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      Analysis of Circulating Immune Biomarkers by Race in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Sipuleucel-T

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          Abstract

          Among racial subgroups, Black men have the highest prostate cancer–specific death rate, yet they also exhibit prolonged overall survival compared with White men when treated with standard therapies, including sipuleucel-T. Differential immune responses may play a role in these observations. We compared circulating immune markers from 54 men (18 Black and 36 White) with metastatic castrate-resistant prostate cancer who received sipuleucel-T and were enrolled on an immune monitoring registry. Markers included longitudinal serum cytokine concentrations, humoral responses, and cellular immunity from baseline until 52 weeks after sipuleucel-T administration. Black men had statistically significantly higher median concentrations of T H2-type (interleukin [IL]-4, IL-10, and IL-13) and inflammatory cytokines (IL-2, IL-12, and IL-6) compared with prostate-specific antigen-matched White men both at baseline and 52 weeks after sipuleucel-T (2-sided P <  .05). No differences by race were seen in either the antigen-specific T-cell response or the humoral responses to the immunizing antigen PA2024 and select secondary antigens.

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          Sipuleucel-T immunotherapy for castration-resistant prostate cancer.

          Philip Kantoff, Celestia Higano, Neal Shore … (2010)
          Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer. In this double-blind, placebo-controlled, multicenter phase 3 trial, we randomly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or placebo (171 patients) administered intravenously every 2 weeks, for a total of three infusions. The primary end point was overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase. In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P=0.03). This reduction represented a 4.1-month improvement in median survival (25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group). The 36-month survival probability was 31.7% in the sipuleucel-T group versus 23.0% in the placebo group. The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test (hazard ratio, 0.77; 95% CI, 0.61 to 0.97; P=0.02) and after adjustment for use of docetaxel after the study therapy (hazard ratio, 0.78; 95% CI, 0.62 to 0.98; P=0.03). The time to objective disease progression was similar in the two study groups. Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills, fever, and headache. The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to disease progression was observed. (Funded by Dendreon; ClinicalTrials.gov number, NCT00065442.)
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            Cancer statistics for African Americans, 2019

            Carol DeSantis, Kimberly D Miller, Ann Goding Sauer … (2019)
            In the United States, African American/black individuals bear a disproportionate share of the cancer burden, having the highest death rate and the lowest survival rate of any racial or ethnic group for most cancers. To monitor progress in reducing these inequalities, every 3 years the American Cancer Society provides the estimated number of new cancer cases and deaths for blacks in the United States and the most recent data on cancer incidence, mortality, survival, screening, and risk factors using data from the National Cancer Institute, the North American Association of Central Cancer Registries, and the National Center for Health Statistics. In 2019, approximately 202,260 new cases of cancer and 73,030 cancer deaths are expected to occur among blacks in the United States. During 2006 through 2015, the overall cancer incidence rate decreased faster in black men than in white men (2.4% vs 1.7% per year), largely due to the more rapid decline in lung cancer. In contrast, the overall cancer incidence rate was stable in black women (compared with a slight increase in white women), reflecting increasing rates for cancers of the breast, uterine corpus, and pancreas juxtaposed with declining trends for cancers of the lung and colorectum. Overall cancer death rates declined faster in blacks than whites among both males (2.6% vs 1.6% per year) and females (1.5% vs 1.3% per year), largely driven by greater declines for cancers of the lung, colorectum, and prostate. Consequently, the excess risk of overall cancer death in blacks compared with whites dropped from 47% in 1990 to 19% in 2016 in men and from 19% in 1990 to 13% in 2016 in women. Moreover, the black-white cancer disparity has been nearly eliminated in men <50 years and women ≥70 years. Twenty-five years of continuous declines in the cancer death rate among black individuals translates to more than 462,000 fewer cancer deaths. Continued progress in reducing disparities will require expanding access to high-quality prevention, early detection, and treatment for all Americans.
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              Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer

