A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib

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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 0.05), 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. 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F1000Research 2025, 14 :845 ( https://doi.org/10.12688/f1000research.168812.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Research Article A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] Darren Gosal https://orcid.org/0009-0005-5980-7399 1 , Andi Fachruddin Benyamin 1 , Andi Makbul Aman 1 , Syakib Bakri 1 , Haerani Rasyid 1 , Andi Alfian Zainuddin 2 Darren Gosal https://orcid.org/0009-0005-5980-7399 1 , Andi Fachruddin Benyamin 1 , [...] Andi Makbul Aman 1 , Syakib Bakri 1 , Haerani Rasyid 1 , Andi Alfian Zainuddin 2 PUBLISHED 01 Sep 2025 Author details Author details 1 Department of Internal Medicine, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, 90245, Indonesia 2 Department of Public Health, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, 90245, Indonesia Darren Gosal Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Andi Fachruddin Benyamin Roles: Conceptualization, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Andi Makbul Aman Roles: Conceptualization, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Syakib Bakri Roles: Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Haerani Rasyid Roles: Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Andi Alfian Zainuddin Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Software, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Oncology gateway. Abstract 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 0.05), 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. READ ALL READ LESS Keywords Chronic Myeloid Leukemia, Imatinib, Nilotinib, Hematologic Response Corresponding Author(s) Darren Gosal ( [email protected] ) Close Corresponding author: Darren Gosal Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2025 Gosal D et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Gosal D, Benyamin AF, Aman AM et al. A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.12688/f1000research.168812.1 ) First published: 01 Sep 2025, 14 :845 ( https://doi.org/10.12688/f1000research.168812.1 ) Latest published: 31 Dec 2025, 14 :845 ( https://doi.org/10.12688/f1000research.168812.2 )  There is a newer version of this article available. Suppress this message for one day. Introduction Chronic Myeloid Leukemia (CML) is a clonal myeloproliferative neoplasm caused by the BCR–ABL1 fusion gene, which results from a reciprocal translocation between chromosomes 9 and 22, known as the Philadelphia chromosome (t(9;22)(q34;q11)). This fusion gene encodes a constitutively active tyrosine kinase, leading to uncontrolled proliferation of myeloid cells and resistance to apoptosis. 1 – 3 Globally, the incidence of CML is estimated to range from 0.6 to 2.8 per 100,000 population per year. 4 Although the median age at diagnosis in Western countries is around 60 years, several studies indicate that the age at diagnosis in some Asian countries, including Indonesia, tends to be younger. In addition, many CML cases in Indonesia are detected in the late chronic phase while still asymptomatic. 4 Over the past two decades, the management of CML has advanced dramatically with the advent of tyrosine kinase inhibitors (TKIs) such as imatinib, which have significantly improved patient outcomes. 5 – 7 TKIs work by phosphorylating amino acids on enzyme substrates, thereby altering signal transduction and inducing cellular changes. Imatinib is a first-generation TKI that directly inhibits tyrosine kinase activity, affecting cell cycle and adhesion, ultimately leading to apoptosis. Second-generation TKIs such as nilotinib were developed to overcome resistance to imatinib by specifically and selectively inhibiting BCR-ABL autophosphorylation and suppressing cancer cell proliferation. 8 , 9 Currently, second-generation TKIs like dasatinib, nilotinib, and bosutinib are available as first-line therapies, with the potential to induce faster and deeper molecular responses, especially in high-risk patients based on the Sokal or ELTS score. 1 , 3 Although there is no conclusive evidence from large clinical trials showing significant survival benefits of second-generation TKIs over first-generation ones, real-world data suggest that second-generation TKIs can accelerate the achievement of early molecular response (EMR) and increase the likelihood of achieving treatment-free remission (TFR). 3 , 10 TKIs have not only transformed the prognosis of CML into a controllable chronic disease but have also made TFR a realistic treatment goal for some patients. Nevertheless, around 20–30% of patients experience resistance or intolerance to TKIs, and 6–7% remain at risk of progressing to the blast phase, which continues to pose a challenge in long-term management. Moreover, most patients still require long-term therapy, as not all are eligible for TFR. 11 , 12 Response to TKI therapy is assessed through hematologic, cytogenetic, and molecular parameters, with molecular response being the primary monitoring parameter due to its sensitivity and specificity for residual disease burden. Early molecular response, particularly achieving BCR–ABL1 ≤10% at 3 months, has been strongly correlated with better long-term outcomes such as improved progression-free survival (PFS) and overall survival (OS). Hematologic response is assessed via complete blood count during the first three months of therapy. Studies have shown that imatinib and nilotinib produce similar hematologic responses. 2 , 3 , 10 , 13 Therapeutic response in CML patients is influenced by several factors. Higher body weight and BMI have been associated with poorer treatment response due to reduced drug levels in the blood. Other factors such as age and height were found not to affect treatment response. 14 Although numerous large clinical trials have evaluated the efficacy of various TKIs, most of these studies were conducted in Western populations. Meanwhile, real-world data from Indonesia and other low- to middle-income countries remain minimally known. Considering regional differences in disease presentation, access to healthcare, drug availability, and cost, local evaluation of treatment outcomes becomes crucial. In Indonesia, the availability of TKIs is still uncommon and highly dependent on regional government support for procurement through local health budgets (APDB), particularly in primary care settings such as community health centers. Cost also plays a significant role, with imatinib being more accessible through the national health insurance due to its lower price, compared to nilotinib, which is more expensive and only available in major hospitals. Evaluating hematologic response at the third month as the most simple method is strongly associated with long-term prognosis which can provide valuable insights for optimizing treatment strategies for CML patients in Indonesia. 