碘-125粒子植入治疗碘难治性分化型甲状腺癌淋巴结转移灶的临床研究

Clinical study of iodine-125 seeds implantation in the treatment of lymph node metastasis of radioactive iodine-refractory differentiated thyroid cancer

背景与目的:随着甲状腺癌发病率不断攀升,碘难治性分化型甲状腺癌(radioactive iodine-refractory differentiated thyroid cancer,RAIR-DTC)成为目前临床诊疗的难点。探索碘-125(125I)粒子植入治疗RAIR-DTC的疗效及安全性。方法:对中南大学湘雅医学院附属肿瘤医院自2013年—2017年收治的39例RAIR-DTC患者颈部淋巴结转移灶行125I粒子植入治疗,每3个月监测血清甲状腺球蛋白(thyroglobulin,Tg)水平及病灶变化情况。采用实体瘤疗效评价标准1.1(response evaluation criteria in solid tumors,RECIST 1.1)评估疗效,采用常见不良事件评价标准5.0(common terminology criteria for adverse events,CTCAE 5.0)评估安全性。结果:治疗后39例患者的客观缓解率为43.6%,疾病控制率为92.3%。治疗3个月血清Tg水平较治疗前有显著降低(t=2.2,P<0.05);治疗后6个月较治疗后3个月、治疗后9个月较治疗后6个月、治疗后12个月较治疗后9个月差异无统计学意义(P均>0.05)。治疗后3、6、9和12个月的淋巴结最大截面短径分别为(15.1±1.1)、(13.8±1.0)、(12.9±1.0)和(12.9±1.0)mm,与治疗前的(18.3±1.2)mm相比,差异均有统计学意义(P<0.001)。粒子植入数量与可测量病灶短径缩小量弱相关(P<0.05),与Tg水平减少量不相关(P>0.05)。未观察到与该治疗相关的严重不良事件。结论:125I粒子植入治疗RAIR-DTC颈部淋巴结转移灶疗效及安全性良好。

Background and purpose:With the increasing incidence of thyroid cancer,radioactive iodine-refractory differentiated thyroid cancer(RAIR-DTC)has become difficult to diagnose and treat.The purpose of this study was to explore the efficacy and safety of iodine-125(125I)seeds implantation in the treatment of RAIR-DTC.Methods:Thirty-nine RAIR-DTC patients with cervical lymph node metastasis were treated with 125I seeds in the Affiliated Cancer Hospital of Xiangya School of Medicine,Central South University from 2013-2017.The level of serum thyroglobulin(Tg)and the changes of the target lesions were monitored every 3 months.We evaluated the response according to the response evaluation criteria in solid tumors version 1.1(RECIST 1.1).Meanwhile,the adverse events were monitored during the therapy according to common terminology criteria for adverse events version 5.0(CTCAE 5.0).Results:After treatment,the objective remission rate of 39 patients was 43.6%,and the disease control rate was 92.3%.The level of serum Tg at 3 months after treatment was significantly lower than that before treatment(t=2.2,P<0.05);6 months versus 3 months after treatment,9 months versus 6 months after treatment,and 12 months versus 9 months after treatment,there was no statistically significant difference in serum Tg level.The maximum short diameters of lymph nodes at 3,6,9 and 12 months after treatment were(15.1±1.1)mm,(13.8±1.0)mm,(12.9±1.0)mm and(12.9±1.0)mm,respectively,significantly lower than that before treatment(18.3±1.2)mm(P<0.001).There was a weak correlation between the number of 125I seeds and the reduction of short diameter of the target lesions(P<0.05),but not with the reduction of Tg level(P>0.05).No serious adverse event associated with the treatment was observed.Conclusion:125I seeds implantation is an effective and safe way in the treatment of cervical lymph node metastasis of RAIR-DTC.