Abstract
BackgroundThere is no consensus therapy recommended for recurrent malignant gliomas (MGs). In 2009, Bevacizumab (BEV) was approved by the FDA as single-agent for recurrent glioblastoma (GBM). The aim of this retrospective study was to evaluate the efficacy and the safety of BEV alone or in combination with Fotemustine (FTM) in recurrent MGs. This represents an interim analysis of a larger study on BEV in MGs patients.MethodsWe analyzed 17 recurrent MGs patients, 12 GBM (70.6%) and 5 anaplastic gliomas (29.4%), underwent first-line therapy with Stupp regimen. BEV was administered as off-label therapy, at a dose of 10 mg/kg every 14 days, in 13 patients as third-line therapy and in 4 patients as second-line therapy associated with FTM. The assessment of MGMT methylation and IDH1 mutation was conducted.ResultsOne complete response (5.9%), 7 partial responses (41.2%), 3 stable diseases (17.6%) and 6 progression diseases (35.3%) were assessed using RANO criteria. Median PFS (mPFS) and OS (mOS) were 5 and 8.3 months respectively, with a 6 months-PFS of 41.2%. Methylated patients and wild-type IDH1 patients showed longer mPFS and mOS without statistical significance. Six patients (35.3%) experienced long response with high number of cycles (11-40), long PFS (11-40 months) and OS (12-42 months). BEV was well-tolerated with grade 1-2 proteinuria and hypertension in 53% and 47.1% of patients respectively. Only one patient developed grade 3 proteinuria after 30 cycles and another one developed pulmonary embolism. No other grade 3-4 toxicities were observed.ConclusionsThis retrospective study showed the efficacy and the safety of BEV alone or in association with FTM in the treatment of MGs.The protocol (No: Beva-Glio/Sep 2016).
Highlights
There is no consensus therapy recommended for recurrent malignant gliomas (MGs)
FTM treatment, according to the Addeo schedule [25], consists of an induction phase dose of 80 mg/mq every 2 weeks for 5 consecutive weeks followed by a 4-week rest period and a maintenance phase dose of 80 mg/mq every 4 weeks
Patients’ characteristics Between August 2011 and May 2016, 17 patients with recurrent MGs receiving BEV as second-line or third line treatment were included in the analysis
Summary
In 2009, Bevacizumab (BEV) was approved by the FDA as single-agent for recurrent glioblastoma (GBM). It has been demonstrated that VEGF inhibition leads to a decreased growth of glioma cells and to reduce both peritumoral edema and, the need for corticosteroid therapy [9, 11]. This decrease of steroids use for prolonged periods reduce long-term adverse effects improving quality of life of patients
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