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Sipuleucel-T is an immunotherapeutic vaccine that was approved in April 2010 based on the results of the IMPACT trial, which showed that the use of sipuleucel-T prolonged overall survival in individuals with metastatic castration-resistant prostate cancer (mCRPC). Prior to the approval of sipuleucel-T, docetaxel was the primary therapeutic option for this population of patients.
The preparation of sipuleucel-T requires the extraction of a patient’s white blood cells through leukapheresis. The patient's immune cells are then incubated with a protein designed to activate the immune cells to mount a response against prostate cancer cells. The final activated product is given as a series of 3 doses administered at approximately 2-week intervals.
Michael Williams, MD, comments that sipuleucel-T is generally well tolerated; common reactions include fever and chills. Kenneth Kernen, MD, adds that because a course of therapy with sipuleucel-T can be completed in approximately 1 month, clinicians may prefer to use this agent first in terms of sequencing of lines of therapy.
Phillippa Cheetham, MD, remarks that it is important for clinicians and patients to understand the relevance of PSA levels. Patients may experience a survival benefit with therapy; however, PSA levels may not necessarily improve with therapy. Cheetham emphasizes the need to carefully monitor patients and take into account the overall clinical situation.