title: Safety and activity of sorafenib in different histotypes of advanced renal cell carcinoma.
abstract: BACKGROUND
  The aim of our study was to evaluate the efficacy and safety in unresectable or advanced renal carcinoma treated with sorafenib, in a situation closely similar to the everyday medical practice.
  
  
  METHODS
  One hundred and thirty-six patients have been treated with 400 mg b.i.d. of sorafenib administered orally until disease progression or unacceptable toxicity. They were either previously untreated or relapsed after one or more previous treatments with systemic therapy. Most of them had clear cell renal carcinoma (RCC), but other histological types such as papillary, chromophobe, Bellini ducts, sarcomatoid and mixed forms were also represented.
  
  
  RESULTS
  Overall disease control of 70.6% was achieved with 7.9% of partial remissions. Response was observed in the majority of patients with RCC, but also in some patients with non-clear cell RCC. Safety was acceptable, with the most common adverse events consisting of hand-foot skin reaction, cutaneous rash, diarrhoea, fatigue and hypertension.
  
  
  CONCLUSIONS
  The results confirm previous ones reported in the literature concerning the efficacy and the safety of sorafenib as second-line treatment in patients with RCC. In addition, they disclose the hypothesis that sorafenib could be effective also in patients who underwent multiple previous treatments and in those with histology different from clear cells.
authors.affiliation: Medical Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. emilio.bajetta@istitutotumori.mi.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Procopio
authors.forename: Elena
authors.initials: E
authors.lastname: Verzoni
authors.forename: Arpine
authors.initials: A
authors.lastname: Gevorgyan
authors.forename: Maddalena
authors.initials: M
authors.lastname: Mancin
authors.forename: Sara
authors.initials: S
authors.lastname: Pusceddu
authors.forename: Laura
authors.initials: L
authors.lastname: Catena
authors.forename: Marco
authors.initials: M
authors.lastname: Platania
authors.forename: Valentina
authors.initials: V
authors.lastname: Guadalupi
authors.forename: Antonia
authors.initials: A
authors.lastname: Martinetti
authors.forename: Emilio
authors.initials: E
authors.lastname: Bajetta
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D001557:Benzenesulfonates / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D002291:Carcinoma, Papillary / Q000188:drug therapy / Q000556:secondary; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011379:Prognosis; D011725:Pyridines / Q000627:therapeutic use*; D012074:Remission Induction; D016879:Salvage Therapy; D000077157:Sorafenib; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib