Evidence map›Paper›PMID 32642691›Full record

ArticleNeuro-oncology advances

Phase I trial of convection-enhanced delivery of nimustine hydrochloride (ACNU) for brainstem recurrent glioma.

Ryuta Saito, Masayuki Kanamori, Yukihiko Sonoda, Yoji Yamashita, Kenichi Nagamatsu, Takaki Murata, Shunji Mugikura, Toshihiro Kumabe, Eva Wembacher-Schröder, Rowena Thomson and 1 more

Open 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. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

11 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
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 2 institutions in 2 countries.

Ryuta SaitoDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Masayuki KanamoriDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yukihiko SonodaDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yoji YamashitaDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Kenichi NagamatsuDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Takaki MurataDepartment of Diagnostic Radiology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Shunji MugikuraDepartment of Diagnostic Radiology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Toshihiro KumabeDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Eva Wembacher-SchröderBrainlab AG, Munich, Germany.
Rowena ThomsonBrainlab AG, Munich, Germany.
Teiji TominagaDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Tohoku University · JPBrainlab (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment options for patients suffering brainstem gliomas are quite limited as surgery is not an option against intrinsic tumors at brainstem and chemotherapy generally failed to demonstrate its efficacy. Intracerebral convection-enhanced delivery (CED) is a novel approach for administering chemotherapy to patients with brain tumors. We present the results of phase I trial of CED of nimustine hydrochloride (ACNU), designed to determine the maximum tolerable concentration of ACNU, for patients with recurrent brainstem gliomas.

methodsSixteen patients, aged 3-81 years old, suffering from recurrent brainstem gliomas, including diffuse intrinsic pontine glioma patients as well as patients with recurrent gliomas that originated from non-brainstem sites, were enrolled in this trial between February 2011 and April 2016. The dose/concentration escalation trial included 3 dose/concentration groups (0.25, 0.5, and 0.75 mg/mL, all at 7 mL) to determine the safety and tolerability of CED of ACNU. Real-time monitoring of drug distribution was performed by mixing gadolinium-tetraazacyclododecanetetraacetic acid (Gd-DOTA) in the infusion solution. CED of ACNU was given in combination with oral or intravenous temozolomide chemotherapy.

resultsCED of ACNU demonstrated antitumor activity, as assessed by radiographic changes and prolonged overall survival. The recommended dosage was 0.75 mg/mL. Drug-associated toxicity was minimal.

conclusionsIntracerebral CED of ACNU under real-time monitoring of drug distribution, in combination with systemic temozolomide, was well tolerated among patients with recurrent brainstem gliomas. The safety and efficacy observed suggest the clinical benefits of this strategy against this devastating disease. Based on this phase I study, further clinical development of ACNU is warranted.

Indexed as

brainstemconvection-enhanced deliverynimustine hydrochloriderecurrent gliomatemozolomide

Identifiers

PMID32642691
PMCPMC7212853
OpenAlexW3010652862

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.