title: Biweekly sunitinib regimen reduces toxicity and retains efficacy in metastatic renal cell carcinoma: a single-center experience with 31 patients.
abstract: OBJECTIVE
  Sunitinib is the standard care for first-line treatment of metastatic renal cell carcinoma. The aim of this study was to determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could maintain the same dose-intensity as the standard 4-weeks on/2-weeks off schedule, and provide the same efficacy in terms of objective response, progression-free survival and overall survival, while reducing drug-related toxicity.
  
  
  METHODS
  A total of 31 patients with metastatic renal cell carcinoma received sunitinib orally at the dose of 50 mg/day in a 2-weeks on/1-week off regimen until disease progression or intolerable toxicities occurred.
  
  
  RESULTS
  All enrolled patients were assessable in terms of toxicity and response. They received treatment for a median of 16 months (range 2.0-36.0+ months). A total of 13 patients (42%) obtained an objective response; disease stabilization was achieved in 10 patients (32%), whereas eight patients (26%) experienced disease progression. The most important toxicities were anemia, gastrointestinal effects, fatigue and hypertension, but they were all controlled.
  
  
  CONCLUSIONS
  Sunitinib 50 mg given orally in a 2-weeks on/1-week off regimen can provide a high response rate and avoid drug-related toxicities, achieving the same dose intensity as the standard schedule, and probably longer disease control.
authors.affiliation: Department of Oncology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy. bruno.neri@unifi.it
authors.forename: Bruno
authors.initials: B
authors.lastname: Neri
authors.forename: Agnese
authors.initials: A
authors.lastname: Vannini
authors.forename: Marco
authors.initials: M
authors.lastname: Brugia
authors.forename: Andrea
authors.initials: A
authors.lastname: Muto
authors.forename: Sheila
authors.initials: S
authors.lastname: Rangan
authors.forename: Mattia
authors.initials: M
authors.lastname: Rediti
authors.forename: Renato
authors.initials: R
authors.lastname: Tassi
authors.forename: Carmine
authors.initials: C
authors.lastname: Cerullo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D000077210:Sunitinib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib