Trabectedin (Tr) in the treatment of advanced uterine leiomyosarcomas (U-LMS): Results of a pooled analysis of five single-agent phase II studies using the recommended dose.

Authors:
  • IJI. R. Judson
    I. R. Judson
  • JBJ. Blay
    J. Blay
  • SCS. P. Chawla
    S. P. Chawla
  • ACA. Le Cesne
    A. Le Cesne
  • JVJ. Verweij
    J. Verweij
  • MMM. von Mehren
    M. von Mehren
  • JPJ. Pontes
    J. Pontes
  • EBE. Bayever
    E. Bayever
  • GDG. D. Demetri
    G. D. Demetri
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Abstract
10028 Background: Trabectedin is approved in Europe and 19 other countries around the world for second-line treatment of advanced soft tissue sarcomas (STS), with activity documented in several phase II studies. Uterine sarcoma represent 1% of all gynecological malignancies and 30% of all uterine sarcoma are U-LMS. A pooled analysis of activity and tolerability of Tr in U-LMS patients (pts) from five phase II trials is presented. Methods: Retrospective analysis was done on data from 5 different trials, with a total of 62 generally pretreated pts with advanced U-LMS (prior anthracycline-based chemotherapy: 91.9%; prior surgery: 98.4%; prior radiotherapy: 48.4%), exposed to a median of two prior chemotherapy lines (range 0-6), received iv Tr 1.5 mg/m2 24-h q3wk. Efficacy endpoints were response rate (RR) by investigator assessment (IA), progression-free survival (PFS) and overall survival (OS). Safety was also analyzed. Results: Median age 53 (range:34-75) years; median No. cycles 3 (1-38); median relative ...