Safety profile across four trials shows most adverse events are either mild or moderate

-- Rick Ansorge

Tuesday, June 1, 2010 (Last Updated: 06/02/2010)

TUESDAY, June 1 (HealthDay News) -- In men with metastatic castrate-resistant prostate cancer or androgen-dependent prostate cancer, sipuleucel-T immunotherapy appears to be safe, according to research presented at the annual meeting of the American Urological Association, held from May 29 to June 3 in San Francisco.

Simon J. Hall, M.D., of the Mount Sinai Medical Center in New York City, and colleagues described the safety profile of sipuleucel-T across three phase 3 studies in metastatic castrate-resistant prostate cancer, and one randomized trial in androgen-dependent prostate cancer. The safety population included 904 patients, 601 of whom received at least one infusion of sipuleucel-T and 303 of whom received placebo.

The researchers found that adverse events more commonly experienced by sipuleucel-T patients were chills (53.1 percent), pyrexia (31.3 percent), headache (18.1 percent), myalgia (11.8 percent), influenza-like illness (9.7 percent), and hyperhidrosis (5 percent). However, they found that most of these events were mild or moderate, occurred less than one day after infusion, and resolved within two days. Only 3.5 percent of sipuleucel-T-treated patients experienced grade 3 acute infusion reactions, while none experienced any grade 4 or 5 acute infusion reactions. The researchers also found that rates of cerebrovascular events were 3.5 percent in the treatment arm versus 2.6 percent in the placebo arm, but observed no evidence of a difference in the time to onset of these events or in the incidence of non-neurologic arterial or venous vascular events.

"Sipuleucel-T is well tolerated in both the castrate-resistant prostate cancer and androgen-dependent prostate cancer settings," the authors conclude. "Acute infusion reactions can be managed in the outpatient setting."

Abstract No. 674

Specialties Hematology & Oncology

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