Summary

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• This summary is based on the review of 11 systematic review(s)/meta-analysis(es). ^[1-11]
• Second-generation TKIs (dasatinib, nilotinib, radotinib) achieved higher rates of Major Molecular Response (MMR) and Complete Cytogenetic Response (CCyR) compared to imatinib, with imatinib 800 mg performing better than imatinib 400 mg. New-generation TKIs (NG-TKIs) also showed increased early molecular response rates, including at the 3-month mark.
• Studies comparing second-generation TKIs (dasatinib, nilotinib) to imatinib showed no significant differences in 5-year Overall Survival (OS) or Progression-Free Survival (PFS), though NG-TKIs indicated higher OS at 12 months compared to imatinib.
• NG-TKIs were associated with lower rates of Chronic Myeloid Leukemia (CML)-related death and progression to the accelerated phase or blast crisis compared to imatinib.
• Second-generation TKIs consistently outperformed imatinib in achieving MMR and CCyR.
• All TKIs caused severe hematologic adverse events (AEs), with dasatinib showing a higher likelihood for anemia, bosutinib for thrombocytopenia, imatinib for neutropenia, and nilotinib displaying a relatively better safety profile regarding severe hematologic AEs. The prevalence of hematologic AEs was highest for dasatinib and lowest for nilotinib.
• Second-generation TKIs had a higher risk of cutaneous AEs (rash and pruritus) and increased hepatotoxicity (elevated ALT and AST levels) compared to imatinib. Nilotinib was associated with a significantly higher risk of cardiovascular events, including coronary artery disease, acute coronary syndrome, cerebrovascular accidents, and peripheral arterial occlusive disease, with a higher incidence of hypertension compared to imatinib.
• Malformation rates in offspring of fathers who did not discontinue TKI treatment before conception were comparable to the general population, though data on nilotinib were limited.
• The effectiveness outcomes for Chronic Myeloid Leukemia (CML) patients indicate that second-generation TKIs show favorable rates of major molecular response (MMR) and complete cytogenetic response (CCyR), while patients in accelerated CML phases experience significantly higher rates of hematologic adverse events, particularly when treated with nilotinib, which also poses increased risks for those with pre-existing cardiovascular conditions.