A Matched Cohort Study of the Risk of Cancer in Users of Becaplermin

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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.

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