Observation Of Imatinib And Nilotinib In The Treatment Of Chronic Myeloid Leukemia

Objective: To investigate the difference of efficacy and safety between imatinib and nilotinib in patients with chronic myeloid leukemia.Methods: A total of 150 patients treated with TKIs were enrolled in this study.The imatinib(IM)treatment group with 70 patients consisted of Group A(newly diagnosed)and Group B(diagnosed over 6 months).The nilotinib(NI)treatment group with 50 patients consisted of Group C(first-line treatment)and Group D(second-line treatment).The clinical data and follow-up results were analysed retrospectively.The data was analysis by SPSS 21.0,with P < 0.05 for the test of significance level.Results:1 Evaluation of efficacy: After treatment of 3 months,the rates of patients that achieved satisfactory effect(BCR-ABLIS≤10%)in Group A,Group B,Group C and Group D were 47.3%,6.7%,82.8% and 47.6% respectively.By6 months,the rates of patients that achieved satisfactory effect(BCR-ABLIS≤1%)in four groups were 47.3%,13.3%,72.4% and 47.6%.The rates of major molecular response(MMR)in IM and NI groups by 3 months were 5.7% and18.0%(P<0.05),in four groups were 7.3%,0%,27.6% and 4.8%.The rates of MMR at 6 months in IM and NI groups were 15.7% and 36.0%(P<0.05),in four groups were 21.8%,6.7%,48.3% and 19.0%.MMR rate for NI(67.3%)by 12 months was significantly higher than that for IM(24.6%)(P<0.01),in four groups were 29.6%,6.7%,85.7% and 42.8%.MMR rates at 18 months in IM and NI groups were 31.7% and 63.6%(P < 0.05),in four groups were38.8%,7.1%,78.9%,42.8%.MMR rates at 24 months in IM and NI groups were 38.1% and 69.7%(P<0.01),in four groups were 44.9%,14.3%,89.5%and 42.8%.3 patients progressed to accelerated or blast phase in imatinib treatment group,as many as that in nilotinib treatment group.2 Evaluation of safety: The rates of hematology adverse reactions in IM group and NI group were 18.6% and 20%,the rates of nonhematology adverse reactions were 35.7% and 30%.The rates of level Ⅲ-Ⅳ adverse reactions in two treatment groups were both 10%.Conclusion:1 The efficacy of imatinib in the treatment of newly diagnosed CML patients was better than that of patients who were diagnosed for more than 6months.The efficacy of imatinib in the treatment of low-risk patients was better than that of intermediate/high-risk patients.2 Nilotinib induced strikingly higher and faster major molecular response,with a statistically significant difference compared with imatinib.The efficacy of nilotinib in low-risk patients was similar with that in intermediate/high-risk patients.3 Nilotinib was confirmed to be effective for patients with imatinib-resistant or intolerant.The efficacy of nilotinib in the treatment of newly diagnosed CML patients was better than that of patients with imatinib failure.4 Imatinib and nilotinib both showed generally good safety,and the safety profiles of nilotinib and imatinib were similar.