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

H. I. Hurwitz, Tanios Bekaii-Saab, J. C. Bendell, A. L. Cohn, M. Kozloff, N. Roach, Y. Mun, S. Fish, E. D. Flick, Axel F Grothey

Research output: Contribution to journalArticle

16 Scopus citations


Aims: 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. Materials and 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. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)323-332
Number of pages10
JournalClinical Oncology
Issue number6
StatePublished - 2014



  • Bevacizumab
  • Colorectal cancer
  • Observational cohort study

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

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