2 , 10 , 15 , 16 Therefore, this study aims to evaluate the hematologic responses in CML patients after three months of TKI therapy and analyze the influence of demographic and confounding factors such as age, sex, disease phase at diagnosis, and baseline laboratory parameters on early treatment outcomes. Methods This analytical observational study employed a retrospective cohort design. Informed consent was not required for this study, as no direct contact was made with participants where data derived from patient medical records. The study was conducted at the Hematology Medical Oncology Outpatient Clinic of Wahidin Sudirohusodo Hospital, spanning from January to December 2024. Data management and statistical analysis were performed at the Department of Public Health, Faculty of Medicine, Hasanuddin University. The target population was adult patients diagnosed with CML. The accessible population included all adult CML patients treated at Wahidin Sudirohusodo Hospital during the specified study period. Study participants were selected using non-random consecutive sampling. Inclusion criteria were: aged 18 years or older, diagnosed with CML based on history, physical and laboratories examination, and treated with TKIs either imatinib or nilotinib for at least three consecutive months conducted at the study site. Patients who had received hydroxyurea prior to TKI therapy were excluded. The primary dependent variable was therapeutic response which is hematologic response after three months of treatment, classified as complete (WBC and PLT count back to normal, no immature granulocytes, no blasts in peripheral blood, no blasts and basophil in peripheral blood, and no sign or symptoms of disease), partial (improvement in blood counts, but not all complete response met), or failed (no improvement in blood counts) response based on hematologic parameters and NCCN guidelines. The independent variable was the type of TKI therapy—imatinib (400 mg once daily, orally) or nilotinib (300 mg twice daily, or 150 mg × 2 every 12 hours, orally). Confounding variables included age, sex, weight, height, and Body Mass Index (BMI), all derived from patients’ identity cards and standard measurements recorded at the first visit of the outpatient clinic. BMI was calculated by dividing body weight in kilograms by the square of height in meters (kg/m 2 ). Statistical analysis began with descriptive statistics, assessing qualitative data as frequency and percentage distributions, and quantitative data using means, standard deviations, medians, and ranges. Data normality was evaluated using the Kolmogorov–Smirnov or Shapiro–Wilk tests. For comparisons of hematologic parameters across four time points (diagnosed to three moths therapy), Repeated Measures ANOVA was applied to normally distributed data, while the Friedman test was used for non-normally distributed data. Post-hoc analysis (e.g., Bonferroni correction) was conducted when needed. To evaluate the effect of treatment type on changes over time, Mixed Between-Within Subjects ANOVA or Repeated Measures ANCOVA was employed, accounting for interactions between treatment and time. The General Linear Model (GLM) was used to assess covariate influences on laboratory outcomes. Chi-square tests were applied to examine associations between treatment regiment and therapeutic response category; McNemar’s test was considered when comparing paired binary outcomes. Statistical significance was defined as a p-value < 0.05 with a 5% alpha level and 80% statistical power. All analyses were conducted using SPSS version 22. Results This study involved 43 subjects, all diagnosed with Chronic Myeloid Leukemia (CML) who received imatinib or nilotinib for a period of three months at Wahidin Sudirohusodo Hospital, Makassar, from January to December 2024. The sample was predominantly female (60.5%), with most patients receiving imatinib (65.1%) rather than nilotinib (34.9%). The mean age of the respondents was 42.28 years, with a mean body weight of 53 kg, mean height of 157 cm, and a mean body mass index (BMI) of 21.56 kg/m 2 ( Table 1 ). Table 1. Subject Characteristics. Table 1 shows the basic subject characteristic where dominantly (60.5%) are female gender with 65.1% with imatinib treatment. The average age of the subject was 42 years old, with 54 kg of bodyweight, 157 cm of height and 21.56 kg/m 2 of body mass index. Parameter N (%) Mean (SD) Median (Min – Max) Gender • Male 17 (39.5%) • Female 26 (60.5%) - - Treatment • Imatinib 28 (65.1%) • Nilotinib 15 (34.9%) Age, years old 42.28 (16.13) 44 (18 – 80) Weight, kg 53 (10.08) 50 (38–81) Height, cm 157.02 (8.24) 156 (136–173) BMI, kg/m 2 21.56 (4.12) 19.31 (14.48–32.05) Overall, the patients demonstrated a progressive improvement in hematological parameters over the three-month treatment course. A substantial reduction was observed in leukocyte counts, from a mean of 252,398 cells/μL at baseline to 17,219 cells/μL by the third month ( Figure 1 ). Similarly, hemoglobin levels increased from 9.42 g/dL to 11.48 g/dL ( Figure 2 ), and hematocrit improved from 28.45% to 35.16% ( Figure 3 ). The platelet count, initially high (640,953 cells/μL), decreased significantly to 318,186 cells/μL by the third month, indicating hematological stabilization in response to therapy ( Figure 4 ). Figure 1. Comparison of Leukocyte Count between Imatinib and Nilotinib Regiments Over Three Months of Treatment. Line graph showing serial measurements of leukocyte count over the first 3 months of treatment. The imatinib group is depicted in green, the nilotinib in blue. A rapid decline in leukocyte count was observed within the three month of therapy, consistent with a complete hematologic response (CHR). Figure 2. Comparison of Hemoglobin Level between Imatinib and Nilotinib Regiments over Three Months of Treatment. Line graph showing serial measurements of hemoglobin level over the first 3 months of treatment. The imatinib group is depicted in green, the nilotinib in blue. Hemoglobin gradually improved over