title: Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: the BRiTE observational cohort study.
abstract: BACKGROUND
  The Bevacizumab Regimens' Investigation of Treatment Effects (BRiTE) study is a prospective, observational cohort study designed to elucidate safety and effectiveness outcomes associated with bevacizumab combined with chemotherapy as used in clinical practice for first-line treatment of metastatic colorectal cancer (mCRC).
  
  
  METHODS
  Baseline characteristics, prespecified bevacizumab-related adverse events, and effectiveness data were collected from 1,953 mCRC patients who were receiving first-line treatment including bevacizumab at 248 U.S. sites.
  
  
  RESULTS
  At database lock, the median follow-up was 20.1 months. At baseline, 46% of patients were aged >or=65 years and 49% had an Eastern Cooperative Oncology Group performance status score >or=1. Fluorouracil, leucovorin, and oxaliplatin was the most common first-line chemotherapy regimen (56%). Overall rates of bevacizumab-related adverse events in the BRiTE study, such as gastrointestinal perforation (1.9%), arterial thromboembolic events (2%), grade 3-4 bleeding (2.2%), and de novo hypertension requiring medication (22%), were consistent with those reported in randomized clinical trials (RCTs) of bevacizumab in first-line mCRC treatment. The median progression-free survival (PFS) and overall survival (OS) times were 9.9 (95% confidence interval [CI], 9.5-10.3) months and 22.9 (95% CI, 21.9-24.4) months, respectively.
  
  
  CONCLUSIONS
  The median PFS and OS durations and safety profile of bevacizumab in the BRiTE study were similar to those in RCTs of bevacizumab plus chemotherapy in first-line mCRC patients. The observations from the BRiTE study complement and expand upon RCT data, providing clinical information in a large cohort of bevacizumab-treated patients and subgroups such as the elderly.
authors.affiliation: Ingalls Hospital, Suite 401, Harvey, Illinois 60426, USA. mfkozloff@aol.com
authors.forename: Mark
authors.initials: M
authors.lastname: Kozloff
authors.forename: Marianne Ulcickas
authors.initials: MU
authors.lastname: Yood
authors.forename: Jordan
authors.initials: J
authors.lastname: Berlin
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Flynn
authors.forename: Fairooz F
authors.initials: FF
authors.lastname: Kabbinavar
authors.forename: David M
authors.initials: DM
authors.lastname: Purdie
authors.forename: Mark A
authors.initials: MA
authors.lastname: Ashby
authors.forename: Wei
authors.initials: W
authors.lastname: Dong
authors.forename: Mary M
authors.initials: MM
authors.lastname: Sugrue
authors.forename: Axel
authors.initials: A
authors.lastname: Grothey
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols; D000068258:Bevacizumab; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D006973:Hypertension / Q000139:chemically induced / Q000453:epidemiology; D007416:Intestinal Perforation / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016032:Randomized Controlled Trials as Topic; D013923:Thromboembolism / Q000139:chemically induced / Q000453:epidemiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab