Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry
Open Access
- 1 September 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Prostate Cancer and Prostatic Diseases
- Vol. 23 (3), 517-526
- https://doi.org/10.1038/s41391-020-0213-7
Abstract
Purpose African Americans experience greater prostate cancer risk and mortality than do Caucasians. An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. We explored this in PROCEED (NCT01306890), an FDA-requested registry in over 1900 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with sipuleucel-T. Patients and methods OS for patients who received >= 1 sipuleucel-T infusion was compared between African American and Caucasian men using an all patient set and a baseline prostate-specific antigen (PSA)-matched set (two Caucasians to every one African American with baseline PSAs within 10% of each other). Univariable and multivariable analyses were conducted. Survival data were examined using Kaplan-Meier and Cox proportional hazard methodologies. Results Median follow-up was 46.6 months. Overall survival differed between African American and Caucasian men with hazard ratios (HR) of 0.81 (95% confidence interval [CI]: 0.68-0.97, P = 0.03) in the all patient set and 0.70 (95% CI: 0.57-0.86, P < 0.001) in the PSA-matched set. Median OS was longer in African Americans than in Caucasian men for both analysis sets, e.g., 35.3 and 25.8 months, respectively, in the PSA-matched set. Similar results were observed in the all patient set. Differences were larger when treatment began at lower baseline PSA; curves were more similar among patients with higher baseline PSA. In patients with baseline PSA below the median, the HR was 0.52 (95% CI: 0.37-0.72, P < 0.001), with median OS of 54.3 versus 33.4 months. Known prognostic factors and African American race (multivariable analyses; HR: 0.60, 95% CI: 0.48-0.74, P < 0.001) were independently associated with OS. Use of post-sipuleucel-T anticancer interventions was balanced between races. Conclusion In this exploratory analysis of a registry including nearly 12% African American men with mCRPC, OS was significantly different between African Americans and Caucasians, indicating further research is warranted.Funding Information
- Dendreon Pharmaceuticals, LLC
This publication has 36 references indexed in Scilit:
- Real‐world outcomes of sipuleucel‐T treatment in PROCEED, a prospective registry of men with metastatic castration‐resistant prostate cancerCancer, 2019
- African-American Prostate Cancer DisparitiesCurrent Urology Reports, 2017
- Racial disparities in prostate cancer a molecular perspectiveFrontiers in Bioscience-Landmark, 2017
- African American Participation in Oncology Clinical Trials—Focus on Prostate Cancer: Implications, Barriers, and Potential SolutionsClinical Genitourinary Cancer, 2015
- Novel Biomarker Signature That May Predict Aggressive Disease in African American Men With Prostate CancerJournal of Clinical Oncology, 2015
- Lower Baseline Prostate-specific Antigen Is Associated With a Greater Overall Survival Benefit From Sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) TrialUrology, 2013
- Expression differences between African American and Caucasian prostate cancer tissue reveals that stroma is the site of aggressive changesInternational Journal of Cancer, 2013
- Disparities at presentation, diagnosis, treatment, and survival in African American men, affected by prostate cancerThe Prostate, 2010
- Sipuleucel-T Immunotherapy for Castration-Resistant Prostate CancerThe New England Journal of Medicine, 2010
- Tumor Immunobiological Differences in Prostate Cancer between African-American and European-American MenCancer Research, 2008