Trial reportNeurologia medico-chirurgica2014
A multicenter phase I/II study of the BCNU implant (Gliadel(®) Wafer) for Japanese patients with malignant gliomas.
Trial report in Neurologia medico-chirurgica, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Gliadel wafer implantation combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma: a systematic literature review.World journal of surgical oncology · 2016Pooled it
- Survival outcomes and safety of carmustine wafers in the treatment of high-grade gliomas: a meta-analysis.Journal of neuro-oncology · 2015Pooled it
- Phase I/II Study of Temozolomide Plus Nimustine Chemotherapy for Recurrent Malignant Gliomas: Kyoto Neuro-oncology Group.Neurologia medico-chirurgica · 2017Trial
- Retrospective Monocentric Analysis of Carmustine Wafer Implantation in Recurrent Glioblastoma: Impact on Survival and Key Prognostic Factors.Current oncology (Toronto, Ont.) · 2026Article
- Impact of Carmustine wafer implantation in epileptic seizures of newly diagnosed glioblastomas, IDH-wildtype in adults.Journal of neuro-oncology · 2026Observational
- Using a pre-radiation window to identify potentially active cytotoxic agents in adults with newly diagnosed glioblastoma.Neuro-oncology · 2025Review
- Trends in Efficacy Endpoints in Phase II Glioblastoma Trials: A Regulatory Science Analysis (FY2020-FY2022).Cancers · 2025Article
- Unmanageable Cerebrospinal Fluid Leakage With Eosinophilic Meningitis in a Gliadel Wafer Implant Patient.Cureus · 2024Article
- Golden Buckwheat Extract-Loaded Injectable Hydrogel for Efficient Postsurgical Prevention of Local Tumor Recurrence Caused by Residual Tumor Cells.Molecules (Basel, Switzerland) · 2023Article
- Carmustine wafer implantation for supratentorial glioblastomas, IDH-wildtype in "extreme" neurosurgical conditions.Neurosurgical review · 2023Article
- Cerebral Edema Due to Chemotherapeutic Wafer Implantation for Malignant Glioma: Registry Study of Correlation with Perioperative Epileptic Seizures.Neurologia medico-chirurgica · 2022Article
- Is Interstitial Chemotherapy with Carmustine (BCNU) Wafers Effective against Local Recurrence of Glioblastoma? A Pharmacokinetic Study by Measurement of BCNU in the Tumor Resection Cavity.Brain sciences · 2022Article
- Safety of Gliadel Implant for Malignant Glioma: Report of Postmarketing Surveillance in Japan.Neurologia medico-chirurgica · 2021Article
- Symptomatic cerebral vasospasm in the setting of carmustine wafer placement for glioblastoma: A case presentation and review of literature.Surgical neurology international · 2020Article
- Viral and other therapies for recurrent glioblastoma: is a 24-month durable response unusual?Neuro-oncology · 2019Review
- Symptomatic Remote Cyst after BCNU Wafer Implantation for Malignant Glioma.Neurologia medico-chirurgica · 2018Article
- Tumor microenvironment after biodegradable BCNU wafer implantation: special consideration of immune system.Journal of neuro-oncology · 2018Article
- Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry.CNS oncology · 2018Observational
- Localized targeted antiangiogenic drug delivery for glioblastoma.Journal of neuro-oncology · 2018Review
- Glioblastoma fed by middle meningeal artery and displaying cyst formation soon after repeated implantation of carmustine wafers: A case report.Molecular and clinical oncology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 9 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Carmustine (BCNU) implants (Gliadel(®) Wafer, Eisai Inc., New Jersey, USA) for the treatment of malignant gliomas (MGs) were shown to enhance overall survival in comparison to placebo in controlled clinical trials in the United States and Europe. A prospective, multicenter phase I/II study involving Japanese patients with MGs was performed to evaluate the efficacy, safety, and pharmacokinetics of BCNU implants. The study enrolled 16 patients with newly diagnosed MGs and 8 patients with recurrent MGs. After the insertion of BCNU implants (8 sheets maximum, 61.6 mg BCNU) into the removal cavity, various chemotherapies (including temozolomide) and radiotherapies were applied. After placement, overall and progression-free survival rates and whole blood BCNU levels were evaluated. In patients with newly diagnosed MGs, the overall survival rates at 12 months and 24 months were 100.0% and 68.8%, and the progression-free survival rate at 12 months was 62.5%. In patients with recurrent MGs, the progression-free survival rate at 6 months was 37.5%. There were no grade 4 or higher adverse events noted due to BCNU implants, and grade 3 events were observed in 5 of 24 patients (20.8%). Whole blood BCNU levels reached a peak of 19.4 ng/mL approximately 3 hours after insertion, which was lower than 1/600 of the peak BCNU level recorded after intravenous injections. These levels decreased to less than the detection limit (2.00 ng/mL) after 24 hours. The results of this study involving Japanese patients are comparable to those of previous studies in the United States and Europe.
Indexed as
Identifiers
24739422PMC4533485W1995127245What OpenQuestion holds
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.