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安罗替尼联合碘-125粒子植入治疗碘难治性甲状腺癌的疗效与安全性

Efficacy and safety of anlotinib combined with I seed implantation for iodine-refractory thyroid cancer.

作者信息

Chen Zhijun, Tang Xinlan, Tan Liling, Su Yu, Wang Wenjun, Wu Zhen

机构信息

Department of Nuclear Medicine, Jiangxi Cancer Hospital, Nanchang, Jiangxi, China.

Nanchang University, Nanchang, Jiangxi, China.

出版信息

Front Endocrinol (Lausanne). 2025 Aug 22;16:1587412. doi: 10.3389/fendo.2025.1587412. eCollection 2025.

Abstract

BACKGROUND AND OBJECTIVE

Radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) remains challenging to treat due to a lack of effective therapies. This study aimed to evaluate the efficacy and safety of combining anlotinib with iodine-125 (I) seed implantation in patients with RAIR-DTC.

METHODS AND MATERIALS

We retrospectively compared three treatment groups in 52 patients with advanced RAIR-DTC: anlotinib monotherapy (Group A, = 14), I seed brachytherapy monotherapy (Group B, = 25), and combined therapy (Group C, = 13). Clinical outcomes including local progression-free survival (LPFS), overall survival (OS), tumor response, serum thyroglobulin (Tg) levels, and adverse events were analyzed.

RESULTS

As of February 2025, the combination therapy group achieved a longer median LPFS (42.2 months) than either monotherapy group (18.6-18.7 months; = 0.023) and a higher objective response rate at 6 months (77% vs. 21-32% with monotherapies; < 0.05). Tumor volumes in all groups decreased after treatment, with the greatest reduction within 6 months in the combination group ( < 0.001). By 12 months, response differences between groups narrowed, and median OS was similar across groups (~22-43 months, = 0.425). Serum Tg levels declined significantly from baseline in all groups. No major procedural complications occurred, and treatment-related adverse reactions were mostly mild (Grade 1-2) and comparable among groups.

CONCLUSION

Combining I seed brachytherapy with anlotinib demonstrated superior short-term tumor control and prolonged local disease remission in RAIR-DTC, without increasing toxicity. This combination may offer a promising therapeutic option for RAIR-DTC, pending further validation in larger studies.

CLINICAL TRIAL REGISTRATION

https://clinicaltrials.gov, identifier NCT06362772.

摘要

背景与目的

由于缺乏有效的治疗方法,放射性碘难治性分化型甲状腺癌(RAIR-DTC)的治疗仍然具有挑战性。本研究旨在评估安罗替尼联合碘-125(I)粒子植入治疗RAIR-DTC患者的疗效和安全性。

方法与材料

我们回顾性比较了52例晚期RAIR-DTC患者的三个治疗组:安罗替尼单药治疗组(A组,n = 14)、I粒子近距离放射治疗单药治疗组(B组,n = 25)和联合治疗组(C组,n = 13)。分析了局部无进展生存期(LPFS)、总生存期(OS)、肿瘤反应、血清甲状腺球蛋白(Tg)水平和不良事件等临床结局。

结果

截至2025年2月,联合治疗组的中位LPFS(42.2个月)长于单药治疗组(18.6 - 18.7个月;P = 0.023),且6个月时的客观缓解率更高(77% vs. 单药治疗组的21% - 32%;P < 0.05)。治疗后所有组的肿瘤体积均减小,联合组在6个月内减小最为显著(P < 0.001)。到12个月时,组间反应差异缩小,各组的中位OS相似(约22 - 43个月,P = 0.425)。所有组的血清Tg水平均较基线显著下降。未发生重大手术并发症,治疗相关不良反应大多为轻度(1 - 2级),且组间相当。

结论

I粒子近距离放射治疗联合安罗替尼在RAIR-DTC中显示出卓越的短期肿瘤控制效果,并延长了局部疾病缓解期,且未增加毒性。在更大规模研究中进一步验证之前,这种联合治疗可能为RAIR-DTC提供一种有前景的治疗选择。

临床试验注册

https://clinicaltrials.gov,标识符NCT06362772。

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