FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (mCRC): Analysis of patients with KRAS-mutated tumors in the randomized German AIO study KRK-0306.

摘要: 3575 Background: The German AIO study KRK-0306 is a randomized phase III trial that investigates the efficacy and safety of cetuximab plus FOLFIRI versus bevacizumab in first-line treatment mCRC. Until September 2008, patients (pts) without knowledge their KRAS mutational status had been enrolled. Here, results subgroup pts with mCRC carrying mutated gene are presented. Methods: total 336 were to (irinotecan 180mg/m2, folinic acid 400mg/m2, 5-FU 400mg/m2 bolus application, day 1 followed by continuous infusion 2,400mg/m2 over 46h q2w) (400mg/m2 1, 250mg/m2 weekly = arm A) or (5mg/kg q2w B). At time analysis, mutation was documented 96 (ITT population). primary endpoint this objective response rate (ORR). Secondary endpoints progression-free survival (PFS), overall (OS), secondary liver resections, t...