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. 2019 Dec 1;125(23):4172-4180.
doi: 10.1002/cncr.32445. Epub 2019 Sep 4.

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

Celestia S Higano  1 , Andrew J Armstrong  2   3 , A Oliver Sartor  4 , Nicholas J Vogelzang  5 , Philip W Kantoff  6 , David G McLeod  7 , Christopher M Pieczonka  8 , David F Penson  9   10 , Neal D Shore  11 , Jeffrey Vacirca  12 , Raoul S Concepcion  13 , Ronald F Tutrone  14 , Luke T Nordquist  15 , David I Quinn  16 , Vahan Kassabian  17 , Mark C Scholz  18 , Matt Harmon  19 , Robert C Tyler  20 , Nancy N Chang  20 , Hong Tang  20 , Matthew R Cooperberg  21   22
Affiliations

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

Celestia S Higano et al. 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.

Keywords: immunotherapy; overall survival; prostate cancer; safety.

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Conflict of interest statement

Celestia S. Higano has served in an advisory role for Aptevo, Asana, Astellas, Bayer, Blue Earth Diagnostics, Churchill Pharma, Clovis Oncology, Dendreon, Endocyte, Ferring, Medivation, Orion Corporation, and Pfizer; she has also participated in sponsored research for Aptevo, Bayer, Aragon Pharma, Astellas, AstraZeneca, Dendreon, Genentech, Hoffman‐LaRoche, Medivation, Sanofi, and Pfizer, and her spouse was in a leadership role for CTI Biopharma. Andrew J. Armstrong has received grants and personal fees from Dendreon, Pfizer/Astellas, Janssen, Bayer, and Sanofi‐Aventis during this study as well as grants from Novartis, Gilead, Bristol‐Myers Squibb, and Genentech/Roche outside the submitted work. A. Oliver Sartor has served as a consultant for and received personal fees from Advanced Accelerator Applications, Astellas, AstraZeneca, Bavarian‐Nordic, Bayer, Bellicum, Blue Earth Diagnostics, Celgene, Constellation, Dendreon, EMD Serono, Endocyte, Johnson & Johnson, Bristol‐Myers Squibb, Myovant, Pfizer, Progenics, Sanofi, Teva, and Hinova during this study; he has also received grants from AstraZeneca, Bayer, Constellation, Dendreon, Endocyte, Johnson & Johnson, Bristol‐Myers Squibb, Progenics, Sanofi, Innocrin, Invitae, Merck, Roche, and Sotio. Philip W. Kantoff has received personal fees from Astellas, Bayer, Bellicum, BIND Biosciences, Bavarian Nordic Immunotherapies, DRGT, Genentech/Roche, Ipsen Pharmaceuticals, Janssen, Metamark, Merck, Millennium/Prometrika, MTG, Omnitura, OncoCell MDx, OncoGenex, Progenity, Sanofi, Tarveda Pharmaceuticals, Thermo Fisher, GE Healthcare, Context Therapeutics, New England Research Institutes, SEER Biosciences, and Placon; he also has investment interests in DRGT, Tarveda Pharmaceuticals, Context Therapeutics, SEER Biosciences, and Placon. Christopher M. Pieczonka has received personal fees as a consultant for Dendreon, Bayer, Janssen, and Pfizer and as an investigator for Dendreon, Bayer, Janssen, Pfizer, Merck, AstraZeneca, Taiho, Innocrin, and Myovant outside the submitted work. David F. Penson has received personal fees from Dendreon and Janssen as well as a grant from the Vanderbilt University Research Center. Neal D. Shore has served as a consultant for and received personal fees from Ferring, Bayer, Amgen, Janssen, Dendreon, Tolmar, Astellas, Pfizer, AstraZeneca, Genentech/Roche, Myovant Sciences, Merck, Bristol Meyers Squibb, and Nymox outside the submitted work. Raoul S. Concepcion has served in an advisory role for Dendreon and received personal fees outside the submitted work. David I. Quinn has been involved in payments to the University of Southern California for trial conduct with Dendreon; he has also acted as an advisor for and received personal fees from Dendreon, Bayer, Janssen, Pfizer, Astellas, Genzyme, Clovis, and AstraZeneca. Vahan Kassabian has served as a consultant or speaker for Dendreon, Amgen, Astellas, Pfizer, Janssen, Bayer, UroGPO, Tolmar, and Genomic Health outside the submitted work and is a shareholder of UroGPO. Matt Harmon reports stock ownership in Amgen. Robert C. Tyler has been an employee of Janssen, Dendreon, Medivation, Pfizer, and Innocrin. Nancy N. Chang was a full‐time employee of Dendreon at the time of the analyses and drafting of this manuscript. Hong Tang was a full‐time employee of Dendreon at the time of the analyses and drafting of the manuscript; is a nonexecutive director of OnQuality Pharmaceuticals; and owns stock in BeiGene, Nektar, Sangamo Therapeutics, Tesaro, Verastem, Editas Medicine, and CVS Health Corporation. Matthew R. Cooperberg has received personal fees from Dendreon in relation to a PROCEED trial steering committee and has served in an advisory or consultancy role for Bayer, MDx Health, and Myriad Genetics; he has also participated in a registry steering committee for Astellas. The other authors made no disclosures.

Figures

Figure 1
Figure 1
OS in PROCEED as a Kaplan‐Meier plot with a 95% Hall‐Wellner band. CI indicates confidence interval; OS, overall survival; PROCEED, PROVENGE Registry for the Observation, Collection, and Evaluation of Experience Data.
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