Abstract
Purpose
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).
Patients and 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).
Conclusion
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.
Acknowledgments
We are grateful to all the patients who participated in this study. We thank Dr Kimmo Talvensaari, MD, PhD; Professor Anne Juppo; Perttu Koskenvesa, MD; and Professor Kimmo Porkka for their help in making the study design. We would like to thank Professor Kari Remes; Dr Marjut Kauppila, MD, PhD; Dr Venla Terävä, MD, PhD; Dr Hanna Ollikainen, MD, PhD; Dr Sakari Kakko, MD, PhD; Antti Koponen, MD; Dr Maija Mikkola, MD, PhD; Anu Kutila MD; and Kirsi Launonen, MD for their help in recruiting the patients for the study. Our warm thanks go to study nurses Minna Pajuportti, Raija Aaltonen, Marjut Yrjönen, Ulla Pietilä, Erja Silventoinen, Leena Lahdenmaa, and Riitta Saavalainen for their help with patient contacts.
Disclosure
Meri Kekäle has received a grant from University Pharmacy, Helsinki, for this research. The authors report no other conflicts of interest in this work.