Preliminary Treatment Patterns and Safety Outcomes for Non—Small-Cell Lung Cancer from ARIES, a Bevacizumab Treatment Observational Cohort Study

Abstract Background Bevacizumab, a monoclonal antibody against vascular endothelial growth factor, provides benefit in advanced non—smallcell lung cancer (NSCLC), prolonging progression-free and overall survival. Observational cohort studies such as ARIES (“Avastin® Regimens: Investigation of Treatment Effects and Safety”) provide valuable safety and effectiveness data for a broader patient population than controlled trials, such as Eastern Cooperative Oncology Group (ECOG) 4599, which have strict eligibility criteria required for study participation. The ARIES study objective is to further delineate clinical outcomes associated with bevacizumab use in a real-world setting in patients with advanced NSCLC. Patients and Methods Patients with locally advanced/metastatic nonsquamous NSCLC, whose first therapy includes bevacizumab, may enroll. There are no protocol-specified treatments or assessments. Data are collected at baseline, then quarterly, including targeted safety events, until death, consent withdrawal, loss to follow-up, or study closure. ARIES is conducted at 276 US sites. Planned NSCLC accrual is 2000 patients. Results As of February 14, 2008, 996 evaluable patients with NSCLC have been enrolled. Median follow-up is 6.1 months; 84% of patients have ≥ 1 quarterly update. Key demographics are shown in Table 1. Targeted serious adverse events (SAEs) to date include venous thromboembolic events and other events, 2%; grade 3/4 bleeding and arterial thromboembolic events, 1% each; gastrointestinal perforation, reversible posterior leukoencephalopathy syndrome, pulmonary hemorrhage, hypertension, and wound complications, Conclusion Low rates of targeted SAEs were preliminarily observed despite the inclusion of patients underrepresented in E4599, including those with ECOG performance status ≥ 2, brain metastasis, therapeutic anticoagulation at baseline, and older age. Updated safety data, treatment patterns (with bevacizumab dose and duration), and demographics will be provided at the meeting, based on > 1300 patients.