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BioMed Research International
Volume 2014 (2014), Article ID 351252, 7 pages
http://dx.doi.org/10.1155/2014/351252
Clinical Study

Activity and Safety of Bevacizumab Plus Fotemustine for Recurrent Malignant Gliomas

1Department of Medical Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy
2Diagnostic Oncology Department, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy
3Biostatistic Unit, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy
4Division of Medical Oncology, Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia, Perugia, Italy
5Division of Neurosurgery, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy
6Department of Pathology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy
7Division of Neurology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy
8Department of Radiation Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144 Rome, Italy

Received 14 February 2014; Revised 9 April 2014; Accepted 14 April 2014; Published 4 May 2014

Academic Editor: Roberta Rudà

Copyright © 2014 V. Vaccaro et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. No established chemotherapeutic regimen exists for the treatment of recurrent malignant gliomas (rMGs). Herein, we report the activity and safety results of the bevacizumab (B) plus fotemustine (FTM) combination for the treatment of rMGs. Patients and Methods. An induction phase consisted of B 10 mg/kg days 1, 15 plus FTM 65 mg/m2 days 1, 8, and 15. Nonprogressive patients entered the maintenance phase with B 10 mg/kg plus FTM 75 mg/m2 every 3 weeks. The primary endpoint was response rate; secondary endpoints included safety, progression free survival (PFS), and overall survival (OS). Results. Twenty-six patients affected by recurrent MGs (50% glioblastoma) were enrolled. Eight partial responses (31%) were observed. Median PFS and OS were 4 (95% C.I.: 2.8–5.1) and 6 months (95% C.I.: 4.2–7.8), respectively. Responses were significantly associated with both improved PFS and OS ( and , resp.). Treatment adverse events were mostly mild to moderate in intensity. Bevacizumab-related adverse events included grade 3 venous thromboembolic event (8%), grade 2 epistaxis (4%), hypertension (8%), and gastrointestinal perforation (4%). Conclusions. Bevacizumab plus FTM showed activity and good tolerability in pretreated MGs. Further investigations are needed in order to verify the benefits deriving from the addition of B to a cytotoxic in this clinical setting of patients.