%0 Journal Article
%T Polifeprosan 20, 3.85% carmustine slow-release wafer in malignant glioma: evidence for role in era of standard adjuvant temozolomide
%A Kleinberg L
%J Core Evidence
%D 2012
%I Dove Medical Press
%X Lawrence KleinbergDepartment of Radiation Oncology and Molecular Radiation Sciences, Sidney Kimmel Oncology Center Johns Hopkins University, Baltimore, MD, USA: The Polifeprosan 20 with carmustine (BCNU, bis-chloroethylnitrosourea, Gliadel ) polymer implant wafer is a biodegradable compound containing 3.85% carmustine which slowly degrades to release carmustine and protects it from exposure to water with resultant hydrolysis until the time of release. The carmustine implant wafer was demonstrated to improve survival in blinded placebo-controlled trials in selected patients with newly diagnosed or recurrent malignant glioma, with little increased risk of adverse events. Based on these trials and other supporting data, US and European regulatory authorities granted approval for its use in recurrent and newly diagnosed malignant glioma, and it remains the only approved local treatment. The preclinical and clinical data suggest that it is optimally utilized primarily in the proportion of patients who may have total or near total removal of gross tumor. The aim of this work was to review the evidence for the use of carmustine implants in the management of malignant astrocytoma (World Health Organization grades III and IV), including newly diagnosed and recurrent disease, especially in the setting of a standard of care that has changed since the randomized trials were completed. Therapy has evolved such that patients now generally receive temozolomide chemotherapy during and after radiotherapy treatment. For patients undergoing repeat resection for malignant glioma, a randomized, blinded, placebo-controlled trial demonstrated a median survival for 110 patients who received carmustine polymers of 31 weeks compared with 23 weeks for 122 patients who only received placebo polymers. The benefit achieved statistical significance only on analysis adjusting for prognostic factors rather than for the randomized groups as a whole (hazard ratio = 0.67, P = 0.006). A blinded, placebo-controlled trial has also been performed for carmustine implant placement in newly diagnosed patients prior to standard radiotherapy. Median survival was improved from 11.6 to 13.9 months (P = 0.03), with a 29% reduction in the risk of death. When patients with glioblastoma multiforme alone were analyzed, the median survival improved from 11.4 to 13.5 months, but this improvement was not statistically significant. When a Cox's proportional hazard model was utilized to account for other potential prognostic factors, there was a significant 31% reduction in the risk of death (P = 0.04) in this
%U http://www.dovepress.com/polifeprosan-20-385-carmustine-slow-release-wafer-in-malignant-glioma--a11369