Bevacizumab: Analysis of clinical benefit in females across trials in colorectal cancer and non-small cell lung cancer

Abstract

7634 Background: Bevacizumab (Bv) has demonstrated significant improvement in overall survival (OS) in randomized trials in first- and second-line (FL and SL) metastatic CRC (mCRC), FL NSCLC, and progression-free survival (PFS) in metastatic breast cancer (mBC). However, in FL metastatic non-squamous NSCLC, OS benefit was less robust in females treated with Bv + chemotherapy (CTx). In order to examine whether there is a gender effect upon efficacy in other trials, an analysis of results from randomized ph II and open-label ph III trials with Bv in mCRC (and a randomized ph II trial in SL NSCLC) was conducted for females. Methods: RR, PFS and OS are summarized for females in the following trials (primary endpoint): 1] ph II FL mCRC (PFS); 2] ph III: FL mCRC (OS); 3] ph III SL mCRC (OS); 4] ph II SL NSCLC (PFS); 5] ph III FL NSCLC (OS). Results: Table 1 presents results of Studies 1 - 5. RR is presented as the difference in RR between Bv and respective control arms. Conclusions: Clinical benefit with Bv + CTx compared to CTx-alone was observed in OS for females in studies which included Bv in treatment of mCRC. OS observed in females in Study 5 (FL NSCLC) is inconsistent with findings in mCRC, mBC and SL NSCLC, and the improvement for PFS and RR for females in Study 5. As such, there is no compelling evidence to suggest lack of benefit with Bv in females. [Table: see text] [Table: see text]