| Title |
A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer
|
|---|---|
| Published in |
BMC Cancer, March 2018
|
| DOI | 10.1186/s12885-018-4234-8 |
| Pubmed ID | |
| Authors |
Raghav Sundar, Sun Young Rha, Hiroki Yamaue, Masahiro Katsuda, Koji Kono, Hyo Song Kim, Chan Kim, Kousaku Mimura, Ley-Fang Kua, Wei Peng Yong |
| Abstract |
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. 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. 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). 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. ClinicalTrials.gov Identifier: NCT01227772 , Date registered: 21 Oct 2010. |
X Demographics
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Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 43 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 43 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 7 | 16% |
| Student > Bachelor | 4 | 9% |
| Researcher | 4 | 9% |
| Student > Doctoral Student | 3 | 7% |
| Lecturer | 3 | 7% |
| Other | 6 | 14% |
| Unknown | 16 | 37% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 13 | 30% |
| Nursing and Health Professions | 3 | 7% |
| Environmental Science | 2 | 5% |
| Biochemistry, Genetics and Molecular Biology | 2 | 5% |
| Arts and Humanities | 1 | 2% |
| Other | 3 | 7% |
| Unknown | 19 | 44% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 03 April 2018.
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#15,498,204
of 23,031,582 outputs
Outputs from BMC Cancer
#4,156
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#210,584
of 330,033 outputs
Outputs of similar age from BMC Cancer
#113
of 234 outputs
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