Adjuvant chemotherapy in stage I–II uterine leiomyosarcoma: A multicentric retrospective study of 140 patients

•This is a retrospective analysis on adjuvant treatments of early stage uterine leiomyosarcoma.•Adjuvant chemotherapy does not improve disease-free and overall survival compared to observation.•Mitotic index and age resulted to be the most significant prognostic factors.

ObjectiveAbout 50–60% of patients with stage I–II uterine leiomyosarcoma (ULMS), primarily treated with surgery, relapse and die from progressive disease. In this retrospective study we describe the impact of adjuvant chemotherapy in this subset of patients.Methods140 women treated from 1976 to 2011 were included in the study. Univariate and multivariate analysis were used to test the association of clinical features and adjuvant treatments with overall survival (OS) and disease-free survival (DFS).Results62 women did not receive any further treatment after hysterectomy, 14 had radiotherapy (RT), 52 chemotherapy and 12 chemo-radiotherapy. Chemotherapy based on doxorubicin and ifosfamide combination was used in 54 cases. After a median follow-up of 63 months, 87 women (62%) have relapsed, and 62 (44%) have died. The vast majority of patients who relapsed had distant recurrences (72%).The 5 year median DFS and OS were 43% and 64% respectively. After 5 years of follow up 68.7% of women treated with chemotherapy (± RT) vs 65.6% of patients only observed were alive (p = 0.521). In the univariate analysis no factors had a statistical impact on DFS, while number of mitosis (> 20 × 10HPF), age (> 60 years) and adjuvant radiotherapy were found as negative prognostic factors for OS. In the multivariate analysis only mitosis and age remained significant for OS.ConclusionAdjuvant chemotherapy was not associated with a significant survival benefit and should not be considered as standard of care for patients with stage I–II ULMS until randomized clinical studies will give further information.