CHICAGO, IL USA (UroToday.com) - Presented by Celestia S. Higano,1 Andrew J. Armstrong,2 Matthew R. Cooperberg,3 Philip W. Kantoff,4 James L. Bailen,5 Raoul S. Concepcion,6 Vahan Kassabian,7 Shaker R. Dakhil,8 Steven E. Finkelstein,9 Jeffrey L. Vacirca,10 Robert M. Rifkin,11 Andrew Sandler,12 Candice McCoy,12 James B. Whitmore,12 Robert C.Tyler,12 and Oliver Sartor13 at the American Society of Clinical Oncology (ASCO) Annual Meeting - May 31 - June 4, 2013 - McCormick Place - Chicago, IL USA
1University of Washington, Seattle, WA; 2Duke Urology, Durham, NC; 3University of California, San Francisco, San Francisco, CA; 4Dana-Farber Cancer Institute, Boston, MA; 5First Urology, PSC, Jeffersonville, IN,6Urology Associates, Nashville, TN; 7Georgia Urology, Atlanta, GA 8Cancer Center of Kansas, Wichita, KS; 921st Century Oncology of Arizona, Scottsdale, AZ; 10North Shore Hematology Oncology Associates, East Setauket, NY; 11Rocky Mountain Cancer Centers, Denver, CO; 12Dendreon Corporation, Seattle, WA; 13Tulane University School of Medicine, New Orleans, LA
ABSTRACT:
Impact of prior docetaxel (D) on sipuleucel-T (sip-T) product parameters in PROCEED patients (pts)
Celestia S. Higano, Andrew J. Armstrong, Matthew R. Cooperberg, Philip W. Kantoff, James Bailen, Raoul S. Concepcion, Vahan Kassabian, Shaker R. Dakhil, Steven E. Finkelstein, Jeffrey L. Vacirca, Robert M. Rifkin, Andrew Sandler, Candice McCoy, James Boyd Whitmore, Robert Claude Tyler, A. Oliver Sartor
University of Washington/Seattle Cancer Care Alliance, Seattle, WA; Duke Cancer Institute, Durham, NC; University of California, San Francisco, San Francisco, CA; Dana-Farber Cancer Institute, Boston, MA; First Urology, PSC, Jeffersonville, IN; Urology Associates, Nashville, TN; Georgia Urology, Atlanta, GA; Cancer Center of Kansas, Wichita, KS; 21st Century Oncology, Translational Research Consortium (TRC), Scottsdale, AZ; North Shore Hematology Oncology Associates, PC, East Setauket, NY; Rocky Mountain Cancer Centers, US Oncology Research, Denver, CO; Dendreon Corporation, Seattle, WA; Tulane Cancer Center, New Orleans, LA
Background: Sip-T is an autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic mCRPC. The IMPACT trial excluded pts who received D ≤ 3 months prior to registration. PROCEED is an ongoing, phase IV registry, enrolling pts treated with commercial sip-T. Use of D prior to sip-T is not restricted, so prior D affect on sip-T immune manufacturing parameters can be evaluated.
Methods: Pts treated with sip-T ≤ 6 mo were eligible to provide informed consent. Sip-T parameters assessed included: total nucleated cell (TNC) count, antigen presenting cell (APC) count (CD541large cells) and APC activation (upregulation of CD54).
Results: By Nov. 2012, 108/761 (14%) received D prior to sip-T and had similar median cumulative APC counts (1.83 (Q1, Q3: 1.16, 2.71) vs. 1.82 (1.27, 2.70) x 109) and TNC counts (10.16 (7.30, 13.69) vs. 11.47 (8.56, 15.31) x 109) vs. D naïve, whereas median cumulative APC activation appeared slightly lower (32.39 (25.05, 41.02) vs. 34.84 (28.71, 42.83)), but was well above the release criterion for each infusion (2.6 fold). The group was then split by Eastern Cooperative Oncology Group Performance Status (ECOG PS) and Gleason scores.
Conclusions: Pts with D prior to sip-T appeared to have product parameters comparable to pts without prior D, albeit with a slightly lower APC activation. Further analysis showed that pts receiving D within 3 months of sip-T had higher Gleason and ECOG scores. The clinical significance of these findings is unclear, but suggests that APC activation is not impaired following docetaxel. Clinical trial information: NCT01306890.
