Kim Kyuhwan, Kim Kyu Yean, Kang Hye Seon, Shin Ah Young, Kim Sung Kyoung, Park Chan Kwon, Lee Sang Haak, Kim Seung Joon, Lim Jeong Uk, Yeo Chang Dong
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Department of Internal Medicine, Armed Forces Goyang Hospital, Goyang, Republic of Korea.
Ther Adv Med Oncol. 2025 Feb 7;17:17588359251316200. doi: 10.1177/17588359251316200. eCollection 2025.
This study aimed to compare the efficacy of the second-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) alectinib and brigatinib in the treatment of advanced non-small-cell lung cancer (NSCLC) with ALK rearrangements based on real-world data.
We conducted a multicenter retrospective study using the Clinical Data Warehouse from seven university hospitals affiliated with the Catholic Medical Center. Patients diagnosed with ALK-positive advanced NSCLC and treated with alectinib or brigatinib were included. Key outcomes such as time to discontinuation (TTD), duration of response (DOR), overall survival (OS), and objective response rate (ORR) were analyzed.
A total of 143 patients were included (107 treated with alectinib, 36 with brigatinib). Alectinib was more frequently used as a first-line treatment (71% vs 44.4% for brigatinib, = 0.008). Prior crizotinib treatment was more frequent in the brigatinib group (52.8% vs 22.4% for alectinib, < 0.001). The best ORR was similar between the groups (84.1% for alectinib vs 83.3% for brigatinib, = 0.518). The median TTD was 57.8 months (95% confidence interval (CI): 29.0-86.7) for alectinib and 39.6 months (95% CI: 21.7-57.4) for brigatinib ( = 0.462). No significant differences were observed in intracranial TTD, intracranial DOR, or OS between the groups. Prior crizotinib treatment significantly shortened TTD for second-generation TKIs ( = 0.025), but the overall TKI treatment duration did not show a significant difference between patients who received frontline second-generation ALK TKIs and those who received second-generation ALK TKIs sequentially after crizotinib.
Alectinib and brigatinib demonstrated comparable efficacy in ALK-positive advanced NSCLC. Undergoing crizotinib followed by a second-generation TKI was not significantly different from initiating a second-generation TKI without prior crizotinib in terms of outcomes.
本研究旨在基于真实世界数据，比较第二代间变性淋巴瘤激酶（ALK）酪氨酸激酶抑制剂（TKIs）阿来替尼和布加替尼治疗ALK重排的晚期非小细胞肺癌（NSCLC）的疗效。
我们使用天主教医疗中心下属七家大学医院的临床数据仓库进行了一项多中心回顾性研究。纳入诊断为ALK阳性晚期NSCLC并接受阿来替尼或布加替尼治疗的患者。分析了停药时间（TTD）、缓解持续时间（DOR）、总生存期（OS）和客观缓解率（ORR）等关键结局。
共纳入143例患者（107例接受阿来替尼治疗，36例接受布加替尼治疗）。阿来替尼更常被用作一线治疗（71% vs布加替尼的44.4%，P = 0.008）。布加替尼组先前接受克唑替尼治疗的比例更高（52.8% vs阿来替尼组的22.4%，P < 0.001）。两组的最佳ORR相似（阿来替尼为84.1%，布加替尼为83.3%，P = 0.518）。阿来替尼的中位TTD为57.8个月（95%置信区间（CI）：29.0 - 86.7），布加替尼为39.6个月（95%CI：21.7 - 57.4）（P = 0.462）。两组在颅内TTD、颅内DOR或OS方面未观察到显著差异。先前的克唑替尼治疗显著缩短了第二代TKIs的TTD（P = 0.025），但在接受一线第二代ALK TKIs的患者与在克唑替尼后序贯接受第二代ALK TKIs的患者之间，总体TKI治疗持续时间未显示出显著差异。
阿来替尼和布加替尼在ALK阳性晚期NSCLC中显示出相当的疗效。在疗效方面,先接受克唑替尼治疗然后接受第二代TKI与未接受过克唑替尼直接开始使用第二代TKI没有显著差异。
