title: Testing new regimens in patients with advanced soft tissue sarcoma: analysis of publications from the last 10 years.
abstract: BACKGROUND
  The prognosis of advanced soft tissue sarcoma remains poor. Many phase II trials investigating new regimens have been published in the last 10 years.
  
  
  METHODS
  Full English-language reports of phase II clinical trials from January 1999 to October 2009 have been reviewed. We have defined those that provided 3- and 6-month progression-free survival rates (PFSR) >39% and 14%, respectively, as promising second-line regimens. For studies enrolling both chemonaive and pretreated patients, we have compared the reported PFSR3 to the expected PFSR3 of an active treatment administered in the same proportions of pretreated and nonpretreated patients.
  
  
  RESULTS
  Forty-nine trials were identified. Among the trials investigating new regimens in pretreated patients alone, the promising second-line regimens were ifosfamide, brostallicin, pazopanib (except in liposarcoma), temozolomide, trabectedin, dacarbazine-gemcitabine and docetaxel (Taxotere)-gemcitabine combinations (in uterine leiomyosarcoma). Among the trials enrolling both chemonaive and pretreated patients, most regimens reached the level of efficacy; moreover, in three trials, the reported PFSR3 was particularly high: weekly paclitaxel (Taxol) in angiosarcoma, docetaxel-gemcitabine combination (in uterine leiomyosarcoma) and oral perifosine.
  
  
  CONCLUSIONS
  In the past 10 years, several drugs or combinations have demonstrated promising activity in exploratory phase II trials and warrant further investigation in appropriate phase III trials.
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, EORTC, Brussels, Belgium; Oscar Lambret Comprehensive Cancer Centre and Lille-Nord-de-France University, Lille, France; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group, EORTC, Brussels, Belgium. Electronic address: n-penel@o-lambret.fr.
authors.forename: N
authors.initials: N
authors.lastname: Penel
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, EORTC, Brussels, Belgium; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group, EORTC, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Van Glabbeke
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, EORTC, Brussels, Belgium; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group, EORTC, Brussels, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Marreaud
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, EORTC, Brussels, Belgium; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group, EORTC, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Ouali
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, EORTC, Brussels, Belgium; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group, EORTC, Brussels, Belgium; Léon Bérard Comprehensive Cancer Centre, University Claude Bernard Lyon I, Lyon, France.
authors.forename: J Y
authors.initials: JY
authors.lastname: Blay
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, EORTC, Brussels, Belgium; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group, EORTC, Brussels, Belgium; Division of Surgical Oncology and Thoracic Surgery, Department of Surgery, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Hohenberger
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006801:Humans; D011379:Prognosis; D012509:Sarcoma / Q000175:diagnosis / Q000188:drug therapy*; D012983:Soft Tissue Neoplasms / Q000175:diagnosis / Q000188:drug therapy
chemical_list: D000970:Antineoplastic Agents