Evidence map›Paper›PMID 35118382›Full record

ArticleNeuro-oncology advances

Long-term effectiveness of Gliadel implant for malignant glioma and prognostic factors for survival: 3-year results of a postmarketing surveillance in Japan.

Toshihiko Iuchi, Akihiro Inoue, Yuichi Hirose, Motohiro Morioka, Keishi Horiguchi, Atsushi Natsume, Yoshiki Arakawa, Koichi Iwasaki, Minoru Fujiki, Toshihiro Kumabe and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02300506 (Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
4.7field-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.

NCT02300506 completednot on this map

Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma

TypeobservationalSponsorEisai Co., Ltd.Ran2014 to 2016Enrolled507ConditionsMalignant GliomaArmsNo intervention
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  6. Review
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  8. Review
  9. Article
  10. Rise of implantable drugs: A chronicle of breakthroughs in drug delivery systems.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024
    Review
  11. Review
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  13. Article
  14. Review
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  19. Article
  20. Modeling Polymeric Drug Release: The Emerging Role of Machine Learning.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology
    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

11 authors at 11 institutions in 1 country.

Toshihiko IuchiDivision of Neurological Surgery, Chiba Cancer Center, Chiba, Japan.
Akihiro InoueDepartment of Neurosurgery, Ehime University School of Medicine, Ehime, Japan.
Yuichi HiroseDepartment of Neurosurgery, Fujita Health University, Aichi, Japan.
Motohiro MoriokaDepartment of Neurosurgery, Kurume University School of Medicine, Fukuoka, Japan.ORCID https://orcid.org/0000-0001-7179-1258
Keishi HoriguchiDepartment of Neurosurgery, Gunma University Hospital, Gunma, Japan.
Atsushi NatsumeDepartment of Neurosurgery, Nagoya University Hospital, Aichi, Japan.
Yoshiki ArakawaDepartment of Neurosurgery, Kyoto University Hospital, Kyoto, Japan.
Koichi IwasakiDepartment of Neurosurgery, Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan.
Minoru FujikiDepartment of Neurosurgery, Oita University Hospital, Oita, Japan.
Toshihiro KumabeDepartment of Neurosurgery, Kitasato University Hospital, Kanagawa, Japan.
Yukinori SakataClinical Planning Department, Medical Headquarters, Eisai Co., Ltd, Tokyo, Japan.
Chiba Cancer Center · JPEhime University · JPEisai (Japan) · JPFujita Health University · JPGunma University Hospital · JPKitano Hospital · JPKitasato University Hospital · JPKurume University · JPKyoto University Hospital · JPNagoya University Hospital · JPOita University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdjuvant treatment with Gliadel wafers may prolong overall survival (OS) for malignant glioma patients without increasing toxicity. In Japan, the long-term OS of these patients treated with Gliadel 7.7 mg implants has not been studied. We evaluated OS and prognostic factors that might affect OS in Japanese patients with malignant glioma who received the Gliadel 7.7 mg implant.

methodsThis observational, long-term, postmarketing surveillance was an extension of a previous surveillance. Data were collected through case report forms at 2 and 3 years after Gliadel implant. Up to 8 Gliadel wafers (61.6 mg of carmustine) were placed over the tumor resection site. Primary endpoints were OS and prognostic factors that may influence OS.

resultsAmong the 506 patients analyzed, 62.6% had newly diagnosed disease, and 37.4% had recurrent disease; 79.1% had glioblastoma histological type and 79.6% had World Health Organization Grade IV disease. Patients received a median of 8 wafers. The median OS was 18.0 months; OS rates were 39.8% and 31.5% at 2 and 3 years, respectively. Age ≥65 years (hazard ratio [HR]: 1.456;

conclusionsThis study confirmed the 2- and 3-year OS of Japanese malignant glioma patients with varied backgrounds after Gliadel implant. With a careful interpretation of indirect comparisons with previously reported data, the results suggest that prognosis could be improved with Gliadel implants. CLINICAL

trial registrationNCT02300506.

Indexed as

effectivenessGliadelimplantmalignant gliomasurvival

Identifiers

PMID35118382
PMCPMC8807118
OpenAlexW4206821065

What OpenQuestion holds

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Registered trials

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.