Retrospective cohort study assesses hematologic response to two TKIs in CML patients, indicating comparable efficacy and influencing factors.
<ns3:p>Background Chronic Myeloid Leukemia (CML) is a myeloproliferative neoplasm driven by the BCR–ABL1 fusion gene. Tyrosine kinase inhibitors (TKIs), such as imatinib and nilotinib, have transformed CML management by significantly improving hematologic and molecular responses. However, real-world data from low- to middle-income countries, including Indonesia, remain limited. Objective This study aimed to evaluate early hematologic responses after three months of TKI therapy in CML patients and to assess the influence of demographic and clinical factors on treatment outcomes. Methods A retrospective cohort study was conducted at Wahidin Sudirohusodo Hospital, Makassar, reviewing medical records of 43 adult CML patients treated with imatinib or nilotinib from January to December 2024. Hematologic parameters were analyzed at baseline and monthly for three months. Associations between treatment response and patient characteristics were assessed using GLM-Repeated Measures and MANOVA. Results Both TKI regiments significantly improved hematologic parameters (p < 0.001), with reductions in leukocyte counts and increases in hemoglobin and hematocrit. No significant interaction was found between time and treatment type (p > 0.05), indicating comparable efficacy. Patients receiving nilotinib showed a higher rate of complete response (60%) than those on imatinib (32.1%), though not statistically significant (p = 0.078). Body weight and BMI significantly influenced hematologic improvements (p < 0.05), while age did not. Conclusion Imatinib and nilotinib both effectively induce early hematologic responses in CML patients. While nilotinib showed a trend toward superior outcomes, statistical equivalence suggests both remain viable options. BMI and body weight are important predictors of response, highlighting the need for individualized treatment strategies. Further large-scale studies with extended follow-up are warranted to confirm long-term benefits and refine patient-specific therapy.</ns3:p>
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