Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer

Kantoff, Philip W.; Higano, Celestia S.; Shore, Neal D.; Berger, E. Roy; Small, Eric J.; Penson, David F.; Redfern, Charles H.; Ferrari, Anna C.; Dreicer, Robert; Sims, Robert B.; Xu, Yi; Frohlich, Mark W.; Schellhammer, Paul F.

doi:10.1056/nejmoa1001294

Cited by 5,572Prostate Cancer Treatment and ResearchImmunotherapy and Immune ResponsesProstate Cancer Diagnosis and Treatment

Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer

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Kantoff, Philip W., Higano, Celestia S., Shore, Neal D., Berger, E. Roy, Small, Eric J., Penson, David F., Redfern, Charles H., Ferrari, Anna C. +5 more·2010·New England Journal of Medicine

DOI 10.1056/nejmoa1001294

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Abstract

BACKGROUND: Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer. METHODS: In this double-blind, placebo-controlled, multicenter phase 3 trial, we randomly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or placebo (171 patients) administered intravenously every 2 weeks, for a total of three infusions. The primary end point was overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase. RESULTS: In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P=0.03). This reduction represented a 4.1-month improvement in median survival (25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group). The 36-month survival probability was 31.7% in the sipuleucel-T group versus 23.0% in the placebo group. The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test (hazard ratio, 0.77; 95% CI, 0.61 to 0.97; P=0.02) and after adjustment for use of docetaxel after the study therapy (hazard ratio, 0.78; 95% CI, 0.62 to 0.98; P=0.03). The time to objective disease progression was similar in the two study groups. Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills, fever, and headache. CONCLUSIONS: The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to disease progression was observed. (Funded by Dendreon; ClinicalTrials.gov number, NCT00065442.)

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Approval of novel therapies for mCRPC has resulted in uncertainties on optimal treatment sequencing, and utilization of these treatments is limited, demonstrating the need for improved real-world treatment practices.
“Although improvements in clinical outcomes have been observed with novel therapies [20–31], their approval has resulted in uncertainties on optimal treatment sequencing, and utilization of these treatments is limited, demonstrating the need for improved real-world treatment practices.”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [24]
Three nonhormonal systemic approaches prolong survival: docetaxel as first-line, cabazitaxel as second-line, and sipuleucel-T.
“Three nonhormonal systemic approaches have been found to prolong survival: docetaxel4 as first-line and cabazitaxel5 as second-line cytotoxic chemotherapy, and active cellular immunotherapy with sipuleucel-T.6”
From Abiraterone and Increased Survival in Metastatic Prostate Cancer (2011) · cites this paper as [6]

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“Sipuleucel-T was reported to prolong overall survival of patients with metastatic prostate cancer, but did not delay disease progression (14).”
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Authors: Kantoff, P. W., Higano, C. S., Shore, N. D., Berger, E. R., Small, E. J., Penson, D. F., Redfern, C. H., Ferrari, A. C., Dreicer, R., Sims, R. B., Xu, Y., Frohlich, M. W., & Schellhammer, P. F.
Affiliations: Harvard University (US)
Seattle Cancer Care Alliance (US)
Carolina Urologic Research Center (US)
Stony Brook University (US)
University of California, San Francisco (US)
Vanderbilt University Medical Center (US)
Sharp HealthCare (US)
NYU Langone Health (US)
Cleveland Clinic (US)
Dendreon (United States) (US)
Eastern Virginia Medical School (US)
ORCID: Kantoff, Philip W.
Higano, Celestia S.
Shore, Neal D.
Small, Eric J.
Penson, David F.
Ferrari, Anna C.
Dreicer, Robert
Xu, Yi
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2010-07-29
Volume: 363
Issue: 5
Pages: 411-422
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1001294
OpenAlex: W2103959341
Cited by: 5,572
References: 116
Citations by year: 2026: 182 · 2025: 255 · 2024: 270 · 2023: 282 · 2022: 313 · 2021: 337 · 2020: 306 · 2019: 294 · 2018: 320 · 2017: 353 · 2016: 371 · 2015: 453 · 2014: 502 · 2013: 490 · 2012: 440
FWCI: 352.08
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Cancer Institute (P30CA008748)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
Keywords: sipuleucel-T, castration-resistant prostate cancer, metastatic prostate cancer, autologous dendritic cell vaccine, overall survival, docetaxel, prostate-specific antigen, immune response, adverse events
MeSH terms: Aged, Aged, 80 and over, Androgen Antagonists, Antigen-Presenting Cells, Antineoplastic Agents, Combined Modality Therapy, Double-Blind Method, Humans, Immunotherapy, Infusions, Intravenous, Male, Middle Aged, Prostatic Neoplasms, Tissue Extracts, Proportional Hazards Models, Disease Progression, Intercellular Adhesion Molecule-1, Cell Culture Techniques, Cancer Vaccines, Kaplan-Meier Estimate

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Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer

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