Clinical Follow Up Of Patients Receiving Tyrosine Kinase Inhibitors For The Treatment Of Chronic Myelogenous Leukemia

The background and objective: Before 2001,interferon,hydroxyurea and other treatment methods were used to control CML,but the prognosis was poor,and mostly in sick entered the accelerated phase after four years,and eventually stepped into blastic phase leading to death,only hematopoietic stem cell transplantation by allogeneic obtained a long survival.As research on the disease, targeted therapies- tyrosine kinase inhibitor(TKI) was developed based on the pathogenesis of CML in 2001.The long-term follow-up studies of domestic and international multi-center clinical show TKI significantly improved overall survival and progression-free survival of CML patients. With the deepening of the pathogenesis and mechanisms of resistance research,clinicians paid even more attention to CML patients on first-line drug efficacy monitoring,adverse reactions and medication timing choice in terms of diagnosis and treatment of patients with CML,as TKI’s generation,second generation and third generation of products coming out.This study is a follow-up research on generation and second-generation TKI treatment for adults and children of CML,monitoring its efficacy and adverse reactions,to deepen the overall cognition of therapy for CML and provide thebasis for the treatment of patients with CML.Methods: This study included adult and child patients with a pathologic diagnosis of CML treated at the Department of Xijing Hospital,Xi’an,China,form March1,2006 to December 31,2014. 1.Relevant clinical and laboratory materials were viewed and analyed. 2.Monitoring and assessment were graded according to Guideline for the diagnosis and management in the disease monitoring of patients with chronic myeloid leukemia in China(2014)and NCCN guidelines(2014) 3.Adverse events due to imatinib were graded according to the Common Toxicity Criteria of the National Cancer Institute(NCI-CTC) version2.Results: 1.Follow-up of CML child patients receiving imatinib( n=6):The median age was 10.5 years(range,3-13),all of them are CML – CP.All patients had been treated by imatinib monotherapy at an initial dose of 260mg/m2.day.The number of patients who received molecular monitoring was 6,Median time to MMR was 12 months.Imatinib therapy was well tolerated.Most AEs wereⅠ-Ⅱ,but two of them were growth deceleration. 2.Follow-up of CML adult patients receiving imatinib(n=43):The cumulative rates of CCy R at 3,6 and 12 months of 32 patients in the initial treatment group were 9.4%,59.4%,65.6%.Median time to CCy R was 6 months.The cumulative rates of CCy R at 3,6 and 12 months of 32 patients in the re-treatment group were 0%,54.5%,81.8%.Median time to CCy R was 6 months.Until,December 31,2014,The number of all patients who received MMR was 27(62.8%).AEs included Ⅰ-Ⅱhematologic AEs(10),Ⅲ-Ⅳhematologic AEs(6),gastrointestinal reaction(8), puffiness(1),rash(1),elevations of total bilirubin(1).14% patients can’t tolerate treatment therapy of imatinib. 3. Follow-up of CML adults patients receiving nilotinib(n=24):8 patients achieved CCy R(88.9%) of 9 cases receiving nilotinib as first-line treatment, the median time achieved CCy R was 4.5 months.8 patients achieved MMR( 88.9%),the median timeachieved MMR was 10 months,and one case with CML-AP was dead.15 cases of CML patients treated with imatinib were drug-resistant or intolerant to switch to nilotinib as second-line therapy,and 12 patients achived CCy R(80%),the median time achieved CCy R was 6 months.8 patients achieved MMR(53.3%),the median time achieved MMR was 12 months. There were fewer side effects,mostly Ⅰ-Ⅱ grade,only one case of cardiovascular disease,three cases of high blood sugar.Conclusion: 1.Child patients receiving imatinib therapy acquired a good response and was well tolerated.We did not find the article about the AEs of chlidren’s growth development related to imatinib in China. 2.The cumulative rates of CCy R in the CML adult patients who receiving imatinib therapy was 72.1%,The cumulative rates of MMR was62.8%. Compared with the retreatment groups,the initial treatment group achieved molecular response deeper. 3.Compared with imatinib,nilotinib can achieve CCy R and MMR more faster.Patients with imatinib-resistant or –intolerant and the elderly patients receiving the reducing dose of nilotinib acquired a good response.