©TheCanadian Journal ofUrology™: International Supplement, April 2014
lowerbaselinePSAvalues. This suggests thatpatients
with less advanceddiseasemaybenefit themost from
sipuleucel-Ttreatment. Itprovidesadditionalrationale
for immunotherapy as an early treatment strategy in
sequencingalgorithms formCRPC. PSAquartiledata
and survival is found inTable2.
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Practicalaspectsofsipuleucel-Tadministration
Sipuleucel-Tadministrationcanbelogisticallyintensive,
requiring a good communication infrastructure
between clinicians who perform leukapheresis, the
manufacturing facility that performs the ex-vivo
procedures on the patient’s APCs and prepares the
cells for infusion, the patient and the infusion staff.
Sipuleucel-T is administered in three treatment cycles
and is typically completed in1month. Leukapheresis
is usually completed early in theweekwith infusion
later in theworkweek, seeFigure1.
• Eachcycleconsistsof twovisits: leukapheresisatan
approvedcellcollectioncenter followedby infusion
3days laterwhen theproduct is returned from the
processing center
• Each leukapheresis/infusion cycle is generally 1
week
• After the three cycles are completed, no further
sipuleucel-T treatments are administered
The manufacturer of sipuleucel-T (Dendreon,
Seattle, WA, USA), provides patient and physician
scheduling logistical support to insure that the
collection, processing and infusion are coordinated.
Inmostcases, insurancecompanypre-authorization is
required. Onlymanufacturerapproved leukapheresis
centerscanbeused for theautologousAPCcollection.
The majority of the information presented below is
basedon the approvedFDA label (available atwww.
PROVENGE.com; accessed December 15, 2013) and
published clinical data.
Figure1 .
Sequenceof sipuleucel-T treatment (CourtesyDendreon, Seattle,Washington).
53
GomellaETAL.
