ALK 酪氨酸激酶抑制剂（ALK TKI）在临床实践中的应用、总生存期和治疗持续时间 - 一项瑞典全国性回顾性研究。
Use of ALK-tyrosine kinase inhibitors (ALK TKI) in clinical practice, overall survival, and treatment duration - a Swedish nationwide retrospective study.
机构信息
Quantify Research, Stockholm, Sweden.
Pfizer AB, Stockholm, Sweden.
出版信息
Acta Oncol. 2022 Nov;61(11):1354-1361. doi: 10.1080/0284186X.2022.2133972. Epub 2022 Nov 11.
BACKGROUND
The real-world treatment and outcomes of patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer treated with ALK Tyrosine Kinase Inhibitor (TKI) drugs in Sweden is not well described.
MATERIAL AND METHODS
A retrospective population-based cohort study was conducted using Swedish national registers. All patients with a filled prescription for an ALK TKI between January 2012 and October 2020 were included. The sequencing of ALK TKI and duration of treatment (DOT) were described, and overall survival (OS) was estimated using the Kaplan-Meier method. Patients were stratified based on treatment with frontline chemotherapy, presence of CNS metastases prior to the first ALK TKI, and generation of ALK TKI agent.
RESULTS
Among the total of 579 patients, 549 (95%) underwent a therapy sequence in line with current clinical practice with 204 (37%) patients receiving frontline chemotherapy. Single-line ALK TKI was given to 366 patients (crizotinib: 211; alectinib: 146; ceritinib: 9), whereas 128 patients received two different ALK TKI (frontline crizotinib: 100, alectinib: 24, ceritinib: 4); 40 patients received three lines and 15 patients four ALK TKI lines or more. With frontline chemotherapy, the mean (standard deviation) DOT was 1.07 (1.25) years for the entire TKI therapy sequence compared to 1.23 (1.28) years with frontline ALK TKI. The median (95% confidence interval) OS was 1.83 (1.48-2.13) years for the entire cohort, 1.44 (0.89-1.98) years for patients given frontline chemotherapy, and 2.02 (1.60-2.58) years for patients given frontline ALK TKI.
CONCLUSION
This study provides a unique overview of the patient population treated with ALK TKI in Sweden and reveals the treatment patterns applied in real clinical practice. More research is needed when longer follow-up data are available for later-generation ALK TKI, to fully understand ALK TKI sequencing and its effect on patient survival in a real-world setting.
背景
在瑞典，针对间变性淋巴瘤激酶阳性（ALK+）晚期非小细胞肺癌患者使用 ALK 酪氨酸激酶抑制剂（TKI）药物的真实世界治疗和结局尚不清楚。
材料和方法
本研究使用瑞典国家登记处进行了一项回顾性基于人群的队列研究。所有在 2012 年 1 月至 2020 年 10 月期间有 ALK TKI 处方的患者均被纳入研究。描述了 ALK TKI 的测序和治疗持续时间（DOT），并使用 Kaplan-Meier 方法估计总生存期（OS）。根据一线化疗、ALK TKI 前是否存在中枢神经系统转移以及 ALK TKI 药物的代际进行分层。
结果
在总共 579 名患者中，549 名（95%）患者按照当前临床实践进行了治疗序列，其中 204 名（37%）患者接受了一线化疗。366 名患者接受了单一线 ALK TKI（克唑替尼：211 例；阿来替尼：146 例；塞瑞替尼：9 例），而 128 名患者接受了两种不同的 ALK TKI（一线克唑替尼：100 例，阿来替尼：24 例，塞瑞替尼：4 例）；40 名患者接受了三线和 15 名患者接受了四线或更多线的 ALK TKI。对于整个 TKI 治疗序列，接受一线化疗的患者的 DOT 平均值（标准差）为 1.07（1.25）年，而接受一线 ALK TKI 的患者为 1.23（1.28）年。整个队列的中位（95%置信区间）OS 为 1.83（1.48-2.13）年，接受一线化疗的患者为 1.44（0.89-1.98）年，接受一线 ALK TKI 的患者为 2.02（1.60-2.58）年。
结论
本研究提供了瑞典接受 ALK TKI 治疗的患者人群的独特概述，并揭示了实际临床实践中应用的治疗模式。当更长的随访数据可用于评估新一代 ALK TKI 时，需要进一步研究，以充分了解 ALK TKI 测序及其对真实世界环境中患者生存的影响。
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