Clinical outcomes (CO) for special populations of patients (pts) with advanced non-small cell lung cancer (NSCLC): Results from ARIES, a bevacizumab (BV) observational cohort study (OCS).

Abstract

7618 Background: BV (Avastin) prolongs progression-free (PFS) and overall survival (OS) in advanced NSCLC. ARIES, a prospective OCS evaluating BV in a real world setting, includes pts underrepresented in randomized controlled trials (RCTs), i.e., pts ≥70y, with poor performance status (PS), or with CNS metastases (mets). Preliminary COs (effectiveness and safety) in ARIES subpopulations are presented. Methods: Pts with locally advanced nonsquamous NSCLC on first-line chemotherapy (CT) and BV enrolled. No prespecified treatments, doses or assessments. Data are collected electronically at baseline (BL) and quarterly (QU), including BV-targeted adverse events (AEs) and serious AEs (SAEs). Descriptive safety analyses were conducted for all pts and for subgroups. Median (med) PFS and OS are Kaplan-Meier estimates. Results: ARIES enrolled 1,970 NSCLC pts. Med follow-up at the 09/2009 data cut was 9.6 mo; 98% have ≥1 QU follow-up. Med PFS is 6.7 mo and OS is 13.6 mo for the entire cohort and were similar across subgroups except pts with PS≥2. The most common 1st-line CT is carboplatin/paclitaxel (CP). Pts ≥70y and pts with PS≥2 or CNS mets at BL generally used more nonplatin-containing CT and pemetrexed. AE rates across subgroups were similar to the overall cohort except for increased arterial thromboembolic events (ATE) in pts ≥70y and with PS≥2. No CNS bleeding events occurred in pts with CNS mets at BL. Conclusions: The COs (safety/effectiveness) of BV in pts ≥70y, or with PS≥2 or CNS mets are consistent with the known BV efficacy and safety profile. Pts with PS≥2 received less CP and had worse COs but not more AEs/SAEs. Pts ≥70y had COs similar to the overall cohort despite less doublet CT, suggesting that advanced age, poor PS, or CNS mets should not necessarily exclude pts from receiving BV therapy. All NSCLC pts (n = 1,970) Age ≥70 (n = 650) PS ≥2 (n = 182) CNS Mets(n = 150) Med PFS (mo) 6.7 6.8 5.8 6.0 Med OS (mo) 13.6 12.6 8.1 11.7 CP 1st-line CT, n (%) 1,215 (62) 382 (59) 107 (59) 82 (55) Severe pulmonary hemorrhage (PH), n (%) 15 (0.8) 2 (0.3) 2 (1) Gr 3-5 bleeding excluding PH, n (%) 52 (3) 20 (3) 7 (4) ATEs, n (%) 35 (2) 20 (3) 6 (3) Gr 3-5 CNS bleed, n (%) 2 (0.1) 0 1 (0.5) 0 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech AstraZeneca, BIPI, Genentech, GlaxoSmithKline, Inifinity Pharma, Lilly, Merck, sanofi-aventis Inifinity Pharma, Roche Genentech, GlaxoSmithKline, Lilly, sanofi-aventis Genentech