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通过在经EUTOS认证的实验室中评估国际范围内的实际分子反应,识别接受伊马替尼治疗且可能符合停药条件的慢性髓性白血病患者。

Identification of chronic myeloid leukemia patients treated with imatinib who are potentially eligible for treatment discontinuation by assessing real-life molecular responses on the international scale in a EUTOS-certified lab.

作者信息

Heinrichs Amélie, Dessars Barbara, El Housni Hakim, Pluymers Wim, Peeters Karen, Benghiat Fleur S, Heimann Pierre

机构信息

Erasme Hospital, Université Libre de Bruxelles, Route de Lennik 808, B-1070 Brussels, Belgium.

Novartis Pharma SA/NV, Medialaan 40, B-1800, Vilvoorde, Belgium.

出版信息

Leuk Res. 2018 Apr;67:27-31. doi: 10.1016/j.leukres.2018.01.018. Epub 2018 Feb 2.

Abstract

A retrospective study was performed to describe molecular responses (MR) on the international scale (IS) in patients with chronic myeloid leukemia (CML) treated with imatinib in routine clinical practice in Belgium and to identify patients potentially eligible for treatment discontinuation. The analysis included 116 patients with CML in chronic phase at treatment centers sending blood samples for molecular follow-up to a single EUTOS-certified laboratory. IS MR from the last patient visit between October 2014 and April 2015 were retrospectively collected. Most patients (93.1%) had an IS MR corresponding to an optimal response per European LeukemiaNet 2013 guidelines; 53.4% (62/116) of patients were in deep molecular responses ≥MR at their last visit (mean treatment duration: 91.0 months) among whom 36.2% (42/116) had been receiving imatinib for >5.8 years and 26.7% (31/116) for >8 years (margins of error: 8.74% and 8.05%, respectively). These patients would likely have the highest chance of staying in treatment-free remission (TFR) upon discontinuation, based on published TFR trial data. Although our study only provides a snapshot in time of a patient's last MR reported, without precise information regarding MR duration, the study settings could nevertheless support the feasibility of attempting TFR outside clinical trials in the future.

摘要

开展了一项回顾性研究,以描述在比利时常规临床实践中接受伊马替尼治疗的慢性髓性白血病(CML)患者的国际标准(IS)分子反应(MR),并确定可能符合治疗中断条件的患者。分析纳入了116例处于慢性期的CML患者,这些患者来自向一家获得EUTOS认证的单一实验室送检血液样本进行分子随访的治疗中心。回顾性收集了2014年10月至2015年4月期间最后一次患者访视时的IS MR。大多数患者(93.1%)的IS MR符合欧洲白血病网2013年指南中的最佳反应;53.4%(62/116)的患者在最后一次访视时处于深度分子反应≥MR(平均治疗持续时间:91.0个月),其中36.2%(42/116)接受伊马替尼治疗>5.8年,26.7%(31/116)接受治疗>8年(误差幅度分别为8.74%和8.05%)。根据已发表的无治疗缓解(TFR)试验数据,这些患者在停药后保持TFR的机会可能最高。尽管我们的研究仅提供了患者最后报告的MR的一个时间点快照,没有关于MR持续时间的精确信息,但研究设置仍可支持未来在临床试验之外尝试TFR的可行性。

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