6533b836fe1ef96bd12a1b73

RESEARCH PRODUCT

Compliance and arthralgias in clinical therapy (COMPACT): Assessment of the incidence of arthralgia, therapy costs, and compliance in the first year of adjuvant anastrozole.

subject

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e11040^ Background: Aromatase Inhibitors (AI) are well established as adjuvant endocrine treatment for postmenopausal women with HR+ early breast cancer (EBC). However, clinical trial data show higher frequently of arthralgia with AI than tamoxifen. As arthralgia may be greatly influencing compliance to adjuvant therapy, we designed a prospective trial to collect real world data on the effects of AI-associated arthralgia on patient compliance, patient outcomes and treatment costs of arthralgia. Methods: COMPACT is an open, prospective non-interventional study (NCT00857012) assessing the incidence of arthralgia, therapy costs, and compliance within the first year of adjuvant anastrozole (ANA) therapy in postmenopausal patients with HR+ EBC. Patients on adjuvant ANA for 3-6 months were enrolled and stratified by initial adjuvant ANA or switch from tamoxifen. All patients receive regular standardized information about breast cancer from baseline to week 20 to support treatment compliance. Data on demographics, arthralgia, therapy thereof and QoL are collected at baseline, 3, 6 and 9 months. Primary endpoints are scaled data on arthralgia and compliance within the first year of ANA therapy. Secondary endpoints include the incidence of arthralgia, therapy costs, reasons for non-compliance, and influence of arthralgia on clinical outcome. Results: From Apr 2009 to Mar 2011, 2313 patients were enrolled, 2007 on upfront ANA and 306 patients on switch therapy. The mean age was 64.5 years, mean BMI 27.7. Only 16.8% had received HRT prior to their EBC. 41.5% had symptoms relating to skeleton or musculature, and 11.9% stated arthralgia existing prior to ANA. 13.1% reported a worsening of pre-existing arthralgias or new arthralgia after starting ANA. Predictors for non-adherence to AI and scaled data on arthralgia are under analysis. Conclusions: COMPACT aims to provide valid data on AI-associated arthralgia, treatment, treatment costs and compliance to AI. This may help to better inform patients and health care providers about these clinically important issues with the aim to improve adherence to adjuvant ANA, breast cancer outcomes, and therapy costs.