title: Contraindicated use of bevacizumab and toxicity in elderly patients with cancer.
abstract: OBJECTIVE
  Drugs are approved on the basis of randomized trials conducted in selected populations. However, once approved, these treatments are usually expanded to patients ineligible for the trial.
  
  
  METHODS
  We used the SEER-Medicare database to identify subjects older than 65 years with metastatic breast, lung, and colon cancer, diagnosed between 2004 and 2007 and undergoing follow-up to 2009, who received bevacizumab. We defined a contraindication as having at least two billing claims before bevacizumab for thrombosis, cardiac disease, stroke, hemorrhage, hemoptysis, or GI perforation. We defined toxicity as first development of one of these conditions after therapy.
  
  
  RESULTS
  Among 16,085 metastatic patients identified, 3,039 (18.9%) received bevacizumab. Receipt of bevacizumab was associated with white race, later year of diagnosis, tumor type, and decreased comorbid conditions. Of patients who received bevacizumab, 1,082 (35.5%) had a contraindication. In multivariate analysis, receipt of bevacizumab with a contraindication was associated with black race (odds ratio [OR] = 2.6; 95% CI, 1.4 to 4.9), increased age, comorbidity, later year of diagnosis, and lower socioeconomic status. Patients with lung (OR = 1.7; 95% CI, 1.1 to 2.4) and colon cancer (OR = 1.4; 95% CI, 1.1 to 1.9) were more likely to have a contraindication. In the group with no contraindication, 30% had a complication after bevacizumab; black patients were more likely to have a complication than were white patients (OR = 1.9; 95% CI, 1.21 to 2.93).
  
  
  CONCLUSIONS
  Our study demonstrates widespread use of bevacizumab among patients who had contraindications. Black patients were less likely to receive the drug, but those who did were more likely to have a contraindication. Efforts to understand toxicity and efficacy in populations excluded from clinical trials are needed.
authors.affiliation: Dawn L. Hershman, Jason D. Wright, Emerson Lim, Donna L. Buono, Wei Yann Tsai, and Alfred I. Neugut, Columbia University; and Dawn L. Hershman, Jason D. Wright, Emerson Lim, and Alfred I. Neugut, New York Presbyterian Hospital, New York, NY.
authors.forename: Dawn L
authors.initials: DL
authors.lastname: Hershman
authors.forename: Jason D
authors.initials: JD
authors.lastname: Wright
authors.forename: Emerson
authors.initials: E
authors.lastname: Lim
authors.forename: Donna L
authors.initials: DL
authors.lastname: Buono
authors.forename: Wei Yann
authors.initials: WY
authors.lastname: Tsai
authors.forename: Alfred I
authors.initials: AI
authors.lastname: Neugut
mesh_terms: D001741:Black or African American; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy / Q000556:secondary; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D015331:Cohort Studies; D003110:Colonic Neoplasms / Q000188:drug therapy / Q000556:secondary; D015897:Comorbidity; D000075202:Contraindications; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D006278:Medicare; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D009367:Neoplasm Staging; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D018426:SEER Program; D014481:United States; D044465:White People
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab