title: A phase II trial of first-line sorafenib in patients with metastatic renal cell carcinoma unwilling to receive or with early intolerance to immunotherapy: SOGUG Study 06-01.
abstract: OBJECTIVE
  Our aim was to evaluate first-line treatment of metastatic renal cell carcinoma (mRCC) with sorafenib in patients unwilling to receive immunotherapy or with early intolerance to immunotherapy.
  
  
  METHODS
  Patients had clear-cell mRCC with good or intermediate risk status, were unsuited to cytokine therapy due to preference or intolerance (based on <4 weeks prior immunotherapy) and had not received antiangiogenic agents. Patients received sorafenib 400 mg twice daily until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS).
  
  
  RESULTS
  Twenty-six evaluable patients were enrolled at six centres between March and July 2006. The most common metastatic sites were lung and bone; nine patients had one or two metastatic lesions. Median PFS was 7.5 months (95% confidence interval [CI] 5.1-17.5) and overall survival (OS) 15.4 months (95% CI 12.9-17.4). Among 21 patients evaluable for response, 19 (90.5%) experienced disease control (including one complete response; four partial responses; 14 stable disease). The majority of adverse events were grade 1-2 (87.3%). The most common were asthenia (53.0%) and diarrhoea (50.0%).
  
  
  CONCLUSIONS
  In patients with mRCC who were unwilling to receive or intolerant to immunotherapy, treatment with sorafenib led to a high rate of disease control with toxicities that were generally mild and manageable. The PFS achieved in this essentially treatment-naïve population compares favourably with that obtained in the randomised first-line phase II study.
authors.affiliation: Medical Oncology Service, University Hospital del Mar, Barcelona, Spain. jbellmunt@imas.imim.es
authors.forename: Joaquim
authors.initials: J
authors.lastname: Bellmunt
authors.forename: Pablo
authors.initials: P
authors.lastname: Maroto-Rey
authors.forename: José M
authors.initials: JM
authors.lastname: Trigo
authors.forename: Joan
authors.initials: J
authors.lastname: Carles
authors.forename: Vicente
authors.initials: V
authors.lastname: Guillem
authors.forename: José A
authors.initials: JA
authors.lastname: López-Martín
authors.forename: Antonio
authors.initials: A
authors.lastname: Antón-Torres
authors.forename: Leyrer
authors.initials: L
authors.lastname: Urruticoechea
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000473:pathology / Q000556:secondary; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary*; D005260:Female; D006801:Humans; D007167:Immunotherapy; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008175:Lung Neoplasms / Q000473:pathology / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000627:therapeutic use*; D012074:Remission Induction; D000077157:Sorafenib
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib