title: Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracycline-based therapy.
abstract: BACKGROUND
  We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS).
  
  
  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.
authors.affiliation: Department of Oncology-Haematology, Humanitas Cancer Center, IRCCS, Milan, Italy. armando.santoro@cancercenter.humanitas.it
authors.forename: A
authors.initials: A
authors.lastname: Santoro
authors.forename: A
authors.initials: A
authors.lastname: Comandone
authors.forename: U
authors.initials: U
authors.lastname: Basso
authors.forename: H
authors.initials: H
authors.lastname: Soto Parra
authors.forename: R
authors.initials: R
authors.lastname: De Sanctis
authors.forename: E
authors.initials: E
authors.lastname: Stroppa
authors.forename: I
authors.initials: I
authors.lastname: Marcon
authors.forename: L
authors.initials: L
authors.lastname: Giordano
authors.forename: F R
authors.initials: FR
authors.lastname: Lutman
authors.forename: A
authors.initials: A
authors.lastname: Boglione
authors.forename: A
authors.initials: A
authors.lastname: Bertuzzi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007890:Leiomyosarcoma / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D000077157:Sorafenib
chemical_list: D018943:Anthracyclines; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D009536:Niacinamide; D000077157:Sorafenib