title: Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: final results from the Avastin(®) Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study.
abstract: OBJECTIVE
  The Avastin(®) Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) was designed to prospectively examine outcomes associated with bevacizumab-containing treatment for metastatic colorectal cancer (mCRC) in a community-based setting, where patient populations are less restricted than those in randomised trials.
  
  
  METHODS
  Patients with mCRC who were eligible for bevacizumab in combination with chemotherapy in first- or second-line treatment were enrolled from November 2006 to September 2008. There were no protocol-specified treatment regimens; the dose and schedule of bevacizumab and chemotherapy were at the treating physician's discretion. The objectives in the ARIES OCS included analyses of progression-free survival (PFS), overall survival, treatment patterns and safety in each of the first- and second-line treatment cohorts.
  
  
  RESULTS
  ARIES enrolled 1550 patients with mCRC receiving first-line therapy with bevacizumab. The median follow-up time was 20.6 months. The median PFS in this cohort was 10.2 months (95% confidence interval 9.8-10.6) and the median overall survival was 23.2 months (95% confidence interval 21.2-24.8). In a separate cohort of 482 patients with second-line mCRC, the median follow-up time was 16.9 months, the median PFS and overall survival from the start of second-line treatment to the end of follow-up was 7.9 months (95% confidence interval 7.2-8.3) and 17.8 months (95% confidence interval 16.5-20.7), respectively. Incidences of known bevacizumab-associated adverse events in ARIES were generally consistent with those previously reported in OCSs and randomised trials.
  
  
  CONCLUSIONS
  Results from the prospective ARIES OCS add further evidence to support the effectiveness and safety of bevacizumab when added to first- and second-line treatment regimens for patients with mCRC in community treatment settings.
authors.affiliation: Division of Hematology and Oncology, Duke University Medical Center, Durham, NC, USA. Electronic address: herbert.hurwitz@duke.edu.
authors.forename: H I
authors.initials: HI
authors.lastname: Hurwitz
authors.affiliation: Department of Internal Medicine, The Ohio State University Medical Center, Columbus, OH, USA.
authors.forename: T S
authors.initials: TS
authors.lastname: Bekaii-Saab
authors.affiliation: Department of Gastrointestinal Oncology, Sarah Cannon Research Institute, Nashville, TN, USA.
authors.forename: J C
authors.initials: JC
authors.lastname: Bendell
authors.affiliation: Department of Medical Oncology, Rocky Mountain Cancer Center, Denver, CO, USA.
authors.forename: A L
authors.initials: AL
authors.lastname: Cohn
authors.affiliation: Department of Hematology & Oncology, Ingalls Hospital and University of Chicago, Harvey, IL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Kozloff
authors.affiliation: Patient Advocacy, FightColorectalCancer.org, Alexandria, VA, USA.
authors.forename: N
authors.initials: N
authors.lastname: Roach
authors.affiliation: U.S. Medical Affairs, Genentech, Inc., South San Francisco, CA, USA.
authors.forename: Y
authors.initials: Y
authors.lastname: Mun
authors.affiliation: U.S. Medical Affairs, Genentech, Inc., South San Francisco, CA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Fish
authors.affiliation: U.S. Medical Affairs, Genentech, Inc., South San Francisco, CA, USA.
authors.forename: E D
authors.initials: ED
authors.lastname: Flick
authors.affiliation: Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
authors.forename: A
authors.initials: A
authors.lastname: Grothey
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D000068258:Bevacizumab; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab
keywords: Bevacizumab; colorectal cancer; observational cohort study