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Abstract D084: Overall survival (OS) of African-American (AA) and Caucasian (CAU) men who received sipuleucel-T for metastatic castration-resistant prostate cancer (mCRPC)—final PROCEED analysis

Publication ,  Conference
Sartor, O; Armstrong, AJ; Ahaghotu, C; McLeod, DG; Cooperberg, MR; Penson, DF; Kantoff, PW; Vogelzang, NJ; Hussain, A; Pieczonka, CM; Shore, ND ...
Published in: Cancer Epidemiology, Biomarkers & Prevention
June 1, 2020

BACKGROUND: Prostate cancer risk and mortality are higher in AAs versus CAUs. Post-hoc analyses of pooled Phase 3 data (n = 737) suggested substantial OS benefit for AA men receiving sipuleucel-T (n=33) vs placebo (n = 10) (McLeod 2012). Compared with pooled placebo patients (n = 249), number needed to treat for OS benefit at 3 years was 3 for AAs and 8 for all sipuleucel-T-treated patients (n = 488) (Moses 2017). Herein we analyzed PROCEED (NCT01306890), a large real-world registry, in which all patients received sipuleucel-T. Previously presented at ASCO Annual Meeting 2019 (Sartor 2019).METHODS: In PROCEED, 1902 mCRPC patients received 1 or more sipuleucel-T infusions. OS of all AA (n=221) and CAU (n=1649) men were compared. Baseline prostate-specific antigen (PSA), the most important prognostic variable for OS after sipuleucel-T (Schellhammer 2013), substantially differed by race. Thus, OS for a PSA-matched cohort (n=219 AA; n=438 CAU) was compared and univariable/multivariable analyses were performed. Post-sipuleucel-T use of OS-prolonging anticancer interventions was also assessed. RESULTS: After a median follow-up of 46.6 mo, median OS was 35.2 (all sipuleucel-T-treated AAs) and 29.9 mo (all sipuleucel-T-treated CAUs): HR 0.81, 95% CI 0.68–0.97; P=0.03. In the PSA-matched cohort, median OS was 35.3 and 25.8 mo, respectively (HR 0.70, 95% CI 0.57–0.86; p<0.001). Sipuleucel-T-treated AAs with lower baseline PSA had markedly longer median OS vs sipuleucel-T-treated CAUs. Among those with PSA less than or equal to median baseline PSA (29.48 ng/ml), median OS was 54.3 mo (AA) vs. 33.4 (CAUs); HR 0.52, 95% CI 0.37–0.72; p<0.001. Along with other known prognostic factors, AA race was independently associated with prolonged OS on detailed multivariable analyses (HR 0.60, 95% CI 0.48–0.74; p<0.001) and confirmed on sensitivity analyses. Post-sipuleucel-T life-prolonging anti-cancer therapies were balanced between groups. CONCLUSIONS: Sipuleucel-T-treated AAs had significantly improved OS vs sipuleucel-T-treated CAUs. This analysis marks the largest known racial difference in OS in response to any therapy for mCRPC, a finding with implications for both prostate cancer pathophysiology and cancer immunotherapy. REFERENCES: Sartor 2012 (DOI: 10.1200/JCO.2019.37.15_suppl.5035); McLeod 2012 (DOI: 10.1016/j.juro.2012.02.1051); Moses KA et al 2017 (DOI: 10.1016/j.urology.2016.07.045); Schellhammer 2013 (DOI: 10.1016/j.urology.2013.01.061)Citation Format: Oliver Sartor, Andrew J Armstrong, Chiledum Ahaghotu, David G McLeod, Matthew R Cooperberg, David F Penson, Philip W Kantoff, Nicholas J Vogelzang, Arif Hussain, Christopher. M Pieczonka, Neal D Shore, David I Quinn, Elisabeth I Heath, Ronald F Tutrone, Paul F Schellhammer, Matthew Harmon, Nancy N Chang, Stephen J Freedland, Celestia S Higano. Overall survival (OS) of African-American (AA) and Caucasian (CAU) men who received sipuleucel-T for metastatic castration-resistant prostate cancer (mCRPC)—final PROCEED analysis [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr D084.

