674 DELAYED PSA RESPONSES IN PERSONALIZED PEPTIDE VACCINATION FOR CASTRATE-RESISTANT PROSTATE CANCER PATIENTS PHASE II STUDY

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced I1 Apr 2012674 DELAYED PSA RESPONSES IN PERSONALIZED PEPTIDE VACCINATION FOR CASTRATE-RESISTANT PROSTATE CANCER PATIENTS PHASE II STUDY Masanori Noguchi, Fukuko Moriya, Shigetaka Suekane, Kei Matsuoka, Satoko Matsueda, Tetsuro 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 , Satoko MatsuedaSatoko Matsueda Kurume, Japan More articles by this author , Tetsuro SasadaTetsuro 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.2012.02.756AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Personalized peptide vaccine (PPV) is a multiple peptide vaccine regimen planned according to the pre-existing immunity that could prolong overall survival (OS) of patients with castrate-resistant prostate cancer (CRPC). The purpose of this study was to prospectively assess the efficacy, safety and biomarkers of the PPV in CRPC patients. METHODS This study was a non-randomized, open-label, phase II study of patients with CRPC. Participants were treated with PPV using positive peptides chosen from 31 peptides in patients with positive 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 responses, expected prognostic factors including age, performance status (PS), lymphocyte counts, prostate-specific antigen (PSA), PSA doubling time, C-reactive protein (CRP), serum amino acid, interleukin -6, prior chemotherapy status and IgG responses, and overall survival was studied. RESULTS One hundred patients with CRPC received PPV and median times of vaccination was 15.5 (range; 5 to 38). 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 42/90 (47%) patients tested at the 6th vaccination. Confirmed PSA decline ≥50% was observed in 21% of the patients, median time to PSA decline was 6.4 months and median duration of PSA decline was 4.2 months. Median OS time was 17.1 months in all patients. Multivariate Cox proportional hazard regression analysis showed that baseline PS status, PSA and CRP levels are independent prognostic factors. CONCLUSIONS PPV in patients with CRPC is active and well tolerated improving survival with delayed PSA responses. Activity was observed in patients with good PS status, low PSA and CRP levels. Further randomized trials are needed to confirm our preliminary results. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e275 Advertisement Copyright & Permissions© 2012 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 Satoko Matsueda Kurume, Japan More articles by this author Tetsuro 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 ...