Sipuleucel-T immunotherapy for men with metastatic castration-resistant prostate cancer (mCRPC) is associated with longer survival among those with lower disease burden, according to a new analysis of real-world data presented at the 20th annual meeting of the Society of Urologic Oncology in Washington, DC.
Sipuleucel-T is an autologous cell-based immunotherapy that the FDA approved in 2010 for use in men with asymptomatic or minimally symptomatic mCRPC. In the previous IMPACT trial, treatment with sipuleucel-T was associated with a significant 22% decreased risk of death compared with placebo. The trial had excluded patients with PSA levels below 5 ng/mL.
The new finding is from a study of men in the PROCEED (PROVENGE Registry for the Observation, Collection, and Evaluation of Experience Data) registry who received 1 or more infusions of sipuleucel-T and had a reported baseline PSA value. Ronald F. Tutrone, MD, of Chesapeake Urology and the Greater Baltimore Medical Center in Towson, Maryland, and colleagues divided patients according to PSA level: below 5.0 and 5.0 ng/mL or higher (low- and high-PSA groups, respectively). The low- and high-PSA groups included 451 and 1435 men, respectively.
The median survival time was significantly longer in the low-PSA than high-PSA group (47.9 vs 26.4 months), according to the investigators.
Results also showed that black men had a significantly lower risk of death than white men regardless of baseline PSA level. Among men in the low-PSA group, black men had a 51% decreased risk of death compared with white men. In the high-PSA group, black men had a 20% decreased risk of death.
Use of sipuleucel-T in men with lower disease burden may improve their survival, Dr Tutrone and his colleagues concluded.
Tutrone R, Pieczonka C, Nordquist L, et al. Survival outcomes for metastatic castration-resistant prostate cancer with PSA less than 5 ng/mL treated with sipuleucel-T, overall and by race: Data from the PROCEED registry. Presented at the 20th annual meeting of the Society of Urologic Oncology held December 4 to 6 in Washington, DC. Poster 74.