900 OPEN-LABEL PHASE II STUDY EVALUATING THE EFFICACY AND SAFETY OF PERSONALIZED PEPTIDE VACCINATION (PPV) IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER(CRPC)

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced1 Apr 2011900 OPEN-LABEL PHASE II STUDY EVALUATING THE EFFICACY AND SAFETY OF PERSONALIZED PEPTIDE VACCINATION (PPV) IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER(CRPC) Masanori Noguchi, Fukuko Moriya, Shigetaka Suekane, Kei Matsuoka, Gaku Arai, Satoko Matsueda, Tetsurou Sasada, Akira Yamada, and Kyogo Itoh Masanori NoguchiMasanori Noguchi Kurume, Japan More articles by this author , Fukuko MoriyaFukuko Moriya Kurume, Japan More articles by this author , Shigetaka SuekaneShigetaka Suekane Kurume, Japan More articles by this author , Kei MatsuokaKei Matsuoka Kurume, Japan More articles by this author , Gaku AraiGaku Arai Koshigaya, Japan More articles by this author , Satoko MatsuedaSatoko Matsueda Kurume, Japan More articles by this author , Tetsurou SasadaTetsurou Sasada Kurume, Japan More articles by this author , Akira YamadaAkira Yamada Kurume, Japan More articles by this author , and Kyogo ItohKyogo Itoh Kurume, Japan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.2609AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES A personalized selection of the right peptides for each patient could be a novel approach for a cancer vaccine to boost anti-cancer immunity in the majority of patients along with the potential of survival benefits. The purpose of this study was to prospectively assess the efficacy and safety of the PPV in CRPC patients while evaluating progression status with or without prior docetaxel-based chemotherapy (DBC). METHODS This study was a non-randomized, open-label, phase II study of patients with CRPC who had received previous hormone therapy with or without DBC, but whose disease had progressed. Participants were treated with PPV using positive peptides chosen from 31 peptides in patients with human leukocyte antigen (HLA)-A24, -A2, A26, -A3 super-type, respectively. Peptide-reactive immunoglobulin G (IgG) using an enzyme-linked immunosorbent assay was monitored during every 6th vaccination. The association between immunological response, progression status with or without prior DBC, and overall survival was studied. RESULTS Forty-two patients with CRPC with (n = 20) or without (22) prior DBC received PPV. Median times of vaccination was 13.5 (range; 5 to 26) in patients with prior DBC and 14 (range; 6 to 30) in patients without prior DBC, respectively. The peptide vaccination was safe and well tolerated with no major adverse effects during PPV in all patients. Increases of the anti-peptide IgG titer were revealed in 29.4% patients with prior DBC and in 40.9% patients without prior DBC at 6th vaccination. Prostate specific antigen (PSA) decrease by d50% was observed in 15% of the patients with prior DBC and in 9% of the patients without prior DBC. Median overall survival time was 14.8 months in patients with prior DBC and undefined in patients without prior DBC (log-rank; p=0.0945). To assess the usefulness of PPV, we compared median overall survival time from progression after DBC treated by PPV with those of our historical data in which patients did not receive PPV (n=17). The median overall survival was 17.8 months in patients with PPV and 10.5 months in patients with DBC alone (log-rank; p=0.0596). CONCLUSIONS PPV in patients with CRPC is active and well tolerated improving survival in spite of limited PSA response. Activity was observed in CRPC with or without prior DBC. Further randomized trials are needed to confirm our preliminary results. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e360-e361 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Masanori Noguchi Kurume, Japan More articles by this author Fukuko Moriya Kurume, Japan More articles by this author Shigetaka Suekane Kurume, Japan More articles by this author Kei Matsuoka Kurume, Japan More articles by this author Gaku Arai Koshigaya, Japan More articles by this author Satoko Matsueda Kurume, Japan More articles by this author Tetsurou Sasada Kurume, Japan More articles by this author Akira Yamada Kurume, Japan More articles by this author Kyogo Itoh Kurume, Japan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...