- Adjuvant chemotherapy (ACT) failed to extend survival and increased toxicity in patients with high-grade uterine leiomyosarcoma (LMS) who were participating in a prematurely terminated phase 3 study.
Why this matters
- Observation remains the standard of care in these patients.
- Phase 3 randomized study of 38 patients (vs targeted accrual, 216) with uterus-limited high-grade LMS who underwent complete hysterectomy±bilateral salpingo-oophorectomy.
- Patients received either ≥1 cycle of ACT (gemcitabine+docetaxel followed by doxorubicin; n=17) or observation (n=18).
- Funding: National Cancer Institute; NRG Oncology; Memorial Sloan Kettering Cancer Center; others.
- Median follow-up for was 19.1 months.
- 47% of patients in the ACT group experienced grade 3/4 adverse events.
- 1 patient in the observation group had grade 3 hypertension.
- 5 patients in the ACT group and 1 in the observation group died.
- The restricted mean estimated OS was 34.3 and 46.4 months in the ACT and observation groups, respectively.
- The restricted mean estimated recurrence-free survival was 18.1 and 14.6 months, respectively in the ACT and observation group.
- Study terminated prematurely due to slow accrual.