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

Authors :
AOKI, Tomokazu
NISHIKAWA, Ryo
SUGIYAMA, Kazuhiko
NONOGUCHI, Naosuke
KAWABATA, Noriyuki
MISHIMA, Kazuhiko
ADACHI, Jun-ichi
KURISU, Kaoru
YAMASAKI, Fumiyuki
TOMINAGA, Teiji
KUMABE, Toshihiro
UEKI, Keisuke
HIGUCHI, Fumi
YAMAMOTO, Tetsuya
ISHIKAWA, Eiichi
TAKESHIMA, Hideo
YAMASHITA, Shinji
ARITA, Kazunori
HIRANO, Hirofumi
YAMADA, Shinobu
MATSUTANI, Masao
Source :
Neurologia medico-chirurgica
Publication Year :
2013
Publisher :
The Japan Neurosurgical Society, 2013.

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.

Details

Language :
English
ISSN :
13498029 and 04708105
Volume :
54
Issue :
4
Database :
OpenAIRE
Journal :
Neurologia medico-chirurgica
Accession number :
edsair.pmid..........721a87af0408e10aa4e6681e3b16a0e8