Determinants of frontline tyrosine kinase inhibitor choice for patients with chronic‐phase chronic myeloid leukemia: A study from the Registro Italiano LMC and Campus CML

Background Imatinib, dasatinib, and nilotinib are tyrosine kinase inhibitors (TKIs) approved in Italy for frontline treatment of chronic‐phase chronic myeloid leukemia (CP‐CML). The choice of TKI is based on a combined evaluation of the patient’s and the disease characteristics. The aim of this study was to analyze the use of frontline TKI therapy in an unselected cohort of Italian patients with CP‐CML to correlate the choice with the patient’s features. Methods A total of 1967 patients with CP‐CML diagnosed between 2012 and 2019 at 36 centers throughout Italy were retrospectively evaluated; 1089 patients (55.4%) received imatinib and 878 patients (44.6%) received a second‐generation (2G) TKI. Results Second‐generation TKIs were chosen for most patients aged 65 years (p 3 concomitant drugs. We observed a greater use of imatinib (61.1%) in patients diagnosed in 2018–2019 compared to 2012–2017 (53.2%; p = .002). In multivariable analysis, factors correlated with imatinib use were age > 65 years, spleen size, the presence of comorbidities, and ≥3 concomitant medications. Conclusions This observational study of almost 2000 cases of CML shows that imatinib is the frontline drug of choice in 55% of Italian patients with CP‐CML, with 2G‐TKIs prevalently used in younger patients and in those with no concomitant clinical conditions. Introduction of the generic formulation in 2018 seems to have fostered imatinib use. Among 1967 Italian patients diagnosed between 2012 and 2019 with chronic‐phase chronic myeloid leukemia (CP‐CML), 1089 patients (55.4%) received imatinib and 878 patients (44.6%) received a second‐generation tyrosine kinase inhibitor: nilotinib or dasatinib. Factors associated with the predominant use of imatinib were age >65 years, enlarged spleen, the presence of comorbidities (hypertension, diabetes, chronic obstructive pulmonary disease, previous neoplasms, ischemic heart disease, and stroke), and ≥3 concomitant medications at the time of CML diagnosis.