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Cellular immunotherapy for prostate cancer is a treatment for androgen-independent metastatic disease before significant symptomatic manifestations have occurred. The quantity of cancer cells in the patient during this time is considered to be relatively low, and an effective immune response against the cancer could effectively delay or prevent progression. Such a delay could allow effective chemotherapy associated with adverse effects, such as docetaxel, to be deferred or delayed until necessary, thereby, providing an overall survival benefit.
Sipuleucel-T (Provenge®) is an autologous cellular immunotherapy used in the treatment of asymptomatic or minimally symptomatic, androgen-independent (hormone-refractory), metastatic prostate cancer. It consists of specially treated dendritic cells obtained from the patient with leukapheresis. The cells are exposed in vitro to proteins that contain prostate antigens and immunologic stimulating factors, and then reinfused back into the patient. The cells are administered as three intravenous infusions, each infusion given approximately two weeks apart. The treatment is proposed to stimulate the patient’s own immune system to resist spread of the cancer.
Provenge® (sipuleucel-T) has been approved by the U.S. Food and Drug Administration (FDA) via a biologics licensing application for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. It is approved for autologous use only. Serious adverse events that have occurred with sipuleucel-T therapy include acute infusion reactions, thromboembolic events, and vascular disorders. Use of sipuleucel-T therapy in combination with chemotherapy or immunosuppressive agents, such as systemic corticosteroids, has not been studied.
Definitions
Eastern Cooperative Oncology Group (ECOG) Performance Scale
I. Sipuleucel-T therapy may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL the following criteria are met:
II. Sipuleucel-T therapy is considered EXPERIMENTAL/INVESTIGATIVE for all other indications, including but not limited to treatment of the following conditions, due to the lack of evidence demonstrating an impact on improved health outcomes:
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Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.