DI-104 Tyrosine kinase inhibitors in chronic myeloid leukaemia: use and safety profile

Abstract

Background Chronic myeloid leukaemia (CML) is a myeloproliferative disorder associated with the Philadelphia chromosome resulting in the BCR-ABL fusion gene. This produces a continued proliferative signal resulting in the clinical manifestations of CML. Purpose To analyse the use of tyrosine kinase inhibitors (TKIs) in CML patients, and their safety profile. Materials and methods Descriptive observational study in a third level hospital. We included patients who were under treatment with TKIs at the time of the data collection (September 2013). Data was compiled through the electronic prescription program (APD Prisma). Variables included demographics (age, sex); clinical data (age at diagnosis, time since diagnosis, treatment) and adverse reactions (ADRs). Data were obtained from medical records. Results We analysed 54 patients who picked up TKIs in a pharmacy service at the time of data collection. Fifty percent (n = 27) were male, with a mean age of 58.0 (8.83). Mean time since diagnosis was 7.1 years (1.26). 67% of the patients (n = 37) received imatinib, 21.8% (n = 12) nilotinib, and 10.9% (n = 6) dasatinib. More than 66% of patients receiving second generation TKIs were on second-line treatment after imatinib, the remaining 33% were first-line. ADRs for imatinib included: 10 patients with oedema (8 relating to the eyelids), 8 musculoskeletal pain and cramps, 4 asthenia, 2 skin rash, 1 pleural effusion, and 4 other. ADRs for nilotinib: 2 patients with oedema, 2 irritability, and 5 other. ADRs for dasatinib: 1 fatigue and 1 muscle pain. ADRs were not reported in 34 patients. Conclusions Clinical practice in our hospital is consistent with the Summary of Product Characteristics. All the ADRs reported are included as very common (>1/10) in the above-mentioned summary. Only 11% of CML patients are initially treated with second generation TKIs. Although this approach has gradually increased in our hospital, there are not enough cases of CML patients treated with nilotinib and dasatinib to draw definitive conclusions. No conflict of interest.