Absetzkonzepte in der CML: Vertrauensvolle Arzt-Patienten-Beziehung als zentrale Voraussetzung

Stefanie Jilg
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Abstract

Background: Most patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) will relapse if treatment is withdrawn, but various trials have recently demonstrated that a significant proportion of patients who achieved a stable and deep molecular response (DMR) can stop therapy without relapsing. However, most information on treatment cessation was obtained from clinical trials with strict recruiting criteria. Methods: We evaluated the outcome of 25 patients with CML that discontinued TKI therapy in our institute in real-world clinical practice. Results: Of the 25 patients, 76% discontinued therapy in sustained deep molecular response (SDMR) and 24% were in unsustained DMR (UDMR). Discontinuation of therapy due to adverse effects was observed in 5 and 50% of the patients in the SDMR and UDMR groups, respectively. After TKI discontinuation, patients were followed for a median of 24 months. At the time of this analysis, 56% patients had a molecular relapse after a median of 4 months. SDMR and longer treatment duration were associated with lower probability of molecular relapse: 25% in SDMR patients with TKI treatment > 96 months and 85% in UDMR patients with TKI treatment ≤96 months. All relapsed patients promptly resumed TKI therapy and regained at least major molecular response (MMR). Conclusions: Our results suggest that TKI discontinuation is safe outside clinical trials and particularly effective in CML patients who are in SDMR with longer TKI treatment duration.
cmi使用的核心概念是信任住院病人关系
背景:大多数接受酪氨酸激酶抑制剂(TKIs)治疗的慢性髓性白血病(CML)患者在停止治疗后会复发,但最近的各种试验表明,有相当一部分获得稳定和深度分子反应(DMR)的患者可以停止治疗而不会复发。然而,大多数关于停止治疗的信息是从具有严格招募标准的临床试验中获得的。方法:我们在现实世界的临床实践中评估了25例停止TKI治疗的CML患者的结果。结果:在25例患者中,76%的患者在持续深度分子反应(SDMR)中停止治疗,24%的患者在非持续深度分子反应(UDMR)中停止治疗。在SDMR组和UDMR组中,分别有5%和50%的患者因不良反应而停药。TKI停药后,患者随访时间中位数为24个月。在此分析时,56%的患者在中位4个月后出现分子复发。SDMR和较长的治疗时间与较低的分子复发概率相关:25%的SDMR患者TKI治疗> 96个月,85%的UDMR患者TKI治疗≤96个月。所有复发患者均迅速恢复TKI治疗,并至少恢复主要分子反应(MMR)。结论:我们的研究结果表明,在临床试验之外,TKI停药是安全的,对TKI治疗时间较长的SDMR CML患者尤其有效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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