title: Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer.
abstract: OBJECTIVE
  We describe the safety of sipuleucel-T using an integrated analysis of 4 randomized, controlled studies in patients with prostate cancer.
  
  
  METHODS
  Adverse events, survival data and laboratory evaluations were examined for common, rare and latent events.
  
  
  RESULTS
  In 5% or more of sipuleucel-T cases some adverse events were reported at a rate at least twice that in controls, including chills in 53.1%, pyrexia in 31.3%, headache in 18.1%, myalgia in 11.8%, influenza-like illness in 9.7% and hyperhidrosis in 5.0%. These events generally occurred within 1 day of infusion, were grade 1 or 2 in severity and resolved in 2 days or less. The incidence of serious adverse events reported was 24.0% in sipuleucel-T cases and 25.1% in controls. Grade 3 or greater adverse events were reported within 1 day of infusion in 40 of 601 sipuleucel-T cases (6.7%) and 7 of 303 controls (2.3%). The incidence rate of reported cerebrovascular events was 3.5% for sipuleucel-T cases and 2.6% in controls.
  
  
  CONCLUSIONS
  Sipuleucel-T therapy in patients with prostate cancer has a side effect profile that is characterized by mild to moderate, short-term, reversible adverse events. There was no evidence of a treatment related increase in autoimmune complications or secondary malignancies after treatment with sipuleucel-T. Sipuleucel-T can be administered safely in the outpatient setting.
authors.affiliation: Department of Urology, Mount Sinai School of Medicine, New York, New York 10029, USA. Simon.Hall@mountsinai.org
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Hall
authors.forename: Laurence
authors.initials: L
authors.lastname: Klotz
authors.forename: Allan J
authors.initials: AJ
authors.lastname: Pantuck
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: George
authors.forename: James B
authors.initials: JB
authors.lastname: Whitmore
authors.forename: Mark W
authors.initials: MW
authors.lastname: Frohlich
authors.forename: Robert B
authors.initials: RB
authors.lastname: Sims
mesh_terms: D000368:Aged; D019496:Cancer Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D014020:Tissue Extracts / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019496:Cancer Vaccines; D014020:Tissue Extracts; C511774:sipuleucel-T