Bevacizumab + folfiri as first-line treatment in advanced colorectal cancer (ACC): A multicenter phase II study of the Gruppo Oncologico dell'Italia Meridionale (prot. GOIM 2601)

15048 Background: The addition of Bevacizumab (BEV) to Irinotecan (CPT-11) plus bolus Fluorouracil (FU) and folinic acid (FA) (IFL) demonstrated to be more active and more effective than chemotherapy alone in a phase III trial. However IFL is more toxic than FOLFIRI. So we started a phase II trial to evaluate the activity and the safety of the combination of BEV plus FOLFIRI as first-line therapy in ACC pts. Methods: Untreated pts with histologically diagnosis of ACC entered into the trial if they satisfied the following inclusion criteria: presence of measurable disease, age > 18 yrs, PS ≤ 2 (ECOG), adequate bone marrow reserve and renal and hepatic function, informed written consent. An history of cardiovascular disease, thromboembolic events and/or coagulative desorders were exclusion criteria. The enrolled pts were treated with CPT-11 at 180 mg/m2 on day 1, FA at 100 mg/m2 as 2h infusion on days 1–2, FU at 400 mg/m2 as bolus on days 1–2 and FU at 600 mg/m2 as 22h infusion on days 1–2 (FOLFIRI) plus BE...