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韩国甲状腺癌筛查的终点:甲状腺专家的观点。

Endpoints for screening thyroid cancer in the Republic of Korea: thyroid specialists' perspectives.

作者信息

An J H, Kim H Y, Kim S G, Dralle H, Randolph G W, Piantanida E, Tanda M L, Dionigi G

机构信息

Division of Endocrinology, Department of Internal Medicine, KUMC Thyroid Center, Korea University College of Medicine, Seoul, Korea.

Department of Surgery, KUMC Thyroid Center, Korea University College of Medicine, Seoul, Korea.

出版信息

J Endocrinol Invest. 2017 Jun;40(6):683-685. doi: 10.1007/s40618-016-0596-4. Epub 2016 Dec 22.

Abstract

Cancer screening is aimed primarily at reducing deaths from the specific cancer. Thyroid-specific cancer mortality may be the most ambitious endpoint for obtaining estimates of screening effect. Numerous observations have accumulated over the years, indicating that thyroid cancer mortality endpoint has been difficult to study and is confounded by population heterogeneity, provision of randomization, and requirement of large cohorts with sufficiently long follow-up due to the excellent prognosis of the cancer. Accordingly, it may be important to reconsider how to best measure thyroid cancer screening efficacy. Recommendations against thyroid cancer screening should be based upon trials designed to evaluate its effectiveness not only in significant reduction in cancer mortality, but also of other distinct endpoints. It is desirable to evaluate derivative endpoints that can reliably predict reductions in mortality. The term "derivative" means a variable that is related to the true endpoint and is likely to be observable before the primary endpoint. Derivative endpoints may include thyroid cancer incidence, the proportion of early-stage tumors detected, more treatable stage, the identification of small tumors (to maintain in observation), decrease in the number of people who develop metastatic disease, the increased chance of lesser extent surgery, and the application of minimally invasive approaches, as well as no need for lifelong thyroid replacement therapy, a consistent follow-up, low-dose or no RAI administration and risk factor assessments where case findings should be continuous. The Korean guidelines for thyroid cancer national-level screening were published by a relevant group of multidisciplinary thyroid experts. It was concluded that the evidence is insufficient to balance the benefits and harms of thyroid cancer screening. However, the paper seems to raise the necessary investments in future research and demand a complete analysis for derivative endpoints, and offer screening participants with complete information necessary to make decisions that will provide them with the most value when a small thyroid cancer is screen-identified.

摘要

癌症筛查主要旨在降低特定癌症导致的死亡。甲状腺特异性癌症死亡率可能是用于评估筛查效果的最具挑战性的终点指标。多年来积累了大量观察结果,表明甲状腺癌死亡率终点指标难以研究,且因人群异质性、随机化的实施以及由于该癌症预后良好而需要有足够长时间随访的大型队列而受到混淆。因此,重新考虑如何最佳衡量甲状腺癌筛查效果可能很重要。反对甲状腺癌筛查的建议应基于旨在评估其有效性的试验,不仅要评估在显著降低癌症死亡率方面的有效性,还要评估在其他不同终点指标方面的有效性。期望评估能够可靠预测死亡率降低的衍生终点指标。“衍生”一词是指与真实终点相关且可能在主要终点之前就可观察到的变量。衍生终点指标可能包括甲状腺癌发病率、检测到的早期肿瘤比例、更易治疗的阶段、小肿瘤的识别(以便持续观察)、发生转移性疾病的人数减少、进行范围较小手术的机会增加、微创方法的应用,以及无需终身甲状腺替代治疗、持续一致的随访、低剂量或不进行放射性碘给药以及风险因素评估(病例发现应持续进行)。韩国甲状腺癌国家级筛查指南由多学科甲状腺专家相关小组发布。得出的结论是,证据不足以平衡甲状腺癌筛查的利弊。然而,该论文似乎提出了对未来研究的必要投资,并要求对衍生终点指标进行全面分析,为筛查参与者提供做出决策所需的完整信息,当筛查发现小甲状腺癌时,这些信息将为他们提供最大价值。

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