Please use this identifier to cite or link to this item: https://doi.org/10.1186/s12885-018-4234-8
Title: A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer
Authors: Sundar, R 
Rha, S.Y
Yamaue, H
Katsuda, M
Kono, K 
Kim, H.S
Kim, C
Mimura, K
Kua, L.-F 
Yong, W.P 
Keywords: alkaline phosphatase
aspartate aminotransferase
cancer vaccine
HLA A antigen
otgsc a24
otsgc a24
peptide vaccine
unclassified drug
biological marker
cancer vaccine
HLA A24 antigen
subunit vaccine
abdominal pain
adult
advanced cancer
adverse outcome
aged
alkaline phosphatase blood level
anemia
antineoplastic activity
Article
aspartate aminotransferase blood level
cancer pain
clinical article
cohort analysis
constipation
controlled study
coughing
cytotoxic T lymphocyte
decreased appetite
diarrhea
dizziness
drug effect
drug efficacy
drug response
drug safety
drug tolerability
dyspepsia
dysphagia
dyspnea
enzyme linked immunospot assay
ex vivo study
female
fever
gastrointestinal reflux
haplotype
human
hyperbilirubinemia
hyperkalemia
hypokalemia
hyponatremia
immune response
injection site erythema
injection site ulcer
loss of appetite
lung infection
malaise
male
myalgia
nausea
open study
overall survival
peripheral edema
phase 1 clinical trial
progression free survival
pruritus
stomach cancer
stomach tumor
survival rate
treatment outcome
upper respiratory tract infection
vaccination
vomiting
cancer staging
clinical trial
cytotoxicity
genetics
immunology
metabolism
metastasis
middle aged
mortality
multimodality cancer therapy
pathology
stomach tumor
Adult
Aged
Biomarkers
Cancer Vaccines
Combined Modality Therapy
Cytotoxicity, Immunologic
Female
Haplotypes
HLA-A24 Antigen
Humans
Male
Middle Aged
Neoplasm Metastasis
Neoplasm Staging
Stomach Neoplasms
T-Lymphocytes, Cytotoxic
Vaccines, Subunit
Issue Date: 2018
Citation: Sundar, R, Rha, S.Y, Yamaue, H, Katsuda, M, Kono, K, Kim, H.S, Kim, C, Mimura, K, Kua, L.-F, Yong, W.P (2018). A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer. BMC Cancer 18 (1) : 332. ScholarBank@NUS Repository. https://doi.org/10.1186/s12885-018-4234-8
Abstract: Background: We conducted a phase I/Ib, open-label, single-arm trial to assess the safety, tolerability and optimal scheduling regimen of OTSGC-A24 cancer vaccine in patients with advanced gastric cancer. Methods: Patients with advanced gastric cancer with HLA-A*24:02 haplotype were included in this study. OTSGC-A24 was administered at 1 mg in 3-weekly (3w), 2-weekly (2w), and weekly (1w) cohorts to evaluate the safety, immunological response and schedule. Based on the highest specific cytotoxic T lymphocyte (CTL) induction rate at 4 weeks, using the ELISPOT test, cohorts were expanded to define the optimal dosing schedule for OTSGC-A24. Results: In this study, 24 advanced gastric cancer patients with HLA-A*24:02 haplotype were enrolled and treated in 3 cohorts (3w cohort: 3; 2w cohort: 11 and 1w cohort: 10 patients). The most common adverse events were decreased appetite (29%), diarrhea (21%), myalgia (25%). The most common treatment-related adverse event was injection site erythema (25%). No dose-limiting toxicities were observed in any cohort and OTSGC-A24 was well tolerated. Positive CTL responses after vaccination were observed in 15 patients (75%) at 4 weeks: 3w cohort (33%), 2w cohort (88%), 1w cohort (78%). At 12 weeks, 18 patients had responded (90%); 3w cohort (100%), 2w cohort (100%), 1w cohort (78%). The best radiological was stable disease (40%). Median progression free survival was 1.7 months (95% CI: 1.4 to 3.5) and median overall survival was 5.7 months (95% CI 3.8 to 8.6). Conclusions: OTSGC-A24 combined peptide cancer vaccine was well tolerated. Significant responses in CTL were observed and the recommended phase 2 dose is 1 mg OTSGC-A24 sub-cutaneous, every 2 weeks. Although no radiological response was observed, a respectable overall survival was achieved, consistent with other immunotherapy agents being investigated in gastric cancer. © 2018 The Author(s).
Source Title: BMC Cancer
URI: https://scholarbank.nus.edu.sg/handle/10635/175397
ISSN: 1471-2407
DOI: 10.1186/s12885-018-4234-8
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