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1Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
2Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
3Department of Internal Medicine, National Cancer Center, Goyang, Korea.
4Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
5Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
6Department of Radiology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
7Department of Otorhinolaryngology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
8Department of Radiology, National Cancer Center, Goyang, Korea.
9Department of Otorhinolaryngology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
10Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
11Department of Otorhinolaryngology, National Cancer Center, Goyang, Korea.
12Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
13Department of Biomedical Science, Seoul National University College of Medicine, Seoul, Korea.
14Cancer Research Institute, Seoul National University, Seoul, Korea.
15Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
16Director General, Korea National Institute of Health, Cheongju, Korea.
Copyright © 2018 Korean Endocrine Society
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Participants are included if all following criteria are met:
- Agreement to participate in the study and signed the consent form
- A diagnosis of suspicious of malignancy or malignancy (Bethesda category V or VI) based on fine needle aspiration (FNA), or suggestive of malignancy or malignancy by core needle biopsy
- Age of ≥18 years
- A maximum nodule diameter of ≤1 cm
The overall exclusion criteria were:
- Unable or unwilling to attend regular follow-ups
- A diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV) based on FNA or, or benign, indeterminate by core needle biopsy
Patients were not excluded if they had:
- ≥2 unilateral or bilateral PTMCs
- Cytologically or histologically confirmed benign >1 cm nodules with intermediate or highly suspicious ultrasonographic findings (Korean Thyroid Imaging Reporting and Data System [K-TIRADS] Class 4–5)
- Cytologically unconfirmed >1 cm nodules with ultrasonographic findings suggestive of benign lesions (K-TIRADS Class 2–3)
- Hypothyroidism or hyperthyroidism
- Pregnancy before or during the study
- A family history of non-medullary thyroid cancer
Participants were allowed to choose AS if they fulfilled the following criteria:
- No evidence of organ involvement (e.g., esophagus, nerves, trachea, major vessels, or muscle) in imaging studies including high-resolution of ultrasonography (PTMC adjacent or abutting to organs were included if it is not suspected of organ involvement)
- No clinically suspicious or pathological diagnosis of lymph node/distant metastasis
- No poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants
Participants were recommended to undergo immediate surgery if they fulfilled the following criteria:
- Suspected organ involvement (e.g., trachea, esophagus, nerves, vessels, or muscles)
- Clinical suspicious or pathological diagnosis of lymph node/distant metastasis
- Poorly differentiated histology or a variant with a poor prognosis such as tall-cell, diffuse sclerosing, columnar cell, or solid variant
- Presence of Graves' disease with an indication for radioactive iodine therapy or surgery
Disease progression is defined as:
- A size increase of ≥3 mm in at least one dimension, or ≥2 mm in at least two dimensions
- Suspected organ involvement during the follow-up, such as trachea, esophagus, nerves, vessels, or muscles in imaging study including high-resolution ultrasonography
- Pathological diagnosis of lymph node/distant metastasis
Patients in the AS groups are also recommended to undergo surgery if:
- They elect to undergo surgery in the absence of progression
- Combined Graves' disease is suitable for radioactive iodine ablation therapy or surgery
- Clinical symptoms (hoarseness or dysphagia) during a vocal cord inspection suggest recurrent laryngeal nerve involvement.
CONFLICTS OF INTEREST: No potential conflict of interest relevant to this article was reported.
AUTHOR CONTRIBUTIONS: Drafting the work or revising: J.H.M., J.H.K., E.K.L., K.E.L., S.H.K. Acquisition, analysis, or interpretation of data: Y.K.K., W.J.J., C.Y.L., R.E.Y., Y.H., Y.S.S., M.J.K., S.W.C., S.J.K., E.J.J., J.Y.C., C.H.R., Y.J.L., J.H.H., Y.S.J., J.R., Y.H., S.K.P., H.K.S., K.H.Y. Conception or design: D.J.P., Y.J.P. Final approval of the manuscript: Y.J.P.
Variable | AS (n=419) | Surgery (n=313) | P value |
---|---|---|---|
Age at diagnosis, yr | 48.4±12.2 | 46.4±10.6 | 0.023 |
Age >55 years | 237 (56.5) | 190 (60.7) | 0.289 |
Female sex | 311 (74.4) | 247 (79.4) | 0.133 |
Maximal tumor diameter at diagnosis, mm | 6.2±1.9 | 6.6±2.0 | 0.008 |
Maximal tumor diameter ≥7 mm | 149 (35.3) | 144 (46.0) | 0.002 |
Follow-up duration, mo | 6.0 (5.0–8.0) | 5.0 (4.0–10.0) | <0.001 |
TSH, µIU/mL | 1.54 (1.01–2.23) | 1.28 (0.77–2.06) | 0.136 |
Free T4, ng/dL | 1.23 (1.12–1.35) | 1.27 (1.04–1.41) | 0.344 |
Total T3, ng/dL | 116 (94–130) | 99 (76–116) | 0.707 |
Thyroglobulin, ng/mL | 6.5 (2.7–10.9) | 3.5 (0.5–9.5) | 0.949 |
Values are expressed as mean±SD, number (%), or median (interquartile range). AS, active surveillance; TSH, thyroid-stimulating hormone; T4, thyroxine; T3, triiodothyronine.