Adjuvant epirubicin with or without Ifosfamide for adult soft-tissue sarcoma

Am J Clin Oncol. 2002 Oct;25(5):468-73. doi: 10.1097/00000421-200210000-00009.

Abstract

This randomized study compared the efficacy of epirubicin-based adjuvant chemotherapy on the disease-free interval (DFI) and overall survival of patients with high-risk soft-tissue sarcomas. After curative surgery, 43 of the 88 enrolled patients were assigned to surgery with or without radiotherapy and 45 to surgery plus chemotherapy (26 epirubicin, 19 epirubicin + ifosfamide) with or without radiotherapy. The trial closed prematurely because of poor patient accrual. There was a statistical significant difference in the 5-year disease-free survival of the patients receiving adjuvant chemotherapy with or without radiotherapy (69%) and that of those treated with surgery with or without radiotherapy (44%) ( p= 0.01). The 5-year survival of the patients treated with adjuvant chemotherapy with or without radiotherapy was 72% as against 47% of those treated with surgery with or without radiotherapy ( p= 0.06). The power of the study was 0.65 for both the DFI and overall survival. The results of the study suggest a possible advantage of epirubicin-based adjuvant chemotherapy in patients with soft-tissue sarcoma at high risk of relapse.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Antibiotics, Antineoplastic / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chemotherapy, Adjuvant
  • Combined Modality Therapy
  • Epirubicin / administration & dosage
  • Epirubicin / therapeutic use*
  • Female
  • Humans
  • Ifosfamide / administration & dosage
  • Male
  • Middle Aged
  • Sarcoma / drug therapy*
  • Sarcoma / radiotherapy
  • Sarcoma / surgery
  • Survival Analysis

Substances

  • Antibiotics, Antineoplastic
  • Epirubicin
  • Ifosfamide