Abstract P5-08-02: The Impact of Educational Material (EM) on Compliance and Persistence Rates with Adjuvant Aromatase Inhibitor (AI) Treatment: First Year Data from Turkish Arm of the CARIATIDE Study
Authors: A Arican, C Ozaslan, M Benekli, MA Gulcelik, A Sevinc, MK Altundag, NS Bese
Journal: Cancer Research (2010)

Abstract Background: Patient compliance with long-term use of adjuvant AI treatment is a multidimensional problem. EM may improve patients’ treatment compliance, and understanding the reasons for non-compliance may aid the design of future interventions aimed at improving patients’ compliance. Methods: This 2-year, global observational study (NCT00681122) recruited 2,758 patients in 18 countries to investigate whether EM could influence patients’ motivation and behaviour, and improve treatment compliance. A total of 352 patients from 23 centres were randomised 1:1 to Group A: Standard Therapy or Group B: Standard Therapy + EM in the Turkey arm of the CARIATIDE study. Group B patients received regular EM with a range of information on breast cancer-related topics. The primary study endpoint was compliance rate for the adjuvant AI medication and secondary endpoints were persistence rate after 1 and 2 years, and reasons for and time to treatment discontinuation of AI. Specialised questionnaires were used to evaluate patients’ compliance and behaviour (EORTC-INPATSAT-32, OPTIMA-X, GHQ-12, FACT-ES, compliance questionnaire and EM feedback in Group B). Study accrual was completed in March 2009. Results: Preliminary, investigator-assessed analysis at 1 year: data did not show statistical difference for compliance rates and compliance with initial AI in groups A and B (91% vs. 89% and 85% vs. 82%, respectively). Persistence rates were also similar (91% vs. 90%). Treatment discontinuation rates were 15% in Group A and 19% in Group B at 1 year; discontinuation was mainly attributed to lost to follow up (46% in Group A and 55% in Group B). AI medication discontinuation was the third most common reason for discontinuation in Group A (15%) and Group B (9%). Total scores of Subject Mental Well-being evaluated by GHQ-12 were 2.8±3.4 in Group A and 2.5±3.2 in Group B at baseline and were determined to be 1.5±2.5 and 2.0±2.8 at the end of the first year in Group A and B, respectively. Summary scores obtained for EORTC INPATSAT-32 for subj ects were 71.0±21.8 and 72.6±20.4 at baseline while 76.6±18.6 and 78.5±18.3 at the end of the first year in Group A and B, respectively. Total scores obtained for FACT-ES scale were 128.4±23.6 and 126.6±23.6 at the end of the first year in Group A and B, respectively. Summary scores obtained for Medication Adherence Profile OPTIMA-X were 70.5±14.9 and 72.6±13.5 in the baseline while 75.1±12.4 and 74.2±11.5 at the end of the first year in Group A and B, respectively. Discussion: At 1 year, CARIATIDE data showed that the provision of EM did not improve patients’ compliance. Compliance with initial AI, compliance with AI and persistence with therapy rates at 1 year did not show statistically significant differences between treatment arms. Specialised questionnaires did not reveal differences between the two groups. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-08-02.