title: A matched cohort study of the risk of cancer in users of becaplermin.
abstract: BACKGROUND
  Becaplermin is recombinant human platelet-derived growth factor for topical administration that might plausibly be related to cancer risk. Extended follow-up of patients from clinical trials of becaplermin compared with placebo identified a relative risk of cancer of 2.8 (95% confidence interval [CI], 0.6-12.8). The authors aimed to further investigate any association between becaplermin use and the occurrence of cancer by following a large cohort of patients in a clinical practice setting.
  
  
  METHODS
  In a cohort of insured people, becaplermin initiators were matched to similar people who did not initiate becaplermin and were followed for up to 6 years for cancer incidence (up to 9 years for cancer mortality). Cancer incidence was identified from health insurance claims and validated by review of medical records. Cancer mortality was identified through linkage to the National Death Index.
  
  
  RESULTS
  Among 1622 becaplermin initiators, there were 28 confirmed cancers and 9 cancer deaths, and among the 2809 matched comparators, there were 43 confirmed cancers and 16 cancer deaths. There was no increased risk of cancer with becaplermin (hazard ratio, 1.2; 95% CI, 0.7-1.9). Cancer mortality through 2003 was increased (rate ratio [RR] = 5.2; 95% CI, 1.7-17.6) among subjects with 3 or more dispensings. Additional follow-up through 2006 indicated no elevated cancer mortality risk overall (RR, 1.0; 95% CI, 0.5-2.3) and no statistically significant increase in the subgroup with more than 3 dispensings (RR, 2.4; 95% CI, 0.8-7.4).
  
  
  CONCLUSIONS
  Becaplermin does not appear to increase the risk of cancer or cancer mortality.
authors.affiliation: Ingenix, i3 Drug Safety, Waltham, Massachusetts, USA.
authors.forename: Najat
authors.initials: N
authors.lastname: Ziyadeh
authors.forename: Daniel
authors.initials: D
authors.lastname: Fife
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Walker
authors.forename: Gregg S
authors.initials: GS
authors.lastname: Wilkinson
authors.forename: John D
authors.initials: JD
authors.lastname: Seeger
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D043925:Angiogenesis Inducing Agents / Q000009:adverse effects*; D000077214:Becaplermin; D015331:Cohort Studies; D016001:Confidence Intervals; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced* / Q000453:epidemiology; D010982:Platelet-Derived Growth Factor / Q000009:adverse effects*; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins / Q000009:adverse effects*; D012189:Retrospective Studies; D012306:Risk; D012307:Risk Factors; D014481:United States / Q000453:epidemiology
chemical_list: D043925:Angiogenesis Inducing Agents; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; D000077214:Becaplermin