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

Ziyadeh, Najat MPH, MA; Fife, Daniel MD; Walker, Alexander M. MD, DrPH; Wilkinson, Gregg S. PhD, MA; Seeger, John D. PharmD, DrPH

Advances in Skin & Wound Care: January 2011 - Volume 24 - Issue 1 - pp 31-39
doi: 10.1097/01.ASW.0000392922.30229.b3
Features: Original Investigations

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.

In this study, the authors investigate any association between becaplermin use and the occurrence of cancer by following a large cohort of patients in a clinical practice setting.

Najat Ziyadeh, MPH, MA, is an epidemiologist at Ingenix, i3 Drug Safety, Waltham, Massachusetts. Daniel Fife, MD, is Senior Director of Pharmacoepidemiology at Johnson & Johnson Pharmaceutical Research and Development, Titusville, New Jersey. Alexander M. Walker, MD, DrPH, is a Principal at World Health Information Science Consultants, Wellesley, Massachusetts and is Adjunct Professor of Epidemiology, at Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts. Gregg S. Wilkinson, PhD, MA, is Professor at Department of Preventive Medicine and Community Health, Department of Family Medicine, Center for Interdisciplinary Research in Women's Health, Sealy Center on Aging, University of Texas Medical Branch, Galveston, Texas. John D. Seeger, PharmD, DrPH, is Vice President for Epidemiology at Ingenix, i3 Drug Safety, Waltham, Massachusetts and is Adjunct Assistant Professor of Epidemiolgy at Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts.

Submitted October 26, 2009; accepted in revised form March 11, 2010.

© 2011 Lippincott Williams & Wilkins, Inc.