title: Optimizing clinical care in patients with advanced soft tissue sarcoma: a phase II study of a new schedule of high-dose continuous infusion ifosfamide and doxorubicin combination.
abstract: BACKGROUND
  Ifosfamide and doxorubicin combination is an active regimen for patients with advanced soft tissue sarcomas (STS) but is burdened by high toxicity. A phase II trial was designed to assess the activity of continuous infusion ifosfamide and doxorubicin combination.
  
  
  METHODS
  Thirty-four chemotherapy-naive patients with advanced STS were treated with ifosfamide (13 g/m(2)/12 days as continuous infusion) and doxorubicin (75 mg/m(2) on day 8) every 28 days with granulocyte colony-stimulating factor.
  
  
  RESULTS
  The major toxicity was hematological: grade 3/4 neutropenia, anemia and thrombocytopenia occurred in 63, 30 and 12% of patients, respectively. The disease control rate was 68% and the median time to progression was 7.1 months. Among leiomyosarcomas, 2 partial responses and 4 stable diseases were observed.
  
  
  CONCLUSIONS
  Our study confirms that the ifosfamide and doxorubicin combination has a very low non-hematological toxicity profile. This regimen attained a high disease control rate with moderate activity. Further investigation into leiomyosarcoma is warranted.
authors: Divisions of New Drug Development, European Institute of Oncology, Milan, Italy. tommaso.de-pas@ieo.it
authors: T
authors: T
authors: De Pas
authors: G
authors: G
authors: Rosati
authors: G
authors: G
authors: Spitaleri
authors: C
authors: C
authors: Boni
authors: A
authors: A
authors: Tucci
authors: S
authors: S
authors: Frustaci
authors: R
authors: R
authors: Scalamogna
authors: D
authors: D
authors: Radice
authors: S
authors: S
authors: Boselli
authors: F
authors: F
authors: Toffalorio
authors: C
authors: C
authors: Catania
authors: C
authors: C
authors: Noberasco
authors: A
authors: A
authors: Delmonte
authors: F
authors: F
authors: Vecchio
authors: F
authors: F
authors: de Braud