time, reflecting recovery of normal hematopoiesis. Figure 3. Comparison of Hematocrit Level between Imatinib and Nilotinib Regiments over Three Months of Treatment. Line graph showing serial measurements of hematocrit level over the first 3 months of treatment. The imatinib group is depicted in green, the nilotinib in blue. Hemoglobin gradually improved over time, reflecting recovery of normal hematopoiesis. Figure 4. Comparison of Platelet Count between Imatinib and Nilotinib Regiments over Three Months of Treatment. Line graph showing serial measurements of Platelet count over the first 3 months of treatment. The imatinib group is depicted in green, the nilotinib in blue. A rapid decline in platelet count was observed within the three month of therapy, consistent with a complete hematologic response (CHR). Both imatinib and nilotinib regiments showed similar trends of improvement across major hematological indices, including decreased leukocyte and platelet count, increased hemoglobin, and hematocrit, over the course of three months. Using Generalized Linear Model Repeated Measures (GLM-RM) analysis, a significant main effect of time was observed for these parameters (p < 0.001), indicating that hematological values improved with continued therapy. However, the interaction between time and drug regiment did not yield statistically significant differences for most parameters (p > 0.05), suggesting that both imatinib and nilotinib had comparable efficacy in modifying hematological profiles within the longer observed period ( Table 2 ). Although slight variations in response dynamics were noted, such as for example, nilotinib showed a steeper decline in leukocyte count and a more pronounced increase in hemoglobin, these differences were not statistically significant. Likewise, changes in MCV, MCH, neutrophils, lymphocytes, monocytes, eosinophils, and basophils were observed over time, but again without meaningful distinction between regiments in their interaction with time. Table 2. Hematological Parameter Improvement in Patients Treated with Imatinib vs Nilotinib Use for Three Months. Table 2 refers to the changes in the hematological parametes, where improvement in leukocyte and platelet counts over 3 months therapy, and increase in hemoglobin and hematocrit wither in imatinib or nilotinib group. The p-value for time is p 0.05. Parameter Regiment Result (Mean, SD), Med (Min – Max) p-value (GLM) p-value (time) p-value (time + regiment) Month 0 Month 1 Month 2 Month 3 Leukocyte Imatinib 245123.21 (131160.77). 228900 (12200–539500) 104707.14 (138680.66). 14100 (2500–415500) 36571.43 (84779.47). 6700 (900–333600) 19155 (52334.23). 5700 (1800–269100) <0.001 <0.001 0.885 Nilotinib 265978.67 (164842.44). 246200 (34100–592300) 101266.67 (132102). 14900 (5500–333800) 22720 (47060.91). 7500 (4400–189800) 13606.67 (25379.73). 8400 (1900–104700) <0.001 Hemoglobin Imatinib 9.54 (1.87). 9.65 (5.90–15.70) 9.77 (1.82). 9.70 (6.10–15.90) 10.50 (1.82). 10.30 (7–15.10) 11.19 (2.27). 11.10 (7.20–17) <0.001 <0.001 0.455 Nilotinib 9.20 (1.48). 9.40 (5.10–10.90) 9.90 (1.61). 9.90 (4.90–11.60) 10.90 (2.31). 10.60 (7.70–15.70) 12.03 (2.83). 12.40 (6.80–16.10) <0.001 Hematocrit Imatinib 28.64 (6.05). 28 (18–46) 30.32 (5.59). 30 (20–46) 32.64 (5.44). 32 (22–45) 34.29 (6.76). 33 (21–50) 0.002 <0.001 0.416 Nilotinib 28.10 (5.39). 28 (13–35) 31.33 (5.33). 32 (16–38) 33.13 (6). 33 (25–46) 36.80 (8.41). 37 (19–51) 0.002 MCV Imatinib 90.11 (5.25). 90 (78–105) 91.25 (7.37). 90 (79–115) 90.21 (8.62). 88.50 (78–115) 90.29 (8.34). 89.50 (73–111) 0.250 0.048 0.297 Nilotinib 87.19 (5.51). 87 (76–98) 88.13 (7.12). 89 (72–99) 84 (8.67). 83 (67–96) 83.60 (7.92). 85 (67–96) 0.230 MCH Imatinib 30.29 (2.61). 30 (26–36) 29.68 (2.40). 29 (26–35) 29.36 (2.87). 29 (24–36) 29.43 (2.70). 29 (25–36) 0.555 0.198 0.924 Nilotinib 28.98 (3.03). 29 (24–35) 28.13 (2.59). 28 (23–32) 28.07 (3.35). 29 (21–34) 27.73 (3.77). 28 (19–33) 0.432 Platelets Imatinib 574357.14 (303059.37). 521000 (106000–1.35E+6) 423785.71 (300207.01). 365500 (44000–1.25E+6) 306785.71 (261998.35). 206000 (9000–1.03E+6) 288250 (301415.75). 181000 (56000–1.46E+6) <0.001 <0.001 0.267 Nilotinib 765266.67 (736361.76). 423000 (36000–2.50E+6) 468133.33 (455380.67). 341000 (58000–1.79E+6) 259333.33 (313427.52). 160000 (33000–1.31E+6) 374066.67 (607980.91). 168000 (19000–2.34E+6) 0.072 Neutrophils Imatinib 81.65 (8.07). 82.90 (59.10–95.10) 68.59 (15.85). 69.20 (27.30–88.50) 57.43 (17.27). 59 (27.30–85) 56.57 (15.07). 56.60 (34.40–85.10) <0.001 <0.001 0.736 Nilotinib 78.19 (16.57). 82.40 (25.60–94.30) 64.17 (20.70). 64 (2.20–96) 54.65 (17.73). 58.80 (6.20–78.10) 48.97 (18.44). 48.80 (7.80–82.70) <0.001 Lymphocyte Imatinib 6.08 (4.62). 5.05 (1.50–23.60) 18.66 (16.40). 15.55 (2–62.60) 29.47 (16.53). 27.55 (3.10–62.60) 33.03 (14.30). 32.65 (3.60–61.20) <0.001 <0.001 0.790 Nilotinib 5.97 (3.43). 4.90 (1.30–14.50) 17.49 (10.66). 15.70 (1.10–35.20) 28.37 (13.83). 27.30 (7–54.40) 36.24 (16.38). 34.50 (6.70–71.50) <0.001 Monocyte Imatinib 4.01 (2.11). 3.35 (1.60–8.90) 5.35 (2.67). 4.80 (1.20–13.10) 6.04 (4.09). 5.35 (0.60–20.70) 6.15 (3.59). 5.25 (1.70–18.20) 0.107 0.003 0.407 Nilotinib 6.80 (13.01). 3.60 (0.80–53.50) 5.52 (3.56). 4.80 (0.70–11.80) 10.87 (15.76). 7.30 (3.30–67.20) 6.77 (2.96). 6.70 (2.70–15.20) 0.014 Eosinophil Imatinib 3.16 (2.51). 3.05 (0.50–11.20) 3.52 (3.61). 2.75 (0.20–19.20) 4.49 (7.53). 2.60 (0.10–40.50) 2.41 (2.49). 1.60 (0–10.80) 0.316 0.220 0.345 Nilotinib 4.15 (2.81). 3.20 (1.20–11.60) 9.01 (19.04). 4 (0.30–77.20) 4.01 (4.59). 2.30 (0.50–17.40) 6.50 (13.01). 1.80 (0.20–51.10) 0.429 Basophil Imatinib 5.10 (3.37). 5.05 (0.30–13.90) 3.88 (3.56). 3.30 (0–14.30) 2.55 (2.58). 1.70 (0.20–11.80) 1.84 (1.84). 1.10 (0–6.90) < 0.001 <0.001 0.991 Nilotinib 4.89 (4.12). 4.10 (0.10–15.70) 3.81 (3.71). 3.30 (0.10–13.70) 2.09 (3.01). 0.90 (0–11) 1.52 (2.98). 