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668 A RANDOMIZED PHASE II STUDY OF IPILIMUMAB WITH ANDROGEN ABLATION COMPARED WITH ANDROGEN ABLATION ALONE IN PATIENTS WITH ADVANCED PROSTATE CANCER

2010; Lippincott Williams & Wilkins; Volume: 183; Issue: 4S Linguagem: Inglês

10.1016/j.juro.2010.02.1055

1527-3792

Matthew K. Tollefson, R. Jeffrey Karnes, R. Houston Thompson, Candace F. Granberg, David W. Hillman, Rodney H. Breau, James P. Allison, Eugene D. Kwon, Michael L. Blute,

Prostate Cancer Diagnosis and Treatment

You have accessJournal of UrologyProstate Cancer: Advanced II1 Apr 2010668 A RANDOMIZED PHASE II STUDY OF IPILIMUMAB WITH ANDROGEN ABLATION COMPARED WITH ANDROGEN ABLATION ALONE IN PATIENTS WITH ADVANCED PROSTATE CANCER Matthew Tollefson, R. Jeffrey Karnes, R. Houston Thompson, Candace Granberg, David Hillman, Rodney Breau, James Allison, Eugene Kwon, and Michael Blute Matthew TollefsonMatthew Tollefson Rochester, MN , R. Jeffrey KarnesR. Jeffrey Karnes Rochester, MN , R. Houston ThompsonR. Houston Thompson Rochester, MN , Candace GranbergCandace Granberg Rochester, MN , David HillmanDavid Hillman Rochester, MN , Rodney BreauRodney Breau Rochester, MN , James AllisonJames Allison New York, NY , Eugene KwonEugene Kwon Rochester, MN , and Michael BluteMichael Blute Rochester, MN View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1055AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Androgen ablation (AA) is one of the few treatments available for patients that present with- or develop- advanced CaP and has been shown to induce a robust T-cell infiltrate in the prostate. CTLA-4 blockade potentiates T-cell responses and therefore may work synergistically with AA in the treatment of advanced forms of CaP. We now report initial phase II results with ipilimumab in concert with AA. METHODS 108 patients with locally advanced CaP were randomized to treatment with a single dose of 3 mg/kg ipilimumab with AA (54 patients) versus AA alone (54 patients) from June 2005 to April 2009. Upon progression, those randomized to AA alone were allowed to cross-over into the treatment group. PSA and testosterone were monitored monthly. The primary endpoints of this study were safety and initial efficacy as measured by PSA and clinical response. RESULTS The median age at entry to the study was 65 years, 32% had an initial PSA > 50, and 67% of patients had a Gleason score > 8. No baseline differences were noted between the treatment groups. Percent decline in testosterone level was > 97% in both arms. Patients treated with ipilimumab + AA were more likely to have an undetectable PSA by 3 months (55% vs. 38%). Furthermore, some patients treated with ipilimumab experienced a robust clinical response and disease downstaging. The most common severe (grade 3 or 4) immune related adverse events (irAEs) were colitis (ipilimumab + AA – 4.5%) and diarrhea (ipilimumab + AA – 4.5%). Interestingly, 15 patients (27.7%) treated with ipilimumab experienced cutaneous changes, including localized vitiligo and desquamation of atypical nevi. CONCLUSIONS Ipilimumab appears to act synergistically with AA, potentiating T-cell responses and providing significant clinical responses. Further study with ipilimumab in patients with advanced prostate cancer is warranted, particularly utilizing higher and repeated dosages and in combination with other treatment modalities. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e261 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.Metrics Author Information Matthew Tollefson Rochester, MN More articles by this author R. Jeffrey Karnes Rochester, MN More articles by this author R. Houston Thompson Rochester, MN More articles by this author Candace Granberg Rochester, MN More articles by this author David Hillman Rochester, MN More articles by this author Rodney Breau Rochester, MN More articles by this author James Allison New York, NY More articles by this author Eugene Kwon Rochester, MN More articles by this author Michael Blute Rochester, MN More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...