A Multicenter Phase I/II Study of the BCNU Implant (Gliadel<sup>®</sup> Wafer) for Japanese Patients with Malignant Gliomas

Access this Article

Search this Article

Author(s)

    • AOKI Tomokazu
    • Department of Neurosurgery, National Hospital Organization Kyoto Medical Center
    • TOMINAGA Teiji
    • Department of Neurosurgery, Tohoku University Graduate School of Medicine
    • KUMABE Toshihiro
    • Department of Neurosurgery, Tohoku University Graduate School of Medicine|Department of Neurosurgery, Kitasato University School of Medicine (current affiliation)
    • UEKI Keisuke
    • Department of Neurosurgery, Dokkyo Medical University Hospital
    • HIGUCHI Fumi
    • Department of Neurosurgery, Dokkyo Medical University Hospital
    • ISHIKAWA Eiichi
    • Department of Neurosurgery, Faculty of Medicine, University of Tsukuba
    • TAKESHIMA Hideo
    • Department of Neurosurgery, Faculty of Medicine, University of Miyazaki Hospital
    • YAMASHITA Shinji
    • Department of Neurosurgery, Faculty of Medicine, University of Miyazaki Hospital
    • ARITA Kazunori
    • Department of Neurosurgery, Graduate School of Medical and Dental Sciences, Kagoshima University
    • HIRANO Hirofumi
    • Department of Neurosurgery, Graduate School of Medical and Dental Sciences, Kagoshima University
    • NISHIKAWA Ryo
    • Department of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center
    • MATSUTANI Masao
    • Department of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center
    • SUGIYAMA Kazuhiko
    • Department of Neurosurgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
    • MISHIMA Kazuhiko
    • Department of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center
    • ADACHI Jun-ichi
    • Department of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center
    • KURISU Kaoru
    • Department of Neurosurgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
    • YAMASAKI Fumiyuki
    • Department of Neurosurgery, Graduate School of Biomedical and Health Sciences, Hiroshima University

Abstract

Carmustine (BCNU) implants (Gliadel<sup>®</sup> 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.

Journal

  • Neurologia medico-chirurgica

    Neurologia medico-chirurgica 54(4), 290-301, 2014

    The Japan Neurosurgical Society

Codes

Page Top