[Therapeutic decisions and treatment with @entity2857 in XXXX : final analysis of GIDEON study in Italy].

@entity1 @entity101 @entity1910 @entity294 @entity2857 @entity1295 @entity157
INTRODUCTION: @entity2857 , an oral multikinase inhibitor, is the only targeted agent approved for the treatment of @entity1 with @entity157 ( @entity157 ) after demonstration to increase overall survival compared to placebo in two randomized phase III study. GIDEON (Global Investigation of therapeutic DEcisions in @entity157 and Of its treatment with @entity2857 ) is the largest, global, non-interventional, prospective study of @entity1 with uHCC (n>3200) treated with @entity2857 in real-life clinical practice conditions. Here we report the final analysis of safety and efficacy in the Italian cohort of @entity1 . METHODS: @entity1 with unresectable @entity157 who are candidates for systemic therapy, and for whom a decision has been made to treat with @entity2857 , are eligible for inclusion. @entity1 demographics disease characteristics and treatment history were recorded at baseline visit. @entity2857 dose, concomitant medications, performance status, liver function, adverse events and efficacy (survival and response rate) were collected throughout the study. RESULTS: In the Italian cohort of the GIDEON study 278 @entity1 were included in 36 centers. The global rate of adverse events was 81%. Drug-related events accounted for 67%, mostly of grade 1 and 2, and only 8% were classified as serious. The most common were @entity294 (24%), @entity1295 (23%), dermatological (14%), @entity1910 /exfoliation (10%), @entity101 (9%), hemorrage/bleeding of gastrointestinal tract (6%). Overall survival was 14.4 months and time to progression 6.2 months. Objective responses were observed in 14 @entity1 (5%) with 3 complete responses (1%). Stable diseases of at least 6 weeks were observed in 113 @entity1 (41%) with a 30% of disease control rate. DISCUSSION: The safety profile of @entity2857 in terms of rate and type of adverse events is similar to that emerged in the global international GIDEON study as well as in the pivotal registration studies.
