title: 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.
abstract: OBJECTIVE
  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).
  
  
  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.affiliation: Loyola University Stritch School of Medicine, Maywood, Illinois, USA. rflanig@lumc.edu
authors.forename: Robert C
authors.initials: RC
authors.lastname: Flanigan
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Polcari
authors.forename: Neil D
authors.initials: ND
authors.lastname: Shore
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Price
authors.forename: Robert B
authors.initials: RB
authors.lastname: Sims
authors.forename: Johnathan C
authors.initials: JC
authors.lastname: Maher
authors.forename: James B
authors.initials: JB
authors.lastname: Whitmore
authors.forename: John M
authors.initials: JM
authors.lastname: Corman
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use; D002405:Catheterization, Central Venous / Q000009:adverse effects; D003131:Combined Modality Therapy; D019008:Drug Resistance, Neoplasm; D006801:Humans; D007937:Leukapheresis; D008297:Male; D009362:Neoplasm Metastasis; D011471:Prostatic Neoplasms / Q000473:pathology / Q000628:therapy*; D014020:Tissue Extracts / Q000627:therapeutic use*; D014611:Vaccination
chemical_list: D000726:Androgen Antagonists; D014020:Tissue Extracts; C511774:sipuleucel-T