0.50 (0–11.20) 0.052 Further analysis using Multivariate Analysis of Variance (MANOVA) examined the influence of confounding factors on hematological improvements. The study revealed that body weight and BMI significantly affected changes in leukocyte count, hemoglobin, hematocrit, and MCV during the therapy period (p < 0.05). Conversely, age did not show a statistically significant influence on any of the hematological parameters assessed. This indicates that patient anthropometric factors may play a role in hematological response to TKI therapy, whereas age alone does not appear to be a determinant of hematological recovery in the short-term therapeutic window ( Table 3 ). Table 3. Confounding Factors and Hematological Parameter Improvement among Treatment Regiments. Table 3 shows the relationship between hematological parameters with several confounding factors such as: age, body weight, body height, BMI and regiment type. Among all, body weight and BMI were significant with the hematological parameters. Parameter Source Type III Sum of Squares df Mean Square F Sig. Leukocyte Intercept 88193979288.803 1 88193979288.803 4.092 .050 Age 27057146535.048 1 27057146535.048 1.255 .270 Weight 91871510683.101 1 91871510683.101 4.262 .046 Height 79320524045.203 1 79320524045.203 3.680 .063 BMI 95654056212.084 1 95654056212.084 4.438 .042 Type 679577014.781 1 679577014.781 .032 .860 Error 797496802025.844 37 21553967622.320 Hemoglobin Intercept 20.449 1 20.449 2.426 .128 Age 42.731 1 42.731 5.070 .030 Weight 22.129 1 22.129 2.625 .114 Height 30.279 1 30.279 3.592 .066 BMI 25.760 1 25.760 3.056 .089 Type .771 1 .771 .091 .764 Error 311.856 37 8.429 Hematocrit Intercept 302.774 1 302.774 3.760 .060 Age 274.102 1 274.102 3.404 .073 Weight 348.058 1 348.058 4.322 .045 Height 417.514 1 417.514 5.184 .029 BMI 385.200 1 385.200 4.783 .035 Type 5.459 1 5.459 .068 .796 Error 2979.703 37 80.533 MCV Intercept 266.245 1 266.245 1.651 .207 Age 330.504 1 330.504 2.050 .161 Weight 621.310 1 621.310 3.854 .057 Height 585.183 1 585.183 3.630 .065 BMI 663.781 1 663.781 4.117 .050 Type 899.774 1 899.774 5.581 .024 Error 5964.967 37 161.215 MCH Intercept .037 1 .037 .002 .967 Age 13.212 1 13.212 .605 .442 Weight 4.530 1 4.530 .207 .651 Height 5.831 1 5.831 .267 .608 BMI 5.918 1 5.918 .271 .606 Type 69.315 1 69.315 3.174 .083 Error 807.969 37 21.837 Platelet Intercept 54789602438.232 1 54789602438.232 .141 .709 Age 2072802138.859 1 2072802138.859 .005 .942 Weight 160883076988.209 1 160883076988.209 .415 .523 Height 93426389055.728 1 93426389055.728 .241 .626 BMI 116772025681.136 1 116772025681.136 .301 .586 Type 51136459107.064 1 51136459107.064 .132 .719 Error 14344007879991.970 37 387675888648.432 Neutrophil Intercept 58.476 1 58.476 .094 .761 Age 119.814 1 119.814 .193 .663 Weight 4.346 1 4.346 .007 .934 Height 3.397 1 3.397 .005 .941 BMI 2.920 1 2.920 .005 .946 Type 655.312 1 655.312 1.056 .311 Error 22958.585 37 620.502 Lymphocyte Intercept 363.250 1 363.250 1.068 .308 Age 20.969 1 20.969 .062 .805 Weight 439.293 1 439.293 1.291 .263 Height 437.325 1 437.325 1.286 .264 BMI 461.097 1 461.097 1.356 .252 Type 1.347 1 1.347 .004 .950 Error 12585.883 37 340.159 Monocyte Intercept 32.906 1 32.906 .283 .598 Age 2.875 1 2.875 .025 .876 Weight 21.216 1 21.216 .182 .672 Height 24.522 1 24.522 .211 .649 BMI 24.005 1 24.005 .206 .652 Type 164.957 1 164.957 1.418 .241 Error 4302.890 37 116.294 Eosinophil Intercept 185.234 1 185.234 1.200 .280 Age 145.350 1 145.350 .942 .338 Weight 149.463 1 149.463 .969 .331 Height 162.560 1 162.560 1.053 .311 BMI 160.198 1 160.198 1.038 .315 Type 243.640 1 243.640 1.579 .217 Error 5709.770 37 154.318 Basophil Intercept 3.453 1 3.453 .174 .679 Age 3.191 1 3.191 .160 .691 Weight 4.408 1 4.408 .222 .641 Height 2.058 1 2.058 .103 .750 BMI 5.123 1 5.123 .258 .615 Type 2.794 1 2.794 .140 .710 Error 736.033 37 19.893 After three months of treatment, patients receiving nilotinib exhibited a higher rate of complete response (60%) compared to those receiving imatinib (32.1%). Although this trend suggests a potential clinical advantage of nilotinib, statistical analysis using Chi-square and McNemar tests showed no significant difference across response categories (p > 0.05). When treatment outcomes were simplified into dichotomous categories (“response” vs “failure”), the results remained statistically non-significant (p = 0.894), indicating that both therapies were generally comparable in terms of achieving initial treatment success. Nevertheless, the observed trend toward better response in the nilotinib group warrants further investigation, particularly in larger cohorts or with extended follow-up periods ( Table 4 ). Table 4. 3-Months Therapy Response Comparison among Treatment Groups. Table 4 shows that more subjects reached complete response after 3 months in the nilotinib group compared to imatinib, however there were no relationship in the statistical analysis (p>0.05). Therapy Therapy response after 3 months (N,%) Total Failure Partial Complete Nilotinib 15 4 (26,7%) 2 (13,3%) 9 (60,0%) Imatinib 28 8 (28,6%) 11 (39,3%) 9 (32,1%) p-value for all category 0,135 ( Chi-square ) p-value for response vs failure Failure : 26,7 vs 28,6 ~~ Response 73,3 vs 71,4 0,894 ( Chi-square ) /0,648 ( McNemar Test ) p-value for complete vs incomplete Complete : 60,0 vs 32, 1 ~~ Incomplete 40 vs 67,9 0,078 ( Chi-square ) /0,087 ( McNemar Test ) Discussion After three months of TKI therapy, both imatinib and nilotinib significantly improved hematological parameters in patients with CML. Overall, leukocyte counts markedly decreased from a baseline mean of 252,398/μL to 17,219/μL by month three, consistent with the known mechanism of TKIs in inhibiting BCR–ABL1 tyrosine kinase activity and promoting leukemic cell apoptosis. 17 , 18 Hemoglobin levels increased from 9.42 g/dL to 11.48 g/dL, and hematocrit from 28.45% to 35.16%, reflecting recovery of erythropoiesis. Platelet counts also dropped from 640,953/μL to 318,186/μL, aligning with the hematologic remission criteria established by the European LeukemiaNet (ELN) 2020. 19 In the imatinib group, leukocytes declined from 245,123/μL to 19,155/μL, with hemoglobin rising from 9.54 g/dL to 11.19 g/dL and hematocrit from 28.64% to 34.29%. Prior studies report 60–80% of patients achieve complete hematologic response (CHR) within 3 months of imatinib therapy. 18 , 20 In the nilotinib group, leukocytes dropped more sharply, from 265,979/μL to 13,607/μL, with hemoglobin rising to 12.03 g/dL and hematocrit to 36.80%. Although nilotinib showed a trend of faster response, the difference was not statistically significant (p > 0.05), supporting evidence that it induces deeper early responses than imatinib. 21 Additional markers such as mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) were evaluated. MCV was significantly higher in the imatinib group (p = 0.024), suggesting mild macrocytosis, which may reflect active erythroid regeneration. Song et al. linked this macrocytosis to favorable molecular responses in TKI therapy. 22 MCH showed a slight, non-significant decrease, possibly indicating early-stage erythrocyte production or compensatory hypochromia due to rapid erythropoiesis. 