Oncology Medical News about advanced prostate cancer;active cellular immunotherapy;sipuleucel-T

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Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer
Cancer, 06/23/09

Higano CS et al. - In a study to evaluate the safety and efficacy of sipuleucel-T in 2 identically designed, randomized, double-blind, placebo-controlled trials (D9901 and D9902A) in men with advanced prostate cancer (PC), the integrated results of D9901 and D9902A demonstrate a survival benefit for pts treated with sipuleucel-T vs those treated with placebo. The generally modest toxicity profile, coupled with the survival benefit, suggests a favorable risk-benefit ratio for sipuleucel-T in pts with advanced PC.

Methods

225 pts were randomized in D9901 or D9902A to sipuleucel-T (n=147) or placebo (n=78), given as 3 intravenous infusions approximately 2 wks apart.
Pts were followed for survival until death or a prespecified cutoff of 36 mos after randomization.

Results

Pts randomized to sipuleucel-T demonstrated a 33% reduction in the risk of death.
The treatment effect remained strong after performing adjustments for imbalances in baseline prognostic factors, poststudy treatment chemotherapy use, and non-PC-related deaths.
Additional support for the activity of sipuleucel-T is provided by the correlation between a measure of the product's potency, CD54 up-regulation, and overall survival.
Most common adverse events associated with treatment were chills, pyrexia, headache, asthenia, dyspnea, vomiting, and tremor.
These events were primarily grade 1 and 2, with durations of 1 to 2 days.

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