临床研究
ENGLISH ABSTRACT
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
赵宁宁
慕转转
郭文婷
魏星
林岩松
作者及单位信息
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DOI: 10.3760/cma.j.cn321828-20220811-00260
Effect of 131I therapy on the clinical outcome of patients with differentiated thyroid cancer evaluated as indeterminate response after surgery
Zhao Ningning
Mu Zhuanzhuan
Guo Wenting
Wei Xing
Lin Yansong
Authors Info & Affiliations
Zhao Ningning
Department of Nuclear Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences; State Key Laboratory of Complex Severe and Rare Diseases; Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Beijing 100730, China
Department of Nuclear Medicine, Weifang People′s Hospital, Weifang 261041, China
Mu Zhuanzhuan
Department of Nuclear Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences; State Key Laboratory of Complex Severe and Rare Diseases; Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Beijing 100730, China
Guo Wenting
Department of Medical Research Center, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences; State Key Laboratory of Complex Severe and Rare Diseases, Beijing 100730, China
Wei Xing
Department of Oncology, Peking University International Hospital, Beijing 102206, China
Lin Yansong
Department of Nuclear Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences; State Key Laboratory of Complex Severe and Rare Diseases; Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Beijing 100730, China
·
DOI: 10.3760/cma.j.cn321828-20220811-00260
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摘要

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-Whitney U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。

甲状腺肿瘤;放射疗法;碘放射性同位素;治疗结果
ABSTRACT

ObjectiveTo 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.

MethodsA 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.

ResultsMedian 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).

ConclusionFor DTC patients assessed as IDR after surgery, 131I therapy may not provide more benefit than follow-up with TSH suppressive therapy.

Thyroid neoplasms;Radiotherapy;Iodine radioisotopes;Treatment outcome
Lin Yansong, Email: mocdef.3ab618691gnosnaynil
引用本文

赵宁宁,慕转转,郭文婷,等. 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 [J]. 中华核医学与分子影像杂志,2023,43(12):736-740.

DOI:10.3760/cma.j.cn321828-20220811-00260

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*以上评分为匿名评价
131I治疗是大多数中高危分化型甲状腺癌(differentiated thyroid cancer, DTC)患者的重要辅助治疗手段。复发风险分层多建立在病理等静态资料的评估基础上,仅以此作为 131I治疗决策存在片面性。目前,人们已意识到术后疾病状态评估应被常规整合用于DTC的后续临床诊疗决策中 [ 1 , 2 ]。2015版美国甲状腺协会(American Thyroid Association, ATA)指南推荐应用动态风险分层(dynamic risk stratification, DRS)来评估DTC患者初始治疗后的疗效反应及疾病状态 [ 3 , 4 ],这一评估体系也正在被越来越多地用于 131I治疗前评估及决策中。在DRS体系中,疗效不确切(indeterminate response, IDR)是指0.2 μg/L≤抑制性甲状腺球蛋白(thyroglobulin, Tg)<1 μg/L或1 μg/L≤刺激性Tg<10 μg/L,Tg抗体(Tg antibody, TgAb)稳定或下降;同时无影像学证实的结构或功能性疾病存在证据,诊断性 131I全身显像(diagnostic whole-body scan, Dx-WBS)示仅甲状腺床区微弱显影。前期研究显示,在近10年的随访期内,15%~20%的IDR患者会转变为结构性疗效不佳(structural incomplete response, SIR),总体疾病特异性死亡率小于1% [ 4 ]。近年来,国内对DTC术后 131I治疗效果方面的研究及指南渐增 [ 5 , 6 , 7 , 8 , 9 ],但针对术后评估为IDR的患者是否应行 131I治疗的问题鲜有涉及。因此,本研究回顾性观察了这类患者经 131I治疗和仅促甲状腺激素(thyroid stimulating hormone, TSH)抑制治疗后的临床转归,以期为临床 131I治疗决策提供依据。
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备注信息
A
林岩松,Email: mocdef.3ab618691gnosnaynil
B

赵宁宁:研究实施、论文撰写;慕转转:研究实施与指导;郭文婷、魏星:研究指导;林岩松:研究指导、论文修改、经费支持

C
所有作者声明无利益冲突
D
国家重点研发计划 (2019YFE0106400)
中国医学科学院医学与健康科技创新工程 (2020-I2M-2-003)
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