Evidence map›Paper›PMID 34586548›Full record

ArticleInternational journal of clinical oncology2021

Efficacy and safety of nivolumab in Japanese patients with first recurrence of glioblastoma: an open-label, non-comparative study.

Tomokazu Aoki, Naoki Kagawa, Kazuhiko Sugiyama, Toshihiko Wakabayashi, Yoshiki Arakawa, Shigeru Yamaguchi, Shota Tanaka, Eiichi Ishikawa, Yoshihiro Muragaki, Motoo Nagane and 13 more

Abstract read
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In one paragraph

Article in International journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 5 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

11 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Anti-PD-1 and anti-PD-L1 antibodies for glioma.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. 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
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Advances and challenges in glioblastoma immunotherapy: a meta-analysis of immune checkpoint inhibitors.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  8. Review
  9. Tumor-infiltrating CD8Heliyon · 2024
    Article
  10. Review
  11. Review
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

23 authors.

Tomokazu AokiDepartment of Neurosurgery, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusa Mukaihatacho, Fushimi Ward, Kyoto, 612-8555, Japan. totorolangdom@yahoo.co.jp.ORCID http://orcid.org/0000-0003-0405-7680
Naoki KagawaDepartment of Neurosurgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Kazuhiko SugiyamaDepartment of Clinical Oncology and Neuro-Oncology Program, Hiroshima University Hospital, Hiroshima, Japan.
Toshihiko WakabayashiDepartment of Neurosurgery, Nagoya University Hospital, Nagoya, Japan.
Yoshiki ArakawaDepartment of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Shigeru YamaguchiDepartment of Neurosurgery, Hokkaido University Hospital, Hokkaido, Japan.
Shota TanakaDepartment of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan.
Eiichi IshikawaDepartment of Neurosurgery, University of Tsukuba Hospital, Ibaraki, Japan.
Yoshihiro MuragakiDepartment of Neurosurgery, Tokyo Women's Medical University Hospital, Tokyo, Japan.
Motoo NaganeFaculty of Medicine, Department of Neurosurgery, Kyorin University, Tokyo, Japan.
Mitsutoshi NakadaDepartment of Neurosurgery, Kanazawa University Hospital, Kanazawa, Japan.
Satoshi SuehiroDepartment of Neurosurgery, Ehime University Hospital, Ehime, Japan.
Nobuhiro HataDepartment of Neurosurgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Junichiro KurodaDepartment of Neurosurgery, Kumamoto University Hospital, Kumamoto, Japan.
Yoshitaka NaritaDepartment of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, Tokyo, Japan.
Yukihiko SonodaDepartment of Neurosurgery, Yamagata University Hospital, Yamagata, Japan.
Yasuo IwadateDepartment of Neurological Surgery, Chiba University Hospital, Chiba, Japan.
Manabu NatsumedaDepartment of Neurosurgery, Niigata University Medical and Dental Hospital, Niigata, Japan.
Yoichi NakazatoHidaka Center for Pathologic Diagnosis and Research, Hidaka Hospital, Gunma, Japan.
Hironobu MinamiDepartment Medical Oncology/Hematology, Kobe University, Kobe, Japan.
Yuki HirataOncology Early Clinical Development Planning, Ono Pharmaceutical Co., Ltd, Osaka, Japan.
Shunsuke HagiharaDepartment of Statistical Analysis, Ono Pharmaceutical Co., Ltd, Osaka, Japan.
Ryo NishikawaDepartment of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center, Saitama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn open-label, non-comparative study assessed the efficacy and safety of nivolumab in Japanese patients with first recurrence glioblastoma.

methodsPatients with first recurrence of histologically confirmed World Health Organization Grade IV glioma, after treatment with temozolomide and radiotherapy, received nivolumab 3 mg/kg every 2 weeks until confirmed disease progression (Response Assessment in Neuro-Oncology criteria) or toxicity. Primary endpoint was 1-year overall survival rate assessed by Bayesian approach. The prespecified efficacy criterion was that the Bayesian posterior probability threshold for exceeding the 1-year overall survival of bevacizumab (34.5%) from the Japanese phase 2 study (JO22506) would be 93%.

resultsOf the 50 enrolled patients, 44 (88.0%) had recurrent malignant glioma (glioblastoma, gliosarcoma), and of these, 26 (59.1%) had at least one measurable lesion at baseline. The Bayesian posterior mean 1-year overall survival (90% Bayesian credible intervals) with nivolumab was 54.4% (42.27-66.21), and the Bayesian posterior probability of exceeding the threshold of the 1-year overall survival rate of bevacizumab (34.5%) was 99.7%. Median (90% confidence interval) overall and progression-free survival was 13.1 (10.4-17.7) and 1.5 (1.4-1.5) months, respectively. One partial response was observed (objective response rate 1/26 evaluable patients [3.8%]). Treatment-related adverse event rates were 14.0% for Grade 3-4 and 2.0% for Grade 5; most adverse events resolved and were manageable.

conclusionsThe 1-year overall survival with nivolumab monotherapy in Japanese patients with glioblastoma met the prespecified efficacy criterion. The safety profile of nivolumab was consistent with that observed in other tumor types. CLINICAL

trial registrationJapicCTI-152967.

Indexed as

GlioblastomaNivolumabAntineoplastic Combined Chemotherapy ProtocolsBayes TheoremHumansJapanNeoplasm Recurrence, LocalNivolumabBayesian approachBevacizumabClinical TrialGlioblastomaNivolumabPhase IIProgrammed cell death

Identifiers

PMID34586548
PMCPMC8580927

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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.