Evidence map›Paper›PMID 24612787›Full record

ArticleJournal of translational medicine2014

A phase I study of combination vaccine treatment of five therapeutic epitope-peptides for metastatic colorectal cancer; safety, immunological response, and clinical outcome.

Shoichi Hazama, Yusuke Nakamura, Hiroko Takenouchi, Nobuaki Suzuki, Ryouichi Tsunedomi, Yuka Inoue, Yoshihiro Tokuhisa, Norio Iizuka, Shigefumi Yoshino, Kazuyoshi Takeda and 4 more

Open access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of translational medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed
4.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 93 citations in OpenAlex.

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  17. Tumor vaccines: Toward multidimensional anti-tumor therapies.Human vaccines & immunotherapeutics · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 4 institutions in 2 countries.

Shoichi HazamaDepartment of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, Japan. hazama@yamaguchi-u.ac.jp.
Yusuke Nakamura
Hiroko Takenouchi
Nobuaki Suzuki
Ryouichi Tsunedomi
Yuka Inoue
Yoshihiro Tokuhisa
Norio Iizuka
Shigefumi Yoshino
Kazuyoshi Takeda
Hirokazu Shinozaki
Akira Kamiya
Hiroyuki Furukawa
Masaaki Oka
Yamaguchi University · JPYamaguchi University Hospital · JPJuntendo University · JPUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the safety of combination vaccine treatment of multiple peptides, phase I clinical trial was conducted for patients with advanced colorectal cancer using five novel HLA-A*2402-restricted peptides, three peptides derived from oncoantigens, ring finger protein 43 (RNF43), 34 kDa-translocase of the outer mitochondrial membrane (TOMM34), and insulin-like growth factor-II mRNA binding protein 3 (KOC1), and the remaining two from angiogenesis factors, vascular endothelial growth factor receptor 1 (VEGFR1) and VEGFR2.

methodsEighteen HLA- A*2402-positive colorectal cancer patients who had failed to standard therapy were enrolled in this study. 0.5 mg, 1.0 mg or 3.0 mg each of the peptides was mixed with incomplete Freund's adjuvant and then subcutaneously injected at five separated sites once a week. We also examined possible effect of a single site injection of "the cocktail of 5 peptides" on the immunological responses. ELISPOT assay was performed before and after vaccinations in the schedule of every 4 weeks.

resultsThe vaccine treatment using multiple peptides was well tolerated without any severe treatment-associated systemic adverse events. Dose-dependent induction of peptide-specific cytotoxic T lymphocytes was observed. The single injection of "peptides cocktail" did not diminish the immunological responses. Regarding the clinical outcome, one patient achieved complete response and 6 patients revealed stable disease for 4 to 7 months. The median overall survival time (MST) was 13.5 months. Patients, in which we detected induction of cytotoxic T lymphocytes specific to 3 or more peptides, revealed significantly better prognosis (MST; 27.8 months) than those with poorer immune responses (MST; 3.7 months) (p = 0.032).

conclusionOur cancer vaccine treatment using multiple peptides is a promising approach for advanced colorectal cancer with the minimum risk of systemic adverse reactions. CLINICAL

trial registrationUMIN-CTR number UMIN000004948.

Indexed as

AgedAged, 80 and overBiomarkers, TumorCancer VaccinesColorectal NeoplasmsDose-Response Relationship, ImmunologicEpitopesFemaleHumansInterferon-gammaKaplan-Meier EstimateMaleMiddle AgedMonitoring, ImmunologicMultivariate AnalysisNeoplasm MetastasisBiomarkers, TumorCancer VaccinesEpitopesInterferon-gammaVaccines, CombinedVaccines, Subunit

Identifiers

PMID24612787
PMCPMC4007571
OpenAlexW2113364379

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.