PMID- 24373380
OWN - NLM
STAT- MEDLINE
DCOM- 20140321
LR  - 20211122
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 13
DP  - 2013 Dec 30
TI  - A phase II trial of personalized peptide vaccination in castration-resistant 
      prostate cancer patients: prolongation of prostate-specific antigen doubling 
      time.
PG  - 613
LID - 10.1186/1471-2407-13-613 [doi]
AB  - BACKGROUND: Cancer vaccine is one of the attractive treatment modalities for 
      patients with castration-resistant prostate cancer (CRPC). However, because of 
      delayed immune responses, its clinical benefits, besides for overall survival 
      (OS), are not well captured by the World Health Organization (WHO) and Response 
      Evaluation Criteria in Solid Tumors (RECIST) criteria. Several surrogate markers 
      for evaluation of cancer vaccine, including prostate-specific antigen doubling 
      time (PSADT), are currently sought. The purpose of this study was to assess 
      prospectively the PSA kinetics and immune responses, as well as the efficacy, 
      safety, and biomarkers of personalized peptide vaccination (PPV) in progressive 
      CRPC. METHODS: One hundred patients with progressive CRPC were treated with PPV 
      using 2-4 positive peptides from 31 candidate peptides determined by both human 
      leukocyte antigen (HLA) class IA types and the levels of immunoglobulin G (IgG) 
      against each peptide. The association between immune responses and PSADT as well 
      as overall survival (OS) was studied. RESULTS: PPV was safe and well tolerated in 
      all patients with a median survival time of 18.8 months. Peptide-specific IgG and 
      T-cell responses strongly correlated with PSADT (p < 0.0001 and p = 0.0007, 
      respectively), which in turn showed correlation with OS (p = 0.018). Positive IgG 
      responses and prolongation of PSADT during PPV were also significantly associated 
      with OS (p = 0.001 and p = 0.004) by multivariate analysis. CONCLUSIONS: PSADT 
      could be an appropriate surrogate marker for evaluation of the clinical benefit 
      of cancer vaccine. Further randomized trials are needed to confirm these results. 
      TRIAL REGISTRATION: UMIN000001850.
FAU - Noguchi, Masanori
AU  - Noguchi M
AD  - Clinical Research Division of the Research Center for Innovative Cancer Therapy, 
      Kurume University School of Medicine, 67 Asahi-machi, Kurume 830-0011, Japan. 
      noguchi@med.kurume-u.ac.jp.
FAU - Moriya, Fukuko
AU  - Moriya F
FAU - Suekane, Shigetaka
AU  - Suekane S
FAU - Ohnishi, Rei
AU  - Ohnishi R
FAU - Matsueda, Satoko
AU  - Matsueda S
FAU - Sasada, Tetsuro
AU  - Sasada T
FAU - Yamada, Akira
AU  - Yamada A
FAU - Itoh, Kyogo
AU  - Itoh K
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20131230
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Cancer Vaccines)
RN  - 0 (Vaccines, Subunit)
RN  - EC 3.4.21.- (KLK3 protein, human)
RN  - EC 3.4.21.- (Kallikreins)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
MH  - Adenocarcinoma/blood/immunology/mortality/*therapy
MH  - Aged
MH  - Aged, 80 and over
MH  - Cancer Vaccines/immunology/*therapeutic use
MH  - Humans
MH  - Immunity, Cellular
MH  - Immunity, Humoral
MH  - *Immunotherapy, Active
MH  - Kallikreins/blood
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Precision Medicine
MH  - Proportional Hazards Models
MH  - Prostate-Specific Antigen/blood
MH  - Prostatic Neoplasms, Castration-Resistant/blood/immunology/mortality/*therapy
MH  - Treatment Outcome
MH  - Vaccines, Subunit/*immunology
PMC - PMC3882108
EDAT- 2014/01/01 06:00
MHDA- 2014/03/22 06:00
PMCR- 2013/12/30
CRDT- 2013/12/31 06:00
PHST- 2013/06/07 00:00 [received]
PHST- 2013/09/03 00:00 [accepted]
PHST- 2013/12/31 06:00 [entrez]
PHST- 2014/01/01 06:00 [pubmed]
PHST- 2014/03/22 06:00 [medline]
PHST- 2013/12/30 00:00 [pmc-release]
AID - 1471-2407-13-613 [pii]
AID - 10.1186/1471-2407-13-613 [doi]
PST - epublish
SO  - BMC Cancer. 2013 Dec 30;13:613. doi: 10.1186/1471-2407-13-613.