131I治疗对术后评估为疗效不确切的分化型甲状腺癌患者近期临床转归的影响

Effect of 131I therapy on the clinical outcome of patients with differentiated thyroid cancer evaluated as indeterminate response after surgery

目的探讨131I治疗对分化型甲状腺癌(DTC)术后131I治疗前被评估为疗效不确切(IDR)患者临床转归的影响。方法回顾性分析2009年4月至2022年3月就诊于北京协和医院核医学科,甲状腺全切或近全切术后131I治疗前被评估为IDR的281例DTC患者[男89例、女192例,年龄(38.4±10.2)岁]。根据是否行131I治疗,将患者分为131I治疗组与仅促甲状腺激素(TSH)抑制治疗组,并针对不同复发风险分层(低危、中危、高危)进行亚组分析;另依据甲状腺球蛋白抗体(TgAb)水平将患者分为TgAb阳性组(TgAb≥115 kU/L)与TgAb阴性组(TgAb<115 kU/L),比较各组内经131I治疗与仅TSH抑制治疗后随访期末疗效反应。分析2种治疗方案下TgAb阳性者的TgAb转阴时间及转阴率。采用两独立样本t检验、Mann-WhitneyU检验和χ^(2)检验、Fisher确切概率法比较组间差异。结果中位随访39(6~146)个月。在基线特征可比的情况下,131I治疗组(199例)与仅TSH抑制治疗组(82例)的随访期末疗效反应差异无统计学意义(χ^(2)=6.50,P=0.075)。对于低危、中危、高危不同复发风险分层的患者,2种治疗方案下的疗效反应差异也均无统计学意义(P=0.221;χ^(2)=4.21,P=0.223;χ^(2)=3.01,P=0.274)。TgAb阳性组(50例)及阴性组(231例)内2种治疗方案的疗效反应差异亦无统计学意义(χ^(2)=4.02,P=0.242;χ^(2)=3.14,P=0.341)。TgAb阳性者经2种方案治疗后TgAb转阴率及转阴时间差异亦无统计学意义[71.0%(22/31)与14/19,χ^(2)=0.04,P=0.836;7.0(5.0,9.3)与7.0(5.0,7.3)个月,z=-0.89,P=0.375]。结论针对DTC术后评估为IDR的患者,131I治疗相较于仅TSH抑制治疗下随访并未产生更多获益。

Objective To investigate the effect of 131I therapy on the clinical outcome of patients with differentiated thyroid cancer(DTC)who were evaluated as indeterminate response(IDR)after surgery and before 131I therapy.Methods A total of 281 DTC patients(89 males,192 females,age(38.4±10.2)years)assessed as IDR before 131I therapy and after total or near-total thyroidectomy in the Department of Nuclear Medicine of Peking Union Medical College Hospital from April 2009 to March 2022 were retrospectively analyzed.Patients were divided into 131I therapy group(131I group)and just thyroid stimulating hormone(TSH)suppressive therapy group(TSH group)according to whether receiving 131I therapy,and the efficacies of two groups at the end of follow-up were compared.Subgroup analysis was conducted in different risk stratifications(low-risk,moderate-risk and high-risk),positive thyroglobulin antibody(TgAb)group(TgAb≥115 kU/L)and negative TgAb group(TgAb<115 kU/L).For patients with positive TgAb,the duration and rate for TgAb declining to negative level under the 2 regimens were compared.Independent-sample t test,Mann-Whitney U test,χ^(2) test and Fisher exact test were performed to compare the differences between groups.Results Median follow-up time was 39(6-146)months.There was no statistical difference between patients in 131I group and TSH group in baseline characteristics,and the efficacies at the end of follow-up was similar between the 2 groups(χ^(2)=6.50,P=0.075).For low-,moderate-and high-risk stratification,there were also no statistical differences of response to 2 regimens(P=0.221;χ^(2)=4.21,P=0.223;χ^(2)=3.01,P=0.274).Similar results were showed for patients with positive and negative TgAb(n=50,n=231;χ^(2)=4.02,P=0.242;χ^(2)=3.14,P=0.341).For patients with positive TgAb,the duration and rate for TgAb declining to negative level were not statistically different either between 2 regimens(71.0%(22/31)vs 14/19,χ^(2)=0.04,P=0.836;7.0(5.0,9.3)vs 7.0(5.0,7.3)months,z=-0.89,P=0.375).Conclusion For DTC patients assessed as IDR after surgery,131I therapy may not provide more benefit than follow-up with TSH suppressive therapy.