title: Sorafenib in platinum-treated patients with extensive stage small cell lung cancer: a Southwest Oncology Group (SWOG 0435) phase II trial.
abstract: BACKGROUND
  Sorafenib is a multikinase inhibitor affecting pathways involved in tumor progression and angiogenesis. We conducted a phase II trial of sorafenib in platinum-treated patients with extensive stage small cell lung cancer to determine the tumor response rate, toxicity, and overall survival.
  
  
  METHODS
  Patients with histologically confirmed, measurable disease, Zubrod performance status 0 to 1, and no more than 1 prior platinum-based treatment were eligible. Patients were stratified by platinum-sensitivity status: sensitive (progression >90 days after platinum) or refractory (progression during or ≤90 days after platinum). Patients were treated with sorafenib 400 mg orally twice a day continuously on a 28-day cycle.
  
  
  RESULTS
  Of 89 patients registered, 82 were evaluable for toxicity assessment, and 83 were evaluable for response. There were four partial responses seen among the 38 patients in the platinum-sensitive stratum, for an estimated response rate of 11% (95% confidence interval: 3-25%), and one partial response among the 45 patients in the platinum-refractory stratum, for an estimated response rate of 2% (95% confidence interval: 0-12%). The median overall survival estimates were 6.7 months (95% confidence interval: 6.1-9.1 months) for the platinum-sensitive stratum and 5.3 months (95% confidence interval: 3.3-7.5 months) in the platinum-refractory stratum. Nineteen patients discontinued treatment because of adverse events or side effects from therapy.
  
  
  CONCLUSIONS
  Based on the lack of disease control seen in our trial, further investigation of single-agent sorafenib in the small cell lung cancer population is not recommended. Combination trials of sorafenib and chemotherapy are ongoing.
authors.affiliation: University of Southern California, Los Angeles, California 90033, USA. gitlitz@usc.edu
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Gitlitz
authors.forename: James
authors.initials: J
authors.lastname: Moon
authors.forename: Bonnie S
authors.initials: BS
authors.lastname: Glisson
authors.forename: H Joachim
authors.initials: HJ
authors.lastname: Reimers
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Bury
authors.forename: Justin D
authors.initials: JD
authors.lastname: Floyd
authors.forename: Thomas K
authors.initials: TK
authors.lastname: Schulz
authors.forename: P Kothai
authors.initials: PK
authors.lastname: Sundaram
authors.forename: Christopher
authors.initials: C
authors.lastname: Ho
authors.forename: David R
authors.initials: DR
authors.lastname: Gandara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy*; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D010671:Phenylurea Compounds; D011725:Pyridines / Q000627:therapeutic use*; D012074:Remission Induction; D016879:Salvage Therapy; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000473:pathology; D000077157:Sorafenib; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D009944:Organoplatinum Compounds; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib