The clinical analysis of frontline nilotinib vs imatinib therapies for newly diagnosed chronic myeloid leukemia in chronic phase / 中华内科杂志

ABSTRACT

Objective To compare the clinical efficacy and safety of nilotinib and imatinib as frontline therapy in newly diagnosed patients with chronic myeloid leukemia in chronic phase ( CML-CP ) . Methods Until December 31st 2016, 18 patients using nilotinib and 83 using imatinib were recruited in our study.The efficacy and safety of two groups were evaluated .Results A total of 101 patients with CML-CP included 18 receiving nilotinib and 83 imatinib.The optimal response rates at 3, 6, 12 and 18 months in nilotinib and imatinib group were 88.9%(16/18) vs 57.3%(47/82) (P=0.012), 82.4%(14/17) vs 55.7%(44/79) (P=0.041), 9/12 vs 63.9% (39/61) (P=0.460), 6/9 vs 68.9% (31/45) (P=0.896) respectively.The optimal response rates by 3 months in low sokal risk group on nilotinib and imatinib were 9/9 vs 76.5%(26/34) (P=0.107), in intermediate and high sokal risk group were 7/8 vs 45.2%(14/31) (P=0.032).At the end of follow-up, the rate of major molecular response (MMR) in nilotinib group was 72.2%, which was higher than 56.6% in imatinib group (P=0.021).The rate of complete cytogenetic response ( CCyR ) in nilotinib group was 100%, which was higher than 71.1% in imatinib group (P =0.002).Progression free survival (PFS) rates in nilotinib and imatinib groups were 94.4%and 98.8%(P=0.019) respectively; whereas event free survival (EFS) rates were 88.9% and 48.2%(P=0.045).The incidence of drug related adverse reactions in nilotinib and imatinib was similar with only minor proportion of grade 3/4 adverse reactions .Conclusions Nilotinib achieves a deeper molecular response in a shorter time than imatinib in newly diagnosed patients with CML-CP, especially in patients with high risk outcome .Good safety is obtained in both groups so as to ensure a long-term administration and improving prognosis .