Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 11 June 2023 / Approved: 13 June 2023 / Online: 13 June 2023 (12:52:05 CEST)

A peer-reviewed article of this Preprint also exists.

Wen, B.; Zhang, Y.; Lin, H.; Lou, J.; Tu, C.; Jiang, Y.; Liu, X.; Chen, Y.; He, H.; Liu, Z.; et al. 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. Frontiers in Medicine 2023, 10, doi:10.3389/fmed.2023.1267512. Wen, B.; Zhang, Y.; Lin, H.; Lou, J.; Tu, C.; Jiang, Y.; Liu, X.; Chen, Y.; He, H.; Liu, Z.; et al. 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. Frontiers in Medicine 2023, 10, doi:10.3389/fmed.2023.1267512.

Abstract

Early stable deep molecular response (DMR) of nilotinib is associated with goal of treatment-free remission (TFR) for patients with chronic-phase chronic myeloid leukemia (CML-CP). It is significant to early distinguish patients who can obtain DMR and fit for TFR. We performed a multicenter study to explore early cumulative MR4.5 rate by 18 months with nilotinib in patients with newly diagnosed CML-CP (ND-CML-CP) in China. From 29 institutes, 106 ND-CML-CP patients received nilotinib (300mg BID). The cumulative MR4.5 rate of nilotinib by 18 months was 69.8% (74/106). The cumulative MMR and MR4.0 rates of nilotinib by 18 months were 94.3% (100/106) and 84.9% (90/106), respectively. Patients with ultra-early molecular response (u-EMR) at 6 weeks were not significantly different to obtain DMR or MMR by 24 months compared to those without u-EMR (P=0.7584, P=0.9543, respectively). Our study demonstrated that treatment with nilotinib in patients with ND-CML-CP contributed to obtain high early MR4.5.

Keywords

18 months; deep molecular response; nilotinib; newly diagnosed; chronic-phase chronic myeloid leukemia

Subject

Medicine and Pharmacology, Clinical Medicine

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