CLINICAL REPORTSBevacizumab plus irinotecan in recurrent malignant glioma shows high overall survival in a multicenter retrospective pooled series of the Spanish Neuro-Oncology Research Group (GEINO)Gil, Miguel J.a; de las Peñas, Ramóne; Reynés, Gasparf; Balañá, Carmeg; Peréz-Segura, Pedroh; García-Velasco, Adelaidaj; Mesia, Carlosa; Gallego, Óscarb; Fernández-Chacón, Concepcióni; Martínez-García, Maríac; Herrero, Anak; Andrés, Raquell; Benavides, Manuelm; Quintanar, Teresan; Pérez-Martin, XavierdAuthor Information aDepartment of Medical Oncology, Institut Català d’Oncologia-IDIBELL, L’Hospitalet de Llobregat bDepartment of Medical Oncology, Hospital Sant Pau, Barcelona cDepartment of Medical Oncology, Hospital del Mar, Barcelona dBiostatistics, Clinical Research Unit, Institut Català d’Oncologia-IDIBELL, L’Hospitalet Llobregat eDepartment of Medical Oncology, Consorcio Hospitalario Provincial de Castellón, Castellón fDepartment of Medical Oncology, Hospital Universitario La Fe de Valencia, Valencia gDepartment of Medical Oncology, Institut Català d’Oncologia, Badalona hDepartment of Medical Oncology, Hospital Clínico San Carlos, Madrid iDepartment of Medical Oncology, MDAndeson Internacional España, Madrid jDepartment of Medical Oncology, Institut Català d’Oncologia, Girona kDepartment of Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza lDepartment of Medical Oncology, Hospital Clínico Universitario Lozano Blesa, Zaragoza mDepartment of Medical Oncology, Hospital Regional Universitario Carlos Haya, Málaga nDepartment of Medical Oncology, Hospital General de Elche, Elche, Spain Correspondence to Miguel J. Gil, Department of Medical Oncology, Institut Català d’Oncologia-IDIBELL, Avenida Gran Via, s/n Km 2.7, 08907 L’Hospitalet de Llobregat, Barcelona, Spain Tel: +34 932 607 744; fax: +34 932 607 741; e-mail: [email protected] Received September 29, 2011 Accepted March 5, 2012 Anti-Cancer Drugs: July 2012 - Volume 23 - Issue 6 - p 659-665 doi: 10.1097/CAD.0b013e3283534d3e Buy Metrics Abstract There is no ‘standard of care’ for recurrent malignant glioma (MG). Our aim is to confirm the efficacy and safety of bevacizumab 10 mg/kg plus irinotecan 125 mg/m2 (or 340 mg/m2 if enzyme-inducing antiepileptic drugs) every 2 weeks for a maximum of 1 year in a retrospective pooled series of patients with recurrent MG. The inclusion criteria were as follows: age 18 years and above, histology of MG, progression after radiation and temozolomide, Karnofsky performance status (KPS) of at least 60, and signed informed consent for bevacizumab compassionate use. Response was assessed by MRI using the Macdonald criteria and evaluation of the FLAIR sequence every 8 weeks. A total of 130 patients were enrolled; 72% had glioblastoma (GBM). The median age of the patients was 53 years (20–78); the median KPS was 80%; the median number of prior chemotherapy lines was 2 (1–5); the median interval between the diagnosis of MG and inclusion was 14.6 months (2–166); and the median number of bevacizumab infusions was 8 (1–39). The median follow-up duration was 7.2 months (1–47). The median overall survival (OS) was 8.8 months for GBM and 11.2 months for anaplastic glioma (AG). The median progression-free survival was 5.1 months for GBM and 4.6 months for AG. The response rate was 56% for GBM and 68% for AG. Neurological and KPS improvements were observed in 49 and 45% of patients. Only KPS less than 80% was associated with a worse significant response rate (odds ratio, 0.57; 95% confidence interval, 0.22–0.96). The most frequent grades 3–4 toxicities were asthenia (7%), diarrhea (6%), and thromboembolic events (5%). There were five toxic deaths (4%). Bevacizumab plus irinotecan in recurrent MG improves responses, progression-free survival, and OS compared with historical data. KPS of at least 80% was a predictive factor for response and OS. © 2012 Lippincott Williams & Wilkins, Inc.