Department of Endocrine and Metabolic Diseases, IRCCS Istituto Auxologico Italiano, Milan, Italy.
Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
Endocrine. 2021 May;72(2):462-469. doi: 10.1007/s12020-020-02477-0. Epub 2020 Sep 3.
Lenvatinib (LEN) has been approved for the treatment of patients with progressive radioiodine-refractory differentiated thyroid cancer (RAI-R DTC). Real-life studies reported a lower progression-free survival (PFS) than the registration study, likely due to the more advanced stage of tumors, the more frequent pretreatment with other TKIs, the limited follow-up, and the worse clinical condition of the patients included.
We evaluated the clinical data of our cohort of 13 consecutive patients, all receiving LEN as a first-line TKI treatment, and followed-up in a single tertiary Center.
All patients had an ECOG of 0-1 and regional or distant metastases were documented in 61.5% and 77% of patients, respectively. Median PFS was 22 months (95% CI 14-35) with partial response in 69% and stable disease in 31% of patients. All patients experienced at least one adverse event (AE), the most frequent being fatigue, anorexia, diarrhea, and hypertension. The daily dose was reduced in 70% of patients and only one patient (7.7%) discontinued the drug for AEs.
In this series of RAI-R DTC patients, with the unique features to have an ECOG 0 or 1 and to be naive for TKI treatments, PFS was the longest among all real-life published so far, with the highest rate of patients with partial response and one of the lowest drug discontinuation rate for AEs. The correct timing of treatment start, the tailoring of the dose, and a proper management of the AEs may have a significant impact on the treatment response to LEN.
仑伐替尼（LEN）已被批准用于治疗进展性放射性碘难治性分化型甲状腺癌（RAI-R DTC）患者。真实世界研究报告的无进展生存期（PFS）低于注册研究，可能是由于肿瘤分期更晚、预处理其他 TKI 的频率更高、随访时间有限以及纳入患者的临床状况较差。
我们评估了我们连续 13 例患者队列的临床数据，所有患者均接受 LEN 作为一线 TKI 治疗，并在一家三级中心进行随访。
所有患者的 ECOG 评分为 0-1，分别有 61.5%和 77%的患者有局部或远处转移。中位 PFS 为 22 个月（95%CI 14-35），部分缓解率为 69%，疾病稳定率为 31%。所有患者均至少出现 1 次不良事件（AE），最常见的是疲劳、厌食、腹泻和高血压。70%的患者减少了每日剂量，只有 1 名患者（7.7%）因 AE 停药。
在本系列 RAI-R DTC 患者中，由于 ECOG 为 0 或 1 且对 TKI 治疗无耐药性的独特特征，PFS 是迄今为止所有真实世界研究中最长的，部分缓解率最高，因 AE 停药率最低之一。正确的治疗开始时间、剂量的调整和 AEs 的适当管理可能对 LEN 的治疗反应有重大影响。
