Bevacizumab plus irinotecan in patients with recurrent high grade malignant gliomas.

e13057 Background: Recurrent high grade malignant gliomas (MGs) have a short survival. Initial standard therapy is based on surgery followed by concurrent radiotherapy with Temozolomide (TMZ) and subsequent TMZ, however most patients relapse from their disease. On 2009, the FDA accelerated the approval of humanized IgG1 monoclonal antibody against VEGF bevacizumab as a single agent for patients (pts) with progressive MG following prior therapy, supported by durable objetive response rates. Further studies demonstrated an increased response rate (RR) and PFS with the addition of Irinotecan to Bevacizumab (I+B). Methods: We retrospectively analyzed 62 pts with recurrent MG treated in our hospital with Irinotecan plus Bevacizumab. Pts received Irinotecan 150 mg/m2 and Bevacizumab 10 mg/m2 every two weeks. Study endpoints were safety, RR and survival. Toxicity was scored according to NCI-CTC v4.0. Results: Sixty-two pts were included with a median 54 years old (range: 18-76). 75.8 % of them have the diagnosis of glioblastoma and 24.2% WHO grade 3 gliomas. Regarding the intake of enzyme-inducing antiepileptic drugs (EIAEDs), 10% of the patients; 40% were on non-EIAED and 50% have no needed for AED. Half of the pts were on dexamethasone by the beginning of the schedule (52%). Most of the pts have a good performance status (ECOG 0-2 in 89% versus ECOG 3-4 in 11%). 54 patients (87%) got standard treatment, but 8 (13%) received one more chemotherapy regimen before I+B. Fifty patients were evaluated for response: complete response (CR) was observed in 2 patients (4%), partial response (PR) in 17 (34%), stable disease (SD) over 4 months in 21 pts (42%) and progression in 10 pts (20%). Clinical benefit (CR+PR+SD) was seen in 40 patients (80%). We reported 2 severe toxicities (1 septic death due to a bowel perforation and 1 grade 3 pulmonary embolia) and 39 pts with mild toxicity (grade 1-2) (26% hypertransaminasemmia, 24% asthenia, 21% neutropenia, 8% high-blood pressure, and 6% with diarrhea). Since the start of I+B, median PFS was 9.14 m (95% CI: 6.26-12.02) and median Overall Survival was 13.84 m (95% CI: 9.58-18.10). Conclusions: Irinotecan plus Bevacizumab can be a good option in recurrent MGs with acceptable toxicity and a good outcome.