Active surveillance for a small low-risk papillary thyroid cancer: a 10-year prospective, observational study in an Italian tertiary care centre
Eleonora Molinaro, Arianna Ghirri, Alessandro Prete, Valeria Tascini, Antonio Matrone, Paolo Piaggi, Gabriele Materazzi, Liborio Torregrossa, Clara Ugolini, Rossella EliseiObjective
To evaluate the long-term safety and feasibility of active surveillance (AS) for Italian patients with low-risk papillary thyroid microcarcinoma (mPTC) and to analyse trends in patient enrolment and factors associated with discontinuation of surveillance. This study represents the first prospective European investigation with long-term follow-up assessing AS for mPTC.
Design
Prospective, observational, non-randomised study with a duration of 10 years (2014–2024).
Setting
Single tertiary referral centre (University Hospital of Pisa, Italy).
Participants
260 adult patients with a mPTC (≤13 mm) who voluntarily opted for AS instead of immediate surgery.
Interventions
AS consisting of periodic clinical evaluation and neck ultrasonography every 6 months for the first 2 years and annually thereafter. Surgery was recommended only in the presence of predefined disease progression or at patient request.
Main outcome measures
Rates of disease progression, delayed surgical intervention, oncologic outcomes after surgery and patient discontinuation of AS.
Results
A total of 260 patients were enrolled and followed for up to 10 years. Disease progression occurred in approximately 5% of patients. All patients who underwent delayed surgery achieved excellent outcomes, with no evidence of recurrence after a median postoperative follow-up of 43.5 months. No disease-specific deaths occurred during AS or after surgery. Over the study period, patient enrolment progressively increased, reflecting growing acceptance of AS. However, 18.5% of patients discontinued surveillance without evidence of progression, most frequently within the first year. Younger age and cytology suspicious for malignancy were associated with higher dropout rates.
Conclusions
This study provides the first long-term prospective evidence that AS is a safe and feasible management strategy for patients with mPTC also in a European country. These findings support AS as a valid first-line approach and reinforce the need for improved patient education to optimise adherence and reduce unnecessary surgery.