Abstract
Simple SummaryThis review discusses the optimal selection of BCR-ABL1 tyrosine kinase inhibitors (TKIs) as the first-line treatment for newly diagnosed chronic myelogenous leukemia in chronic phase (CML-CP). With the advent of TKIs, the treatment goals for CML-CP patients have changed from “simply survival” to “survival with adequate quality of life”, hence the number of CML-CP patients aiming to achieve treatment-free remission has increased, irrespective of age or comorbidities. Therefore, optimal selection of TKIs for maximizing the number of patients to achieve treatment-free remission is an important factor for consideration in future studies. To this end, we must understand the advantages and disadvantages of each TKI in terms of treatment response, disease risk at diagnosis, comorbidities, and medical expenses, and use of effective 2GTKIs based on patient background. This review provides insights into “shared decision-making” in individual cases, including the elderly population.With the use of tyrosine kinase inhibitors (TKIs), chronic myelogenous leukemia in chronic phase (CML-CP) has been transformed into a non-fatal chronic disease. Hence, “treatment-free remission (TFR)” has become a possible treatment goal of patients with CML-CP. Currently, four types of TKIs (imatinib, nilotinib, dasatinib, and bosutinib) are used as the first-line treatment for newly diagnosed CML-CP. However, the second-generation TKI (2GTKI), the treatment response of which is faster and deeper than that of imatinib, is not always recommended as the first-line treatment for CML-CP. Factors involved in TKI selection in the first-line treatment of CML-CP include not only patients’ medical background, but also patients’ choice regarding the desired treatment goal (survival or TFR?). Therefore, it is important that clinicians select an appropriate TKI to successfully achieve the desired treatment goal for each patient, while minimizing the development of adverse events. This review compares the pros and cons of using imatinib and 2GTKI for TKI selection as the first-line treatment for CML-CP, mainly considering treatment outcomes, medical history (i.e., desire for pregnancy, aging factor, and comorbidity), and cost. The optimal use of 2GTKIs is also discussed.
Highlights
The guidelines ver1.2022 of the National Comprehensive Cancer Network (NCCN) state that even if the IS at 3 months is slightly over 10%, if the IS at 6 months is less than 10%, the case should be considered sensitive to tyrosine kinase inhibitors (TKIs) [20]
29.7% in the imatinib group, respectively, 20.9% and 48.6% in the nilotinib 300 mg bid group, respectively, and 20.6% and 47.3% in the nilotinib 400 mg bid group, respectively, showing that nilotinib was significantly better than imatinib [17]. These results suggest that 2GTKI is more advantageous than imatinib in patients with chronic myelogenous leukemia in the chronic phase (CML-chronic phase (CP)) who aim for treatment-free remission (TFR)
In the ENEST freedom study with the re-initiated criterion defined as a loss of MMR [34,47], the TFR rate was 51.6% at 48 weeks and 42.6% at 5-year follow-up, with a median period from nilotinib initiation to discontinuation of 43.5 months
Summary
Only a limited number of patients can achieve TFRs, while approximately 70–80% of patients with CML-CP remain on longterm TKIs. Since the early 2000s, imatinib has been the only treatment option for TKIs. second-generation TKIs (2GTKIs) with increased affinity for BCR–ABL1, as well as ponatinib, a third-generation TKI with high effectiveness for T315I mutations, for which imatinib and 2GTKIs are resistant [12], became available. This review compares the advantages and disadvantages of using imatinib and 2GTKI from various points of view, and discusses the precautions to be considered for selecting TKIs as the first-line treatment for CML-CP
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