23 Platelet counts progressively normalized in both groups, though nilotinib-treated patients exhibited rebound thrombocytosis at month three, possibly due to megakaryopoietic rebound or a drug-specific effect. This fluctuation is acceptable if not accompanied by thrombosis or bleeding, per Hughes et al. 6 , 24 These results suggest that TKIs improve not only leukocyte and hemoglobin levels but also secondary hematologic indicators like MCV, MCH, and platelets—reflecting hematopoietic recovery. MCV and MCH may offer early signals of therapeutic response, while differences in MCV trends between regiments suggest potential as pharmacodynamic biomarkers. Body weight and body mass index (BMI) were significantly associated with hematologic response after 3 months of TKI therapy (p < 0.05). These factors influence drug pharmacokinetics and tissue distribution. Maroselli et al. found that patients with BMI 53 kg) experienced greater leukocyte and platelet reduction, and more consistent hemoglobin improvement—especially in the nilotinib group. Similar findings by Abdulla et al. show better molecular responses in overweight patients. 26 Although height showed no significant association with hematologic response, it influences body surface area (BSA), which historically guided chemotherapy dosing. However, studies including Kawaguchi et al. indicate that BSA does not correlate with imatinib trough levels, supporting the safety of fixed dosing strategies. 27 Abdulla et al. also emphasized that BMI is more clinically relevant than height alone in determining TKI response. 26 BMI was significantly associated with leukocyte (p = 0.042) and hematocrit (p = 0.035) improvements. Patients with normal or mildly elevated BMI responded better than those underweight, likely due to more stable hematopoiesis. Joseph et al. found plasma imatinib levels were 61.5% higher in underweight patients, increasing the risk of hematologic and systemic toxicities. 24 Therapeutic drug monitoring (TDM) is thus advisable for patients with extreme BMI values. Yu et al. highlighted the link between poor nutrition and impaired hematopoiesis, reinforcing the role of BMI in drug efficacy and prognosis. 11 , 28 Malnutrition impairs bone marrow regeneration and alters inflammatory profiles, contributing to suboptimal therapy response. Age ranged from 18 to 80 years (mean: 42.3), younger than typical Western cohorts. Younger patients have more regenerative hematopoietic capacity and fewer comorbidities. 12 Although Jabbour and Kantarjian identified age 0.05). 2 After 3 months of TKI therapy, both imatinib and nilotinib led to significant clinical responses. While 60% of nilotinib-treated patients achieved complete response (CR) versus 32.1% in the imatinib group, the difference was not statistically significant (p = 0.078). Imatinib, a first-generation TKI, effectively induces CHR and major molecular response (MMR), particularly in chronic-phase CML. 19 Nilotinib, a second-generation TKI, binds BCR-ABL1 with 20–30 times greater affinity and achieves faster, deeper responses. 29 Despite a shorter half-life, its higher plasma exposure and greater selectivity enhance its pharmacodynamic effects. 30 , 31 Nilotinib also promotes early molecular response (EMR) at 3 months (BCR-ABL1 ≤10%), which is associated with improved long-term progression-free and overall survival, as well as greater potential for treatment-free remission (TFR). 19 , 31 However, the lack of statistical significance in this study may be due to sample size limitations (n = 43), demographic variability, and comorbidities. Similar findings were reported by Belohlavkova et al., where short-term hematologic and molecular responses did not differ significantly between imatinib and nilotinib in newly diagnosed CML patients, despite a trend favoring nilotinib. 21 Long-term use of nilotinib is associated with metabolic side effects, including hyperglycemia and cardiovascular risks. 32 Thus, treatment selection should consider not only efficacy but also comorbidities. Imatinib may be preferable for patients with cardiovascular risk factors, given its safer long-term profile. Overall, this study supports a personalized approach in CML management. Drug selection should account for cardiovascular risk, metabolic status, age, BMI, and therapeutic goals. 33 Moreover, achieving CR at 3 months is only an early milestone—regular molecular monitoring through month 12 is essential, as recommended by ELN and NCCN. 19 , 33 This study has several notable strengths. It provides real-world evidence on the early hematologic response to TKI therapy in Indonesian patients with CML, a population that is often underrepresented in large-scale clinical trials. The comparative analysis of first-generation (imatinib) and second-generation (nilotinib) TKIs offers clinically relevant insights, particularly in resource-limited settings where drug accessibility and cost are major concerns. Furthermore, the study tracked detailed hematological parameters over a three-month period, allowing for a comprehensive evaluation of treatment dynamics. Importantly, the investigation into anthropometric factors such as body weight and BMI as predictors of hematologic response adds a valuable perspective for individualized treatment approaches. However, the study also has several limitations. The relatively small sample size (n = 43) may limit the statistical power to detect significant differences between treatment groups, particularly in categorical response rates. As a single-center, retrospective analysis, there is also a risk of selection bias and limited generalizability to other populations or healthcare systems. The absence of molecular response data, such as BCR–ABL1 transcript levels, prevents evaluation of deeper responses beyond hematologic remission. In addition, the follow-up period was limited to three months, which restricts conclusions about long-term outcomes, including progression-free survival, overall survival, and treatment-free remission. Lastly, potential confounding variables such as comorbid conditions, treatment adherence, nutritional status, and TKI plasma concentrations were not controlled for and may have influenced the observed responses. Conclusions In conclusion, both imatinib and nilotinib demonstrated significant improvements in hematological parameters within the first three months of therapy in patients with chronic myeloid leukemia. Although nilotinib showed a higher proportion of complete hematologic responses compared to imatinib, the difference was not statistically