Bartenstein Peter, Calabuig Elisa Caballero, Maini Carlo Ludovico, Mazzarotto Renzo, Muros de Fuentes M Angustias, Petrich Thorsten, Rodrigues Fernando José Cravo, Vallejo Casas Juan Antonio, Vianello Federica, Basso Michela, Balaguer Marcelino Gómez, Haug Alexander, Monari Fabio, Vaňó Raquel Sánchez, Sciuto Rosa, Magner James
1 Department of Nuclear Medicine, University of Munich , Munich, Germany .
Thyroid. 2014 Mar;24(3):480-7. doi: 10.1089/thy.2013.0157. Epub 2014 Jan 17.
Few data exist on using thyrotropin alfa (recombinant human thyroid-stimulating hormone [rhTSH]) with radioiodine for thyroid remnant ablation of patients who have T4 primary tumors (invasion beyond the thyroid capsule).
A retrospective chart review protocol at nine centers in Europe was set up with special waiver of need for informed consent, along with a careful procedure to avoid selection bias when enrolling patients into the database. Data on 144 eligible patients with T4 tumors were collected (T4, N0-1, M0-1; mean age 49.7 years; 65% female; 88% papillary cancer). All had received (131)I remnant ablation following TSH stimulation with rhTSH or thyroid hormone withdrawal (THW) since January 2000 (rhTSH n=74, THW n=70). The primary endpoint was based on evaluation of diagnostic radioiodine scan thyroid bed uptake more than six months after the ablation procedure, while stimulated serum Tg was a secondary endpoint. Safety was evaluated within 30 days after rhTSH or (131)I.
Successful ablation judged by scan was achieved in 65/70 (92.9%) of rhTSH and in 61/67 (91.0%) of THW patients; the success rates were comparable, since noninferiority criteria were met. Although some patients in the initial cohort had tumor in cervical nodes and metastases, considering all evaluable patients regardless of various serum anti-Tg antibody assessments, the stimulated Tg was <2 ng/mL in 48/70 (68.6%) and 39/67 (58.2%) in rhTSH and THW groups respectively; if patients with anti-Tg antibody levels >30 IU/mL were excluded, the stimulated Tg was <2 ng/mL in 42/62 (67.7%) and 37/64 (57.8%) respectively. No serious adverse events occurred within the 30-day window after ablation.
Use of rhTSH as preparation for thyroid remnant ablation in patients with T4 primary tumors achieved a rate of ablation success that was high and noninferior to the rate seen after THW, and rhTSH was well tolerated.
关于使用促甲状腺素α（重组人促甲状腺激素[rhTSH]）联合放射性碘对T4期原发性肿瘤（侵犯超出甲状腺包膜）患者进行甲状腺残余组织消融的数据很少。
在欧洲的九个中心设立了一项回顾性病历审查方案，特别豁免了知情同意的要求，并制定了一项谨慎的程序以避免在将患者纳入数据库时出现选择偏倚。收集了144例符合条件的T4期肿瘤患者的数据（T4，N0 - 1，M0 - 1；平均年龄49.7岁；65%为女性；88%为乳头状癌）。自2000年1月以来，所有患者在rhTSH刺激或甲状腺激素撤减（THW）后接受了（131）I甲状腺残余组织消融（rhTSH组n = 74，THW组n = 70）。主要终点基于消融术后六个月以上对诊断性放射性碘扫描甲状腺床摄取情况的评估，而刺激后的血清Tg是次要终点。在rhTSH或（131）I治疗后30天内评估安全性。
根据扫描判断，rhTSH组65/70例（92.9%）和THW组61/67例（91.0%）实现了成功消融；由于满足非劣效性标准，成功率相当。尽管初始队列中的一些患者有颈部淋巴结肿瘤和转移，但考虑所有可评估的患者，无论血清抗Tg抗体评估情况如何，rhTSH组和THW组刺激后的Tg分别在48/70例（68.6%）和39/67例（58.2%）中<2 ng/mL；如果排除抗Tg抗体水平>30 IU/mL的患者，刺激后的Tg分别在42/62例（67.7%）和37/64例（57.8%）中<2 ng/mL。消融后30天内未发生严重不良事件。
对于T4期原发性肿瘤患者，使用rhTSH作为甲状腺残余组织消融的准备措施，消融成功率高且不劣于甲状腺激素撤减后的成功率，并且rhTSH耐受性良好。
