Beyond the 2-year treatment with sirolimus.
pain
RECURRENCE
Based on the 107 patients who completed at least 1 year of treatment, sirolimus resulted in feasibility of surgery in 14 patients (7 during the second year of sirolimus treatment and 7 after the 2-year sirolimus treatment) and sclerotherapy in 4 patients (all after the 2-year sirolimus treatment). While deemed feasible in an additional 2 patients after 2 years of treatment, surgery was refused, as clinical benefit was already met. Among the 61 patients who completed the 2-year sirolimus treatment, and after a median follow-up after sirolimus cessation of 17 months (ranging from 12 months to 36 months), 33 patients (54%) reported symptom recurrence (pain and/or functional limitation): 19 of them within 6 months after discontinuation of sirolimus, 8 between 6 and 12 months, and 6 after 12 months. Twenty-two patients (36%) restarted sirolimus (at the same dosage that previously resulted in the best clinical effect), after a median of 6 months (range 1–18 months) from discontinuation of treatment, due to marked symptom resurgence, all with subsequent clinical benefit (