AUTHOR=Wen Bingbing , Zhang Yuming , Lin Haiqing , Lou Jin , Tu Chuangqing , Jiang Yirong , Liu Xiaolian , Chen Yan , He Huiqing , Liu Zelin , Xie Xiaoling , Huang Wangxiang , Pang Liping , Du Xin 

TITLE=18 months follow-up of deep molecular response 4.5 (MR4.5) with nilotinib in patients with newly diagnosed chronic-phase chronic myeloid leukemia: a prospective, multi-center study in China

JOURNAL=Frontiers in Medicine

VOLUME=10

YEAR=2023

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1267512

DOI=10.3389/fmed.2023.1267512

ISSN=2296-858X

ABSTRACT=<sec id="sec1"><title>Introduction</title><p>Early stable deep molecular response (DMR) to nilotinib is associated with goal of treatment-free remission (TFR) in patients with chronic-phase chronic myeloid leukemia (CML-CP). It is important to early distinguish between patients who can achieve a DMR and those who are fit for TFR.</p></sec><sec id="sec2"><title>Methods</title><p>We performed a multicenter study to explore the early cumulative MR<sup>4.5</sup> rate at 18 months with nilotinib in patients with newly diagnosed CML-CP (ND-CML-CP) in China. Of the 29 institutes, 106 patients with ND-CML-CP received nilotinib (300 mg BID).</p></sec><sec id="sec3"><title>Results and discussion</title><p>The cumulative MR<sup>4.5</sup> rate of nilotinib treatment at 18 months was 69.8% (74/106). The cumulative MMR and MR<sup>4.0</sup> rates for nilotinib at 18 months were 94.3% (100/106) and 84.9% (90/106), respectively. Patients with an ultra-early molecular response (u-EMR) at 6 weeks were not significantly different in obtaining DMR or MMR by 24 months compared with those without u-EMR (<italic>p</italic> = 0.7584 and <italic>p</italic> = 0.9543, respectively). Our study demonstrated that nilotinib treatment in patients with ND-CML-CP contributed to obtain high early MR<sup>4.5</sup>.</p></sec>