Abstract

Background:Tyrosine kinase inhibitors (TKIs) have been standard‐of‐care for patients with chronic myeloid leukemia (CML) and improvements with TKIs have been obtained in survival rates. In Turkey, imatinib is the only reimbursed TKI for first line treatment and second generation TKI's are reserved for later lines. Some concerns such as TKI tolerability, adverse event profile, patient comorbidities, and concomitant drug use may affect the choice of second generation TKIs.Aims:This study aimed to evaluate demographic and clinical features and treatment patterns of chronic phase CML (CP‐CML) patients treated with TKIs in Turkey.Methods:This study was a national, multicenter, retrospective study conducted on CP‐CML patients followed‐up between 2005‐2018. After approval of the Ethics Committee, demographic and clinical data, certain laboratory findings, BCR‐ABL levels, applied treatments, response to treatment, comorbidities, and adverse events were recorded on the data collection form. It was predicted that 1000 patients would have been recruited and data collection would have ended in April 2019. Herein, the interim results of this study are presented.Results:Data of 487 patients with a median age of 55 years (17‐88) who were followed‐up median 57 months (3‐168) were included in the analysis. Demographics and treatment outcomes of the patients are summarized in Table 1. Of the patients, 68.2% were still on the first line treatment and the median duration for the second, third, and fourth line treatments in the remaining patients were 18 months (3‐109), 36 months (7‐143), and 36 months (24‐84), respectively. The main reason for switching to subsequent treatment was disease progression and/or loss /depth of response. The rate of complete hematological response (CHR) with any TKI was 96.2% in all patients and time to CHR was median 2 months (0‐123.07). The rate of molecular response (MR) in any TKI was 76.6% in all patients and time to MR was median 12 months (0‐120). The rate of complete cytogenetic response (CCyR) in any TKI was 74.8% in all patients and time to CCyR was median 12 months (0‐71.07). Leukemic transformation to acute phase in any time point was 4.4% and mortality rate was 6.1% for all patients. The rate of comorbid diseases were 9.9%, 11.9%, 1.9%, and 23.6% for diabetes mellitus (DM), cardiovascular disorders (CVDs), pulmonary disorders (PDs), and other reported concomitant disorders, respectively.The frequencies of adverse events during the second, third, and fourth line treatments were 24.8%, 25.7%, and 50.0%, respectively.Summary/Conclusion:This study analyzed one of the largest CML cohorts in Turkey in terms of demographic and clinical characteristics and treatment outcomes. Success rates regarding CHR, CCyR, and MR in patients treated with imatinib, dasatinib, and nilotinib were relatively high and satisfactory. Although the study population is relatively young, there were surprisingly high comorbidities including DM, CVD, and PD which may have an effect on choice of TKI. The choice of treatment, based on patient's comorbidity profile should be personalized as it is an important factor in the management of CML.image

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