The Take Home:
1- Sipuleuce-T (Provenge) provides men of African American descent a significant overall survival advantage.
2- Sipuleuce-T (Provenge) offers men with lower PSA scores an improved survival advantage.
In a prospective, real-world analysis, it was shown that African American men who have castrate resistant, metastatic prostate cancer, benefited by receiving an additional overall survival (OS) benefit when they received Sipuleucel-T (Provenge).
This important finding was released in an oral session at the current, on going AUA 2017, meeting being held in Boston, MA. This finding is particularly important because prostate cancer disproportionately affects African-American men who have twice the mortality from the disease than Caucasian men!
These results come from a new analysis of Dendreon’s PROCEED registry. The registry followed men with metastatic castrate-resistant (hormone-refractory) prostate cancer (mCRPC) who had been treated with Provenge in a real-world treatment setting.
The analysis found that African-American men had an additional median overall survival (OS) benefit of 9.3 months compared with Caucasian men (37.3 months vs 28.0 months, respectively).
In addition, it was found that among the group of men whose prostate specific antigen (PSA) levels was low at the time they received Provenge, African-American men fared even better. They had an additional overall survival (OS) benefit of nearly two additional years (20.9 months) compared with Caucasian men (54.3 months vs. 33.4 months, respectively).
According to the lead author of the report, A. Oliver Sartor, M.D., the Laborde Professor of Cancer Research in the Departments of Medicine and Urology at Tulane University School of Medicine, “These new findings are very encouraging given that African-American men with prostate cancer have a mortality rate more than twice as high as Caucasian men and historically have presented with aggressive disease and have had worse outcomes in both real-world settings and controlled clinical trials. The fact that we saw an even greater benefit in African-American patients within the lower PSA quartile ranges is also important and provides further evidence that Provenge should be used as early as possible within its labeled indication.”
The PROCEED registry was large, enrolling more than 1,900 men with mCRPC who received Provenge, in a clinical treatment setting, between 2011 and 2013. Of those men receiving the Provenge treatment, approximately 12 percent were African-American. The analysis presented at the AUA meeting compared OS in a subset of African-American men (n=210) and Caucasian men (n=420) matched by baseline PSA.
Provenge, since it’s approval by the FDA, has received mixed reviews by both he medical and the prostate cancer communities. Since its underlying mechanism of action is not understood and it does not immediately affect PSA or disease progression as demonstrated on scans, many have questioned its actual efficacy. This author has and continues to dismiss any of these efficacy concerns. The findings from this PROCEED analysis regarding the full population are consistent with an analysis of the Phase 3 IMPACT registration trial of Provenge which led to its approval.
In that trial it was shown that a lower baseline PSA level was associated with a greater overall survival benefit in men taking Provenge. Among the men with a baseline PSA ≤22.1 ng/mL, the median OS was 41.3 months for those treated with Provenge vs. 28.3 months for those in the control arm – an improvement of 13 months.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with 5 primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma and a rare cancer, Appendiceal Cancer.