First Results from the “Patient's Anastrozole Compliance to Therapy Programme” (PACT) Evaluating the Impact of a Standardized Information Service on Compliance in Postmenopausal Women with Early Breast Cancer (EBC) Receiving Adjuvant Endocrine Therapy.

Abstract

Abstract Background: In adjuvant treatment of hormone-responsive breast cancer, existing data document that 23% and 50% of patients were non-compliant after the first and fourth year of tamoxifen (TAM) therapy, respectively. Here, we present the PACT-study that aims to increase awareness, motivation and adherence to oral hormonal therapy, namely the aromatase inhibitor anastrozole, in routine clinical practice by simple interventions such as written standardized mailings and reminder services.Materials and Methods: In this two arm, parallel group trial with a primary duration of 12 months and 60 months follow-up, women with hormone receptor positive EBC receiving anastrozole once daily were randomized to either routine clinical care alone or to receiving additional standardized information for the first 12 months of adjuvant therapy. Primary endpoint is compliance rate in the standard versus intervention arm after 12 months, where compliance is defined by an 80% intake of the total medication. Secondary endpoints include persistence on therapy, reasons for non-compliance, influence of baseline characteristics, and of compliance on clinical outcome parameters.Compliance was evaluated by self report using standardized, detailed questionnaires at baseline and after each year of treatment. In addition, the prescription data for each patient from hospital records and physician recall was collected. Finally, quality of life and patient satisfaction were assessed using standardized questionnaires.Results: From July 2006 until November 2008, 4.924 women were enrolled with a median patient age of 64 years. Besides demographic data and patient characteristics results of patient's self reporting data will be shown for the first time at this meeting.Conclusion: PACT is the largest prospective investigation on compliance regarding an aromatase inhibitor as adjuvant therapy so far. The programme's goals are to clarify what aspects influence patients' adherence to prescribed medication and how motivation for regular intake can be accomplished. Furthermore, PACT seeks to prove if a simple intervention such as a standardized information and reminder services throughout the first year of treatment may improve compliance and thus eventually influence treatment outcomes. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 6079.