Abstract
8114 Background: Preliminary data on the safety of Bv in subjects with advanced or metastatic NSCLC with previously treated brain metastases due to NSCLC revealed no CNS hemorrhagic events (Akerley, IASLC 2007). This preliminary safety report investigates the occurrence of NSCLC progression and CNS hemorrhage among patients receiving Bv. Methods: E4599 and AVAiL are randomized, phase III studies combining Bv with carboplatin/paclitaxel (CP) and cisplatin/gemcitabine (CG), respectively, in the first-line treatment of non- squamous NSCLC. As the presence of CNS metastases rendered a subject ineligible, both studies required baseline imaging of the CNS and as clinically indicated thereafter. In both studies, Bv was continued until disease progression or unacceptable toxicity (including Grade ≥3 hemorrhage and Grade ≥2 non-pulmonary hemorrhage in E4599 and AVAiL, respectively). Results: See Table. Conclusions: Among treated subjects with documented CNS progression, Bv does not appear to increase the risk of CNS hemorrhage compared to controls. In AVAiL, CNS progression is less frequent in subjects treated with Bv in this series. E4599 AVAiL CP CP + Bv 15 mg/kg CG CG + Bv 7.5 mg/kg CG + Bv 15 mg/kg N 441 427 327 330 329 Progression Event in CNS n (%) 14 (3.2) 13 (3.0) 12 (3.7) 7 (2.1) 4 (1.2) CNS hemorrhages in treated patients with documented CNS progression event 0 1 0 0 0 CNS hemorrhages, in all treated patients (with and without CNS progression) 1 3 2 2 1 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genentech™ BioOncology, Roche Boehringer Ingelheim, Eli Lilly, Genentech™ BioOncology, Idera, Merck, Roche, Taiho Genentech™ BioOncology Bayer, Boehringer Ingelheim, Eli Lilly, Genentech™ BioOncology, Roche Genentech™ BioOncology
Published Version
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