Analyses of the PROCEED registry at the 112th American Urological Association (AUA) Annual Meeting in Boston found that Provenge (sipuleucel-T) vaccine treated African-American men demonstrated an additional average survival benefit of 9.3 months compared with Caucasian patients (37.3 months verses 28.0 months, respectively).1 . The PROCEED registry followed men with metastatic hormone-refractory prostate cancer (mCRPC) treated with the Provenge® in a real-world treatment setting. In addition, among the group of patients treated with prostate specific antigen (PSA) levels below the average at the time of Provenge treatment, African-American patients demonstrated an additional survival benefit of nearly two additional years when compared with Caucasian patients (54.3 months vs. 33.4 months).1
About Prostate Cancer in African-American Men
Prostate cancer is the most frequently occurring non-cutaneous cancer among men in the United States and is second only to lung cancer among the leading causes of cancer-related deaths.2
Prostate cancer is also the most commonly diagnosed cancer in African-American men, representing 31 percent of all cancers.3 It is estimated that in 2016, one in six African-American men were diagnosed with prostate cancer – an estimated 29,530 new cases – and one in 23 had a lifetime probability of dying from their disease.4 The incidence of prostate cancer is 60 percent higher among African-American than Caucasian men, and the mortality rate is more than twice as high,5 which prostate cancer incidence patterns from population modeling suggest is likely due to a higher incidence of preclinical disease and higher risk of progression to metastatic disease before clinical diagnosis among African-American men compared with the general population.6 Based on this modeling, African-American men are more likely to be diagnosed with prostate cancer at a younger age and a higher stage and to have their disease progress after treatment compared with Caucasian men.5 The lifetime probability of an African-American man dying of prostate cancer is almost double that of a Caucasian man (4.4 percent vs. 2.4 percent).3
About PROVENGE® (sipuleucel-T)
PROVENGE® is an autologous cellular immunotherapy vaccine currently FDA indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.
The PROCEED registry enrolled more than 1,900 patients with mCRPC who received Provenge between 2011 and 2013 in everyday treatment settings. Overall approximately 12 percent of treated patients were African-American, and the analysis presented at the AUA meeting compared the overall survival in a subset of African-American patients (n=210) and Caucasian patients (n=420) matched by baseline PSA.
The analysis showed that the overall survival on average was significantly better for the African-American patients than the Caucasian patients (37.3 months verses 28 months). African-American men also had better outcomes than Caucasian men when survival was assessed based on PSA levels. Among those with a PSA level below the median, the overall survival was 54.3 months for African-Americans compared to only 33.4 months for Caucasian patients. African-American race was an independent predictor of improved survival following treatment with Provenge.
This new clinical data about how metastatic prostate cancer patients respond to and benefit from Provenge in everyday clinical practice should be useful to urologists and oncologists in supporting treatment decisions for their patients, especially their African-American patients.
1.Sartor O, et al. Overall Survival Analysis of African American and Caucasian Patients Receiving Sipuleucel-T: Preliminary Data from the PROCEED Registry. Presented at the 2017 American Urological Association (AUA) Annual Meeting; May 13, 2017; Boston, Mass.
2.Jemal A, et al. Cancer statistics, 2009. CA Cancer J Clin. 2009;59:225–249.
4.American Cancer Society. Cancer Facts & Figures for African Americans 2016-2018. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/cancer-facts-and-figures-for-african-americans-2016-2018.pdf. Accessed April 2017.
5.Sultan DH, et al. Affecting African American men’s prostate cancer screening decision-making through a mobile tablet-mediated intervention. J Health Care Poor Underserved. 2014;25(3):1262–1277. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4160127/. Accessed April 2017.
6.Tsodikov A, et al. Is prostate cancer different in black men? Answers from 3 natural history models. April 24, 2017. DOI: 10.1002/cncr.30687.