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

一项在中国开展的前瞻性多中心研究,对新诊断的慢性期慢性粒细胞白血病患者使用尼洛替尼治疗后达到深度分子学缓解4.5(MR4.5)的患者进行了18个月的随访。

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Abstract

INTRODUCTION: 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. METHODS: We performed a multicenter study to explore the early cumulative MR(4.5) 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 DISCUSSION: The cumulative MR(4.5) rate of nilotinib treatment at 18 months was 69.8% (74/106). The cumulative MMR and MR(4.0) 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 MR(4.5).

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