significant, indicating that both agents were comparably effective in the short term. The study highlights the potential influence of individual factors such as body weight and BMI on treatment response, reinforcing the importance of a personalized approach in CML management. These findings emphasize the need for larger, prospective studies with longer follow-up durations and molecular response assessments to better guide treatment decisions and optimize outcomes in diverse and resource-constrained settings. Ethical considerations Ethical approval was obtained from the Biomedical Ethics Committee on Human Research, Faculty of Medicine, Hasanuddin University, with clearance number 59/UN 4.6.4.5.31/PP36/2025. Patient confidentiality was maintained by omitting personal identifiers from all research documentation. Informed consent was not required for this study, as no direct contact was made with participants where data derived from patient medical records. The study was conducted at the Hematology Medical Oncology Outpatient Clinic of Wahidin Sudirohusodo Hospital, spanning from January to December 2024. Data management and statistical analysis were performed at the Department of Public Health, Faculty of Medicine, Hasanuddin University. Data availability Underlying data FigShare: A COMPARISON BETWEEN TREATMENT RESPONSE OF CHRONIC MYELOID LEUKEMIA PATIENTS RECEVING IMATINIB OR NILOTINIB. https://doi.org/10.6084/m9.figshare.29814944.v4 (Gosal D., 2025). 34 This project contains the following underlying data: • Data file 1. Master_Data.sav • Data file 2. STROBE Statement.pdf Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). 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PubMed Abstract | Publisher Full Text | Free Full Text 27. Kawaguchi T, Hamada A, Hirayama C, et al. : Relationship between an effective dose of imatinib, body surface area, and trough drug levels in patients with chronic myeloid leukemia. Leukemia. 2009; 89 (3): 642–648. PubMed Abstract | Publisher Full Text 28. Yu X, Zhao J, Xu J, et al. : Association of Dietary Profiles and Nutritional Status Among Patients with Hematologic Diseases: A Prospective Cohort Study. Blood. 2024 Nov 5; 144 (Supplement 1): 7905. Publisher Full Text 29. Kantarjian HM, Shah NP, Hochhaus A, et al. : Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N. Engl. J. Med. 2010; 362 (24): 2260–2270. Publisher Full Text 30. Hochhaus A, Saglio G, Hughes TP, et al. : Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016 May 1; 30 (5): 1044–1054. PubMed Abstract | Publisher Full Text | Free Full Text 31. Zhang BS, Chen YP, Lv JL, et al. : Comparison of the efficacy of nilotinib and imatinib in the treatment of chronic myeloid leukemia. J. coll. physician surg. Pak. 2019 Jul; 29 (7): 631–634. PubMed Abstract | Publisher Full Text 32. Mauro MJ, Deininger MW: Management of drug toxicities in chronic myeloid leukemia. Hematology Am. Soc. Hematol. Educ. Program. 2019; 22 (1): 409–429. Publisher Full Text 33. Eşkazan AE, Kok CH, Yeung D, et al. : Editorial: Advances in the treatment of chronic myeloid leukemia. Front. Oncol. 2023; 13 : 1166588. PubMed Abstract | Publisher Full Text | Free Full Text 34. Gosal D: A COMPARISON BETWEEN TREATMENT RESPONSE OF CHRONIC MYELOID LEUKEMIA PATIENTS RECEVING IMATINIB OR NILOTINIB. [Dataset]. Figshare. 2025. Publisher Full Text Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 01 Sep 2025 ADD YOUR COMMENT Comment Author details Author details 1 Department of Internal Medicine, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, 90245, Indonesia 2 Department of Public Health, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, 90245, Indonesia Darren Gosal Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Andi Fachruddin Benyamin Roles: Conceptualization, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Andi Makbul Aman Roles: Conceptualization, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Syakib Bakri Roles: Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Haerani Rasyid Roles: Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Andi Alfian Zainuddin Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Software, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (2) version 2 Revised Published: 31 Dec 2025, 14:845 https://doi.org/10.12688/f1000research.168812.2 version 1 Published: 01 Sep 2025, 14:845 https://doi.org/10.12688/f1000research.168812.1 Copyright © 2025 Gosal D et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Gosal D, Benyamin AF, Aman AM et al. A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.12688/f1000research.168812.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 01 Sep 2025 Views 0 Cite How to cite this report: Nesr G. Reviewer Report For: A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.5256/f1000research.186027.r419676 ) The direct URL for this report is: https://f1000research.com/articles/14-845/v1#referee-response-419676 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 25 Oct 2025 George Nesr , Imperial College London, London, England, UK Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.186027.r419676 In this manuscript, Gosal et al attempt to compare the efficacy of the first generation TKI imatinib with the second generation TKI nilotinib. The authors base their argument solely on the haematological parameters. All the available literature is based ... Continue reading READ ALL In this manuscript, Gosal et al attempt to compare the efficacy of the first generation TKI imatinib with the second generation TKI nilotinib. The authors base their argument solely on the haematological parameters. All the available literature is based on the molecular responses to both TKIs, rather the haematological parameters. It is therefore not possible for any plausible conclusions to be made from the current manuscript; and essentially none that can be applied to the current clinical praxtice. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? I cannot comment. A qualified statistician is required. Are all the source data underlying the results available to ensure full reproducibility? No source data required Are the conclusions drawn adequately supported by the results? