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在两项针对 ALK 阳性 NSCLC 的艾乐替尼的 II 期研究中,CNS 和非 CNS 进展的累积发生率。

Cumulative incidence rates for CNS and non-CNS progression in two phase II studies of alectinib in ALK-positive NSCLC.

机构信息

Department of Internal Medicine, Division of Hematology and Oncology, The University of Michigan, 1500 E. Medical Center Drive, 7217CC, Ann Arbor, MI 48109, USA.

Department of Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.

出版信息

Br J Cancer. 2018 Jan;118(1):38-42. doi: 10.1038/bjc.2017.395. Epub 2017 Nov 16.

DOI:10.1038/bjc.2017.395
PMID:29149104
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5765233/
Abstract

BACKGROUND

We evaluated the cumulative incidence rate (CIR) of central nervous system (CNS) and non-CNS progression in alectinib-treated patients with anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) to determine the extent to which alectinib may treat or control CNS disease.

METHODS

Patients with crizotinib-pretreated locally advanced or metastatic disease received alectinib 600 mg orally twice daily in two phase II trials. All patients underwent baseline imaging and regular centrally reviewed scans.

RESULTS

At 24 months, the CIR for CNS progression was lower in patients without vs with baseline CNS metastases (8.0 vs 43.9%). Patients with baseline CNS disease and prior radiotherapy had a higher CIR of CNS progression than radiotherapy-naive patients (50.5 vs 27.4%) and a lower CIR of non-CNS progression (25.8 vs 42.5%). Adverse events leading to withdrawal occurred in 5.9% and 6.7% of patients with and without baseline CNS metastases, respectively.

CONCLUSIONS

This analysis indicates a potential role for alectinib in controlling and preventing CNS metastases.

摘要

背景

我们评估了接受艾乐替尼治疗的间变性淋巴瘤激酶(ALK)阳性非小细胞肺癌(NSCLC)患者中枢神经系统(CNS)和非 CNS 进展的累积发生率(CIR),以确定艾乐替尼治疗或控制 CNS 疾病的程度。

方法

在两项 II 期临床试验中,接受过克唑替尼预处理的局部晚期或转移性疾病患者接受艾乐替尼 600mg 口服,每日两次。所有患者均进行基线影像学检查和定期中心审查扫描。

结果

24 个月时,无基线 CNS 转移患者的 CNS 进展 CIR 低于基线有 CNS 转移患者(8.0% vs 43.9%)。基线 CNS 疾病和放疗患者的 CNS 进展 CIR 高于未放疗患者(50.5% vs 27.4%),而非 CNS 进展 CIR 较低(25.8% vs 42.5%)。分别有 5.9%和 6.7%的基线无 CNS 转移和有 CNS 转移患者因不良事件而停药。

结论

这项分析表明艾乐替尼在控制和预防 CNS 转移方面具有潜在作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b0/5765233/772a6139db5b/bjc2017395f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b0/5765233/772a6139db5b/bjc2017395f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b0/5765233/772a6139db5b/bjc2017395f1.jpg

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Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer.阿来替尼对比克唑替尼用于未经治疗的 ALK 阳性非小细胞肺癌。
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Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial.阿来替尼对比克唑替尼用于治疗 ALK 阳性非小细胞肺癌患者(J-ALEX):一项开放标签、随机、III 期临床试验。
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