title: A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results.
abstract: 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.
authors.affiliation: Department of Oncology, Cambridge University Health Partners, Addenbrooke's Hospital, Cambridge, UK.
authors.forename: T
authors.initials: T
authors.lastname: Eisen
authors.affiliation: Medical Department, Boehringer Ingelheim B.V., Alkmaar, The Netherlands.
authors.forename: A-B
authors.initials: AB
authors.lastname: Loembé
authors.affiliation: Department of Chemotherapy, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv, Ukraine.
authors.forename: Y
authors.initials: Y
authors.lastname: Shparyk
authors.affiliation: Cancer Research UK Clinical Research Unit, Beatson West of Scotland Cancer Centre, Glasgow, UK.
authors.forename: N
authors.initials: N
authors.lastname: MacLeod
authors.affiliation: Cancer Research UK Clinical Research Unit, Beatson West of Scotland Cancer Centre, Glasgow, UK.
authors.forename: R J
authors.initials: RJ
authors.lastname: Jones
authors.affiliation: Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Mazurkiewicz
authors.affiliation: Medical Department, Boehringer Ingelheim Ltd., Bracknell, UK.
authors.forename: G
authors.initials: G
authors.lastname: Temple
authors.affiliation: Global Pharmacovigilance, Boehringer Ingelheim Pharma GmbH, Ingelheim, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Dressler
authors.affiliation: Oncology Department, Dnipropetrovsk State Medical Academy, Clinical Hospital #4, Dnipropetrovsk, Ukraine.
authors.forename: I
authors.initials: I
authors.lastname: Bondarenko
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors; D011758:Pyrroles / Q000627:therapeutic use*; D000077210:Sunitinib
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D007211:Indoles; D047428:Protein Kinase Inhibitors; D011758:Pyrroles; D011505:Protein-Tyrosine Kinases; C530716:nintedanib; D000077210:Sunitinib