Patient-reported symptom monitoring and adherence to therapy in patients with newly diagnosed chronic myeloid leukemia

Efficace, Fabio;Cottone, Francesco;Yanez, Betina;Kota, Vamsi;Castagnetti, Fausto;Caocci, Giovanni;Bonifacio, Massimiliano;Patriarca, Andrea;Capodanno, Isabella;Miggiano, Maria Cristina;Tiribelli, Mario;Breccia, Massimo;Luciano, Luigia;Giai, Valentina;Iurlo, Alessandra;Abruzzese, Elisabetta;Fava, Carmen;Dinner, Shira;Altman, Jessica K;Rosti, Gianantonio;Cortes, Jorge;Vignetti, Marco;Cella, David

2023-01-01

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Abstract

Background: The authors assessed the clinical utility of patient-reported symptom monitoring in the setting of newly diagnosed chronic myeloid leukemia (CML). The primary objective was to evaluate adherence to therapy. Methods: The authors conducted an international prospective study that included patients with newly diagnosed, chronic-phase CML. Before clinical consultation, patients were provided a tablet computer to self-rate their symptoms, and the results were available in real time to each physician during the patient's visit. Adherence was assessed by pill count and with a validated self-reported questionnaire. The proportions of optimal responders at 3 and 6 months were assessed according to the European LeukemiaNet criteria. Results: Between July 2020 and August 2021, 94 patients with a median age of 57 years were enrolled. Pill count adherence analysis indicated that 86 of 93 evaluable patients (92.5%) took at least 90% of prescribed tyrosine kinase inhibitor therapy during the 6-month observation period. The online platform was well accepted by patients and physicians. An optimal response was achieved by 69 of 79 patients (87.3%) at 3 months and by 61 of 81 patients (75.3%) at 6 months. Conclusions: Patient-reported symptom monitoring from the beginning of therapy in patients with CML may be critical to improve adherence to therapy and early molecular response rates (ClinicalTrials.gov identifier NCT04384848).