Background
Long-term use of adjuvant aromatase inhibitors (AI) can be associated with patient non-compliance, but the factors that impact this are currently unclear. A comprehensive understanding of the reasons behind non-compliance is important to inform the design of future interventions intending to improve patient compliance. Educational materials (EM) may improve patients’ treatment compliance, as may demographic characteristics such as country, post-operative chemotherapy, age and BMI. Methods
This 2 year, global observational study (NCT00681122) was designed to investigate whether EM could influence patients’ motivation and behavior, and improve treatment compliance with adjuvant AI treatment. Across 18 countries, 2758 patients were randomized 1:1 to Group A: Standard Therapy or Group B: Standard Therapy + EM. EM received by Group B consisted of a range of information on breast cancer related topics. The primary endpoint was compliance rate for the adjuvant AI medication. Secondary endpoints included persistence rate after 1 and 2 years, and reasons for and time to treatment discontinuation of AI. Compliance rate was defined as proportion of subjects being ‘compliant’ with regard to the adjuvant AI medication; switching from AI to tamoxifen would result in a non-compliance score at time of switching. For compliance to initial adjuvant AI medication, switching to another AI or hormone therapy would result in a non-compliance score. A subject was considered a ‘persistent’ user if, during the first year, they did not switch AI medication, AI medication was uninterrupted or there was no discontinuation of the AI medication. Patients’ compliance and behavior were assessed using validated questionnaires (EORTC-INPATSAT-32, GHQ-12, FACT-ES), specifically developed OPTIMA-X, compliance questionnaire and EM feedback in Group B. Results
Analysis of 1 year data did not demonstrate statistically significant differences between compliance rates for Groups A and B. Overall compliance was 81% and 82% for Groups A and B, respectively. Compliance with initial AI was reported as 75% for Group A and 77% for Group B, with persistence rates of 84% and 86%, respectively. EM only significantly improved overall compliance in Sweden/Finland (85% and 100%, Groups A and B respectively, p=0.0264, data combined). Demographic sub-group analysis at 1 year gave overall compliance rates of 83% for patients who received post-operative chemotherapy compared with 79% in patients who did not receive post-operative chemotherapy (p=0.0163). Age-group specific compliance for Groups A and B was 70% and 82% at <50y, 83% and 81% at 50-60y, 80% and 82% at 60-70y, and 81% and 82% at >70y, respectively. Compliance reported in Groups A and B for specific BMI groups was 79% and 81% at BMI <25; 82% and 83% at BMI 25-35, and 78% and 77% at BMI >35, respectively. Discussion
At 1 year, overall compliance, compliance to initial AI and persistence with therapy was not significantly different between treatment arms. Out of 18 countries, only Sweden/Finland demonstrated a significant improvement in compliance when EM were used. Post-operative chemotherapy was a predictor for patient compliance with AI, but age-group and BMI do not appear to be predictors.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-10-03.
