安罗替尼对碘难治性分化型甲状腺癌的短期疗效评价及安全性研究

Short-Term Efficacy Evaluation and Safety Study of Anlotinib in Iodine-Refractory Differentiated Thyroid Cancer

摘要: 目的：探讨安罗替尼治疗碘难治性分化型甲状腺癌的短期疗效及安全性。方法：收集自2021年6月至2023年6月于聊城市人民医院就诊的采用安罗替尼靶向治疗3个月的23例碘难治性分化型甲状腺癌患者的临床资料。目标病灶的疗效评价按照实体瘤疗效评价标准1.1版进行评估，包括客观缓解率(ORR)、疾病控制率(DCR)。对比患者停药前后甲状腺球蛋白(Tg)及靶病灶的最大径变化情况，同时记录患者服药期间不良反应情况。结果：共入组23例患者(女14例，男9例)，接受安罗替尼治疗3个月后，13例达部分缓解(56.52%)，8例(34.78%)患者疾病稳定，没有患者达到完全缓解，ORR为56.52%，DCR为91.3%。末次随访患者Tg水平从基线的119.14 (83.21, 203.47) ng/mL下降至27.98 (13.91, 41.90) ng/mL (Z = −3.8, P < 0.05)；靶病灶最大径水平从基线的1.6 (1.2, 2.0) cm下降至1.1 (0.7, 1.7) cm (Z = −3.6, P < 0.05)。安罗替尼常见的不良反应为高血压6例，手足综合征4例，高甘油三酯血症2例，未观察到与安罗替尼相关的3级以上严重不良反应。其中两名患者因持续性高血压，予以降压药对症处理后，血压控制良好，其余患者均能耐受药物不良反应。结论：本研究提示安罗替尼短期治疗碘难治性分化型甲状腺癌疗效明确，缩瘤效果显著，且不良反应较小，患者耐受好，安全性较高。

Abstract: Objective: To evaluate the short-term efficacy and safety of anlotinib in the treatment of iodine- re-fractory differentiated thyroid carcinoma. Methods: The clinical data of 23 patients with iodine- re-fractory differentiated thyroid cancer who received anlotinib targeted therapy for 3 months were collected from June 2021 to June 2023 in Liaocheng People’s Hospital. The efficacy of the target le-sions was evaluated according to the solid tumor efficacy evaluation criteria version 1.1, including objective response rate (ORR) and disease control rate (DCR). The maximum diameter changes of thyroglobulin (Tg) and target lesions were compared before and after drug withdrawal, and adverse reactions were recorded during medication. Results: A total of 23 patients (14 females and 9 males) were enrolled. After 3 months of treatment with anlotinib, 13 patients achieved partial remission (56.52%), 8 patients (34.78%) were stable, and no patients achieved complete remission, with ORR of 56.52% and DCR of 91.3%. At the last follow-up, Tg levels decreased from 119.14 (83.21, 203.47) ng/mL to 27.98 (13.91, 41.90) ng/mL (Z = −3.8, P < 0.05). The maximum diameter of the target le-sion decreased from 1.6 (1.2, 2.0) cm at baseline to 1.1 (0.7, 1.7) cm (Z = −3.6, P < 0.05). The com-mon adverse reactions of anlotinib were hypertension in 6 cases, hand-foot syndrome in 4 cases, and hypertriglyceridemia in 2 cases. No grade 3 or higher adverse reactions associated with anlo-tinib were observed. Two of the patients had good blood pressure control after symptomatic treat-ment with antihypertensive drugs due to persistent hypertension, and the other patients were able to tolerate adverse drug reactions. Conclusion: This study suggests that anlotinib has clear efficacy in the short-term treatment of iodine-refractory differentiated thyroid cancer, with significant tu-mor shrin- kage effect, small adverse reactions, good tolerance and high safety.