Please use this identifier to cite or link to this item:
https://doi.org/10.1186/s12885-018-4234-8
DC Field | Value | |
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dc.title | A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer | |
dc.contributor.author | Sundar, R | |
dc.contributor.author | Rha, S.Y | |
dc.contributor.author | Yamaue, H | |
dc.contributor.author | Katsuda, M | |
dc.contributor.author | Kono, K | |
dc.contributor.author | Kim, H.S | |
dc.contributor.author | Kim, C | |
dc.contributor.author | Mimura, K | |
dc.contributor.author | Kua, L.-F | |
dc.contributor.author | Yong, W.P | |
dc.date.accessioned | 2020-09-09T10:30:08Z | |
dc.date.available | 2020-09-09T10:30:08Z | |
dc.date.issued | 2018 | |
dc.identifier.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 | |
dc.identifier.issn | 1471-2407 | |
dc.identifier.uri | https://scholarbank.nus.edu.sg/handle/10635/175397 | |
dc.description.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). | |
dc.source | Unpaywall 20200831 | |
dc.subject | alkaline phosphatase | |
dc.subject | aspartate aminotransferase | |
dc.subject | cancer vaccine | |
dc.subject | HLA A antigen | |
dc.subject | otgsc a24 | |
dc.subject | otsgc a24 | |
dc.subject | peptide vaccine | |
dc.subject | unclassified drug | |
dc.subject | biological marker | |
dc.subject | cancer vaccine | |
dc.subject | HLA A24 antigen | |
dc.subject | subunit vaccine | |
dc.subject | abdominal pain | |
dc.subject | adult | |
dc.subject | advanced cancer | |
dc.subject | adverse outcome | |
dc.subject | aged | |
dc.subject | alkaline phosphatase blood level | |
dc.subject | anemia | |
dc.subject | antineoplastic activity | |
dc.subject | Article | |
dc.subject | aspartate aminotransferase blood level | |
dc.subject | cancer pain | |
dc.subject | clinical article | |
dc.subject | cohort analysis | |
dc.subject | constipation | |
dc.subject | controlled study | |
dc.subject | coughing | |
dc.subject | cytotoxic T lymphocyte | |
dc.subject | decreased appetite | |
dc.subject | diarrhea | |
dc.subject | dizziness | |
dc.subject | drug effect | |
dc.subject | drug efficacy | |
dc.subject | drug response | |
dc.subject | drug safety | |
dc.subject | drug tolerability | |
dc.subject | dyspepsia | |
dc.subject | dysphagia | |
dc.subject | dyspnea | |
dc.subject | enzyme linked immunospot assay | |
dc.subject | ex vivo study | |
dc.subject | female | |
dc.subject | fever | |
dc.subject | gastrointestinal reflux | |
dc.subject | haplotype | |
dc.subject | human | |
dc.subject | hyperbilirubinemia | |
dc.subject | hyperkalemia | |
dc.subject | hypokalemia | |
dc.subject | hyponatremia | |
dc.subject | immune response | |
dc.subject | injection site erythema | |
dc.subject | injection site ulcer | |
dc.subject | loss of appetite | |
dc.subject | lung infection | |
dc.subject | malaise | |
dc.subject | male | |
dc.subject | myalgia | |
dc.subject | nausea | |
dc.subject | open study | |
dc.subject | overall survival | |
dc.subject | peripheral edema | |
dc.subject | phase 1 clinical trial | |
dc.subject | progression free survival | |
dc.subject | pruritus | |
dc.subject | stomach cancer | |
dc.subject | stomach tumor | |
dc.subject | survival rate | |
dc.subject | treatment outcome | |
dc.subject | upper respiratory tract infection | |
dc.subject | vaccination | |
dc.subject | vomiting | |
dc.subject | cancer staging | |
dc.subject | clinical trial | |
dc.subject | cytotoxicity | |
dc.subject | genetics | |
dc.subject | immunology | |
dc.subject | metabolism | |
dc.subject | metastasis | |
dc.subject | middle aged | |
dc.subject | mortality | |
dc.subject | multimodality cancer therapy | |
dc.subject | pathology | |
dc.subject | stomach tumor | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Biomarkers | |
dc.subject | Cancer Vaccines | |
dc.subject | Combined Modality Therapy | |
dc.subject | Cytotoxicity, Immunologic | |
dc.subject | Female | |
dc.subject | Haplotypes | |
dc.subject | HLA-A24 Antigen | |
dc.subject | Humans | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Neoplasm Metastasis | |
dc.subject | Neoplasm Staging | |
dc.subject | Stomach Neoplasms | |
dc.subject | T-Lymphocytes, Cytotoxic | |
dc.subject | Vaccines, Subunit | |
dc.type | Article | |
dc.contributor.department | LIFE SCIENCES INSTITUTE | |
dc.contributor.department | DEPT OF SURGERY | |
dc.contributor.department | DEAN'S OFFICE (DUKE-NUS MEDICAL SCHOOL) | |
dc.contributor.department | CANCER SCIENCE INSTITUTE OF SINGAPORE | |
dc.description.doi | 10.1186/s12885-018-4234-8 | |
dc.description.sourcetitle | BMC Cancer | |
dc.description.volume | 18 | |
dc.description.issue | 1 | |
dc.description.page | 332 | |
dc.published.state | Published | |
Appears in Collections: | Staff Publications Elements |
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