P5-16-02: The Impact of Educational Materials on Compliance and Persistence with Adjuvant Aromatase Inhibitors: 2 Year Follow-Up and Final Results from the CARIATIDE Study.
Authors: P Neven, C Markopoulos, MME Tanner, ME Marty, R Kreienberg, L Atkins, AA Franquet, D Serin, MA Gulcelik, V Deschamp
Journal: Cancer Research (2011)

Abstract Rationale Understanding and effectively addressing the factors that affect patient compliance with adjuvant aromatase inhibitors (AI) is required in order for patients to obtain maximum benefit from treatment. The CARIATIDE study sought to determine whether the provision of educational materials (EM) could improve compliance and persistence with adjuvant AI. At 1-y follow-up (FU), there was no improvement in overall compliance with AI therapy, compliance with initial AI or persistence rates when EM were provided. Final results from the 2-y FU are presented here. Methods This 2-y, global observational study (NCT00681122) randomized 2758 patients, across 18 countries, to Group A: Standard Therapy or Group B: Standard Therapy + EM. The EM were developed in collaboration with patient advocates, and consisted of a range of information on breast cancer-related topics. Compliance rate with adjuvant AI medication was the primary endpoint. Secondary endpoints included persistence rate after 1 and 2y, and reasons for, and time to, discontinuation of AI therapy. Compliance rate was defined as the proportion of patients being ‘compliant’ with the adjuvant AI medication; switching from AI therapy to tamoxifen would result in a non-compliance score at time of switching. For compliance with initial adjuvant AI medication, switching to another AI or hormone therapy would result in a non-compliance score. A patient was considered a ‘persistent’ user if they did not switch AI medication, AI medication was uninterrupted and there was no discontinuation of the AI medication during the second year. Patients’ compliance and behavior were evaluated using compliance questionnaires, EM feedback and validated questionnaires (EORTC IN-PATSAT32, GHQ-12, FACT-ES). Results Of the 2758 patients randomized at study initiation, 2242 were available for analysis at 2-y FU. The results confirmed those obtained at 1-y FU. No statistically significant difference in compliance with AI therapy was observed between Group A and Group B (82% and 82%, respectively, p=0.9926). Compliance with initial AI was 81% in Group A and 80% in Group B (p=0.5541), with persistence rates of 90% and 88%, respectively (p=0.2425). Of the proportion of patients who had compliance data for both years (Group A n=1118; Group B n=1111) 72% were compliant for the whole 2-y FU period. Across the full 2-y FU, AI treatment discontinuation rates of 8% and 9% were observed in Group A and B, respectively, with discontinuation most frequently attributed to AI-related side effects. Analysis showed that no specific baseline demographic characteristics were associated with compliance behavior. Compliance rates differed widely between countries. Conclusions At 2-y FU, EM were not found to improve overall patient compliance, compliance with initial AI, or persistence with therapy. In total, 72% of patients were compliant across the full 2-y FU. AI-related side effects remained the most frequent cause of AI treatment discontinuation across the full FU period. The 2-y CARIATIDE data confirm the 1-y findings. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-16-02.