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Published In

Cancer Epidemiology, Biomarkers & Prevention

DOI

EISSN

1538-7755

ISSN

1055-9965

Publication Date

June 1, 2020

Volume

29

Issue

6_Supplement_2

Start / End Page

D084 / D084

Publisher

American Association for Cancer Research (AACR)

Related Subject Headings

  • Epidemiology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 11 Medical and Health Sciences
 

Citation

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Sartor, O., Armstrong, A. J., Ahaghotu, C., McLeod, D. G., Cooperberg, M. R., Penson, D. F., … Higano, C. S. (2020). Abstract D084: Overall survival (OS) of African-American (AA) and Caucasian (CAU) men who received sipuleucel-T for metastatic castration-resistant prostate cancer (mCRPC)—final PROCEED analysis. In Cancer Epidemiology, Biomarkers & Prevention (Vol. 29, pp. D084–D084). American Association for Cancer Research (AACR). https://doi.org/10.1158/1538-7755.disp19-d084
Sartor, Oliver, Andrew J. Armstrong, Chiledum Ahaghotu, David G. McLeod, Matthew R. Cooperberg, David F. Penson, Philip W. Kantoff, et al. “Abstract D084: Overall survival (OS) of African-American (AA) and Caucasian (CAU) men who received sipuleucel-T for metastatic castration-resistant prostate cancer (mCRPC)—final PROCEED analysis.” In Cancer Epidemiology, Biomarkers & Prevention, 29:D084–D084. American Association for Cancer Research (AACR), 2020. https://doi.org/10.1158/1538-7755.disp19-d084.
Sartor O, Armstrong AJ, Ahaghotu C, McLeod DG, Cooperberg MR, Penson DF, et al. Abstract D084: Overall survival (OS) of African-American (AA) and Caucasian (CAU) men who received sipuleucel-T for metastatic castration-resistant prostate cancer (mCRPC)—final PROCEED analysis. In: Cancer Epidemiology, Biomarkers & Prevention. American Association for Cancer Research (AACR); 2020. p. D084–D084.
Sartor, Oliver, et al. “Abstract D084: Overall survival (OS) of African-American (AA) and Caucasian (CAU) men who received sipuleucel-T for metastatic castration-resistant prostate cancer (mCRPC)—final PROCEED analysis.” Cancer Epidemiology, Biomarkers & Prevention, vol. 29, no. 6_Supplement_2, American Association for Cancer Research (AACR), 2020, pp. D084–D084. Crossref, doi:10.1158/1538-7755.disp19-d084.
Sartor O, Armstrong AJ, Ahaghotu C, McLeod DG, Cooperberg MR, Penson DF, Kantoff PW, Vogelzang NJ, Hussain A, Pieczonka CM, Shore ND, Quinn DI, Heath EI, Tutrone RF, Schellhammer PF, Harmon M, Chang NN, Freedland SJ, Higano CS. Abstract D084: Overall survival (OS) of African-American (AA) and Caucasian (CAU) men who received sipuleucel-T for metastatic castration-resistant prostate cancer (mCRPC)—final PROCEED analysis. Cancer Epidemiology, Biomarkers & Prevention. American Association for Cancer Research (AACR); 2020. p. D084–D084.

Published In

Cancer Epidemiology, Biomarkers & Prevention

DOI

EISSN

1538-7755

ISSN

1055-9965

Publication Date

June 1, 2020

Volume

29

Issue

6_Supplement_2

Start / End Page

D084 / D084

Publisher

American Association for Cancer Research (AACR)

Related Subject Headings

  • Epidemiology
  • 42 Health sciences
  • 32 Biomedical and clinical sciences
  • 11 Medical and Health Sciences