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. 2021 Sep 15;61(9):536-548.
doi: 10.2176/nmc.oa.2021-0024. Epub 2021 Jul 9.

Safety of Gliadel Implant for Malignant Glioma: Report of Postmarketing Surveillance in Japan

Ryo Nishikawa  1 , Hisayuki Iwata  2 , Yukinori Sakata  2 , Kenzo Muramoto  2 , Toshiyuki Matsuoka  2
Affiliations

Safety of Gliadel Implant for Malignant Glioma: Report of Postmarketing Surveillance in Japan

Ryo Nishikawa et al. Neurol Med Chir (Tokyo). .

Abstract

Clinical trial data of Carmustine implant (Gliadel Wafer) in Japanese patients with malignant glioma are limited; thus, we conducted a postmarketing surveillance study to evaluate the safety of Gliadel in real-world clinical practice in Japan. In this postmarketing surveillance study, all patients who received Gliadel placement for malignant glioma surgeries from its market launch (January 9, 2013) to July 10, 2013 were enrolled from 229 institutions using a central registration system. Up to eight wafers of Gliadel (containing 61.6 mg of carmustine) were used to cover the site of brain tumor resection intraoperatively according to the size and shape of the tumor resection cavity. The observation period lasted 3 months after Gliadel placement. Patients were followed up for 1 year postoperatively. Safety was assessed by the incidence of adverse events (AEs) and adverse drug reactions (ADRs). In total, 558 patients were included. Most patients (66.7%) received eight Gliadel wafers. The percentage of patients with ADRs was 35.7% (365 ADR episodes in 199 patients). Of the AEs of special interest, the most common were cerebral edema (22.2%, 124/558 patients), convulsion (9.9%, 55/558 patients), impaired healing (4.8%, 27/558 patients), and infection (3.4%, 19/558 patients). This first all-case postmarketing surveillance report of the safety of Gliadel in real-world clinical practice in Japan suggests that the risk of toxicity with Gliadel placement is relatively tolerable. The survival benefits of Gliadel placement should be evaluated and considered carefully by the clinician taking into account possible toxicities.

Keywords: Gliadel implant; malignant glioma; postmarketing surveillance.

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Conflict of interest statement

Conflicts of Interest Disclosure

Dr. Ryo Nishikawa has received a manuscript fee from Eisai Co., Ltd. All authors, except Dr. Ryo Nishikawa, are employees of Eisai Co., Ltd. The study sponsor, Eisai Co., Ltd, was involved in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication.

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