PMID- 30679903
OWN - NLM
STAT- MEDLINE
DCOM- 20190618
LR  - 20200225
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 13
DP  - 2019
TI  - A brief report of toxicity end points of HER2 vaccines for the treatment of 
      patients with HER2(+) breast cancer.
PG  - 309-316
LID - 10.2147/DDDT.S188925 [doi]
AB  - Human epidermal growth factor receptor 2 (HER2)-targeted vaccines are under 
      development, but have so far demonstrated only modest clinical efficacy. 
      Additionally, there has been a lack of adequate safety assessment in large-scale 
      prospective clinical trials. Therefore, we performed a meta-analysis of available 
      clinical trial data to summarize the toxicity profiles of these treatments. 
      Literature search was conducted in February 2018. The trials analyzed had at 
      least one study arm consisting of HER2 vaccine monotherapy. Heterogeneity across 
      studies was analyzed using I (2) statistics. Data were analyzed using 
      random-effects meta-analysis for absolute risk (AR). Eight trials and 248 
      patients were included. There was no evidence of heterogeneity between studies 
      for grades 3/4 adverse events (AEs) or for death. The AR for treatment-related 
      serious AEs was 5% with no treatment-related deaths. The AR of all-grade fatigue, 
      injection site reaction, and fever/chills/rigors was 33%, 23%, and 31%, 
      respectively. Asymptomatic drop in left ventricle ejection fraction was rare 
      (8%). HER2 vaccines are well tolerated with increased AR of fatigue, injection 
      site reactions, and fever/chills/rigors.
FAU - Costa, Ricardo
AU  - Costa R
AD  - Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, Tampa, FL, USA, ricardo.costa@moffitt.org.
FAU - Zaman, Saif
AU  - Zaman S
AD  - Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
FAU - Sharpe, Susan
AU  - Sharpe S
AD  - Moffitt Biomedical Library, H. Lee Moffitt Cancer Center and Research Institute, 
      Tampa, FL, USA.
FAU - Helenowski, Irene
AU  - Helenowski I
AD  - Department of Preventive Medicine, Northwestern University, Chicago, IL, USA.
FAU - Shaw, Colleen
AU  - Shaw C
AD  - Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, Tampa, FL, USA, ricardo.costa@moffitt.org.
FAU - Han, Hyo
AU  - Han H
AD  - Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, Tampa, FL, USA, ricardo.costa@moffitt.org.
FAU - Soliman, Hatem
AU  - Soliman H
AD  - Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, Tampa, FL, USA, ricardo.costa@moffitt.org.
FAU - Czerniecki, Brian
AU  - Czerniecki B
AD  - Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, Tampa, FL, USA, ricardo.costa@moffitt.org.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20190114
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Cancer Vaccines)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Breast Neoplasms/immunology/*metabolism/pathology/*therapy
MH  - Cancer Vaccines/*adverse effects/chemistry/*therapeutic use
MH  - Female
MH  - Humans
MH  - Receptor, ErbB-2/*antagonists & inhibitors/metabolism
PMC - PMC6338114
OTO - NOTNLM
OT  - HER2
OT  - dendritic cells
OT  - immunity
OT  - toxicity
OT  - vaccines
COIS- Disclosure B Czerniecki has a patent filed for DC1 vaccine and intellectual 
      property license with ImmunoRestoration. The authors report no other conflicts of 
      interest in this work.
EDAT- 2019/01/27 06:00
MHDA- 2019/06/19 06:00
PMCR- 2019/01/14
CRDT- 2019/01/26 06:00
PHST- 2019/01/26 06:00 [entrez]
PHST- 2019/01/27 06:00 [pubmed]
PHST- 2019/06/19 06:00 [medline]
PHST- 2019/01/14 00:00 [pmc-release]
AID - dddt-13-309 [pii]
AID - 10.2147/DDDT.S188925 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2019 Jan 14;13:309-316. doi: 10.2147/DDDT.S188925. 
      eCollection 2019.