title: An overview of sipuleucel-T: autologous cellular immunotherapy for prostate cancer.
abstract: Sipuleucel-T, the first autologous active cellular immunotherapy approved by the United States Food and Drug Administration, is designed to stimulate an immune response to prostate cancer. Sipuleucel-T is manufactured by culturing a patient's peripheral blood mononuclear cells (including antigen presenting cells) with a recombinant protein comprising a tumor-associated antigen (prostatic acid phosphatase) and granulocyte-macrophage colony stimulating factor. Treatment consists of 3 infusions at approximately 2-week intervals, resulting in a prime-boost pattern of immune activation, a robust antigen-specific cellular and humoral immune response, and, consequently, a survival benefit in subjects with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. Adverse events are generally mild to moderate and resolve within 2 d. Serious adverse events occur at a low rate. As the first autologous cellular immunotherapy to demonstrate a survival benefit, sipuleucel-T is a novel oncologic therapeutic that warrants the reassessment of the current prostate cancer treatment paradigm.
authors.affiliation: Dendreon Corporation, Research, Seattle, WA, USA.
authors.forename: Johnna D
authors.initials: JD
authors.lastname: Wesley
authors.forename: James
authors.initials: J
authors.lastname: Whitmore
authors.forename: James
authors.initials: J
authors.lastname: Trager
authors.forename: Nadeem
authors.initials: N
authors.lastname: Sheikh
mesh_terms: D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods; D008297:Male; D009362:Neoplasm Metastasis / Q000628:therapy*; D011471:Prostatic Neoplasms / Q000556:secondary* / Q000628:therapy*; D016019:Survival Analysis; D014020:Tissue Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014481:United States
chemical_list: D019496:Cancer Vaccines; D007155:Immunologic Factors; D014020:Tissue Extracts; C511774:sipuleucel-T