RESUMEN
AIM: To determine the impact of educational materials (EMs) on the treatment compliance of postmenopausal women with hormone receptor-positive (HR+) early-stage breast cancer. PATIENTS & METHODS: Patients (n = 2757) were randomized to standard aromatase inhibitors (AI) alone (group A) or with EMs (group B) in a global, real-world setting. RESULTS: The 2-year results (n = 2242) showed EMs had no impact on compliance (82 vs. 82%, group A vs. B), compliance with initial AI (82 vs. 81%) or persistence (90 vs. 88%), confirming the 1-year interim analysis (n = 2567). Of the 2082 patients considered compliant at 1 year, 77% remained compliant at 2 years. Discontinuations (9%) were mainly attributed to AI-related side effects (68% of discontinuations). Exploratory analyses suggest a relationship between patient characteristics and compliance behaviors. CONCLUSION: EMs do not improve compliance in this patient population. Compliance and persistence are complex end points influenced by multiple variables. Side effects were the main reasons for discontinuations.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Anciano , Anastrozol , Androstadienos/administración & dosificación , Inhibidores de la Aromatasa/uso terapéutico , Femenino , Humanos , Letrozol , Persona de Mediana Edad , Nitrilos/administración & dosificación , Cooperación del Paciente , Educación del Paciente como Asunto , Tamoxifeno/administración & dosificación , Triazoles/administración & dosificaciónRESUMEN
The CARIATIDE study was designed to assess the impact of educational materials (EMs) on compliance and persistence rates with aromatase inhibitor (AI) treatment in postmenopausal women with hormone-receptor-positive early breast cancer. Patients were randomized to standard AI treatment (Group A; N = 1379) or standard AI treatment plus EMs containing information on a range of breast-cancer-related topics (Group B; N = 1379). Standardized questionnaires assessed investigator-perceived levels of care and evaluated patient compliance and behavior. At 1 year, there was no significant difference in compliance between Group A and Group B (81% vs. 82%, p = 0.4524). However, higher compliance in patients receiving EMs was observed in Sweden/Finland (p = 0.0246). Compliance with initial AI and persistence rate were not significantly altered by EM. Other factors associated with improved compliance, irrespective of EMs, e.g. administration of chemotherapy were identified.