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An Analysis of Leukapheresis and Central Venous Catheter Use in the Randomized, Placebo Controlled, Phase 3 IMPACT Trial of Sipuleucel-T for Metastatic Castrate Resistant Prostate Cancer.
MedLine Citation:
PMID:  23253957     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSE: Sipuleucel-T is an autologous cellular immunotherapy. We review the safety of the leukapheresis procedure required for sipuleucel-T preparation and complications related to venous catheter use in the randomized, placebo controlled phase 3 IMPACT (IMmunotherapy for ProstAte Cancer Trial) study (NCT 00065442). MATERIALS AND METHODS: A total of 512 patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer were enrolled in the study. All patients were scheduled to undergo 3 standard 1.5 to 2.0 blood volume leukapheresis procedures at 2-week intervals. Leukapheresis related adverse events and those related to venous catheter use were reviewed. Immune cell counts were examined throughout the treatment course. RESULTS: Of 512 enrolled patients 506 underwent 1 or more leukapheresis procedures and were included in this analysis. Adverse events were comparable between the sipuleucel-T and control arms. Leukapheresis related adverse events were primarily associated with transient hypocalcemia (39.3%). Most leukapheresis related adverse events (97%) were of mild/moderate intensity. Median white blood cell count and absolute monocyte and lymphocyte counts were stable and within normal ranges throughout the treatment course. Of all patients 23.3% had a central venous catheter placed primarily for leukapheresis. Patients with vs without a central venous catheter had a higher risk of infection potentially related to catheter use (11.9% vs 1.3%, p <0.0001) and a trend toward a higher incidence of venous vascular events potentially related to catheter use, excluding the central nervous system (5.9% vs 2.1%, p = 0.06). CONCLUSIONS: Adverse events related to leukapheresis are manageable and quickly reversible. The majority of patients can undergo leukapheresis without a central venous catheter. Central venous catheters are associated with an increased risk of infections and venous vascular events. Peripheral intravenous access should be used when feasible.
Authors:
Robert C Flanigan; Anthony J Polcari; Neil D Shore; Thomas H Price; Robert B Sims; Johnathan C Maher; James B Whitmore; John M Corman
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-14
Journal Detail:
Title:  The Journal of urology     Volume:  -     ISSN:  1527-3792     ISO Abbreviation:  J. Urol.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0376374     Medline TA:  J Urol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Affiliation:
Loyola University Stritch School of Medicine, Maywood, Illinois, South Carolina. Electronic address: rflanig@lumc.edu.
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