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J Urol. 2011 Sep;186(3):877-81. doi: 10.1016/j.juro.2011.04.070. Epub 2011 Jul 23.

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

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1
Department of Urology, Mount Sinai School of Medicine, New York, New York 10029, USA. Simon.Hall@mountsinai.org

Abstract

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.

PMID:
21788048
DOI:
10.1016/j.juro.2011.04.070
[Indexed for MEDLINE]
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