Please use this identifier to cite or link to this item: https://doi.org/10.1186/s12885-018-4234-8
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dc.titleA phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer
dc.contributor.authorSundar, R
dc.contributor.authorRha, S.Y
dc.contributor.authorYamaue, H
dc.contributor.authorKatsuda, M
dc.contributor.authorKono, K
dc.contributor.authorKim, H.S
dc.contributor.authorKim, C
dc.contributor.authorMimura, K
dc.contributor.authorKua, L.-F
dc.contributor.authorYong, W.P
dc.date.accessioned2020-09-09T10:30:08Z
dc.date.available2020-09-09T10:30:08Z
dc.date.issued2018
dc.identifier.citationSundar, 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
dc.identifier.issn1471-2407
dc.identifier.urihttps://scholarbank.nus.edu.sg/handle/10635/175397
dc.description.abstractBackground: 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).
dc.sourceUnpaywall 20200831
dc.subjectalkaline phosphatase
dc.subjectaspartate aminotransferase
dc.subjectcancer vaccine
dc.subjectHLA A antigen
dc.subjectotgsc a24
dc.subjectotsgc a24
dc.subjectpeptide vaccine
dc.subjectunclassified drug
dc.subjectbiological marker
dc.subjectcancer vaccine
dc.subjectHLA A24 antigen
dc.subjectsubunit vaccine
dc.subjectabdominal pain
dc.subjectadult
dc.subjectadvanced cancer
dc.subjectadverse outcome
dc.subjectaged
dc.subjectalkaline phosphatase blood level
dc.subjectanemia
dc.subjectantineoplastic activity
dc.subjectArticle
dc.subjectaspartate aminotransferase blood level
dc.subjectcancer pain
dc.subjectclinical article
dc.subjectcohort analysis
dc.subjectconstipation
dc.subjectcontrolled study
dc.subjectcoughing
dc.subjectcytotoxic T lymphocyte
dc.subjectdecreased appetite
dc.subjectdiarrhea
dc.subjectdizziness
dc.subjectdrug effect
dc.subjectdrug efficacy
dc.subjectdrug response
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectdyspepsia
dc.subjectdysphagia
dc.subjectdyspnea
dc.subjectenzyme linked immunospot assay
dc.subjectex vivo study
dc.subjectfemale
dc.subjectfever
dc.subjectgastrointestinal reflux
dc.subjecthaplotype
dc.subjecthuman
dc.subjecthyperbilirubinemia
dc.subjecthyperkalemia
dc.subjecthypokalemia
dc.subjecthyponatremia
dc.subjectimmune response
dc.subjectinjection site erythema
dc.subjectinjection site ulcer
dc.subjectloss of appetite
dc.subjectlung infection
dc.subjectmalaise
dc.subjectmale
dc.subjectmyalgia
dc.subjectnausea
dc.subjectopen study
dc.subjectoverall survival
dc.subjectperipheral edema
dc.subjectphase 1 clinical trial
dc.subjectprogression free survival
dc.subjectpruritus
dc.subjectstomach cancer
dc.subjectstomach tumor
dc.subjectsurvival rate
dc.subjecttreatment outcome
dc.subjectupper respiratory tract infection
dc.subjectvaccination
dc.subjectvomiting
dc.subjectcancer staging
dc.subjectclinical trial
dc.subjectcytotoxicity
dc.subjectgenetics
dc.subjectimmunology
dc.subjectmetabolism
dc.subjectmetastasis
dc.subjectmiddle aged
dc.subjectmortality
dc.subjectmultimodality cancer therapy
dc.subjectpathology
dc.subjectstomach tumor
dc.subjectAdult
dc.subjectAged
dc.subjectBiomarkers
dc.subjectCancer Vaccines
dc.subjectCombined Modality Therapy
dc.subjectCytotoxicity, Immunologic
dc.subjectFemale
dc.subjectHaplotypes
dc.subjectHLA-A24 Antigen
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectNeoplasm Metastasis
dc.subjectNeoplasm Staging
dc.subjectStomach Neoplasms
dc.subjectT-Lymphocytes, Cytotoxic
dc.subjectVaccines, Subunit
dc.typeArticle
dc.contributor.departmentLIFE SCIENCES INSTITUTE
dc.contributor.departmentDEPT OF SURGERY
dc.contributor.departmentDEAN'S OFFICE (DUKE-NUS MEDICAL SCHOOL)
dc.contributor.departmentCANCER SCIENCE INSTITUTE OF SINGAPORE
dc.description.doi10.1186/s12885-018-4234-8
dc.description.sourcetitleBMC Cancer
dc.description.volume18
dc.description.issue1
dc.description.page332
dc.published.statePublished
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