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: CML I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Nesr G. Reviewer Report For: A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.5256/f1000research.186027.r419676 ) The direct URL for this report is: https://f1000research.com/articles/14-845/v1#referee-response-419676 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 07 Jan 2026 Darren Gosal , Department of Internal Medicine, Faculty of Medicine, Hasanuddin University, Makassar, 90245, Indonesia 07 Jan 2026 Author Response We thank the reviewer for this critical correction. We have added literatures specifically regarding haematological responses, albeit limited to non-comparison studies but we have tried to correlate to the current ... Continue reading We thank the reviewer for this critical correction. We have added literatures specifically regarding haematological responses, albeit limited to non-comparison studies but we have tried to correlate to the current findings to further engage in a more feasible applicative outcome. We thank the reviewer for this critical correction. We have added literatures specifically regarding haematological responses, albeit limited to non-comparison studies but we have tried to correlate to the current findings to further engage in a more feasible applicative outcome. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 07 Jan 2026 Darren Gosal , Department of Internal Medicine, Faculty of Medicine, Hasanuddin University, Makassar, 90245, Indonesia 07 Jan 2026 Author Response We thank the reviewer for this critical correction. We have added literatures specifically regarding haematological responses, albeit limited to non-comparison studies but we have tried to correlate to the current ... Continue reading We thank the reviewer for this critical correction. We have added literatures specifically regarding haematological responses, albeit limited to non-comparison studies but we have tried to correlate to the current findings to further engage in a more feasible applicative outcome. We thank the reviewer for this critical correction. We have added literatures specifically regarding haematological responses, albeit limited to non-comparison studies but we have tried to correlate to the current findings to further engage in a more feasible applicative outcome. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Ozmen D. Reviewer Report For: A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.5256/f1000research.186027.r415834 ) The direct URL for this report is: https://f1000research.com/articles/14-845/v1#referee-response-415834 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 06 Oct 2025 Deniz Ozmen , Istanbul University Cerrahpaşa, Istanbul, Turkey Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.186027.r415834 In all of the tables and figures, units of the parameters are missing. This is a paper showing the head to head effectiveness of the two TKIs. The relation of low BMI and drug toxicity is mentioned. And this ... Continue reading READ ALL In all of the tables and figures, units of the parameters are missing. This is a paper showing the head to head effectiveness of the two TKIs. The relation of low BMI and drug toxicity is mentioned. And this nearly equal effectiveness has a more significant meaning in regions where drug prices is a major concern. Nilotinib may be a second line option in higher BMI patients, because of cardiovascular toxicity risks. This can be added to discussion part. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Hematology, all MPNs including CML, histiocytoses, CLL, benign hematology, MDS I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Ozmen D. Reviewer Report For: A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.5256/f1000research.186027.r415834 ) The direct URL for this report is: https://f1000research.com/articles/14-845/v1#referee-response-415834 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 07 Jan 2026 Darren Gosal , Department of Internal Medicine, Faculty of Medicine, Hasanuddin University, Makassar, 90245, Indonesia 07 Jan 2026 Author Response We thank you for the cautious comment, and have added the units accordingly, also we have added the discussion regarding cost-effectiveness and possible drug reaction in the discussion. Competing Interests: No competing interests were disclosed. We thank you for the cautious comment, and have added the units accordingly, also we have added the discussion regarding cost-effectiveness and possible drug reaction in the discussion. We thank you for the cautious comment, and have added the units accordingly, also we have added the discussion regarding cost-effectiveness and possible drug reaction in the discussion. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 07 Jan 2026 Darren Gosal , Department of Internal Medicine, Faculty of Medicine, Hasanuddin University, Makassar, 90245, Indonesia 07 Jan 2026 Author Response We thank you for the cautious comment, and have added the units accordingly, also we have added the discussion regarding cost-effectiveness and possible drug reaction in the discussion. Competing Interests: No competing interests were disclosed. We thank you for the cautious comment, and have added the units accordingly, also we have added the discussion regarding cost-effectiveness and possible drug reaction in the discussion. We thank you for the cautious comment, and have added the units accordingly, also we have added the discussion regarding cost-effectiveness and possible drug reaction in the discussion. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 01 Sep 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 Version 2 (revision) 31 Dec 25 read read Version 1 01 Sep 25 read read Deniz Ozmen , Istanbul University Cerrahpaşa, Istanbul, Turkey George Nesr , Imperial College London, London, UK Ikhwan Rinaldi , Universitas Indonesia, Jakarta, Indonesia Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Rinaldi I. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 27 Feb 2026 | for Version 2 Ikhwan Rinaldi , Cipto Mangunkusumo Hospital, Central Jakarta, Universitas Indonesia, Jakarta, Indonesia 0 Views copyright © 2026 Rinaldi I. