Department of Nuclear Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College (PUMC) Hospital, Chinese Academy of Medical Sciences & PUMC, Beijing 100730, China; Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Beijing 100730, China.
Department of Oncology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao 266012, China.
Endocr Pract. 2024 May;30(5):456-464. doi: 10.1016/j.eprac.2024.02.005. Epub 2024 Mar 4.
We aimed to assess the early efficacy of anlotinib in patients with progressive radioactive iodine refractory differentiated thyroid cancer at the structural, biochemical, and metabolic levels.
Ten eligible patients were prospectively enrolled to receive anlotinib. Their responses were assessed at 6 weeks. Apart from the structural response according to Response Evaluation Criteria in Solid Tumors version 1.1, the biochemical response was assessed by serum thyroglobulin (Tg), and the metabolic response was assessed by 2-deoxy-2-[18F] fluoro-D-glucose positron emission tomography/computed tomography (F-FDG PET/CT) according to the European Organization for Research and Treatment of Cancer criteria. A safety profile was recorded.
Structurally controlled disease (20% partial response + 80% stable disease) was observed in all patients. The median longest diameter of target lesions shrank from 20.8 mm (IQR, 14.9-27.5) to 17.0 mm (IQR, 14.1-23.7) (P < .001), and the average shrinkage rate was -15.1 ± 14.1%. Sharp serum Tg reduction by 72.8 ± 16.4% was observed in 8 measurable patients. The F-FDG PET/CT-mapped glucose metabolic response was not quite comparable to the structural response, with 90% of the patients having controlled disease (30% partial metabolic response + 60% stable metabolic disease), whereas 10% presented progressive metabolic disease. The most common treatment-emergent adverse events (AEs) were hypertension (100%) and proteinuria (70%). Most AEs were grade 1 or 2, whereas grade 3 AEs occurred only in hypertension.
Anlotinib is generally well tolerated and can bring early disease control within the initial 6 weeks of treatment. The sharp biochemical response suggests Tg to be an early sensitive biomarker to anlotinib, whereas the heterogeneous metabolic response might play a complementary role.
评估安罗替尼在结构、生化和代谢水平上对进展性放射性碘难治性分化型甲状腺癌患者的早期疗效。
前瞻性纳入 10 例符合条件的患者接受安罗替尼治疗。6 周时评估其疗效。除了根据实体瘤反应评价标准 1.1 评估结构反应外，还通过血清甲状腺球蛋白（Tg）评估生化反应，根据欧洲癌症研究与治疗组织标准，通过 2-脱氧-2-[18F]氟-D-葡萄糖正电子发射断层扫描/计算机断层扫描（F-FDG PET/CT）评估代谢反应。记录安全性概况。
所有患者均观察到结构性疾病控制（20%部分缓解+80%稳定疾病）。靶病灶最长直径中位数从 20.8mm（IQR，14.9-27.5）缩小至 17.0mm（IQR，14.1-23.7）（P＜0.001），平均缩小率为-15.1±14.1%。8 例可测量患者的血清 Tg 明显降低，降低率为 72.8±16.4%。F-FDG PET/CT 所示葡萄糖代谢反应与结构反应不太可比，90%的患者疾病控制（30%部分代谢反应+60%稳定代谢疾病），而 10%患者出现进行性代谢疾病。最常见的治疗相关不良事件（AE）是高血压（100%）和蛋白尿（70%）。大多数 AE 为 1 级或 2 级，而 3 级 AE 仅发生在高血压中。
安罗替尼总体耐受性良好，在治疗最初 6 周内可迅速控制疾病。明显的生化反应提示 Tg 是安罗替尼的早期敏感生物标志物，而代谢反应的异质性可能起补充作用。
