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Characteristics of African Americans (AAs) treated with sipuleucel-T (sip-T): Comparison of clinical trial and real-world experience.

Publication ,  Conference
Tutrone, RF; Ahaghotu, C; Armstrong, AJ; Higano, CS; Cooperberg, MR; Belkoff, LH; Olsson, CA; Goel, S; Tyler, RC; LIll, JS; Gray, TE; McCoy, C ...
Published in: Journal of Clinical Oncology
March 1, 2015

272 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]

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

March 1, 2015

Volume

33

Issue

7_suppl

Start / End Page

272 / 272

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Tutrone, R. F., Ahaghotu, C., Armstrong, A. J., Higano, C. S., Cooperberg, M. R., Belkoff, L. H., … Sartor, A. O. (2015). Characteristics of African Americans (AAs) treated with sipuleucel-T (sip-T): Comparison of clinical trial and real-world experience. In Journal of Clinical Oncology (Vol. 33, pp. 272–272). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2015.33.7_suppl.272
Tutrone, Ronald F., Chiledum Ahaghotu, Andrew J. Armstrong, Celestia S. Higano, Matthew R. Cooperberg, Laurence H. Belkoff, Carl A. Olsson, et al. “Characteristics of African Americans (AAs) treated with sipuleucel-T (sip-T): Comparison of clinical trial and real-world experience.” In Journal of Clinical Oncology, 33:272–272. American Society of Clinical Oncology (ASCO), 2015. https://doi.org/10.1200/jco.2015.33.7_suppl.272.
Tutrone RF, Ahaghotu C, Armstrong AJ, Higano CS, Cooperberg MR, Belkoff LH, et al. Characteristics of African Americans (AAs) treated with sipuleucel-T (sip-T): Comparison of clinical trial and real-world experience. In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2015. p. 272–272.
Tutrone, Ronald F., et al. “Characteristics of African Americans (AAs) treated with sipuleucel-T (sip-T): Comparison of clinical trial and real-world experience.Journal of Clinical Oncology, vol. 33, no. 7_suppl, American Society of Clinical Oncology (ASCO), 2015, pp. 272–272. Crossref, doi:10.1200/jco.2015.33.7_suppl.272.
Tutrone RF, Ahaghotu C, Armstrong AJ, Higano CS, Cooperberg MR, Belkoff LH, Olsson CA, Goel S, Tyler RC, LIll JS, Gray TE, McCoy C, Sartor AO. Characteristics of African Americans (AAs) treated with sipuleucel-T (sip-T): Comparison of clinical trial and real-world experience. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2015. p. 272–272.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

March 1, 2015

Volume

33

Issue

7_suppl

Start / End Page

272 / 272

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences