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, Yukinori Sakata

研究成果: ジャーナルへの寄稿学術論文査読

20 被引用数 (Scopus)

抄録

Background: Adjuvant 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. Methods: This 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. Results: Among 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; P = .002), lower resection rate (HR: 1.206; P < .001), recurrence (HR: 2.418; P < .001), and concomitant radiotherapy (HR: 0.588; P < .001) were identified as significant prognostic factors. Conclusions: This 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.

本文言語英語
ジャーナルNeuro-Oncology Advances
4
1
DOI
出版ステータス出版済み - 01-01-2022

All Science Journal Classification (ASJC) codes

  • 外科
  • 腫瘍学
  • 臨床神経学

フィンガープリント

「Long-term effectiveness of Gliadel implant for malignant glioma and prognostic factors for survival: 3-year results of a postmarketing surveillance in Japan」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

引用スタイル