Phase ii prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy

A. Santoro, A. Comandone, U. Basso, H. Soto Parra, R. De Sanctis, E. Stroppa, I. Marcon, L. Giordano, F. R. Lutman, A. Boglione, A. Bertuzzi

Research output: Contribution to journalArticlepeer-review


Introduction: We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS). Patients and methods: An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A). Results: Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5) achieved partial response and 25 (32.9) stable disease; 6-month PFS rates were all histologies, 34.5; L, 38.4; and A, 56.3. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5 in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P 0.033). Treatment was well tolerated. Conclusions: Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials.

Original languageEnglish
Article numbermds607
Pages (from-to)1093-1098
Number of pages6
JournalAnnals of Oncology
Issue number4
Publication statusPublished - Apr 2013


  • Angiosarcoma
  • Leiomyosarcoma
  • Soft tissue sarcoma
  • Sorafenib
  • Vascular sarcoma

ASJC Scopus subject areas

  • Oncology
  • Hematology


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