Preliminary discussion of BCNU-loaded biodegradable implants for recurrent malignant gliomas

Objective To evaluate the safety and primary efficacy of BCNU-loaded biodegradable implants for the treatment of recurrent malignant gliomas. Methods From January 2011 to December 2012, 22 patients with recurrent malignant glioma treated at the Department of Neurosurgery, Sun Yat-sen University Cancer Center and the Department of Neurosurgeries of 5 hospitals in China were analyzed retrospectively. The BCNU-loaded implants were placed into the tumor cavities after surgical resection of gliomas. The adverse reactions of the patients within 28 d after procedure were documented in detail. Its safety was evaluated. The survival time and the efficacy of preliminary drug evaluation after placing the implants in patients were recorded. Results A total of 22 patients received local sustained release chemotherapy. The gliomas of 12 patients were totally resected, 8 were subtotally resected, and 2 were partially resected. Three BCNU-loaded biodegradable implants were implanted in 3 cases, 6 were implanted in 3 cases, 8 were implanted in 4 cases, 9 were implanted in 3 cases, 10 were implanted in 3 cases, and 12 were implanted in 6 cases. At day 28 after implantation, 11 patients did not have other treatment, 8 received the chemotherapeutic drugs based on nitrosoureas or temozolomide chemotherapy, and 3 received both radiotherapy and chemotherapy. The most common adverse reaction of the implants was subgaleal effusion (n=9). Other adverse reactions included rash (n=2), thrombocytopenia (n=1), and erythrocytopenia (n=1). The mean follow-up time was 55 months. Twenty of 22 patients died and 2 were still alive up to the last follow-up. The median survival time of the 22 patients was 322 d (95% CI 173-471 d). Conclusions The BCNU-loaded biodegradable implants are well tolerated and safe. The agents have a tendency of prolonging the survival time of patients with recurrent malignant glioma. It is worth conducting phase III clinical trial to evaluate the efficacy. Key words: Glioma; Neurosurgical procedures; Adjuvant chemotherapy