title: Patient-reported adverse drug reactions and their influence on adherence and quality of life of chronic myeloid leukemia patients on per oral tyrosine kinase inhibitor treatment.
abstract: OBJECTIVE
  To evaluate adverse drug reactions (ADRs) experienced by chronic myeloid leukemia (CML) patients during per oral tyrosine kinase inhibitor (TKI) treatment and correlation of ADR symptoms with medication adherence and perceived quality of life (QoL).
  
  
  METHODS
  Eighty-six adult, chronic-phase CML patients who had been on TKI treatment (79% on imatinib, 10.5% dasatinib, and 10.5% nilotinib) for at least 6 months participated in the study (mean age: 57.8 years, 52% males). The mean time from diagnosis was 5.1 years. All patients were interviewed, and patient-reported ADRs were obtained using a structured list. Adherence was assessed using Morisky's 8-item Medication Adherence Scale (MMAS). The symptoms' interference with patient's daily QoL was measured by asking patients about the influence of symptom(s) on their mood, general condition, enjoyment of life, walking, relationships, and work.
  
  
  RESULTS
  Ninety-seven percent of the patients were suffering from at least one ADR. The mean number of different symptoms was seven (range: 0-15, median 6). The most commonly perceived ADRs were muscle soreness or cramp (69/86, 80%); swelling of hands, legs, feet, or around the eyes (59/86, 69%); and fatigue (43/86, 50%). No correlation was found between adherence and ADRs, because symptoms were equally common in each MMAS adherence class. Half of the patients felt that the ADRs had a negative influence on their daily QoL. A quarter of the patients reported that ADRs affected either their mood, general condition, or enjoyment of life. The incidence of almost all ADRs was much higher among patients reporting negative influence of ADRs on their daily life compared to total study population (P=0.016).
  
  
  CONCLUSIONS
  TKI-related ADRs were common among CML patients irrespective of patient's adherence level. Patients who reported that ADRs had a negative influence on their daily QoL perceived more ADRs than those who did not experience a negative influence.
authors.affiliation: Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, University of Helsinki, Helsinki, Finland.
authors.forename: Meri
authors.initials: M
authors.lastname: Kekäle
authors.affiliation: Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland.
authors.forename: Marikki
authors.initials: M
authors.lastname: Peltoniemi
authors.affiliation: Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, University of Helsinki, Helsinki, Finland.
authors.forename: Marja
authors.initials: M
authors.lastname: Airaksinen
keywords: adherence; adverse drug reaction; chronic myeloid leukemia; patient-reported outcomes; quality of life; tyrosine kinase inhibitors