title: Standard vs adapted sunitinib regimen in elderly patients with metastatic renal cell cancer: results from a large retrospective analysis.
abstract: BACKGROUND
  There are no data on the patterns of care and outcome of elderly patients with mRCC treated with sunitinib. In a retrospective study, we assessed the routine use of first-line sunitinib in mRCC patients aged ≥ 70 years.
  
  
  METHODS
  We reviewed the clinical files of 185 patients aged ≥ 70 years with mRCC treated with first-line sunitinib in 17 Italian oncology units from February 2006 to September 2011. One hundred twenty-three patients (66.5%) received a standard 50 mg/d for a 4 weeks on/2 weeks off regimen (SR), and 62 patients (33.5%) received an AR consisting of 37.5 mg/d for a 4 weeks on/2 weeks off in 67.7% of cases.
  
  
  RESULTS
  Median age was 74 years. Patients treated with an AR were older than those treated with the SR (P < .0001). In the overall population, the median progression-free survival (PFS) was 11 months, and the median overall survival (OS) was 25.5 months. Grade 3-4 toxicities occurred in 87 of 123 SR (70.7%) and 32 of 62 AR (51.6%), respectively; dose reductions were required in 82 SR (66.7%) and 26 AR (41.9%), respectively; discontinuations because of therapy-related adverse events occurred in 25 SR (20.3%) and 15 AR (24.2%), respectively. In multivariate analysis, only performance status and the Heng score were predictors of either PFS or OS.
  
  
  CONCLUSIONS
  Sunitinib is active and feasible in elderly patients with mRCC. A sunitinib AR could be considered as an option in selected older mRCC patients. The optimal treatment of frail patients with mRCC remains to be established.
authors.affiliation: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, Italy. Electronic address: u.degiorgi@irst.emr.it.
authors.forename: Ugo
authors.initials: U
authors.lastname: De Giorgi
authors.affiliation: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Scarpi
authors.affiliation: Santa Maria della Misericordia Hospital, Udine, Italy.
authors.forename: Cosimo
authors.initials: C
authors.lastname: Sacco
authors.affiliation: CROB, Rionero in Vulture, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Aieta
authors.affiliation: Santa Maria degli Angeli Hospital, Pordenone, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lo Re
authors.affiliation: Borgo Trento Hospital, Verona, Italy.
authors.forename: Teodoro
authors.initials: T
authors.lastname: Sava
authors.affiliation: University Hospital, Modena, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Masini
authors.affiliation: Humanitas Hospital, Milano, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: De Vincenzo
authors.affiliation: Oncologia 2 - AOU Careggi, Florence, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Baldazzi
authors.affiliation: Versilia Hospital, Lido di Camaiore, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Camerini
authors.affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fornarini
authors.affiliation: University Hospital, Ancona, Italy.
authors.forename: Luciano
authors.initials: L
authors.lastname: Burattini
authors.affiliation: Ca' Foncello Hospital, Treviso, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Rosti
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Ferrari
authors.affiliation: Belcolle Hospital, Viterbo, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Moscetti
authors.affiliation: Fazzi Hospital, Lecce, Italy.
authors.forename: Vincenzo Emanuele
authors.initials: VE
authors.lastname: Chiuri
authors.affiliation: San Salvatore Hospital, Pesaro, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Luzi Fedeli
authors.affiliation: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, Italy.
authors.forename: Dino
authors.initials: D
authors.lastname: Amadori
authors.affiliation: Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Basso
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D011379:Prognosis; D016016:Proportional Hazards Models; D011758:Pyrroles / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077210:Sunitinib; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: Adapted regimen; Clinical outcome; First-line; Older patients; Prognosis