Taiwan Nationwide Study of First-Line ALK-TKI Therapy in ALK-Positive Lung Adenocarcinoma.

IF 4.4 3区医学 Q2 ONCOLOGY Targeted Oncology Pub Date : 2024-11-01 Epub Date: 2024-10-11 DOI:10.1007/s11523-024-01104-6

Zhe-Rong Zheng, Jia-Jun Wu, Chun-Ju Chiang, Tzu-I Chen, Kun-Chieh Chen, Cheng-Hsiang Chu, Sheng-Yi Lin, Sung-Liang Yu, Wen-Chung Lee, Tsang-Wu Liu, Gee-Chen Chang

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引用次数: 0

Abstract

Background: The clinical outcomes of patients with anaplastic lymphoma kinase-positive (ALK+) advanced lung adenocarcinoma vary according to real-world data.

Objective: In this study, we aimed to investigate the treatment discontinuation (TTD) and overall survival (OS) of patients with ALK+ advanced lung adenocarcinoma treated with first-line ALK-TKIs in Taiwan.

Patients and methods: This retrospective study evaluated all advanced lung adenocarcinoma patients registered in the National Taiwan Cancer Registry from 2017 to 2020 who had ALK rearrangement and received ALK-TKI treatment, using data from Taiwan's National Health Insurance Research Database (NHIRD). The TKI treatment sequences were classified into first generation (G1: crizotinib), second generation (G2: ceritinib, alectinib, brigatinib), and third generation (G3: lorlatinib).

Results: A total of 587 patients were analyzed, with a median age of 60.0 years, 91 (15.5%) aged ≥ 74 years, 293 (49.9%) female, 397 (67.6%) never smoked, and 534 (91.0%) with stage IV disease. Patients who received next-generation ALK-TKIs during the treatment course had longer median time to ALK-TKI TTD and OS. The TTD of the G1, G1+2, G1+2+3, G2, and G2+3 groups was 7.5 (5.4-11.1), 40.6 (29.4-not calculated (NC)), 50.3 (41.3-NC), 34.3 (29.2-43.0), and 36.3 (22.4-NC) months, respectively (p < 0.001). The median OS of the patients in the G1, G1+2, G1+2+3, G2, and G2+3 groups was 10.6 (7.5-14.6), not reached (NR) (NC-NC), NR (NC-NC), 43.0 (36.3-NC), and NR (30.3-NC) months, respectively (p < 0.001). Compared with treatment with crizotinib alone, the multivariate analysis revealed that treatment with next-generation TKIs was independently associated with longer TTD (G1+2 (hazard ratio (HR), 0.24; 95% CI 0.17-0.33; p < 0.001), G1+2+3 or G1+3 (HR, 0.17; 95% confidence interval (CI), 0.10-0.28; p < 0.001), G2 (HR, 0.26; 95% CI 0.19-0.36; p < 0.001), and G2+3 (HR, 0.25; 95% CI 0.14-0.44; p < 0.001)) and median OS (G12 (HR, 0.24; 95% CI 0.17-0.35; p < 0.001), G1+2+3 or G1+3 (HR, 0.09; 95% CI 0.04-0.21; p < 0.001), G2 (HR, 0.22; 95% CI 0.15-0.31; p < 0.001), and G2+3 (HR, 0.20; 95% CI 0.10-0.42; p < 0.001)).

Conclusions: For patients with ALK+ NSCLC, treatments including next-generation ALK-TKIs were independently associated with longer survival outcomes.

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ALK 阳性肺腺癌一线 ALK-TKI 治疗的台湾全国性研究。

背景：根据实际数据，无性淋巴瘤激酶阳性（ALK+）晚期肺腺癌患者的临床结局各不相同：在这项研究中，我们旨在调查在台湾接受一线ALK-TKIs治疗的ALK+晚期肺腺癌患者的治疗中断（TTD）和总生存期（OS）：这项回顾性研究利用台湾国民健康保险研究数据库（NHIRD）的数据，评估了2017年至2020年期间在国立台湾癌症登记中心登记的所有晚期肺腺癌患者，这些患者均有ALK重排并接受了ALK-TKI治疗。TKI治疗序列分为第一代（G1：克唑替尼）、第二代（G2：色瑞替尼、阿来替尼、布瑞加替尼）和第三代（G3：洛拉替尼）：共分析了 587 名患者，中位年龄为 60.0 岁，91 人（15.5%）年龄≥ 74 岁，293 人（49.9%）为女性，397 人（67.6%）从不吸烟，534 人（91.0%）为 IV 期患者。在治疗过程中接受新一代ALK-TKIs的患者的ALK-TKI TTD和OS中位时间更长。G1、G1+2、G1+2+3、G2和G2+3组的TTD分别为7.5（5.4-11.1）、40.6（29.4-未计算（NC））、50.3（41.3-NC）、34.3（29.2-43.0）和36.3（22.4-NC）个月（P＜0.001）。G1、G1+2、G1+2+3、G2和G2+3组患者的中位OS分别为10.6（7.5-14.6）个月、未达到（NR）（NC-NC）个月、NR（NC-NC）个月、43.0（36.3-NC）个月和NR（30.3-NC）个月（P < 0.001）。与单独使用克唑替尼治疗相比，多变量分析显示，使用新一代 TKIs 治疗与更长的 TTD（G1+2（危险比（HR），0.24；95% CI 0.17-0.33；p <0.001）、G1+2+3 或 G1+3（HR，0.17；95% 置信区间（CI），0.10-0.28；p <0.001）、G2（HR，0.26；95% CI 0.19-0.36；P < 0.001）和 G2+3 （HR，0.25；95% CI 0.14-0.44；P < 0.001））和中位 OS（G12（HR，0.24；95% CI 0.17-0.35；P < 0.001）、G1+2+3 或 G1+3 （HR，0.09；95% CI 0.04-0.21；P＜0.001）、G2（HR，0.22；95% CI 0.15-0.31；P＜0.001）和G2+3（HR，0.20；95% CI 0.10-0.42；P＜0.001））.结论：结论：对于ALK+ NSCLC患者，包括新一代ALK-TKIs在内的治疗方法与更长的生存期结局密切相关。

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来源期刊

Targeted Oncology 医学-肿瘤学

CiteScore

8.40

自引率

3.70%

发文量

审稿时长

>12 weeks

期刊介绍： Targeted Oncology addresses physicians and scientists committed to oncology and cancer research by providing a programme of articles on molecularly targeted pharmacotherapy in oncology. The journal includes: Original Research Articles on all aspects of molecularly targeted agents for the treatment of cancer, including immune checkpoint inhibitors and related approaches. Comprehensive narrative Review Articles and shorter Leading Articles discussing relevant clinically established as well as emerging agents and pathways. Current Opinion articles that place interesting areas in perspective. Therapy in Practice articles that provide a guide to the optimum management of a condition and highlight practical, clinically relevant considerations and recommendations. Systematic Reviews that use explicit, systematic methods as outlined by the PRISMA statement. Adis Drug Reviews of the properties and place in therapy of both newer and established targeted drugs in oncology.