RAI 难治性分化型甲状腺癌的实际应用模式和结果

IF 3.5 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Andrew G Gianoukakis, Jennifer H. Choe, Daniel W. Bowles, Marcia S. Brose, Lori Wirth, Taofeek Owonikoko, Svetlana Babajanyan, Francis P. Worden
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引用次数: 0

摘要

背景:放射性碘难治性(RAI-R)分化型甲状腺癌(DTC)患者开始使用多激酶抑制剂(MKIs)的最佳时机仍不明确。因此,我们评估了美国(US)和美国以外地区(非US)无症状进展期 RAI-R DTC(≥1 个直径≥1 厘米的病灶)患者的实际治疗模式和疗效。方法:在这项前瞻性、非介入、开放标签的研究中,符合条件的患者由主治医生在研究开始时选择接受 MKI 治疗(队列 1)或接受主动监测(队列 2)。队列 2 患者可在之后过渡到 MKI 治疗。研究的主要终点是研究开始后出现症状进展的时间(TTSP)。对数据进行描述性比较。如果终点无法估计,则计算36个月的比率:在 647 名患者中,478 人接受了主动监测(队列 2),169 人接受了 MKI 治疗(队列 1)。美国患者接受监测的比例(92.6%)高于非美国患者(66.9%)。有资格接受 MKI 治疗的美国和非美国患者中,有一半最初患有美国甲状腺协会(ATA)低至中危疾病。在队列 2 中,美国和非美国患者自研究开始后 36 个月的 TTSP 率分别为 65.6% 和 66.5%。随后接受治疗的队列2患者在美国和非美国的36个月TTSP率分别为30.8%和55.8%:结论:对于无症状的进行性 RAI-R DTC 患者来说,积极监测是一个可行的选择。然而,对其他患者来说,使用 MKI 治疗进行早期干预可能更合适。需要进一步研究来确定哪些患者最适合接受主动监测。注册:NCT02303444
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World Practice Patterns and Outcomes for RAI-Refractory Differentiated Thyroid Cancer

Background: The optimal timing for initiating multi-kinase inhibitors (MKIs) in patients with radioactive iodine-refractory (RAI-R) differentiated thyroid cancer (DTC) remains unclear. Thus, we evaluated the real-world practice patterns and outcomes in asymptomatic patients with progressive RAI-R DTC (≥1 lesion ≥1 cm in diameter) in the United States (US) and outside the US (non-US).

Methods: In this prospective, non-interventional, open-label study, eligible patients were chosen by treating physicians to receive MKI therapy (Cohort 1) or undergo active surveillance (Cohort 2) at study entry. Cohort 2 patients were allowed to transition to MKI therapy later. The primary endpoint was time to symptomatic progression (TTSP) from study entry. Data were compared descriptively. When endpoints were inestimable, 36-month rates were calculated.

Results: Among 647 patients, 478 underwent active surveillance (Cohort 2) and 169 received MKI treatment (Cohort 1). Patients underwent surveillance at a higher rate in the US (92.6%) versus the non-US (66.9%). Half of US and non-US patients who qualified for MKI treatment had initial American Thyroid Association (ATA) low-to-intermediate-risk disease. Among Cohort 2, the 36-month TTSP rates from study entry were 65.6% and 66.5% in the US and non-US, respectively. Cohort 2 patients treated later demonstrated 36-month TTSP rates of 30.8% and 55.8% in the US and non-US, respectively.

Conclusions: Active surveillance is a viable option for asymptomatic patients with progressive RAI-R DTC. However, early intervention with MKI therapy may be more suitable for others. Further research is needed to identify patients who are optimal for active surveillance.

Registration: NCT02303444

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来源期刊
European Thyroid Journal
European Thyroid Journal Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
6.70
自引率
2.10%
发文量
156
期刊介绍: The ''European Thyroid Journal'' publishes papers reporting original research in basic, translational and clinical thyroidology. Original contributions cover all aspects of the field, from molecular and cellular biology to immunology and biochemistry, from physiology to pathology, and from pediatric to adult thyroid diseases with a special focus on thyroid cancer. Readers also benefit from reviews by noted experts, which highlight especially active areas of current research. The journal will further publish formal guidelines in the field, produced and endorsed by the European Thyroid Association.
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