Strategies of Radioiodine Ablation in Patients with Low-Risk Thyroid Cancer
Strategies of Radioiodine Ablation in Patients with Low-Risk Thyroid Cancer
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DOI：
10.1056/nejmoa1108586
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发表时间：
2012-05-03
影响因子：
158.5
通讯作者：
Benhamou, Ellen
中科院分区：
文献类型：
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作者：
Schlumberger, Martin;Catargi, Bogdan;Benhamou, Ellen
背景目前尚不清楚放射性碘的管理是否提供任何好处后，低风险的甲状腺癌患者完全手术切除。在我们的随机、3期试验中，我们比较了两种促甲状腺激素刺激方法（甲状腺激素停药和使用重组人促甲状腺激素）和两种放射性碘（I-131）剂量（即，管理活动）（1.1 GBq和3.7 GBq）。入选标准为年龄≥ 18岁;分化型甲状腺癌的甲状腺全切除术;肿瘤淋巴结转移（TNM）分期，根据手术标本的病理检查（p）确定，为pT 1（肿瘤直径1 - 2 cm）和任何N分期，或pT 2N 0;无远处转移;无碘污染。在放射性碘给药后8个月，通过颈部超声检查和测量重组人促甲状腺素刺激的甲状腺球蛋白评估甲状腺消融。比较是基于一个等效framework.ResultsThere是752例患者在2007年和2010年之间入组，92%的乳头状癌。未发生非预期严重不良事件。在684例有数据可评估的患者中，652例（95%）颈部超声检查正常，621例（95%）刺激甲状腺球蛋白水平为1.0 ng/ml或更低，未检测到甲状腺球蛋白抗体。684例患者中有631例（92%）完成了甲状腺消融。消融率之间的I-131剂量和之间的促甲状腺素刺激methods.ConclusionsThe使用重组人促甲状腺素和低剂量（1.1 GBq）术后放射性碘消融可能是足够的低风险甲状腺癌的管理。（由法国国家癌症研究所[印加]和法国卫生部资助; ClinicalTrials.gov编号，NCT 00435851;印加编号，RECF 0447。）
BackgroundIt is not clear whether the administration of radioiodine provides any benefit to patients with low-risk thyroid cancer after a complete surgical resection. The administration of the smallest possible amount of radioiodine would improve care.MethodsIn our randomized, phase 3 trial, we compared two thyrotropin-stimulation methods (thyroid hormone withdrawal and use of recombinant human thyrotropin) and two radioiodine (I-131) doses (i.e., administered activities) (1.1 GBq and 3.7 GBq) in a 2-by-2 design. Inclusion criteria were an age of 18 years or older; total thyroidectomy for differentiated thyroid carcinoma; tumor-node-metastasis (TNM) stage, ascertained on pathological examination (p) of a surgical specimen, of pT1 (with tumor diameter 1 to 2 cm) and any N stage, or pT2N0; absence of distant metastasis; and no iodine contamination. Thyroid ablation was assessed 8 months after radioiodine administration by neck ultrasonography and measurement of recombinant human thyrotropin-stimulated thyroglobulin. Comparisons were based on an equivalence framework.ResultsThere were 752 patients enrolled between 2007 and 2010; 92% had papillary cancer. There were no unexpected serious adverse events. In the 684 patients with data that could be evaluated, ultrasonography of the neck was normal in 652 (95%), and the stimulated thyroglobulin level was 1.0 ng per milliliter or less in 621 of the 652 patients (95%) without detectable thyroglobulin antibodies. Thyroid ablation was complete in 631 of the 684 patients (92%). The ablation rate was equivalent between the I-131 doses and between the thyrotropin-stimulation methods.ConclusionsThe use of recombinant human thyrotropin and low-dose (1.1 GBq) postoperative radioiodine ablation may be sufficient for the management of low-risk thyroid cancer. (Funded by the French National Cancer Institute [INCa] and the French Ministry of Health; ClinicalTrials.gov number, NCT00435851; INCa number, RECF0447.)