Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry

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...

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Veröffentlicht in:Prostate cancer and prostatic diseases 2020-09, Vol.23 (3), p.517-526
Hauptverfasser: Sartor, Oliver, Armstrong, Andrew J., Ahaghotu, Chiledum, McLeod, David G., Cooperberg, Matthew R., Penson, David F., Kantoff, Philip W., Vogelzang, Nicholas J., Hussain, Arif, Pieczonka, Christopher M., Shore, Neal D., Quinn, David I., Small, Eric J., Heath, Elisabeth I., Tutrone, Ronald F., Schellhammer, Paul F., Harmon, Matthew, Chang, Nancy N., Sheikh, Nadeem A., Brown, Bruce, Freedland, Stephen J., Higano, Celestia S.
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Sprache:eng
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Zusammenfassung: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  
ISSN:1365-7852
1476-5608
DOI:10.1038/s41391-020-0213-7