Shimomura Yuki, Mizutani Megumi, Yoshida Hisako, Ihara Yasutaka, Shintani Ayumi
Department of Medical Statistics, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
Department of Respiratory Medicine, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan.
Target Oncol. 2025 Jan;20(1):171-180. doi: 10.1007/s11523-024-01116-2. Epub 2024 Nov 28.
Although anaplastic lymphoma kinase inhibitors (ALKis) are the effective initial treatment for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), most patients experience resistance to ALKis, leading to the need for alternative therapies. Immune checkpoint inhibitors (ICIs) are a standard NSCLC treatment. On the other hand, their efficacy remains unclear for ALK-positive NSCLC.
We aim to describe the treatment patterns and treatment outcomes for patients with ALK-positive NSCLC receiving later-line ICI treatment.
This retrospective cohort study used claims data from Japanese acute care hospitals and included patients with lung cancer (International Classification of Diseases, 10th version (ICD-10), code: C34) diagnosed between 1 December 2015 and 31 January 2023. We extracted patients who received ALKis as first-line therapy and subsequent lines of treatment. Patient characteristics and treatment patterns and durations were descriptively summarized. Time to treatment discontinuation (TTD) for ICIs was examined using Kaplan-Meier estimates.
Of 478 patients who received ALKi as first-line treatment, 30 received ICIs, 249 ALKis, and 154 non-ICI/ALKi therapy as second-line treatment. Most patient characteristics showed no differences among the groups. ICIs were more likely to be administered to patients who underwent shorter durations of ALKi treatment. The median TTD for ICIs was 66 days, with a 1 year TTD rate of 13%.
Given the rarity of ALK-positive NSCLC, this study contributes to add evidence through an expanded database and increased sample size, supporting previous suggestions that ICIs have limited effectiveness in patients positive for ALK.
尽管间变性淋巴瘤激酶抑制剂（ALKis）是间变性淋巴瘤激酶（ALK）阳性非小细胞肺癌（NSCLC）患者有效的初始治疗方法，但大多数患者会对ALKis产生耐药性，因此需要替代疗法。免疫检查点抑制剂（ICIs）是NSCLC的标准治疗方法。另一方面，其对ALK阳性NSCLC的疗效仍不明确。
我们旨在描述接受二线ICI治疗的ALK阳性NSCLC患者的治疗模式和治疗结果。
这项回顾性队列研究使用了日本急性护理医院的理赔数据，纳入了2015年12月1日至2023年1月31日期间诊断为肺癌（国际疾病分类第10版（ICD-10），编码：C34）的患者。我们提取了接受ALKis作为一线治疗及后续治疗线的患者。对患者特征、治疗模式和持续时间进行了描述性总结。使用Kaplan-Meier估计法检查ICI的治疗中断时间（TTD）。
在478例接受ALKi作为一线治疗的患者中，30例接受了ICI，249例接受了ALKis，154例接受了非ICI/ALKi治疗作为二线治疗。大多数患者特征在各组之间没有差异。接受较短时间ALKi治疗的患者更有可能接受ICI治疗。ICI的中位TTD为66天，1年TTD率为13%。
鉴于ALK阳性NSCLC的罕见性，本研究通过扩大数据库和增加样本量有助于补充证据，支持先前关于ICI在ALK阳性患者中有效性有限的观点。
