Evaluation of the Patterrns and Risks of Erythropoietin Stimulating Agents in Head and Neck Cancers

Background: Although head and neck cancer (HNC) is the sixth most common cancer type by incidence globally, few studies have focused on real world treatment patterns of this disease. A large, randomized study of erythropoietin stimulating agents (ESAs) produced worsened outcomes in patients with HNC. Real-world data on the treatment patterns HNC, and the use and outcomes of ESAs in this population is currently lacking. Methods: SEER Medicare was used to evaluate patients aged ≥65 years with a first diagnosis of HNC between 2002 and 2007. Logistic regression was used to evaluate predictors of treatment. An interrupted time series was used to estimate the changes in ESA use among patients receiving chemotherapy over time. Propensity weighted models predicted survival, thromboembolism (TEE), and disease recurrence outcomes associated with ESA exposure. Results: Characteristics associated with no treatment for HNC included being unmarried (adjusted OR=2.00, 95% CI: 1.75, 2.27) or African American (adjusted OR=1.65, 95% CI: 1.37, 1.98). ESA use was 50.0% among patients receiving chemotherapy and 3.1% among patients not receiving chemotherapy. ESA use was 50.0% among patients receiving chemotherapy and 3.1% among patients not receiving chemotherapy. Combination regimens such as cetuximab+taxane+platinum (63.8%) and taxane+platinum (56.0%) were associated with the highest rates of ESA use, while single-agent cetuximab was associated with the lowest rate of ESA use (22.3%). Use of ESAs significantly declined from 40.3% of patients receiving chemotherapy in January 2007 to 16.7% in August 2007. Patients receiving an ESA were more likely to have a TEE (adjusted HR=1.19 [95% CI: 1.31, 1.81), experience disease recurrence (adjusted HR=1.09 [95% CI: 1.00, 1.16]), or die (adjusted HR=1.17 [95% CI: 1.06, 1.30]). Discussion: Disparities in the diagnosis and treatment of patients with HNC were present, despite the uniform insurance status of patients in the database. Significant declines in ESA occurred following FDA action in January 2007. ESA use increased among HNC patients in the immediate aftermath of previous disclosure of negative trial data (June 2003). ESAs may be associated with modestly worsened outcomes in HNC