Weekly paclitaxel plus bevacizumab versus docetaxel as second or third-line treatment in advanced non-squamous non-small cell lung cancer (NSCLC): Results from the phase III study IFCT-1103 ULTIMATE.

Abstract

9005Background: Adding bevacizumab to weekly paclitaxel (wPB) has shown synergistic effect and increased activity in various tumor types. The ULTIMATE study evaluated wPB vs. docetaxel (DOC) as 2nd or 3rd-line treatment in patients with advanced non-squamous NSCLC. Methods: Patients with non-squamous NSCLC progressing after 1 or 2 lines of treatment including platinum-based chemotherapy were randomized 2:1 (stratified by PS, previous lines, prior exposure to bevacizumab) to wPB (paclitaxel 90 mg/m² D1, 8, 15 and bevacizumab 10 mg/kg D1, 15, q28d) or DOC (75 mg/m² q21d) until progression. Patients were allowed to cross-over to the other arm following progression. The primary endpoint was progression-free survival (PFS). Results: From 05/2013 to 08/2014, 166 patients were randomized (wPB: 111, DOC: 55). Clinical characteristics were balanced between both arms. 31% had received previous bevacizumab and 69% had received 1 previous line of treatment. Median follow-up was 28.9 months. The adjusted hazard ratio ...