Evidence map›Paper›PMID 30500939›Full record

Trial reportNeuro-oncology2019

A randomized, double-blind, phase III trial of personalized peptide vaccination for recurrent glioblastoma.

Yoshitaka Narita, Yoshiki Arakawa, Fumiyuki Yamasaki, Ryo Nishikawa, Tomokazu Aoki, Masayuki Kanamori, Motoo Nagane, Toshihiro Kumabe, Yuichi Hirose, Tomotsugu Ichikawa and 18 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuro-oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 10 pooled it
–field-weighted citation impact
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

68 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  4. A systematic review of immunotherapy in high-grade glioma: learning from the past to shape future perspectives.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
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  14. Vaccine-based cancer immunotherapy in newly diagnosed glioblastoma: a time-to-event meta-analysis of phase II and III randomized controlled trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
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  17. Current Status and Evolution of Immunotherapy in Glioma Management.International journal of medical sciences · 2026
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8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Yoshitaka NaritaNational Cancer Center Hospital, Tokyo, Japan.
Yoshiki ArakawaKyoto University Graduate School of Medicine, Kyoto, Japan.
Fumiyuki YamasakiHiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.
Ryo NishikawaSaitama Medical University International Medical Center, Saitama, Japan.
Tomokazu AokiNational Hospital Organization, Kyoto Medical Center, Kyoto, Japan.
Masayuki KanamoriTohoku University Graduate School of Medicine, Miyagi, Japan.
Motoo NaganeKyorin University Faculty of Medicine, Tokyo, Japan.
Toshihiro KumabeKitasato University School of Medicine, Kanagawa, Japan.
Yuichi HiroseFujita Health University School of Medicine, Aichi, Japan.
Tomotsugu IchikawaOkayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Hiroyuki KobayashiHokkaido University Graduate School of Medicine, Hokkaido, Japan.
Takamitsu FujimakiSaitama Medical University Hospital, Saitama, Japan.
Hisaharu GotoYamaguchi University School of Medicine, Yamaguchi, Japan.
Hideo TakeshimaFaculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Tetsuya UebaKochi Medical School, Kochi, Japan.
Hiroshi AbeFaculty of Medicine, Fukuoka University, Fukuoka, Japan.
Takashi TamiyaKagawa University Faculty of Medicine, Kagawa, Japan.
Yukihiko SonodaYamagata University Faculty of Medicine, Yamagata, Japan.
Atsushi NatsumeNagoya University Graduate School of Medicine, Aichi, Japan.
Tatsuyuki KakumaBiostatistics Center, Kurume University, Fukuoka, Japan.
Yasuo SugitaKurume University School of Medicine, Fukuoka, Japan.
Nobukazu KomatsuKurume University School of Medicine, Fukuoka, Japan.
Akira YamadaKurume University School of Medicine, Fukuoka, Japan.
Tetsuro SasadaCancer Vaccine Center, Kanagawa Cancer Center Research Institute, Kanagawa, Japan.
Satoko MatsuedaCenter for Immunotherapy, Roswell Park Cancer Institute, Buffalo, New York, USA.
Shigeki ShichijoCancer Vaccine Center, Kurume University, Fukuoka, Japan.
Kyogo ItohCancer Vaccine Center, Kurume University, Fukuoka, Japan.
Mizuhiko TerasakiKurume University School of Medicine, Fukuoka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe conducted a phase III trial of personalized peptide vaccination (PPV) for human leukocyte antigen (HLA)-A24+ recurrent glioblastoma to develop a new treatment modality.

methodsWe randomly assigned 88 recurrent glioblastoma patients to receive PPV (n = 58) or the placebo (n = 30) at a 2-to-1 ratio. Four of 12 warehouse peptides selected based on preexisting peptide-specific immunoglobulin G levels or the corresponding placebos were injected 1×/week for 12 weeks.

resultsOur trial met neither the primary (overall survival [OS]) nor secondary endpoints. Unfavorable factors for OS of 58 PPV patients compared with 30 placebo patients were SART2-93 peptide selection (n = 13 vs 8, hazard ratio [HR]: 15.9), ≥70 years old (4 vs 4, 7.87), >70 kg body weight (10 vs 7, 4.11), and performance status (PS)3 (8 vs 2, 2.82), respectively. Consequently, the median OS for PPV patients without SART2-93 selection plus one of these 3 favorable factors (<70 y old, ≤70 kg, or PS0-2) was significantly longer than that for the corresponding placebo patients (HR: 0.49, 0.44, and 0.51), respectively. Preexisting immunity against both all 12 warehouse peptides besides SART2-93 and the other cytotoxic T lymphocyte epitope peptides was significantly depressed in the patients with SART2-93 selection (n = 21) compared with that of the patients without SART2-93 selection (n = 67). Biomarkers correlative for favorable OS of the PPV patients were a lower percentage of CD11b+CD14+HLA-DRlow immunosuppressive monocytes and a higher percentage of CD4+CD45RA- activated T cells, the intermediate levels of chemokine C-C ligand 2 (CCL2), vascular endothelial growth factor, interleukin (IL)-6, IL-17, or haptoglobin, respectively.

conclusionThis phase III trial met neither the primary nor secondary endpoints.

Indexed as

AdultAgedAge FactorsAntigens, NeoplasmBrain NeoplasmsCancer VaccinesDNA-Binding ProteinsFemaleGlioblastomaHLA-A24 AntigenHumansKarnofsky Performance StatusMaleMiddle AgedNeoplasm ProteinsNeoplasm Recurrence, LocalAntigens, NeoplasmCancer VaccinesDNA-Binding ProteinsDSE protein, humanHLA-A24 AntigenNeoplasm ProteinsVaccines, Subunitbiomarker for overall survivalpersonalized peptide vaccinephase III trialpre-existing immunityrecurrent glioblastoma

Identifiers

PMID30500939
PMCPMC6380422

What OpenQuestion holds

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Registered trials

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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.