P17.04RANO CRITERIA APPLIED TO A PHASE II RANDOMIZED, MULTICENTER TRIAL COMPARING TEMOZOLOMIDE (TMZ) VS TMZ-PLUS-BEVACIZUMAB (BEV) BEFORE STANDARD TREATMENT IN UNRESECTABLE GLIOBLASTOMA (GBM) PATIENTS (P).GENOM 009 STUDY BY THE GEINO GROUP

ABSTRACT: BACKGROUND: RANO criteria were applied to evaluate differences in response between the 2 arms: TMZ or TMZ + BEV in a randomized study. We evaluate here the RANO sub-criterion (PI) to evaluate response. METHODS: Between December 2009 and April 2013, p with unresectable GBM, PS < 3 and MMS ≥25 were randomly assigned to receive eitherTMZ (200 mg/m2, days 1–5,for 2 28-day cycles), followed by standard TMZ with concomitant radiotherapy (60Gy) and then adjuvant TMZ for 6 cycles (TMZ Arm), or the same regimen but with the addition of BEV (10mg/kg /15 days) during pre-radiotherapy and concomitant treatment (BEV Arm). The primary endpoint was response according to RANO criteria after the 2 pre-radiotherapy cycles. The study was powered to detect a 30% difference between arms. A centralized revision

SUBMITTER: Balana C 

PROVIDER: S-EPMC4185699 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature