Thomas J Lynch1, David R Spigel, Julie Brahmer, Neal Fischbach, Jennifer Garst, Mohammad Jahanzeb, Priya Kumar, Regina M Vidaver, Antoinette J Wozniak, Susan Fish, E Dawn Flick, Larry Leon, Sebastien J Hazard, Michael P Kosty. 1. *Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut; †Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, Tennessee; ‡Department of Oncology, Johns Hopkins Medical School, Baltimore, Maryland; §Oncology Associates of Bridgeport, PC, Trumbull, Connecticut; ‖Duke University Health Systems, Durham, North Carolina; ¶The University of Miami Sylvester Cancer Center, Deerfield Beach, Florida; #University of Minnesota, Minneapolis, Minnesota; **National Lung Cancer Partnership, Madison, Wisconsin; ††Karmanos Cancer Institute, Detroit, Michigan; ‡‡Genentech, Inc., South San Francisco, California; and §§Scripps Clinic, La Jolla, California.
Abstract
INTRODUCTION:Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor, was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. ARIES (Avastin Regimens: Investigation of Effectiveness and Safety), a prospective observational cohort study, evaluated outcomes in a large, community-based population of patients with first-line NSCLC. METHODS:From 2006 to 2009, ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab, excluding those with predominantly squamous histology. Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment. There were no protocol-defined treatments or assessments. The dosing of bevacizumab and chemotherapy, and the choice of chemotherapy regimen, was at the discretion of the treating physician. RESULTS:ARIES enrolled 1967 patients with first-line NSCLC. At study closure, median follow-up was 12.5 months (range, 0.2-65.5). Median age was 65 years (range, 31-93), and 252 patients (12.8%) identified as never smokers. Median progression-free survival was 6.6 months (95% confidence interval, 6.3-6.9), and median overall survival was 13.0 months (95% confidence interval, 12.2-13.8) with first-line bevacizumab plus chemotherapy. Incidences of bevacizumab-associated adverse events (19.7% overall) were consistent with those in randomized controlled trials of bevacizumab in NSCLC. CONCLUSION: Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC.
RCT Entities:
INTRODUCTION:Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor, was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. ARIES (Avastin Regimens: Investigation of Effectiveness and Safety), a prospective observational cohort study, evaluated outcomes in a large, community-based population of patients with first-line NSCLC. METHODS: From 2006 to 2009, ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab, excluding those with predominantly squamous histology. Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment. There were no protocol-defined treatments or assessments. The dosing of bevacizumab and chemotherapy, and the choice of chemotherapy regimen, was at the discretion of the treating physician. RESULTS: ARIES enrolled 1967 patients with first-line NSCLC. At study closure, median follow-up was 12.5 months (range, 0.2-65.5). Median age was 65 years (range, 31-93), and 252 patients (12.8%) identified as never smokers. Median progression-free survival was 6.6 months (95% confidence interval, 6.3-6.9), and median overall survival was 13.0 months (95% confidence interval, 12.2-13.8) with first-line bevacizumab plus chemotherapy. Incidences of bevacizumab-associated adverse events (19.7% overall) were consistent with those in randomized controlled trials of bevacizumab in NSCLC. CONCLUSION: Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC.
Authors: A M Arance; A Berrocal; J A Lopez-Martin; L de la Cruz-Merino; V Soriano; S Martín Algarra; L Alonso; P Cerezuela; B La Orden; E Espinosa Journal: Clin Transl Oncol Date: 2016-03-17 Impact factor: 3.405
Authors: Michael P Kosty; Antoinette J Wozniak; Mohammad Jahanzeb; Larry Leon; Susan Fish; Sebastien J Hazard; Thomas J Lynch Journal: Target Oncol Date: 2015-01-06 Impact factor: 4.493