Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Cancer Res Treat. 2024 Jan;56(1):61-69. doi: 10.4143/crt.2023.461. Epub 2023 Jul 14.
Alectinib and brigatinib are second-generation anaplastic lymphoma receptor tyrosine kinases (ALKs) that are widely used as first-line therapy for treating ALK-positive advanced non-small cell lung cancer (NSCLC). Given the lack of a head-to-head comparison of these drugs as first-line therapies, this retrospective observational study aimed to compare the real-world efficacy and safety of alectinib and brigatinib.
Patients who received alectinib or brigatinib as the first-line treatment for ALK-positive advanced NSCLC were evaluated for clinical outcomes of objective response rate (ORR), intracranial ORR, time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety profiles.
Of 208 patients who received either alectinib or brigatinib as a first-line treatment, 176 received alectinib and 32 received brigatinib. At the data cutoff point, the median follow-up duration was 16.5 months (95% confidence interval [CI], 14.7 to 18.3) in the brigatinib group and 27.5 months (95% CI, 24.6 to 30.4) in the alectinib group. The ORR was 92.5% with alectinib and 93.8% for brigatinib. The intracranial ORR rates were 92.7% (38/41) and 100% (10/10), respectively. The rate of PFS at 12 months was comparable between the alectinib group and the brigatinib groups (84.4% vs. 84.1%, p=0.64), and the median TTNT, PFS, and OS were not reached in either group. Treatment-related adverse events were usually mild, and treatment discontinuation due to adverse events was rare (alectinib 4.5% vs. brigatinib 6.25%).
Alectinib and brigatinib had similar clinical benefits when used as the first-line treatment of NSCLC patients with ALK rearrangement in the real world.
艾乐替尼和布加替尼是第二代间变性淋巴瘤激酶受体酪氨酸激酶（ALK）抑制剂，广泛用于治疗 ALK 阳性晚期非小细胞肺癌（NSCLC）的一线治疗。鉴于这两种药物作为一线治疗方案缺乏头对头比较，本回顾性观察性研究旨在比较艾乐替尼和布加替尼的真实世界疗效和安全性。
评估接受艾乐替尼或布加替尼作为 ALK 阳性晚期 NSCLC 一线治疗的患者的客观缓解率（ORR）、颅内 ORR、至下一治疗时间（TTNT）、无进展生存期（PFS）、总生存期（OS）和安全性特征。
在 208 例接受艾乐替尼或布加替尼一线治疗的患者中，176 例接受了艾乐替尼治疗，32 例接受了布加替尼治疗。在数据截止点，布加替尼组的中位随访时间为 16.5 个月（95%置信区间 [CI]，14.7 至 18.3），艾乐替尼组为 27.5 个月（95% CI，24.6 至 30.4）。艾乐替尼的 ORR 为 92.5%，布加替尼为 93.8%。颅内 ORR 率分别为 92.7%（38/41）和 100%（10/10）。艾乐替尼组和布加替尼组 12 个月时的 PFS 率相当（84.4% vs. 84.1%，p=0.64），两组均未达到中位 TTNT、PFS 和 OS。治疗相关不良事件通常为轻度，因不良事件而停止治疗的情况很少（艾乐替尼 4.5% vs. 布加替尼 6.25%）。
在真实世界中，艾乐替尼和布加替尼作为 ALK 重排的 NSCLC 患者的一线治疗药物，具有相似的临床获益。
