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Assistant Professor of Medicine

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Submitted By jasouza
Words 5524
Pages 23
de Souza et al. BMC Health Services Research 2012, 12:481 http://www.biomedcentral.com/1472-6963/12/481

RESEARCH ARTICLE

Open Access

Unsupported off-label chemotherapy in metastatic colon cancer
Jonas A de Souza1,2*, Blase Polite1,2,3, Monica Perkins4, Neal J Meropol5, Mark J Ratain1,2,6, Lee N Newcomer4 and G Caleb Alexander7

Abstract
Background: Newer systemic therapies have the potential to decrease morbidity and mortality from metastatic colorectal cancer, yet such therapies are costly and have side effects. Little is known about their non-evidence-based use. Methods: We conducted a retrospective cohort study using commercial insurance claims from UnitedHealthcare, and identified incident cases of metastatic colon cancer (mCC) from July 2007 through April 2010. We evaluated the use of three regimens with recommendations against their use in the National Comprehensive Cancer Center Network Guidelines, a commonly used standard of care: 1) bevacizumab beyond progression; 2) single agent capecitabine as a salvage therapy after failure on a fluoropyridimidine-containing regimen; 3) panitumumab or cetuximab after progression on a prior epidermal growth factor receptor antibody. We performed sensitivity analyses of key assumptions regarding cohort selection. Costs from a payer perspective were estimated using the average sales price for the entire duration and based on the number of claims. Results: A total of 7642 patients with incident colon cancer were identified, of which 1041 (14%) had mCC. Of those, 139 (13%) potentially received at least one of the three unsupported off-label (UOL) therapies; capecitabine was administered to 121 patients and 49 (40%) likely received it outside of clinical guidelines, at an estimated cost of $718,000 for 218 claims. Thirty-eight patients received panitumumab and six patients (16%) received it after being on cetuximab

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