Limited data are available on the impact on quality of life (QoL) of AS, that is an alternative to IS given the low risk of mortality and recurrence of PTMCs.

To study the impact on QoL we aimed to randomize PTMC pts 1:1 to AS or IS, allowing to those refusing randomization to choose AS or IS within two observational cohorts. Primary endpoint was QoL (EORTC QLQ-C30), but also anxiety/depression (HADS), and safety (CTCAE v 5.0 and PRO CTCAE questionnaire) were assessed. Fourty randomized patients were required

From April, 2016 to March, 2023, 70 patients were enrolled at one centre, but only 4 accepted randomization. Results are descriptive only. Among 30 AS pts, 4 underwent delayed surgery due to progressive disease (1 case) or anxiety (3 cases). Pts were mainly female (58/70; 83%), median age was 52yrs (IQR 46-61) in AS and 37yrs (IQR 30-46) in IS. Median tumor diameter was 8 and 10 mm in AS and IS, respectively. Cardiovascular comorbidity was reported in 3 AS pts vs none in IS. After treatment choice, baseline PRO-CTCAE, QoL and HADS showed some statistically significant differences between pts choosing AS or IS: those choosing AS had less problems of concentration, less headache, less anxiety, less depression, better scores of cognitive emotional, role and social functioning scales, less fatigue, and less sleeping disturbance.

The MITICA randomized trial failed, but available data suggest that the choice of undergoing IS for PTMC may be associated with immediate worsening of QoL.