Objective: To analyze and compare therapy responses, outcomes, and incidence of severe hematologic adverse events of flumatinib and imatinib in patients newly diagnosed with chronic phase chronic myeloid leukemia (CML) . Methods: Data of patients with chronic phase CML diagnosed between January 2006 and November 2022 from 76 centers, aged ≥18 years, and received initial flumatinib or imatinib therapy within 6 months after diagnosis in China were retrospectively interrogated. Propensity score matching (PSM) analysis was performed to reduce the bias of the initial TKI selection, and the therapy responses and outcomes of patients receiving initial flumatinib or imatinib therapy were compared. Results: A total of 4 833 adult patients with CML receiving initial imatinib (n=4 380) or flumatinib (n=453) therapy were included in the study. In the imatinib cohort, the median follow-up time was 54 [interquartile range (IQR), 31-85] months, and the 7-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.2%, 88.4%, 78.3%, and 63.0%, respectively. The 7-year FFS, PFS, and OS rates were 71.8%, 93.0%, and 96.9%, respectively. With the median follow-up of 18 (IQR, 13-25) months in the flumatinib cohort, the 2-year cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) were 95.4%, 86.5%, 58.4%, and 46.6%, respectively. The 2-year FFS, PFS, and OS rates were 80.1%, 95.0%, and 99.5%, respectively. The PSM analysis indicated that patients receiving initial flumatinib therapy had significantly higher cumulative incidences of CCyR, MMR, MR(4), and MR(4.5) and higher probabilities of FFS than those receiving the initial imatinib therapy (all P<0.001), whereas the PFS (P=0.230) and OS (P=0.268) were comparable between the two cohorts. The incidence of severe hematologic adverse events (grade≥Ⅲ) was comparable in the two cohorts. Conclusion: Patients receiving initial flumatinib therapy had higher cumulative incidences of therapy responses and higher probability of FFS than those receiving initial imatinib therapy, whereas the incidence of severe hematologic adverse events was comparable between the two cohorts.
Adult ; Humans ; Adolescent ; Imatinib Mesylate/adverse effects* ; Incidence ; Antineoplastic Agents/adverse effects* ; Retrospective Studies ; Pyrimidines/adverse effects* ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy* ; Treatment Outcome ; Benzamides/adverse effects* ; Leukemia, Myeloid, Chronic-Phase/drug therapy* ; Aminopyridines/therapeutic use* ; Protein Kinase Inhibitors/therapeutic use*

Objective To analyze the HbA1c results of double heterozygotes of hemoglobin(Hb) NewYork and β-thalassemia detected by five different HbA1c detection systems,and compare the early-warning abilities of erroneous glycosylated hemoglobin results for Hb NewYork and β-thalassemia heterozygotes.Methods Peripheral blood samples from 40 patients without hemoglobinopathies with different range of HbA1c levels were collected to evaluate the consistency of the detected results.Variant Ⅱ system was used as the reference system which successfully completed NGSP Level Ⅰ laboratory certification.Variant Ⅱ Turbo 2.0 (V Ⅱ-T),Capillary 2 Flex Piercing(2FP),Primus Ultra2 (Ultra2)and Roche Modular PPI(PPI) 800 were used as the comparative systems.The HbA1 c in 2 sera from the patients with compand heterozygotes of Hb NewYork was detected by the above systems.Hemoglobin electrophoresis was performed.Gentypes of á-and β-globin genes were analyzed by GAP-PCR,hybridization and dideoxy chain termination method.Results The HbA1c values in non-hemoglobinophthy samples obtained using V Ⅱ-T 2.0,Ultra2,C2FP and PPI systems were well correlated with that of VⅡ system.The hemoglobin genotypes of the two cases of compand heterozygotes were aa/aa,βIVS-2-654/βNewYork and aa/aa,β41-42/βNewYork,respectively.The proportions of HbA were all 0 while the proportions of Hb NewYork were 93.5％ and 94.0％ respectively.The HbA1c results of the two cases detected were 4.3％ (23 mmol/mol)and 4.5％ (26 mmol/mol)by V Ⅱ,4.5 ％ (26 mmol/mol) and 4.6％ (27 mmol/mol) by VⅡ-T 2.0,no values and no values by C2FP,4.1％ (21 mmol/mol) and 4.3 ％ (23 mmol/mol) by Ultra2 and 4.2％ (22 mmol/mol) and 4.8 ％ (29 mmol/mol) by PPI systems,respectively.All the systems did not send warning for abnormal signs in profiles and results.Conclusion The five systems presented different early-warning ability for the double heterozygotes of Hb NewYork and β-thalassemia.The compand heterozygotes should theoretically not contain HbA1 c,but the systems V Ⅱ,V Ⅱ-T,Ultra2 and PPI showed detectable results of HbA1 c indicating all the four systems were not able to provide with early-warning.C2FP system did not report HbA1c result so it exhibited early-warning ability for the double heterozygote.