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The study addresses early hematologic response to imatinib and nilotinib in CML within an Indonesian real-world setting. The focus on local data from Indonesia is commendable. However, several issues should be addressed to strengthen the manuscript. Abstract The objective may should be more specific and clearly state that the study was conducted in Indonesia. The Results section, if possible, should provide clearer quantitative comparisons between groups. For example, confidence intervals should be reported alongside p-values, particularly for the 60% versus 32.1% complete response rates. Methods The retrospective cohort design is appropriate for real-world evaluation. However, the manuscript does not clearly describe how treatment allocation (imatinib vs. nilotinib) was determined. Since the study was not randomized, potential selection bias and confounding by indication should be explicitly discussed. The authors should clarify whether a sample size or power calculation was performed and whether the study was adequately powered to detect differences between treatment groups, as the sample size (n = 43) is relatively small, particularly for multivariate analyses such as MANOVA and GLM with multiple covariates. The authors should also provide a clear rationale for selecting three months as the primary time point for analysis. Statistical Analysis It should be clearly specified whether the Shapiro–Wilk test or the Kolmogorov–Smirnov test was used to assess normality. Results Baseline comparability between the imatinib and nilotinib groups is not sufficiently detailed. The manuscript should clarify whether there were significant baseline differences in leukocyte counts, disease phase, or risk scores. Without this information, interpretation of comparative outcomes is limited. Discussion Given that nilotinib is more expensive and less accessible in Indonesia, a more structured discussion of cost-effectiveness or health-system implications would strengthen the manuscript’s regional relevance. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Hemato-oncology I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Rinaldi I. Peer Review Report For: A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.5256/f1000research.193981.r454875) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-845/v2#referee-response-454875 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Ozmen D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 07 Jan 2026 | for Version 2 Deniz Ozmen , Istanbul University Cerrahpaşa, Istanbul, Turkey 0 Views copyright © 2026 Ozmen D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The suggested revisions have been implemented; thank you. However, routine genetic analyses are still not available in many centers worldwide. Therefore, an analysis based solely on complete blood count parameters is acceptable in its current form. Competing Interests No competing interests were disclosed. Reviewer Expertise Hematology, all MPNs including CML, histiocytoses, CLL, benign hematology, MDS I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Ozmen D. Peer Review Report For: A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.5256/f1000research.193981.r446490) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-845/v2#referee-response-446490 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Nesr G. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 25 Oct 2025 | for Version 1 George Nesr , Imperial College London, London, England, UK 0 Views copyright © 2025 Nesr G. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions In this manuscript, Gosal et al attempt to compare the efficacy of the first generation TKI imatinib with the second generation TKI nilotinib. The authors base their argument solely on the haematological parameters. All the available literature is based on the molecular responses to both TKIs, rather the haematological parameters. It is therefore not possible for any plausible conclusions to be made from the current manuscript; and essentially none that can be applied to the current clinical praxtice. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? I cannot comment. A qualified statistician is required. Are all the source data underlying the results available to ensure full reproducibility? No source data required Are the conclusions drawn adequately supported by the results? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise CML I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (1) Author Response 07 Jan 2026 Darren Gosal, Department of Internal Medicine, Faculty of Medicine, Hasanuddin University, Makassar, 90245, Indonesia We thank the reviewer for this critical correction. We have added literatures specifically regarding haematological responses, albeit limited to non-comparison studies but we have tried to correlate to the current findings to further engage in a more feasible applicative outcome. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Nesr G. Peer Review Report For: A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.5256/f1000research.186027.r419676) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-845/v1#referee-response-419676 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Ozmen D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 06 Oct 2025 | for Version 1 Deniz Ozmen , Istanbul University Cerrahpaşa, Istanbul, Turkey 0 Views copyright © 2025 Ozmen D. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions In all of the tables and figures, units of the parameters are missing. This is a paper showing the head to head effectiveness of the two TKIs. The relation of low BMI and drug toxicity is mentioned. And this nearly equal effectiveness has a more significant meaning in regions where drug prices is a major concern. Nilotinib may be a second line option in higher BMI patients, because of cardiovascular toxicity risks. This can be added to discussion part. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Yes Are all the source data underlying the results available to ensure full reproducibility? Partly Are the conclusions drawn adequately supported by the results? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Hematology, all MPNs including CML, histiocytoses, CLL, benign hematology, MDS I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 07 Jan 2026 Darren Gosal, Department of Internal Medicine, Faculty of Medicine, Hasanuddin University, Makassar, 90245, Indonesia We thank you for the cautious comment, and have added the units accordingly, also we have added the discussion regarding cost-effectiveness and possible drug reaction in the discussion. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Ozmen D. Peer Review Report For: A Comparison Between Treatment Response of Chronic Myeloid Leukemia Patients Receving Imatinib or Nilotinib [version 1; peer review: 1 approved with reservations, 1 not approved] . F1000Research 2025, 14 :845 ( https://doi.org/10.5256/f1000research.186027.r415834) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-845/v1#referee-response-415834 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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