Clinical Trials of Active Surveillance of Papillary Microcarcinoma of the Thyroid. 2016

Akira Miyauchi
Kuma Hospital, Center for Excellence in Thyroid Care, Kobe, Japan. miyauchi@kuma-h.or.jp.

BACKGROUND The incidence of thyroid cancer is increasing globally. This is mainly due to the increase in the detection of small papillary carcinomas, including papillary microcarcinomas (PMC) 1 cm or smaller. It was suggested recently that PMCs are overdiagnosed and overtreated. METHODS In 1993, the author proposed a clinical trial to compare surgery and observation for low-risk PMC at doctors' meeting in Kuma Hospital, which was approved and the trial started in the same year. Patients choose immediate surgery or observation. This paper shares our 22-year experience with the active surveillance of more than 2000 patients with low-risk PMC and compares the outcomes of immediate surgery with that of active observation. RESULTS The oncological outcomes of these management groups were similarly excellent. In our active surveillance trial on 1235 patients, 8% of patients showed tumor enlargement by 3 mm or more at 10 years of observation, and 3.8% of the patients showed novel appearance of lymph node metastasis at 10 years. Patients 40 years or younger tended to show progression of the disease. Patients with these slight progressions of the disease were successfully treated with a rescue surgery. None of the patients in both study groups died of the disease. However, incidences of unfavorable events, such as temporary vocal cord paralysis (VCP) and temporary and permanent hypoparathyroidism, were significantly higher in the immediate surgery group than in the observation group (4.1 vs. 0.6%, p < 0.0001; 16.7 vs. 2.8%, p < 0.0001; and 1.6 vs. 0.08%, p < 0.0001, respectively). Permanent VCP occurred in two of the surgery group. CONCLUSIONS As a result, although we still offer two options, immediate surgery or observation, to patients with low-risk PMC at Kuma Hospital, we now strongly recommend observation as the best choice.

UI MeSH Term Description Entries
D007564 Japan A country in eastern Asia, island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. The capital is Tokyo. Bonin Islands
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009367 Neoplasm Staging Methods which attempt to express in replicable terms the extent of the neoplasm in the patient. Cancer Staging,Staging, Neoplasm,Tumor Staging,TNM Classification,TNM Staging,TNM Staging System,Classification, TNM,Classifications, TNM,Staging System, TNM,Staging Systems, TNM,Staging, Cancer,Staging, TNM,Staging, Tumor,System, TNM Staging,Systems, TNM Staging,TNM Classifications,TNM Staging Systems
D011159 Population Surveillance Ongoing scrutiny of a population (general population, study population, target population, etc.), generally using methods distinguished by their practicability, uniformity, and frequently their rapidity, rather than by complete accuracy. Surveillance, Population
D002291 Carcinoma, Papillary A malignant neoplasm characterized by the formation of numerous, irregular, finger-like projections of fibrous stroma that is covered with a surface layer of neoplastic epithelial cells. (Stedman, 25th ed) Carcinomas, Papillary,Papillary Carcinoma,Papillary Carcinomas
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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