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二线尼洛替尼或达沙替尼治疗的慢性期-慢性髓性白血病患者的治疗模式和深度分子反应:一项多国家回顾性图表审查研究。

Treatment patterns and deep molecular response in chronic phase - chronic myeloid leukemia patients treated with second-line nilotinib or dasatinib: a multi-country retrospective chart review study.

机构信息

The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Analysis Group, Inc., Boston, MA, USA.

出版信息

Leuk Lymphoma. 2020 Jan;61(1):98-107. doi: 10.1080/10428194.2019.1644332. Epub 2019 Aug 13.

Abstract

Achievement of MR4.5 (BCR-ABL1 ≤ 0.0032% on international scale) is an important goal of tyrosine kinase inhibitor (TKI) treatment for patients with chronic myeloid leukemia (CML). This study describes treatment patterns by region and assesses time to achieve MR4.5 in patients with CML - chronic phase (CP) treated with second-line nilotinib or dasatinib in 10 countries. A multivariate Cox proportional hazards model was used to assess time to MR4.5 for nilotinib versus dasatinib. The model accounted for the competing-risk event of TKI resistance, included random effects for country clustering, and was adjusted for baseline covariates. The study included 280 patients treated with either nilotinib ( = 135 [48%]) or dasatinib ( = 145 [52%]) as second-line TKI with median treatment durations of 19.1 and 18.7 months, respectively. Nilotinib was observed to be better in achieving MR4.5 than dasatinib (adjusted hazard ratio = 1.37, 95% CI [1.11, 1.69]) suggesting second-line nilotinib may perform better in achieving MR4.5 than dasatinib.

摘要

达到国际标准的 MR4.5(BCR-ABL1 ≤ 0.0032%)是慢性髓性白血病(CML)患者接受酪氨酸激酶抑制剂(TKI)治疗的重要目标。本研究按地区描述了治疗模式,并评估了在 10 个国家接受二线尼洛替尼或达沙替尼治疗的 CML-慢性期(CP)患者达到 MR4.5 的时间。使用多变量 Cox 比例风险模型评估尼洛替尼与达沙替尼达到 MR4.5 的时间。该模型考虑了 TKI 耐药的竞争风险事件,包括国家聚类的随机效应,并针对基线协变量进行了调整。该研究纳入了 280 名接受尼洛替尼( = 135 [48%])或达沙替尼( = 145 [52%])作为二线 TKI 治疗的患者,中位治疗持续时间分别为 19.1 个月和 18.7 个月。与达沙替尼相比,尼洛替尼在达到 MR4.5 方面表现更好(调整后的危险比=1.37,95%CI [1.11, 1.69]),这表明二线尼洛替尼在达到 MR4.5 方面可能比达沙替尼表现更好。

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