Objective: To investigate the oncological outcomes of active surveillance (AS) in patients showing thyroid nodules measuring≤1 cm with highly suspicious ultrasound features. Methods: A prospective single-center cohort study. A total of 534 patients with highly suspicious thyroid nodules (2015 American Thyroid Association Nodule Sonographic Patterns and Risk of Malignancy: High Suspicion) were enrolled in this study, the patients received AS at Peking Union Medical College Hospital between January 2017 and November 2022 to assess oncological outcomes (disease progression, recurrence/metastasis rate, etc). The patients were followed up every 6 months for physical examination and neck ultrasound examination. And the value of tumor volume changes in evaluating tumor enlargement was explored too. Results: There were 413 females and 121 males in this cohort, with a mean age of (42.6±11.8) years. During a median follow-up period of 45.6 months (ranged from 3.5 to 176.0 months), disease progression occurred in 26 patients (4.9%) with highly suspicious thyroid nodules, characterized by a minimum 3-mm increase in tumor diameter in 19 patients (3.6%) and lymph node metastases in 7 patients (1.3%). Forty-seven (8.8%) patients opted for delayed surgery, with 29 patients due to a change in preference. There was no significant differences in pathologic and follow-up outcomes between patients with disease progression and preference change. Patients aged≤40 years had a higher cumulative incidence of 5-year disease progression than those aged>40 years (4.9% vs 1.9%, P=0.060). No patients experienced distant metastases or deaths. Among the 595 high-risk thyroid nodules with continuous volume assessment results and an increase in nodule diameter of less than 3 mm (including all high-risk nodules in patients with single or multiple nodules), 184 (30.9%) and 79 (13.3%) nodules exhibited volume increases of more than 50% and 100%, respectively, in multiple measurements. Among the nodules with volume changes exceeding 50% and 100%, the proportion of nodules with a baseline tumor diameter of≤0.5 cm was significantly higher than those with a diameter of>0.5 cm, at 69.0% vs 31.0% (P<0.001) and 77.2% vs 22.8% (P<0.001), respectively. Conclusions: Active surveillance in patients with highly suspicious subcentimeter thyroid nodules has good short-term oncological outcomes and can be considered a safe alternative to surgery. Due to the large variability in the measurement results of tumor volume, it is not suitable as an indicator for evaluating tumor enlargement.
目的： 报道长径≤1 cm高风险甲状腺结节患者主动监测的肿瘤学结局。 方法： 前瞻性、单中心队列研究，纳入2017年1月至2022年11月就诊于中国医学科学院北京协和医院的534例经超声评估为具有高风险甲状腺结节（美国甲状腺协会指南甲状腺结节超声风险分层标准评估为高度可疑恶性结节）的患者，并进行主动监测，入组患者每6个月随诊1次，行体格检查及颈部超声检查。评估随诊过程中患者的肿瘤学结局（疾病进展、疾病复发/转移率等），同时探索了肿瘤体积变化对于评估疾病进展的价值。 结果： 所有患者中，女413例（77.3%），男121例（22.7%），年龄（42.6±11.8）岁。在中位45.6个月（3.5~176.0个月）的随访期间，534例高风险甲状腺结节患者中，共26例（4.9%）出现疾病进展，其中19例（3.6%）肿瘤长径增大≥3 mm，7例（1.3%）发现淋巴结转移。47例患者因各种原因行延迟手术，其中29例原因为意愿改变。延迟手术患者中，疾病进展患者与改变意愿患者的病理结果与随诊结局无明显差别。年龄≤40岁患者的5年疾病进展累积发生率较>40岁患者高（4.9%比1.9%，P=0.060）。所有患者均无远处转移和死亡发生。在可获得连续体积监测数据且结节长径增大未超过3 mm的595个高风险甲状腺结节中，多次测量中出现过体积增大超过50%和100%的结节分别有184个（30.9%）和79个（13.3%）；在体积变化超过50%和100%的结节中，基线肿瘤长径≤0.5 cm结节的比例均明显高于>0.5 cm的结节，分别为（69.0%比31.0%，P<0.001）和（77.2%比22.8%，P<0.001）。 结论： 长径≤1 cm的高风险甲状腺结节患者采取主动监测短期肿瘤学结局较好，可考虑作为手术的替代方案。由于病灶体积测量结果的变异度大，其并不适宜作为评估病灶增大的指标。.