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真实世界数据评估一线阿来替尼治疗晚期 ALK 阳性非小细胞肺癌患者的疗效和安全性:土耳其肿瘤学会研究。

Real-world data on efficacy and safety of first-line alectinib treatment in advanced-stage, ALK-positive non-small-cell lung cancer patients: a Turkish Oncology Group study.

机构信息

Department of Medical Oncology, Ankara City Hospital, Ankara, Turkey.

Atatürk Chest Disease & Chest Surgery Education & Research Hospital, Department of Medical Oncology, Ankara, Turkey.

出版信息

Future Oncol. 2022 Jul;18(23):2573-2582. doi: 10.2217/fon-2022-0083. Epub 2022 Jun 23.

Abstract

In this multicenter study, the authors aimed to determine the real-life efficacy and safety of first-line alectinib. This retrospective trial included advanced-stage, ALK-positive non-small-cell lung cancer patients who were treated with first-line alectinib in terms of ALK-tyrosine kinase inhibitors, regardless of previous chemotherapy. The co-primary end points were progression-free survival both for all patients and for the treatment-naive population. The secondary end points were overall response rate, overall survival, rate of CNS progression and safety. A total of 274 patients (n = 177 for treatment-naive patients) were enrolled in the study. The median progression-free survival was 26 and 28.8 months for all patients and the treatment-naive group, respectively. The overall response rate, CNS progression rate and 1-year overall survival ratio were 77.9, 12.4 and 77%. Alectinib is a highly effective therapy with a favorable safety profile.

摘要

在这项多中心研究中,作者旨在确定一线艾乐替尼的真实疗效和安全性。这项回顾性试验纳入了接受一线艾乐替尼治疗的晚期、ALK 阳性非小细胞肺癌患者,无论其之前是否接受过化疗,均可应用 ALK 酪氨酸激酶抑制剂。主要终点是所有患者和初治人群的无进展生存期。次要终点为总缓解率、总生存期、中枢神经系统进展率和安全性。共有 274 名患者(n=177 名为初治患者)入组该研究。所有患者和初治组的中位无进展生存期分别为 26 个月和 28.8 个月。总缓解率、中枢神经系统进展率和 1 年总生存率分别为 77.9%、12.4%和 77%。艾乐替尼是一种具有良好疗效和安全性的高效治疗药物。

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