• J. Neurol. Sci. · Aug 2014

    Safety evaluation of high-dose BCNU-loaded biodegradable implants in Chinese patients with recurrent malignant gliomas.

    • Ke Sai, Ming-Gu Zhong, Jian Wang, Yin-Sheng Chen, Yong-Gao Mou, Chao Ke, Xiang-Heng Zhang, Qun-Ying Yang, Fu-Hua Lin, Cheng-Cheng Guo, Zheng-He Chen, Jing Zeng, Yan-Chun Lv, Xiang Li, Wen-Chang Gao, and Zhong-Ping Chen.
    • Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, China; Collaborative Innovation Center for Cancer Medicine, 651 Dongfeng Road East, Guangzhou 510060, China; State Key Laboratory of Oncology in South China, 651 Dongfeng Road East, Guangzhou 510060, China. Electronic address: saike@sysucc.org.cn.
    • J. Neurol. Sci. 2014 Aug 15; 343 (1-2): 60-5.

    ObjectivesMalignant gliomas are common primary brain tumors with dismal prognosis. The blood-brain barrier and unacceptable systemic toxicity limit the employment of chemotherapeutic agents. BCNU-impregnated biodegradable polymers (Gliadel®) have been demonstrated to prolong the survival of patients with malignant gliomas. Until now, no biodegradable drug delivery system has been commercially available in China. In the present study, we evaluated the safety of implants with high-dose BCNU in Chinese patients with recurrent malignant gliomas.Patients And MethodsAdults with supratentorial recurrent malignant glioma were eligible. High-dose BCNU-loaded PLGA implants (20mg of BCNU in each implant) were placed in the debulking cavity. The implants were investigated by a classical 3+3 design. Four levels of BCNU, up to 12 implants, were evaluated. Pharmacokinetic sampling was performed. The toxicity of the implants and the survival of patients were recorded.ResultsFifteen recurrent patients were enrolled with 12 glioblastomas and 3 anaplastic gliomas. Among 15 patients, 3 were treated with 3 implants (60 mg of BCNU), 3 with 6 implants (120 mg), 3 with 9 implants (180 mg) and 6 with 12 implants (240 mg). No dose-limiting toxicity was observed in the cohort of patients. Subgaleal effusion was the most common adverse event, presenting in 7 patients (46.7%). The median overall survival (OS) was 322 days (95% CI, 173-471 days). The 6-month, 1-year and 2-year survival rates were 66.7%, 40% and 13.3%, respectively.ConclusionsThe high-dose BCNU-loaded PLGA implants were safe for Chinese patients with recurrent malignant gliomas and further investigation for efficacy is warranted.Copyright © 2014 Elsevier B.V. All rights reserved.

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