P3-08-02: Evaluating the Impact of Educational Material on Anastrozole Treatment Adherence – The Final Results of the ARTEMIS Study.
Authors: J-M Nogaret, M Coibion, P Neven, O Soepenberg, M-P Graas, V Deschamp, T Vanlerberghe
Journal: Cancer Research (2011)

Abstract Rationale: Breast cancer (BC) is the most common cancer in European women. Compliance with the prescribed dosing regimen is essential for optimal effectiveness of cancer treatment. While adjuvant endocrine therapy reduces the risk of BC reoccurrence, only limited information is available regarding patient adherence to this type of treatment. Electronic monitoring of patients’ dosing histories has demonstrated the frequently irregular drug intake of patients. The ARTEMIS study (ARimidex Therapy compliance Electronic MonitorIng System, NCT00936442) evaluated the impact of educational material on the adherence to adjuvant treatment with anastrozole (Ax, Arimidex®). Methods: This randomized (1:1), open-label, parallel-group study in 5 centers in Belgium had two treatment groups: GpA-Standard Treatment, GpB-Standard Treatment+Education. All patients received a 12 month follow-up of Ax treatment according to current clinical practice. Patients in GpB also received additional educational material on a regular basis (9 mailings). Eligible patients were postmenopausal women with hormone sensitive early BC prescribed Ax (&amp;lt;13 weeks duration). All patients received Ax (1mg orally/day) in a Medication Event Monitoring System (MEMS® AARDEX Ltd) that electronically records bottle openings. The 500 ml capacity contained medication for 6 months treatment to avoid additional clinical visits to resupply medication. The sample size was based on the primary objective: adherence to Ax (the daily proportion of patients taking Ax). Secondary variables included persistence with Ax (the estimated length of time during which the medication is taken), execution of the Ax regimen and reasons for treatment discontinuation. Results: 107 patients (mean age 61.4±9.9 years) were enrolled: 54 in GpA, 53 in GpB. 16 patients (9 GpA, 7 GpB) discontinued prematurely based on the case report form with the MEMS system indicating that a further 4 patients (3 GpA, 1 GpB) discontinued. Overall, the adherence rate was high and decreased significantly over time (p=0.0061). There was no significant difference in adherence rate between the two groups (p=0.2358) with the daily average probability of correct intake 80.2±4.16% (GpA) and 86.7±4.94% (GpB). There was a trend for the persistence rate after 12 months to be better in GpB (84.7±5.0%) compared to GpA (77.8±5.7%; p=0.0782). An exploratory analysis showed a significant association between overall persistence and increasing postmenopausal age (Exp(coef)=0.942; p=0.038). The execution of the dosing regimen improved over time (p=0.0126) and was similar throughout the study for both groups (GpA: 96.5±3.1%, GpB: 94.0±3.1%; p=0.1674). Side effects (5 patients, 4.7%) were the most common reason for early discontinuation (GpA: 1 patient, GpB: 4 patients) but overall side effects were low. Conclusion: Educational material by mail did not significantly affect patient adherence to anastrozole. Persistence with treatment was associated with the post-menopausal age of the women and showed a trend for improvement in those receiving educational material. Since anastrozole treatment normally lasts 5 years, a longer-term follow-up study may provide better insight into the usefulness of MEMS on treatment compliance. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-08-02.