Provenge Treatment for Prostate Cancer, Who Is Eligible?
The Food and Drug Administration (FDA) has approved the long-awaited vaccine-like treatment called Provenge for patients with prostate cancer who fit certain criteria. In clinical trials, Provenge was shown to extend the lives of men who had advanced prostate cancer by an average of four months. But who is eligible?
Provenge (sipuleucel-T) was approved for patients who have prostate cancer that has spread (metastasized) to other parts of the body, who have either minimal or no symptoms from the disease, and who have not responded to hormone-blocking drugs such as the anti-androgens bicalutamide, flutamide, and nilutamide. According to Forbes, about 25,000 prostate cancer patients fit this criteria each year. The American Cancer Society reported that about 192,000 men were diagnosed with prostate cancer in 2009.
The introduction of Provenge (Dendreon Corp) is important for many reasons, perhaps first and foremost that it is the first prostate cancer treatment that utilizes the body’s immune system to battle the cancer cells. As such, it is an important alternative to chemotherapy. Although Provenge is often referred to as a vaccine, it does not prevent prostate cancer, but treats it utilizing vaccine-like (immunotherapy) actions. Provenge will be used as an addition to current medical treatment for prostate cancer and not as a replacement, according to medical experts.
A feature of Provenge is that each man’s treatment regimen must be individually tailored to his immune system through a time-consuming process. Clinicians must collect special blood cells from the patient that help the immune system recognize cancer as an invader. These cells are mixed with a protein common to most prostate cancer cells, along with another substance to stimulate the immune system. The resulting drug is administered to the patient in three separate infusions given two weeks apart.
Reported side effects for Provenge include chills, back pain, nausea, joint pain, fatigue, headache, and fever, according to the FDA. Provenge is an expensive therapy, costing $93,000 per treatment course, according to Forbes.
Provenge is the first drug in a new therapeutic class called active cellular immunotherapies, according to Dendreon press information. In addition to extending the lives of men with advanced prostate cancer, the new drug demonstated a 24.1 percent reduction in the risk for death compared with placebo.
For now, prostate cancer patients who are eligible for Provenge include those who fit certain criteria. Men who have advanced metastatic prostate cancer that has not responded to hormone therapy, and other prostate cancer patients as well, will likely be having a serious conversation with their doctors very soon.
American Cancer Society
Associated Press, April 29, 2010
Forbes, April 29, 2010
Medscape, April 29, 2010