Clinical Observation Of Nilotinib In Patients With Imatinib-resistant Or Intolerant Chronic Myeloid Leukemia

Objective:To observe the efficacy and adverse effects of nilotinib in imatinib-resistant or-intolerant chronic myeloid leukemia.Methods:Retrospective analysis of fifty-nine nilotinib in imatinib-resistant or-intolerant CML from the hematology department of Second Affiliated Hospital of Nanchang University and First Affiliated Hospital Hematology,January 1,2010 to October 1,2015.Through case inquiry, regular telephone follow-up and outpatient visits to learn the details of the condition,medication and clinical manifestations(symptoms and signs of change) of patients.Regular monitoring of blood,bone marrow cytology, Ph chromosome, BCR-ABL,liver and kidney function,electrocardiogram and so on.Rates of cytogenetic response and were calculate. Survival curves were done using the Kaplan-Meier method.Results:1. 59 patients with a median follow-up of 18(6-64) months, the median time for medication was 17(6-64) months.There are still 40(67.8%) patients continue nilotinib therapy.19(32.2%) patients discontinued nilotinib therapy,15 patients due to poor efficacy or intolerance change dasatinib treatment, 3 patients died, one case change IM treatment for economic reasons.2.Clinical effect observation(1).The whole group efficacy:31(52.5%) patients were CCy R,,20(33.9%)patients were MMR,17(28.8%) patients were CMR.(2).Patients who get early molecular response(EMR) with nilotinib in 3 months is better than without EMR, Bcr-abl/abl <1% in 12 month,81.3%,7.5% respectively,(P <0.001).(3).Patients who get early molecular response(EMR) with nilotinib in 3 months is better than without EMR, MMR in 12 month,75.0%,0 respectively,(P <0.001).(4).In 12 month, imatinib-resistant or-intolerant CCy R were 81.3%, 31.0%,imatinib-resistant or-intolerant Bcr-abl <1% were 47.4%, 32.4%, P was 0.001,0.04,the difference was statistically significant.3.Survival analysis(1).3-year PFS in chronic phase and accelerate was 80.0% and 35.7%9(P <0.001),3-year OS was 100% and 78.6%(P<0.001).(2)Chronic phase,3-year PFS in patients who reach EMR and without EMR was92.6% and 61.1%(P=0.02)4. The adverse reaction in nilotinib treatment was mild.Thrombocytopenia is the most hematologic adverse reactions.In advance,the hematologic adverse reactions happened more frequently. 3-4 non-hematologic adverse events was low.Conclusions:1.Nilotinib is effective in IM-resistant or intolerant CML-CP or AP patient an effective2.Patients with EMR in Bcr-abl/ abl<1%, MMR was significantly higher than those without EMR3.The efficacy of niluotinib in IM intolerant patients is better than resistant in niluotinib?4. CML-CP patients 3-year PFS, OS was significantly higher in patients with CML-AP; CML-CP patients, 3-year PFS in patients who reach EMR was significantly higher than without EMR5.Nilotinib can be tolerated...