Department of Public Health, University of Naples "Federico II", 80131, Naples, Italy.
Department of Advanced Biomedical Sciences, University of Naples "Federico II", Naples, Italy.
Endocrine. 2021 Aug;73(2):358-366. doi: 10.1007/s12020-021-02634-z. Epub 2021 Feb 3.
The efficacy of lenvatinib for advanced and progressive radioactive iodine refractory differentiated thyroid cancer is well established. Herein, we retrospectively evaluated the long-term safety and efficacy of lenvatinib in 23 patients treated at a single Institution.
Clinical data of all patients treated for a differentiated thyroid cancer with lenvatinib from April 2015 to September 2020 were retrospectively analyzed.
A total of 23 patients were included. In all, 21 patients received lenvatinib as first-line systemic therapy. Median age at initiation of lenvatinib treatment was 68 (44-90) years. Median duration of the study from initiation of lenvatinib to study end was 23 (2-65) months. The indication for lenvatinib treatment was documented progression of distant metastases in 20 patients and of locally advanced disease in the other 3 and median duration of lenvatinib therapy was 15 (2-64) months. Best treatment responses were: partial response in 6 patients, stable disease in 14, progressive disease in 1, and not evaluable in 2. Median progression-free survival was 25 months (95% CI: 12-40) and median overall survival was 46 months (95% CI: 28-65). Three patients had to discontinue lenvatinib treatment due to serious adverse events and no drug-related death was observed. Ten patients continued lenvatinib for more than 24 months and the only newly registered adverse event after this period of time was one case of G2 proteinuria. Six patients continued lenvatinib treatment beyond documented tumor progression due to oligoprogression or slowly progressive disease (median time 18.5 months, 8-42 months). A total of 14 patients were alive at the end of the study: 11 showed partial response/stable disease on lenvatinib, including 3 who had a stable disease after local ablative therapy for oligoprogressive metastases; 3 had to change treatment, including 2 for lenvatinib-related serious adverse events and 1 for progressive disease.
Long-term lenvatinib treatment is safe and some patients may experience persistent long-term control of the disease. Late treatment-related AEs rarely occurred. Oligoprogressive and slowly progressive disease can be managed without treatment withdrawal as long as there are some clinical benefits.
仑伐替尼治疗晚期和进展性放射性碘难治性分化型甲状腺癌的疗效已得到充分证实。在此，我们回顾性评估了单中心 23 例患者接受仑伐替尼治疗的长期安全性和疗效。
回顾性分析 2015 年 4 月至 2020 年 9 月期间所有接受仑伐替尼治疗分化型甲状腺癌的患者的临床资料。
共纳入 23 例患者。所有患者均接受仑伐替尼作为一线系统治疗。仑伐替尼治疗开始时的中位年龄为 68（44-90）岁。从仑伐替尼治疗开始到研究结束的中位研究时间为 23（2-65）个月。20 例患者的仑伐替尼治疗指征为远处转移进展，3 例患者的仑伐替尼治疗指征为局部晚期疾病，仑伐替尼治疗的中位持续时间为 15（2-64）个月。最佳治疗反应为：6 例部分缓解，14 例疾病稳定，1 例疾病进展，2 例无法评估。中位无进展生存期为 25 个月（95%CI：12-40），中位总生存期为 46 个月（95%CI：28-65）。3 例患者因严重不良事件而停止仑伐替尼治疗，未观察到与药物相关的死亡。10 例患者继续仑伐替尼治疗超过 24 个月，在此期间仅新登记了 1 例 G2 蛋白尿不良事件。6 例患者因寡进展或缓慢进展性疾病在有记录的肿瘤进展后继续仑伐替尼治疗（中位时间 18.5 个月，8-42 个月）。研究结束时共有 14 例患者存活：11 例在仑伐替尼治疗中显示部分缓解/疾病稳定，其中 3 例在寡转移灶局部消融治疗后疾病稳定；3 例需要改变治疗方案，包括 2 例因仑伐替尼相关严重不良事件，1 例因疾病进展。
长期仑伐替尼治疗是安全的，一些患者可能会长期持续控制疾病。晚期治疗相关不良事件很少发生。只要有一定的临床获益，就可以不停止治疗来管理寡进展和缓慢进展性疾病。
