In a nutshell
The present study summarized the outcomes of four clinical trials assessing the side-effects reported with sipuleucel-T treatment in patients with prostate cancer. The combined results indicated that this drug is relatively safe with mostly mild to moderate, short-term, and reversible side-effects.
Some background
As of April 2010 sipuleucel-T (PROVENGE) was approved by the FDA for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (cancer that does not respond to anti-androgen therapy, or hormone refractory).
Sipuleucel-T is a special prostate cancer vaccine prepared specifically for each patient. A patient's own white blood cells are extracted and loaded with a ‘target protein’ specific for prostate cancer cells; these cells are then re-infused into the patient to cause an immune response against cancer cells carrying the target protein.
Methods & findings
The cumulative study population from the four clinical trials included 904 prostate cancer patients (601 treated with sipuleucel-T versus 303 controls). Most of the reported side-effects developed within one day of therapy and improved within two days. The most common side effects (occurring in ≥10% of patients) associated with sipuleucel-T treatment were chills, fatigue, fever, headache and muscle pain. Less common adverse effects (occurring in ≥ 5% of patients) included flu-like illness and increased perspiration. More severe infusion reactions (characterized by fever and chills) were observed in 21 patients (3.5%) receiving sipuleucel-T and were manageable.
The bottom line
To conclude, sipuleucel-T therapy appears to be relatively safe and can be given safely in outpatient setting. Therapy is indicated for the treatment of prostate cancer in men whose disease has spread outside the prostate gland and did not respond to hormonal therapy.
What’s next?
Ask your doctor about PROVENGE if you are a suitable candidate for this therapy.
Published By :
Journal of Urology
Date :
Sep 01, 2011
