Frontiers in Medicine (Nov 2023)

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

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

DOI
https://doi.org/10.3389/fmed.2023.1267512
Journal volume & issue
Vol. 10

Abstract

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IntroductionEarly 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.MethodsWe performed a multicenter study to explore the early cumulative MR4.5 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).Results and discussionThe cumulative MR4.5 rate of nilotinib treatment at 18 months was 69.8% (74/106). The cumulative MMR and MR4.0 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 (p = 0.7584 and p = 0.9543, respectively). Our study demonstrated that nilotinib treatment in patients with ND-CML-CP contributed to obtain high early MR4.5.

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