Abstract
Characteristics of African Americans (AAs) treated with sipuleucel-T (sip-T): Comparison of clinical trial and real-world experience
Journal of clinical oncology, v 33(7_suppl), pp 272-272
01 Mar 2015
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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Background: AA men are underrepresented in randomized clinical trials (RCTs) for prostate cancer, despite an almost 2-fold greater incidence in AA vs Caucasian populations. Sip-T is an autologous cellular immunotherapy approved by the FDA and EMA for the treatment of certain patients (pts) with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. AA enrollment in three sip-T phase 3 RCTs was 5.8% (n=43). While no definitive conclusions were drawn, median overall survival (OS) suggested AAs benefit from sip-T. PROCEED, an ongoing phase 4 registry, expanded efforts to increase AA enrollment to better characterize this population and the safety, product parameters (PP), and OS of AAs treated with sip-T. Methods: PROCEED enrolled 1973 pts treated with commercial sip-T within 6 months of registration. Efforts, such as selecting racially diverse sites and highlighting AA enrollment in PROCEED communications and investigator meetings, were used to boost AA enrollment. Baseline Gleason score, Eastern Cooperative Oncology Group performance status (ECOG), prostate-specific antigen (PSA), and alkaline phosphatase (ALP) were compared between RCTs and PROCEED. Safety and survival analyses are ongoing. Results: PROCEED AA enrollment was 11.7% vs 7.1% US RCT nonwhite enrollment rate and approaches the US AA population of 13.7%. Baseline AA pt characteristics were: lower median PSA and ALP levels in PROCEED vs RCTs, higher ECOG >0 in PROCEED vs RCTs, and higher Gleason score ≥8 in PROCEED vs RCTs (Table). Conclusions: Efforts to boost AA enrollment in PROCEED to a proportion comparable to the US AA population succeeded. The lower baseline PSA of AAs in PROCEED is similar to the PSA observed in the entire PROCEED population. Safety, PP, and OS will be reported with longer follow-up. Clinical trial information: NCT01306890. [Table: see text]
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Details
- Title
- Characteristics of African Americans (AAs) treated with sipuleucel-T (sip-T): Comparison of clinical trial and real-world experience
- Creators
- Ronald F. Tutrone - Chesapeake Urology AssociatesChiledum Ahaghotu - Howard University HospitalAndrew J. Armstrong - Duke UniversityCelestia S. Higano - Seattle Cancer Care AllianceMatthew R. Cooperberg - University of California, San FranciscoLaurence H. Belkoff - Urology AssociatesCarl A. Olsson - Columbia University Irving Medical CenterSanjay Goel - Montefiore Medical CenterRobert Claude Tyler - DendreonJennifer Susan LIll - DendreonTodd E. Gray - DendreonCandice McCoy - DendreonA. Oliver Sartor - Tulane University
- Publication Details
- Journal of clinical oncology, v 33(7_suppl), pp 272-272
- Publisher
- AMER SOC CLINICAL ONCOLOGY; ALEXANDRIA
- Number of pages
- 1
- Resource Type
- Abstract
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:000356886700273
- Other Identifier
- 991021916910004721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Oncology