title: Efficacy of sunitinib in patients with metastatic or unresectable renal cell carcinoma and renal insufficiency.
abstract: OBJECTIVE
  The aim of this retrospective, registry-based study was to analyse treatment outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with sunitinib and renal insufficiency (RI).
  
  
  METHODS
  The cohort included 790 patients treated with sunitinib between 2006 and 2013. At the start of sunitinib therapy 22, 234, and 534 patients had severe (glomerular filtration rate [GFR] <30ml/min/1.73m(2)), moderate (GFR 30-60 ml/min/1.73m(2)) or mild RI/normal renal function (GFR >60ml/min/1.73m(2)), respectively.
  
  
  RESULTS
  For the three groups defined above, median progression-free survival (PFS) (95% confidence interval [CI]) was 5.3 months (0.1-18.5), 8.1 months (6.2-9.9) and 11.3 months (9.4-13.2) (p=0.244), and median overall survival (OS) was 26.3 months (1.2-51.4), 21.2 months (13.2-29.1) and 26.3 months (22.6-29.9) (p=0.443), respectively. The disease control rates were 45.5%, 56.4% and 59.2%, respectively (p=0.374). No unexpected toxicity was reported in the patients with RI, but the treatment was more frequently discontinued because of adverse events and the duration of therapy was significantly shorter in these patients (p=0.007).
  
  
  CONCLUSIONS
  Duration of first-line targeted treatment for mRCC was significantly shorter for patients with RI, and may have translated into a trend to shorter PFS. These results highlight the need for optimal management of side-effects in patients with mRCC and RI.
authors.affiliation: Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Zluty kopec 7, 656 53 Brno, Czech Republic.
authors.forename: Alexandr
authors.initials: A
authors.lastname: Poprach
authors.affiliation: Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 126/3, 625 00 Brno, Czech Republic.
authors.forename: Zbynek
authors.initials: Z
authors.lastname: Bortlicek
authors.affiliation: Department of Oncology, Palacky University Medical School and Teaching Hospital, I.P. Pavlova 6, 775 20 Olomouc, Czech Republic.
authors.forename: Bohuslav
authors.initials: B
authors.lastname: Melichar
authors.affiliation: Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Zluty kopec 7, 656 53 Brno, Czech Republic.
authors.forename: Radek
authors.initials: R
authors.lastname: Lakomy
authors.affiliation: Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Zluty kopec 7, 656 53 Brno, Czech Republic.
authors.forename: Marek
authors.initials: M
authors.lastname: Svoboda
authors.affiliation: Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Zluty kopec 7, 656 53 Brno, Czech Republic.
authors.forename: Igor
authors.initials: I
authors.lastname: Kiss
authors.affiliation: Department of Oncology, General University Hospital and Charles University First Faculty of Medicine, U Nemocnice 499/2, 128 08 Prague, Czech Republic.
authors.forename: Milada
authors.initials: M
authors.lastname: Zemanova
authors.affiliation: Department of Oncology, University Hospital, Svobody 80, 304 60 Pilsen, Czech Republic.
authors.forename: Ondrej
authors.initials: O
authors.lastname: Fiala
authors.affiliation: Department of Oncology, Motol University Hospital and Charles University Second Faculty of Medicine,V uvalu 84/1, 150 00 Prague, Czech Republic.
authors.forename: Katerina
authors.initials: K
authors.lastname: Kubackova
authors.affiliation: Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Zluty kopec 7, 656 53 Brno, Czech Republic.
authors.forename: Oldrich
authors.initials: O
authors.lastname: Coufal
authors.affiliation: Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 126/3, 625 00 Brno, Czech Republic.
authors.forename: Tomas
authors.initials: T
authors.lastname: Pavlik
authors.affiliation: Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Kamenice 126/3, 625 00 Brno, Czech Republic.
authors.forename: Ladislav
authors.initials: L
authors.lastname: Dusek
authors.affiliation: Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Faculty of Medicine, Masaryk University, Zluty kopec 7, 656 53 Brno, Czech Republic.
authors.forename: Rostislav
authors.initials: R
authors.lastname: Vyzula
authors.affiliation: Department of Oncology and First Faculty of Medicine, Thomayer Hospital and Charles University, Videnska 800, 140 59 Prague, Czech Republic. Electronic address: tomas.buchler@ftn.cz.
authors.forename: Tomas
authors.initials: T
authors.lastname: Buchler
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011758:Pyrroles / Q000627:therapeutic use*; D051437:Renal Insufficiency / Q000503:physiopathology*; D012189:Retrospective Studies; D000077210:Sunitinib
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: Renal cell carcinoma; Renal insufficiency; Sunitinib; Survival; Treatment duration