS: In patients with advanced RCC, nintedanib has promising efficacy and 
      similar tolerability to sunitinib, and a manageable safety profile with fewer 
      TKI-associated AEs.
FAU - Eisen, T
AU  - Eisen T
AD  - Department of Oncology, Cambridge University Health Partners, Addenbrooke's 
      Hospital, Cambridge, UK.
FAU - Loembe, A-B
AU  - Loembe AB
AD  - Medical Department, Boehringer Ingelheim B.V., Alkmaar, The Netherlands.
FAU - Shparyk, Y
AU  - Shparyk Y
AD  - Department of Chemotherapy, Lviv State Oncology Regional Treatment and Diagnostic 
      Centre, Lviv, Ukraine.
FAU - MacLeod, N
AU  - MacLeod N
AD  - Cancer Research UK Clinical Research Unit, Beatson West of Scotland Cancer 
      Centre, Glasgow, UK.
FAU - Jones, R J
AU  - Jones RJ
AD  - Cancer Research UK Clinical Research Unit, Beatson West of Scotland Cancer 
      Centre, Glasgow, UK.
FAU - Mazurkiewicz, M
AU  - Mazurkiewicz M
AD  - Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland.
FAU - Temple, G
AU  - Temple G
AD  - Medical Department, Boehringer Ingelheim Ltd., Bracknell, UK.
FAU - Dressler, H
AU  - Dressler H
AD  - Global Pharmacovigilance, Boehringer Ingelheim Pharma GmbH, Ingelheim, Germany.
FAU - Bondarenko, I
AU  - Bondarenko I
AD  - Oncology Department, Dnipropetrovsk State Medical Academy, Clinical Hospital #4, 
      Dnipropetrovsk, Ukraine.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151008
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Indoles)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrroles)
RN  - EC 2.7.10.1 (Protein-Tyrosine Kinases)
RN  - G6HRD2P839 (nintedanib)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/*therapeutic use
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Indoles/*therapeutic use
MH  - Kidney Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Protein Kinase Inhibitors/therapeutic use
MH  - Protein-Tyrosine Kinases/antagonists & inhibitors
MH  - Pyrroles/*therapeutic use
MH  - Sunitinib
PMC - PMC4647871
EDAT- 2015/10/09 06:00
MHDA- 2016/01/29 06:00
PMCR- 2015/10/20
CRDT- 2015/10/09 06:00
PHST- 2015/02/27 00:00 [received]
PHST- 2015/07/29 00:00 [revised]
PHST- 2015/07/31 00:00 [accepted]
PHST- 2015/10/09 06:00 [entrez]
PHST- 2015/10/09 06:00 [pubmed]
PHST- 2016/01/29 06:00 [medline]
PHST- 2015/10/20 00:00 [pmc-release]
AID - bjc2015313 [pii]
AID - 10.1038/bjc.2015.313 [doi]
PST - ppublish
SO  - Br J Cancer. 2015 Oct 20;113(8):1140-7. doi: 10.1038/bjc.2015.313. Epub 2015 Oct 
      8.