Implantation of carmustine wafers (Gliadel®) for high-grade glioma treatment. A 9-year nationwide retrospective study.

Abstract

Carmustine wafers (CW) are approved to treat newly or recurrent high-grade gliomas (HGG). Widespread use has been limited regarding some doubtful uncertainties about their efficacy, related increased risk of infection and expensive cost. To describe the epidemiology of CW implantation, search for related complications, long-term survival and associated prognostic factors. We processed the French medico-administrative national database to retrieve appropriate cases operated between 2010 and 2018. A survival analysis was conducted. We identified 1659 patients treated in 39 institutions. Median age at CW implantation was 61years and there was an over-representation of male (63.5%). 491 patients (29.6%) had previous diagnosis of glioma. Time between the first surgery and CW implantation was 0.9years, IQR[0.6, 1.6]. The frontal lobe was the most frequently involved 29%. 131 patients (7.9%) had to be re operated on for a complication of which 121 for surgical site infection. At one year, 514 patients (31%) had died. Median overall survival (OS) was 1.4years, 95% CI [1.3, 1.5]. OS at 1 and 2year was 66%, 95%CI [63.7, 68.5], 32.3%, 95%CI [29.9, 35]. In the adjusted Cox regression, male gender & age at CW implantation were established as independent factors of OS in all three groups. Patients with recurrent HGG have a significant worse prognosis (HR = 0.71, 95% CI [0.62, 0.80] p < 0.001). A post-operative diagnosis of infection or intracranial bleeding eventually leading to a redo surgery was not associated with a decrease OS. Over the past 9years, there is a significant decrease utilisation of CW in France. OS after CW implantation is significantly variable as influenced by many factors such as age, gender or recurrent disease but not by post-operative complications. Compare to previous results, CW may increase the OS and this effect seems more pronounced when adjuvant RT/TMZ is given.