2086 Background: The OMIT (Drugs and Emerging Therapeutics Observatory) is a French structure created in 2003 by the Regional Health Agencies of Western France (Bretagne and Pays de la Loire). This network gathers clinical data from 50 public and private institutions. Its medical staff (oncologists, surgeons, pharmacists, biologists, etc) has a global reflection on drugs management in cancer patients and is also a task force for French Health Authorities. Despite several promising publications (Vredenburgh Clin Cancer Res 07, Kreisl JCO 09, Friedman JCO 09), the approval of bevacizumab in recurrent glioblastoma patients was declined, in November 2009, by European Medical Agencies. Methods: The aim of this retrospective study was to evaluate the objective responses, progression free survival, overall survival and tolerance of bevacizumab and irinotecan in community practice and, eventually, to define relevant criteria of responders. The data of 162 patients out of 200, treated between July 2007 and June 2010, have already been analysed. Results: 65% males, 35% females, mean age: 53 years [51-55]. 87% of the patients underwent a complete or partial tumor resection and 89% received the Stupp protocol as first line therapy. 31% discontinued treatment before 3 months. At 3 months, objective responses were observed in 43% of the patients and disease stabilization was achieved in 42% of them. The progression free survival and overall survival were respectively 5.57 months IC95% [4.88-6.25] and 8.07 months IC95% [7.11-9.03]. Grade 3-4 toxicities included haematologic (10%) and digesitve toxicities (4%), vein thrombosis and pulmonary embolism (3%), high blood pressure (1%), intratumoral bleeding (1%), asthenia (1%) and others (2%). They were mainly manageable. Updated results will be presented at the meeting. Conclusions: The first results of this cohort show that, after 3 months of treatment, 85% of the patients obtained a clinical benefit. Overall survival is comparable to those reported in other retrospective studies. Cost effectiveness and cost utility studies are necessary. A prospective study is needed to identify prognostic and predictive factors.
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