Appears to prolong overall survival in men with metastatic castration-resistant prostate cancer-- Eric Metcalf
Wednesday, July 28, 2010 (Last Updated: 07/29/2010)
WEDNESDAY, July 28 (HealthDay News) -- Sipuleucel-T -- a therapeutic cancer vaccine -- is associated with prolonged overall survival in men with metastatic castration-resistant prostate cancer, but without a longer time to disease progression, according to research published in the July 29 issue of the New England Journal of Medicine.
Philip W. Kantoff, M.D., of Harvard Medical School in Boston, and colleagues analyzed data from 512 patients with metastatic castration-resistant prostate cancer who were randomized to receive intravenous sipuleucel-T or placebo every two weeks, for a total of three infusions. The primary end point was overall survival.
The researchers found that the risk of death was lower in the sipuleucel-T group (hazard ratio, 0.78), for a 4.1-month improvement in median survival (25.8 versus 21.7 months). The probability of survival at 36 months was 31.7 percent with sipuleucel-T versus 23 percent with placebo. However, the groups had similar time to objective disease progression (median 3.7 versus 3.6 months). Adverse events that were more often noted in the treatment group included chills, fever, and headache.
"In our study, the effect of sipuleucel-T on survival was observed consistently across subgroups of patients, including those with prognostic factors known to be adversely correlated with overall survival, such as increased levels of prostate-specific antigen, lactate dehydrogenase, and alkaline phosphatase, as well as an increased number of bone metastases, an increased Gleason score, a decreased performance status, and the presence of pain," the authors write.
The study was supported by Dendreon, which employs several of the co-authors.
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