Abstract
BackgroundPatients with recurrent/metastatic uterine leiomyosarcoma (U-LMS) have a dismal prognosis. This phase II study aims to evaluate trabectedin efficacy and safety in advanced U-LMS.MethodsEligible patients had received ≥ one line of chemotherapy. Gemcitabine ± docetaxel naive patients were randomised to Arm A: trabectedin 1.3 mg/m2 or calibration Arm B: gemcitabine 900 mg/m2 and docetaxel 75 mg/m2. Patients who had already received gemcitabine ± docetaxel directly entered Arm A. Primary end-point: 6-month progression-free rate (PFS-6). The null hypothesis that the true PFS-6 = 14% was tested against a one-sided alternative. This design yielded a 5% type I error rate and 90% power when the true PFS-6 is 25%.ResultsOverall, 126 patients entered Arm A (45 from randomisation and 81 directly) and 42 Arm B. Arm A patients characteristics: median age = 57; ≥2 previous chemotherapy lines = 37.4%; metastatic disease = 93%. The study met the condition for trabectedin activity: PFS-6 = 35.2% (95% CI: 26.2–45). No difference in PFS by the number of previous chemotherapy lines emerged. Median OS = 20.6 months (IQR: 8–36.4). In Arm B, the PFS-6 = 51.5% (95% CI: 33.5–69.2). No toxic deaths occurred. In Arm A, only 4 patients interrupted treatment for toxicity.ConclusionsTrabectedin is active and well tolerated, retaining similar efficacy across one to three previous lines of chemotherapy.
Highlights
Uterine leiomyosarcoma [uterine leiomyosarcoma (U-LMS)] accounts for 1.3% of all uterine malignancies, with an estimated annual incidence of 0.55 per 100,000 women.[1]
From April 2010 through January 2016, 168 women with persistent/recurrent or metastatic U-LMS already treated with chemotherapy were entered into this trial from 26 Italian Centres
The PFS-6 for patients treated with trabectedin was 35.2% and such result is consistent with the literature
Summary
Uterine leiomyosarcoma [U-LMS] accounts for 1.3% of all uterine malignancies, with an estimated annual incidence of 0.55 per 100,000 women.[1]. Patients with metastatic disease at diagnosis, or with early recurrence after initial treatment, except for a subset of patients with completely resectable disease, have a dismal prognosis and usually their median survival is
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