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阿来替尼在美国克唑替尼治疗进展后的间变性淋巴瘤激酶阳性非小细胞肺癌患者中的真实世界使用情况及临床疗效

Real-world usage and clinical outcomes of alectinib among post-crizotinib progression anaplastic lymphoma kinase positive non-small-cell lung cancer patients in the USA.

作者信息

DiBonaventura Marco D, Wong William, Shah-Manek Bijal, Schulz Mathias

机构信息

Ipsos Healthcare, Global Evidence, Value & Access, New York, NY.

Genentech, US Medical Affairs, San Francisco, CA.

出版信息

Onco Targets Ther. 2017 Dec 22;11:75-82. doi: 10.2147/OTT.S144960. eCollection 2018.

Abstract

BACKGROUND

Alectinib is an approved treatment for anaplastic lymphoma kinase (ALK)-positive patients with advanced non-small-cell lung cancer. Despite positive supporting clinical data, there is a lack of real-world information on the usage and patient outcomes of those treated with alectinib post-crizotinib progression.

METHODS

Participating oncologists (N=95) in the USA were recruited from an online physician panel to participate in a retrospective patient chart review. Physicians randomly selected eligible patients (ie, patients who progressed on crizotinib as their first ALK inhibitor and were treated with alectinib as their second ALK inhibitor), collected demographics and clinical history from their medical charts, and entered the data into an online data collection form.

RESULTS

A total of N=207 patient charts were included (age: 60.1±10.4 years; 53.6% male). The patients in our sample were older (median age of 60 vs 53 years), were more likely to be current smokers (12% vs 1%), had better performance status (45% vs 33% had an Eastern Cooperative Oncology Group [ECOG] of 0), and were less likely to have an adenocarcinoma histology (83% vs 96%) relative to published clinical trials. The objective response rate was higher than in clinical trials (67.1% vs 51.3%, respectively) as was the disease control rate (89.9% vs 78.8%, respectively), though it varied by race/ethnicity, ECOG, and prior treatment history. Discontinuation (0.0%) and dose reductions (3.4%) due to adverse events were uncommon in alectinib.

CONCLUSION

Patients using alectinib post-crizotinib in clinical practice are older, more racially/ethnically and histologically diverse than patients in published trials. Real-world response rates were high and similar to those reported in clinical studies, though there is some variation by patient characteristics. Alectinib was well tolerated in clinical practice as reflected by the rates of discontinuation, dose reductions, and dose interruptions.

摘要

背景

阿来替尼是一种已获批准用于治疗间变性淋巴瘤激酶(ALK)阳性晚期非小细胞肺癌患者的药物。尽管有积极的临床数据支持,但缺乏关于克唑替尼进展后接受阿来替尼治疗的患者的使用情况和患者预后的真实世界信息。

方法

从一个在线医生小组招募了美国的95名参与研究的肿瘤学家,参与一项回顾性患者病历审查。医生随机选择符合条件的患者(即作为首个ALK抑制剂使用克唑替尼后进展且作为第二个ALK抑制剂接受阿来替尼治疗的患者),从其病历中收集人口统计学和临床病史信息,并将数据录入在线数据收集表格。

结果

共纳入207份患者病历(年龄:60.1±10.4岁;53.6%为男性)。我们样本中的患者年龄更大(中位年龄60岁对53岁),更有可能是当前吸烟者(12%对1%),体能状态更好(45%对33%的东部肿瘤协作组[ECOG]评分为0),相对于已发表的临床试验,腺癌组织学类型的可能性更小(83%对96%)。客观缓解率高于临床试验(分别为67.1%对51.3%),疾病控制率也是如此(分别为89.9%对78.8%),不过因种族/民族、ECOG评分和既往治疗史而有所不同。因不良事件停药(0.0%)和减量(3.4%)在阿来替尼治疗中并不常见。

结论

在临床实践中,克唑替尼进展后使用阿来替尼的患者比已发表试验中的患者年龄更大,种族/民族和组织学类型更多样化。真实世界的缓解率很高,与临床研究报告的相似,不过因患者特征存在一些差异。从停药、减量和剂量中断率可以看出,阿来替尼在临床实践中耐受性良好。

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