First data from the the Patient's Anastrozole Compliance to Therapy Programme evaluating the influence of a standardized information service on compliance in postmenopausal women with early breast cancer

Abstract

e11592 Background: Retrospective pharmacy data suggest that within the first year of therapy patients’ pick-up rate of aromatase inhibitor (AI) packs prescribed for early breast cancer (EBC) drops below 70%. Little is known about compliance to AI and patient motivation outside of clinical trials and the effect of compliance on patient outcome. Methods: The Patient´s Anastrozole Compliance to Therapy (PACT) programme, a two arm, randomized parallel group trial with 60 months follow-up, randomized postmenopausal women with HR+ EBC receiving anastrozole as adjuvant treatment and who consented to participate, to routine clinical care alone or additional standardized information consisting of 9 mailings of brochures and letters over the first 12 months following initiation of therapy. Primary endpoint is compliance rate in the standard versus intervention arm after 12 months, secondary endpoints include safety, reasons for non-compliance, influence of baseline characteristics, and of compliance on clinical outcome parameters. Compliance was evaluated by patient self reporting via standardized questionnaires, cross-checks of prescription data from hospital records and physician recall. QoL and patients’ satisfaction are assessed with standard questionnaires. Results: From Jul 2006 to Nov 2008, 4,924 patients were enrolled. Demographic data and baseline characteristics including median age, disease parameters, BMI, QoL at study start, co-morbidities and concomitant medication will be presented Conclusions: As of today, PACT is the largest prospective investigation on compliance to AI. It will provide valuable insights into the reasons for non-compliance to adjuvant AI therapy and demonstrate if a simple intervention such as standardized written information throughout the first treatment year may improve compliance and patient outcome. [Table: see text]