Integrated Safety Data From 4 Randomized, Double-Blind, Controlled Trials of Autologous Cellular Immunotherapy With Sipuleucel-T in Patients With Prostate Cancer
2011; Lippincott Williams & Wilkins; Volume: 186; Issue: 3 Linguagem: Inglês
10.1016/j.juro.2011.04.070
ISSN1527-3792
AutoresSimon J. Hall, Laurence Klotz, Allan J. Pantuck, Daniel J. George, James B. Whitmore, Mark W. Frohlich, Robert B. Sims,
Tópico(s)Prostate Cancer Treatment and Research
ResumoWe describe the safety of sipuleucel-T using an integrated analysis of 4 randomized, controlled studies in patients with prostate cancer.Adverse events, survival data and laboratory evaluations were examined for common, rare and latent events.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.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.
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