Department of Thoracic Oncology, National Cancer Center Hospital, 5 Chome-1-1 Tsukiji, Chūō City, Tokyo, 104-0045, Japan.
Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Wakayama Prefecture, 641-8509, Japan.
Adv Ther. 2020 Jul;37(7):3311-3323. doi: 10.1007/s12325-020-01392-0. Epub 2020 May 29.
INTRODUCTION: The anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) alectinib was approved in Japan in 2014 for the treatment of ALK fusion gene-positive advanced non-small cell lung cancer (NSCLC). With the approvals of crizotinib in 2012 and ceritinib in 2017, Japan became the first country with multiple ALK TKIs available for first-line or later use in patients with ALK-positive advanced NSCLC. Here, we collected and evaluated real-world data on ALK TKI clinical usage patterns and sequencing in patients with ALK-positive NSCLC in Japan. METHODS: This retrospective observational study used the Japanese Medical Data Vision database to analyze data from patients with a confirmed diagnosis of lung cancer who visited a healthcare facility in the database between April 2010 and March 2017, underwent an ALK test, received a prescription for an ALK TKI, and were at least 18 years old as of the date of the first ALK TKI prescription. There were no exclusion criteria. Descriptive analyses of demographics, baseline characteristics, ALK TKI treatment patterns and sequences, non-ALK TKI treatments received before, during, and after ALK TKI treatment, and treatment durations were reported. RESULTS: A total of 378 patients met the inclusion criteria and were evaluated in mutually exclusive groups of patients receiving one, two, or three ALK TKIs. The initial ALK TKI prescribed was crizotinib for 52.1% of patients and alectinib for 47.9% of patients; however, the proportion of patients receiving alectinib as the initial ALK TKI increased over time following the Japanese approval of alectinib in 2014. Of the 117 patients who received two or three ALK TKIs, 106 received crizotinib as the first ALK TKI and 11 received alectinib. Before the date of the patient's first ALK TKI prescription, 153 of 378 patients (40.5%) had received chemotherapy. Of 104 patients who discontinued ALK therapy, 46.2% received chemotherapy and 5.8% received immunotherapy as their next treatment. CONCLUSION: At the time of this analysis, most patients who received more than one ALK TKI received crizotinib as the initial ALK TKI. Additional ALK TKIs have since been approved in Japan as first-line or later therapeutic options for patients with ALK-positive NSCLC, but the optimal sequence of ALK TKI usage remains undetermined. As new data continue to emerge, additional research will be warranted to evaluate ALK TKI sequences that do not include crizotinib as the first therapy in this patient population.
简介:间变性淋巴瘤激酶(ALK)酪氨酸激酶抑制剂(TKI)阿来替尼于 2014 年在日本获批,用于治疗 ALK 融合基因阳性的晚期非小细胞肺癌(NSCLC)。随着克唑替尼于 2012 年和塞瑞替尼于 2017 年的获批,日本成为首个有多种 ALK TKI 可供 ALK 阳性晚期 NSCLC 患者一线或后线使用的国家。在这里,我们收集并评估了日本 ALK 阳性 NSCLC 患者接受 ALK TKI 临床应用模式和测序的真实世界数据。
方法:这项回顾性观察性研究使用了日本医疗数据视野数据库,分析了 2010 年 4 月至 2017 年 3 月期间在数据库中就诊的、确诊为肺癌且接受过 ALK 检测、处方了 ALK TKI 且在首次处方 ALK TKI 时至少 18 岁的患者数据。没有排除标准。报告了人口统计学、基线特征、ALK TKI 治疗模式和序列、ALK TKI 治疗前、治疗期间和治疗后接受的非 ALK TKI 治疗以及治疗持续时间的描述性分析。
结果:共有 378 名患者符合纳入标准,并在接受一种、两种或三种 ALK TKI 的患者的相互排斥组中进行了评估。最初处方的 ALK TKI 为克唑替尼的患者占 52.1%,阿来替尼的患者占 47.9%;然而,自 2014 年日本批准阿来替尼以来,接受阿来替尼作为初始 ALK TKI 的患者比例有所增加。在 117 名接受两种或三种 ALK TKI 的患者中,106 名患者接受了克唑替尼作为第一 ALK TKI,11 名患者接受了阿来替尼。在患者首次接受 ALK TKI 处方之前,378 名患者中有 153 名(40.5%)接受了化疗。在 104 名停止 ALK 治疗的患者中,46.2%接受了化疗,5.8%接受了免疫治疗作为下一步治疗。
结论:在本次分析时,大多数接受一种以上 ALK TKI 的患者接受了克唑替尼作为初始 ALK TKI。此后,日本又有其他 ALK TKI 获批作为 ALK 阳性 NSCLC 患者的一线或后线治疗选择,但 ALK TKI 应用的最佳顺序仍不确定。随着新数据的不断涌现,需要开展更多的研究来评估在该患者人群中不将克唑替尼作为一线治疗的 ALK TKI 治疗顺序。
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