Ifosfamide/liposomal daunorubicin is a well tolerated and active first-line chemotherapy regimen in advanced soft tissue sarcoma: results of a phase II study

Cancer. 2005 Aug 1;104(3):611-7. doi: 10.1002/cncr.21211.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Daunorubicin / administration & dosage
  • Disease Progression
  • Drug Administration Schedule
  • Female
  • Granulocyte Colony-Stimulating Factor / administration & dosage
  • Humans
  • Ifosfamide / administration & dosage
  • Infusions, Intravenous
  • Liposomes
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Sarcoma / drug therapy*
  • Sarcoma / pathology
  • Survival Rate
  • Treatment Outcome

Substances

  • Liposomes
  • Granulocyte Colony-Stimulating Factor
  • Ifosfamide
  • Daunorubicin