Real-world outcomes of sipuleucel-T treatment in PROCEED, a prospective registry of men with metastatic castration-resistant prostate cancer Journal Article


Authors: Higano, C. S.; Armstrong, A. J.; Sartor, A. O.; Vogelzang, N. J.; Kantoff, P. W.; McLeod, D. G.; Pieczonka, C. M.; Penson, D. F.; Shore, N. D.; Vacirca, J.; Concepcion, R. S.; Tutrone, R. F.; Nordquist, L. T.; Quinn, D. I.; Kassabian, V.; Scholz, M. C.; Harmon, M.; Tyler, R. C.; Chang, N. N.; Tang, H.; Cooperberg, M. R.
Article Title: Real-world outcomes of sipuleucel-T treatment in PROCEED, a prospective registry of men with metastatic castration-resistant prostate cancer
Abstract: Background: The large registry, PROVENGE Registry for the Observation, Collection, and Evaluation of Experience Data (PROCEED)(NCT01306890), evaluated sipuleucel-T immunotherapy for asymptomatic/minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Methods: PROCEED enrolled patients with mCRPC receiving 3 biweekly sipuleucel-T infusions. Assessments included overall survival (OS), serious adverse events (SAEs), cerebrovascular events (CVEs), and anticancer interventions (ACIs). Follow-up was for ≥3 years or until death or study withdrawal. Results: In 2011-2017, 1976 patients were followed for 46.6 months (median). The median age was 72 years, and the baseline median prostate-specific antigen level was 15.0 ng/mL; 86.7% were white, and 11.6% were African American. Among the patients, 1902 had 1 or more sipuleucel-T infusions. The median OS was 30.7 months (95% confidence interval [CI], 28.6-32.2 months). Known prognostic factors were independently associated with OS in a multivariable analysis. Among the 1255 patients who died, 964 (76.8%) died of prostate cancer (PC) progression. The median time from the first infusion to PC death was 42.7 months (95% CI, 39.4-46.2 months). The incidence of sipuleucel-T–related SAEs was 3.9%. The incidence of CVEs was 2.8%, and the rate per 100 person-years was 1.2 (95% CI, 0.9-1.6). The CVE incidence among 11,972 patients with mCRPC from the Surveillance, Epidemiology, and End Results–Medicare database was 2.8%; the rate per 100 person-years was 1.5 (95% CI, 1.4-1.7). One or more ACIs (abiraterone, enzalutamide, docetaxel, cabazitaxel, or radium 223) were received by 77.1% of the patients after sipuleucel-T; 32.5% and 17.4% of the patients experienced 1- and 2-year treatment-free intervals, respectively. Conclusions: PROCEED provides contemporary survival data for sipuleucel-T–treated men in a real-world setting of new life-prolonging agents, which will be useful in discussing treatment options with patients and in powering future trials with sipuleucel-T. The safety and tolerability of sipuleucel-T in PROCEED were consistent with previous findings. © 2019 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
Keywords: adult; cancer chemotherapy; cancer survival; controlled study; aged; unclassified drug; major clinical study; overall survival; constipation; cancer growth; drug efficacy; outcome assessment; follow up; prospective study; prostate specific antigen; controlled clinical trial; vomiting; dehydration; deep vein thrombosis; hematuria; cancer mortality; docetaxel; asthenia; backache; chill; fever; pneumonia; prostate cancer; lung embolism; medicare; acute kidney failure; hypotension; thorax pain; immunotherapy; heart infarction; multicenter study; spinal cord compression; transient ischemic attack; radiopharmaceutical agent; safety; cancer epidemiology; observational study; atrial fibrillation; brain hemorrhage; congestive heart failure; african american; cerebrovascular accident; brain infarction; castration resistant prostate cancer; abiraterone; subdural hematoma; radium 223; mortality rate; cabazitaxel; sipuleucel t; enzalutamide; faintness; infusion related reaction; human; male; female; priority journal; article; metastatic castration resistant prostate cancer
Journal Title: Cancer
Volume: 125
Issue: 23
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2019-12-01
Start Page: 4172
End Page: 4180
Language: English
DOI: 10.1002/cncr.32445
PUBMED: 31483485
PROVIDER: scopus
PMCID: PMC6856402
DOI/URL:
Notes: Article -- Export Date: 2 December 2019 -- Source: Scopus
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  1. Philip Wayne Kantoff
    103 Kantoff