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仑伐替尼治疗晚期甲状腺未分化癌的真实世界经验。

Real-world experience of lenvatinib in patients with advanced anaplastic thyroid cancer.

机构信息

Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.

Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

出版信息

Endocrine. 2021 Feb;71(2):427-433. doi: 10.1007/s12020-020-02425-y. Epub 2020 Jul 29.

DOI:10.1007/s12020-020-02425-y
PMID:32729092
Abstract

PURPOSE

We aimed to evaluate the clinical efficacy and safety of lenvatinib in patients with advanced anaplastic thyroid cancer (ATC) in real-world practice.

METHODS

This multicenter, retrospective cohort study included 14 patients with advanced ATC who received lenvatinib. We evaluated the response rate according to RECIST.

RESULTS

Ten patients had de novo ATC, and lenvatinib was used as a neoadjuvant treatment in eight patients. During a median follow-up of 6.7 months, patients received lenvatinib at a median dose of 13 mg daily. Overall, four patients (29%) showed partial response, nine (64%) had stable disease, and one (7%) had progressive disease. Tumor burden was reduced in 13 patients (93%), and the median best percent change from the baseline was -15.8%. The median progression-free survival and overall survival were 5.7 months (95% confidence interval [CI], 2.2-8.3) and 6.7 months (95% CI, 3.0-8.4), respectively. All patients experienced adverse events (AEs). Most AEs were manageable but two AEs-tracheal perforation, and pneumothorax and pneumomediastinum-were life-threatening. One patient underwent flap surgery for reconstruction of their tracheal perforation, and another died of pneumothorax and pneumomediastinum, which seemed to be related to lenvatinib.

CONCLUSIONS

In this multicenter real-world study, lenvatinib demonstrated limited clinical activity in advanced ATC. It effectively reduced the tumor burden but showed doubtful survival benefit. Although most AEs were manageable, one fatal AE was related to rapid tumor shrinkage. Further studies are needed to clarify the efficacy and optimal dose of lenvatinib in patients with advanced ATC.

摘要

目的

我们旨在评估仑伐替尼在真实世界实践中治疗晚期间变性甲状腺癌(ATC)患者的临床疗效和安全性。

方法

本多中心回顾性队列研究纳入了 14 例接受仑伐替尼治疗的晚期 ATC 患者。我们根据 RECIST 评估了缓解率。

结果

10 例患者为初诊 ATC,8 例患者接受仑伐替尼新辅助治疗。中位随访 6.7 个月期间,患者接受的仑伐替尼中位剂量为 13mg/天。总体而言,4 例(29%)患者显示部分缓解,9 例(64%)患者疾病稳定,1 例(7%)患者疾病进展。13 例(93%)患者肿瘤负担减轻,最佳基线百分比变化中位数为-15.8%。中位无进展生存期和总生存期分别为 5.7 个月(95%置信区间[CI],2.2-8.3)和 6.7 个月(95%CI,3.0-8.4)。所有患者均发生不良反应(AE)。大多数 AE 可管理,但 2 例 AE-气管穿孔和气胸和纵隔气肿-为危及生命。1 例患者接受皮瓣手术重建气管穿孔,另 1 例患者因气胸和纵隔气肿死亡,似乎与仑伐替尼有关。

结论

在这项多中心真实世界研究中,仑伐替尼在晚期 ATC 中显示出有限的临床活性。它有效减轻了肿瘤负担,但生存获益可疑。尽管大多数 AE 可管理,但 1 例致命 AE 与肿瘤快速缩小有关。需要进一步研究来阐明仑伐替尼在晚期 ATC 患者中的疗效和最佳剂量。

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