索拉非尼治疗碘难治性分化型甲状腺癌的效果及对血清Tg、TgAb水平的影响

Efficacy of sorafenib in the treatment of radioactive iodine-refractory differentiated thyroid cancer and corresponding effects on serum Tg and TgAb

目的探讨索拉非尼治疗碘难治性分化型甲状腺癌(RAIR-DTC)的疗效及对血清甲状腺球蛋白(Tg)、抗甲状腺球蛋白抗体(TgAb)水平的影响。方法选取2019年3月至2020年9月就诊的RAIR-DTC患者30例,均给予甲苯磺酸索拉非尼片序贯治疗,定期监测病灶体积、血清Tg、Tg-Ab水平及临床疗效,随访生存情况、不良反应。结果治疗后1~3个月、6个月、9个月及12个月病灶体积均明显缩小(P<0.05);治疗3个月体积缩小率达42.73%,随后每3个月病灶缩小率逐渐增大,至随访截止时间2021年9月30日,所有患者完成12个月治疗,病灶缩小率达85.30%,治疗后每3个月病灶体积缩小率的差异均有统计学意义(P<0.001);治疗后患者血清Tg、Tg-Ab水平均呈显著下降(P<0.05);其中治疗8周血清Tg、TgAb下降达62.63%、35.40%,治疗16周、24周血清Tg、TgAb下降率高于治疗8周(P<0.05),但治疗16周和24周血清Tg、TgAb下降率无明显差异(P>0.05);治疗3个月后,27例(90%)部分缓解,疾病控制率为100%,客观缓解率为90.00%,治疗6个月疾病控制率及客观缓解率为100%、86.67%,前6个月的临床疗效比较差异无统计学意义(P>0.05);治疗12个月,疾病控制率、客观缓解率依次为93.33%、76.67%,其中客观缓解率较治疗3个月治疗6个月明显降低(P<0.05);生存情况:死亡率6.67%,30例平均总生存期为37.7个月,不良反应:治疗期间患者主要出现皮疹15例(50%)、低钙血症6例(20%),骨髓抑制6例(20%),腹泻3例(10%)。结论索拉非尼治疗RAIR-DTC可有效抑制肿瘤细胞生长,下调肿瘤细胞Tg表达水平,改善患者预后,且安全性较高,是RAIR-DTC治疗的可靠方案。

Objective To explore the efficacy of sorafenib in the treatment of radioactive iodine-refractory differentiated thyroid cancer(RAIR-DTC)and corresponding effects on serum thyroglobulin(Tg)and thyroglobulin antibody(Tg-Ab).Methods Patients with RAIR DTC visited the hospital from March 2019 to September 2020 were given sequential therapy with Sorafenib Tosylate,and the lesion volume,level of Tg and Tg-Ab serum and clinical efficacy,follow-up survival and adverse reactions were monitored regularly.Results The lesion volume within 1~3 months,6 months,9 months,and 12 months after treatment was significantly reduced(P<0.05);the volume reduction rate was 42.73%after 3-month treatment,and the lesion reduction rate gradually increased every 3 months.All patients had completed 12 months of treatment by September 30,2021 or the deadline for follow up,the lesion reduction rate was 85.30%,and the lesion volume reduction rate every 3 months after treatment,and the differences were statistically significant(P<0.001).The serum Tg and Tg-Ab level of patients decreased significantly after treatment(P<0.05),of which,the serum Tg and Tg-Ab decreased to 62.63%and 35.40%,respectively.The decrease rates of serums Tg and Tg-Ab at the 16th and 24th weeks was higher than those at the 8th week(P<0.05),while no difference was significant in the serum lavel of Tg and TgAb between the 16th and the 24th weeks of treatment(P>0.05).27 cases(90%)were subject to partial remission after 3 months of treatment,the disease control rate was 100%,objective remission rate was 90.00%,disease control rate and objective remission rate for 6 months of treatment are 100%and 86.67%,and the difference in clinical efficacy within the first 6 months wasn’t statistically significant(P>0.05).The disease control rate and objective remission rate were 93.33%and 76.67%,successively upon 12 months of treatment.The objective remission rate upon 6 months of treatment was significantly lower than that upon 3 months of treatment(P<0.05).The survival statuses with mortality 6.67%,average overall survival of 30 cases at 37.7 months.For adverse reactions,it was found that there were 15 cases(50%)mainly developing skin rash,6 cases of hypocalcemia(20%),6 cases of bone marrow suppression(20%)and 3 cases of diarrhea(10%).Conclusion Sorafenib in the treatment of RAIR-DTC is capable of effectively inhibiting the tumor cell growth,down-regulating Tg expression of tumor cell,improving patient prognosis with high safety,being a reliable solution for RAIR-DTC treatment.