ORLANDO, FL, USA (UroToday.com) - The Phase 3 IMPACT study showed significant improvement in overall survival with sipuleucel-T immunotherapy. The PROCEED trial is an ongoing Phase 4 registry enrolling patients receiving sipuleucel-T in the real-world setting. Enrollment has no restriction on whether docetaxel has been used to treat.
The poster presented here reflects preliminary results using baseline parameters and product parameters in PROCEED patients, with or without exposure to docetaxel. As of September 2012, 560 patients completed sipuleucel-T treatment. Of this group, 15% had received docetaxel approximately 291 days prior to the first sipuleucel-T infusion. The patients with prior docetaxel had higher PSA levels, and those who had the most recent docetaxel treatment tended to have higher Gleason scores. Overall, the product parameters were very comparable between the two groups. (see Table 1 on poster) regardless of prior docetaxel exposure.
The authors concluded patients enrolled in PROCEED appeared to have different baseline demographics, with or without prior docetaxel exposure; the sipuleucel-T product parameters were comparable, independent of docetaxel use; and sipuleucel-T creates a robust immune response consistent with an immune-prime boost. Given the small sample size, additional evaluation of product parameters is recommended.
Presented by Chadi Nabhan, MD,1 Oliver Sartor, MD,2 Matthew Cooperberg, MD,3 Jeffrey Vacirca, MD,4 Raoul Concepcion, MD,5 William Berry, MD,6 Manish Dhawan, MD,7 Ronald Tutrone, MD,8 Andrew Sandler, MD,9 Candice McCoy, MD,9 James Whitmore, PhD,9 Robert Tyler, PhD,9 and Celestia Higano, MD10 at the 2013 Genitourinary Cancers Symposium - February 14 - 16, 2013 - Rosen Shingle Creek - Orlando, Florida USA
1Advocate Lutheran General Hospital, Park Ridge, IL; 2Tulane University School of Medicine, New Orleans, LA; 3UCSF School of Medicine, San Francisco, CA; 4North Shore Hematology Oncology Associates, East Setauket, NY; 5Urology Associates, Nashville, TN; 6US Oncology, Raleigh, NC 7Highland Clinic, Shreveport, LA; 8Chesapeake Urology Research Associates, Baltimore, MD; 9Dendreon, Corp., Seattle, WA; 10University of Washington, Seattle, WA
Written by Karen Roberts, medical editor for UroToday.com