Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer.

Journal Article (Journal Article)

PURPOSE: We describe the safety of sipuleucel-T using an integrated analysis of 4 randomized, controlled studies in patients with prostate cancer. MATERIALS AND 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.

Full Text

Duke Authors

Cited Authors

  • Hall, SJ; Klotz, L; Pantuck, AJ; George, DJ; Whitmore, JB; Frohlich, MW; Sims, RB

Published Date

  • September 2011

Published In

Volume / Issue

  • 186 / 3

Start / End Page

  • 877 - 881

PubMed ID

  • 21788048

Electronic International Standard Serial Number (EISSN)

  • 1527-3792

Digital Object Identifier (DOI)

  • 10.1016/j.juro.2011.04.070


  • eng

Conference Location

  • United States