安罗替尼治疗远处转移性放射性碘难治性分化型甲状腺癌的有效性及安全性分析

Efficacy and safety analysis of anlotinib in the treatment of distant metastatic radioactive iodine-refractory differentiated thyroid cancer

目的探讨安罗替尼治疗远处转移性放射性碘难治性分化型甲状腺癌(RAIR-DTC)的有效性及安全性。方法回顾性分析2018年10月至2023年2月间就诊于青岛大学附属医院的远处转移性RAIR-DTC患者17例男6例、女11例,年龄57.0(45.5,63.0)岁,其中安罗替尼一线治疗组13例,安罗替尼二线治疗组4例。分析安罗替尼治疗期间血清甲状腺球蛋白(Tg)及末次随访靶病灶最大径变化情况、影像学疗效、治疗相关不良反应;比较安罗替尼一线和二线治疗组血清学及影像学疗效。采用Fisher确切概率法分析组间差异。结果17例患者接受安罗替尼治疗后随访时间为17.3(9.5,21.4)个月,客观缓解率(ORR)、疾病控制率(DCR)分别为7/17、16/17。安罗替尼一线与二线治疗组间ORR(6/13和1/4;P=0.603)、DCR(13/13和3/4;P=0.235)差异无统计学意义。17例患者治疗后3、6周及末次随访血清Tg变化率分别为-30.2%(-61.2%,-15.5%)、-64.8%(-90.6%,-32.3%)、-85.8%(-96.1%,-50.7%);末次随访靶病灶最大径变化率为-20.0%(-45.0%,-5.2%)。治疗相关不良反应发生率为14/17,2例(2/17)患者发生3级及以上不良反应。结论安罗替尼在远处转移性RAIR-DTC一线治疗中具有明显的有效性及良好的安全性,有望在索拉非尼治疗失败后发挥重要的补救作用。

Objective To investigate the efficacy and safety of anlotinib in distant metastatic radioactive iodine-refractory differentiated thyroid cancer(RAIR-DTC).Methods Retrospective analysis was performed on 17 patients with distant metastatic RAIR-DTC(6 males,11 females,age:57.0(45.5,63.0)years)from Affiliated Hospital of Qingdao University between October 2018 and February 2023,including 13 patients receiving first-line treatment and 4 patients receiving second-line treatment with anlotinib.The changes of serum thyroglobulin(Tg)during the treatment of anlotinib,the changes of maximum diameter of the target lesion at the last follow-up compared with the diameter at baseline,the imaging efficacy,and treatment-related adverse events were analyzed.The serological and imaging effects of the first-line treatment group and the second-line treatment group were compared.The Fisher exact test was used to analyze the differences between groups.Results The follow-up time of 17 patients was 17.3(9.5,21.4)months,and the objective response rate(ORR)and disease control rate(DCR)were 7/17 and 16/17,respectively.There were no significant differences of ORR(6/13 vs 1/4;P=0.603)and DCR(13/13 vs 3/4;P=0.235)between the first-line and second-line treatment groups.The change rates of serum Tg at 3,6 weeks and the last follow-up were-30.2%(-61.2%,-15.5%),-64.8%(-90.6%,-32.3%),and-85.8%(-96.1%,-50.7%),respectively.At the last follow-up,the change rate of maximum diameter of target lesions was-20.0%(-45.0%,-5.2%).The incidence of treatment-related adverse reactions was 14/17,and 2 patients(2/17)had grade 3 or above adverse reactions.Conclusion Anlotinib shows superior efficacy with tolerable toxicity in the first-line treatment of distant metastatic RAIR-DTC,and hopefully plays an important role in second-line treatment for RAIR-DTC resistant to sorafenib.