Study On The Efficacy And Safety Of The Conversion Of Original Imatinib To Domestic Imatinib Capsules In The Treatment Of Patients With Chronic Myeloid Leukemia In The Chronic Phase

Objective:To evaluate the efficacy and safety of switching from original imatinib to domestic imatinib capsules for the treatment of patients with chronic myeloid leukemia in the chronic phase（CML-CP）,and patient acceptance of switching to domestic drug therapy.Method:A total of 52 patients with chronic phase of chronic myeloid leukemia who attended the outpatient clinic of the Department of Hematology of a hospital in Anhui Province from February 2020 to October 2020 and were treated with standard doses of the original imatinib drug within 6 months of initial diagnosis,took the drug regularly and uninterruptedly for at least 12 months,did not receive other TKI drugs during treatment and obtained at least a major molecular response（MMR）.Regular outpatient monitoring of international standardized BCR-ABL(BCR-ABL^IS),blood routine,liver and kidney function,and electrocardiogram every 3 months after switching to domestic imatinib capsule therapy,regular monitoring of adverse reactions,and follow-up of patients’acceptance of switching therapy.To compare the molecular response and incidence of adverse reactions and patient acceptance in patients before switching treatment and at months 3,6,9 and 12 after switching domestic imatinib capsule treatment.According to the guidelines,molecular reactions are divided into main molecular reactions（MMR）,molecular reactions 4（MR4）,molecular reactions 4.5（MR4.5）,molecular reactions 5（MR5）,and molecular undetectable（UMRD）.Results:All patients were followed up for a median of 8（3-12）months,with no statistically significant differences in molecular response at each follow-up time point after conversion of the original imatinib to domestic imatinib capsules.Molecular response was maintained in 82.7%,improved in 9.6%,and decreased in 7.7%of 52patients at 3 months,maintained in 80.0%,improved in 14.3%,and decreased in 5.7%of 35 patients at 6 months of conversion therapy,maintained in 87.0%,improved in8.7%,and decreased in 4.3%of 23 patients at 9 months of conversion therapy,and at 12months of conversion therapy The molecular response was maintained in 80.0%and decreased in 20.0%of 5 patients.The molecular response decreased in some patients compared with the previous one,and one patient was not monitored for molecular response at MMR during follow-up;the remaining all patients did not lose MMR.In terms of drug safety,the adverse reactions of the original imatinib and domestic imatinib capsules were similar,and were self-limiting or significantly improved with additional drug therapy.Among them,the hematological adverse reactions were mostly grade 1 to 2 adverse reactions,and grade 3 to 4 adverse reactions were rare,there were 5cases of new or aggravated hematological adverse reactions,the incidence of adverse hematological reactions in 10 patients was less than before,and there was no statistical difference in the incidence of adverse reactions in patients at each follow-up time point compared to before switching treatment.Non-hematologic adverse reactions were mainly elevated total bilirubin,elevated liver enzymes,elevated creatinine,edema,nausea,diarrhea,rash,muscle pain,muscle cramps,and fatigue,mostly grade 1 to 2adverse reactions,of which the incidence of nausea decreased after conversion therapy and was statistically different at 9 months compared to before conversion therapy（P=0.044）,with some patients experiencing new or worsening non-hematologic adverse reactions,but they were not statistically significant compared with the pre-conversion period.At the time of switching treatment,more than half of the patients had concerns about the efficacy and adverse effects of the domestic drug,and were neutral or resistant.After switching treatment,94%of patients received domestic imatinib capsule treatment.Conclusion:In CML-CP patients,second-line treatment with original imatinib converted to domestic imatinib capsules had good efficacy,with significant relief of nausea after conversion therapy and comparable residual adverse effects,and most patients were acceptable to conversion therapy after domestic imatinib treatment and benefited in terms of drug treatment cost and drug purchase mode.