title: Ifosfamide/liposomal daunorubicin is a well tolerated and active first-line chemotherapy regimen in advanced soft tissue sarcoma: results of a phase II study.
abstract: BACKGROUND
  The anthracycline/ifosfamide combination is the most effective chemotherapy in soft tissue sarcoma. To improve the tolerability and potential efficacy of this combination, the authors combined a moderate dose of continuous infusion ifosfamide with liposomal daunorubicin (L-Dauno).
  
  
  METHODS
  In a single-arm, Phase II study, 40 patients with a median age of 57 years (range, 19-78 years) were enrolled. Of these, 35 patients were treated with first-line chemotherapy. The treatment regimen was comprised of ifosfamide at a dose of 5 g/m(2) over 24 hours and L-Dauno at a dose of 100 mg/m(2) every 4 weeks with granulocyte-colony-stimulating factor support.
  
  
  RESULTS
  Eleven (31%) of 35 anthracycline/ifosfamide-naive patients achieved a partial/complete response, 6 patients (17%) had stable disease, and 13 patients (37%) had disease progression. Three patients were not evaluable, and there were two intermittent deaths. The median time to disease progression was 6 months, the median overall survival was 14 months, and the median time to treatment failure was 15 months. Toxicity was tolerable.
  
  
  CONCLUSIONS
  The combination of Ifosfamide and L-Dauno was found to be a highly active chemotherapy regimen for first-line treatment of soft tissue sarcoma. Therefore, we believe randomized studies with this regimen are warranted.
authors.affiliation: Medizinische Klinik III, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany. janmichael.siehl@charite.de
authors.forename: Jan M
authors.initials: JM
authors.lastname: Siehl
authors.forename: Eckhard
authors.initials: E
authors.lastname: Thiel
authors.forename: Alexander
authors.initials: A
authors.lastname: Schmittel
authors.forename: Gero
authors.initials: G
authors.lastname: Hütter
authors.forename: Peter M
authors.initials: PM
authors.lastname: Deckert
authors.forename: Hubert
authors.initials: H
authors.lastname: Szelényi
authors.forename: Ulrich
authors.initials: U
authors.lastname: Keilholz
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003630:Daunorubicin / Q000008:administration & dosage; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007262:Infusions, Intravenous; D008081:Liposomes; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D008081:Liposomes; D016179:Granulocyte Colony-Stimulating Factor; D007069:Ifosfamide; D003630:Daunorubicin