Presentation Authors: Lawrence I Karsh*, Denver, CO, Andrew J Armstrong, Durham, NC, Christopher Pieczonka, Syracuse, NY, Shaker Dakhil, Wichita, KS, Jeffrey Vacirca, New York, NY, Nicholas J Vogelzang, Las Vegas, NV, Raoul S Concepcion, Nashville, TN, James Bailen, Jeffersonville, IN, Constantine Mantz, Fort Myers, FL, Ronald F Tutrone, Towson, MD, Nancy N Chang, Hong Tang, Bruce Brown, Seattle, WA, Mark C Scholz, Marina del Rey, CA
Introduction: PROCEED [NCT01306890], a large real-world study of sipuleucel-T in men with mCRPC, offers an opportunity to examine patients who experienced longer term (â‰¥3 yr) survivals after receiving sipuleucel-T. The current analysis seeks insights regarding these patients, especially noting the timing of sipuleucel-T relative to the other FDA-approved treatments in the modern era.
Methods: Men with mCRPC receiving sipuleucel-T, given every 2 weeks x 3, were eligible for PROCEED. Follow-up continued until death, study withdrawal, or a minimum of 3 years. Long-term survivors were defined as those who survived â‰¥3 yr. Baseline characteristics and treatments received pre/post-sipuleucel-T are reported in this ad-hoc subgroup analysis.
Results: From 2011-2014, 1902 men received â‰¥1 sipuleucel-T infusion. Of these, an estimated 42.3% survived â‰¥3yr. At baseline, long-term survivors (OS â‰¥3 yr) and those who survived < 3 yr had no notable differences in laboratory measures or patterns of metastatic spread. Long-term survivors were less likely to have received OS-prolonging therapies (abiraterone, enzalutamide, docetaxel, or cabazitaxel) prior to sipuleucel-T, but received more lines of OS-prolonging therapies after sipuleucel-T, compared to those who survived < 3yr (median 2.0 v. 1.0).
Conclusions: In the modern era, a considerable number of patients with mCRPC survived â‰¥3 yr. These patients were more likely to have received sipuleucel-T as 1st-line therapy for mCRPC than those with survivals < 3 yr. Long-term survivors also received more lines of agents known to improve OS in mCRPC after sipuleucel-T.
Source of Funding: Dendreon