              Nadeem Sheikh, Daniel P Petrylak, Philip Kantoff … (2012)
              Purpose Sipuleucel-T, the first FDA-approved autologous cellular immunotherapy for treatment of advanced prostate cancer, is manufactured by activating peripheral blood mononuclear cells, including antigen presenting cells (APCs), with a fusion protein containing prostatic acid phosphatase. Analysis of data from three phase 3 trials was performed to immunologically characterize this therapy during the course of the three doses, and to relate the immunological responses to overall survival (OS). Methods Sipuleucel-T product characteristics [APC numbers, APC activation (CD54 upregulation), and total nucleated cell (TNC) numbers] were assessed in three randomized, controlled phase 3 studies (N = 737). Antigen-specific cellular and humoral responses were assessed in a subset of subjects. The relationships between these parameters and OS were assessed. Results APC activation occurred in the first dose preparation [6.2-fold, (4.65, 7.70); median (25th, 75th percentile)] and increased in the second [10.6-fold (7.83, 13.65)] and third [10.5-fold (7.89, 13.65)] dose preparations. Cytokines and chemokines associated with activated APCs were produced during the manufacture of each dose; T-cell activation-associated cytokines were detected in the second and third dose preparations. Antigen-specific T cells were detectable after administration of the first sipuleucel-T dose. Cumulative APC activation, APC number, and TNC number correlated with OS (P < 0.05). Antigen-specific immune responses were observed in 78.8 % of monitored subjects and their presence correlated with OS (P = 0.003). Conclusion Sipuleucel-T broadly engages the immune system by activating APCs ex vivo and inducing long-lived immune responses in vivo. These data indicate antigen-specific immune activation as a mechanism by which sipuleucel-T prolongs OS. Electronic supplementary material The online version of this article (doi:10.1007/s00262-012-1317-2) contains supplementary material, which is available to authorized users.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Natl Cancer Inst
                Journal ID (iso-abbrev): J Natl Cancer Inst
                Journal ID (publisher-id): jnci
                Title: JNCI Journal of the National Cancer Institute
                Publisher: Oxford University Press
                ISSN (Print): 0027-8874
                ISSN (Electronic): 1460-2105
                Publication date Collection: February 2022
                Publication date (Electronic): 24 July 2021
                Publication date PMC-release: 24 July 2021
                Volume: 114
                Issue: 2
                Pages: 314-317
                Affiliations
                [1 ] Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center , New York, NY, USA
                [2 ] Dendreon Pharmaceuticals LLC , Seattle, WA, USA
                [3 ] Columbia Center for Translational Immunology, Columbia University Irving Medical Center , New York, NY, USA
                Author notes
                Correspondence to: Jessica E. Hawley, MD, Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center, Division of Hematology/Oncology, 177 Fort Washington Avenue, Suite 6GN-435, New York, NY 10032, USA (e-mail: jeh2194@ 123456cumc.columbia.edu ).
                Author information
                https://orcid.org/0000-0003-1720-5654
                Article
                Publisher ID: djab145
                DOI: 10.1093/jnci/djab145
                PMC ID: 8826456
                PubMed ID: 34302463
                SO-VID: fb5d9845-85d3-4f3b-b3af-531249512d3f
                Copyright © © The Author(s) 2021. Published by Oxford University Press.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                Date received : 02 March 2021
                Date revision received : 07 June 2021
                Date accepted : 19 July 2021
                Date: 17 August 2021
                Page count
                Pages: 4
                Funding
                Funded by: Prostate Cancer Foundation, DOI 10.13039/100000892;
                Award ID: 2020YI2963
                Funded by: National Cancer Institute at the National Institutes of Health;
                Award ID: T32 CA203703
                Award ID: P30CA013696
                Funded by: Cancer Biostatistics Shared Resource at the Herbert Irving Comprehensive Cancer Center;
                Funded by: Dendreon Pharmaceuticals, LLC;
                Categories
                Subject: Brief Communications
                Subject: AcademicSubjects/MED00010

                ScienceOpen disciplines: Oncology & Radiotherapy
                Data availability:
                ScienceOpen disciplines: Oncology & Radiotherapy

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