Effect of high-dose ifosfamide in advanced soft tissue sarcomas. A multicentre phase II study of the EORTC Soft Tissue and Bone Sarcoma Group.

Abstract

In this phase II study the effect of high-dose ifosfamide (HDI) given as a 3-day continuous infusion at a dose of 12 g/m2 repeated every 4 weeks with adequate mesna protection and hydration was evaluated in patients with advanced soft tissue sarcomas. A total of 124 patients entered the trial of which 10 were ineligible. HDI was given both as first-line and second-line chemotherapy. Median age was 46 years (19-66 years). Median World Health Organization (WHO) performance status was 1 (0-1). Fifty two per cent of the patients were males. The predominant histology was leiomyosarcoma (33%). A maximum of six cycles was given. At the time of analysis 55 patients have died. The partial response (PR) rate was 16%. The median time to progression was 15 weeks. 8 of the 18 responding patients (44%) had synovial sarcomas, whereas only 5% of the patients having leiomyosarcomas responded. The grade 3 + 4 haematological toxicity encountered was neutrophils in 78% and platelets in 12%. The major grade 3 + 4 non-haematological toxicities encountered were febrile neutropenia in 39%, infection in 20%, and acute renal failure in 4%. In conclusion, it is possible to administer HDI on a multicentre basis, but the toxicity is substantial. HDI given as a continuous infusion at this dose cannot be recommended as the standard treatment of advanced soft tissue sarcomas, even in selected patients.

• Authors: O S Nielsen, I Judson, Q van Hoesel, A le Cesne, H J Keizer, J Y Blay, A van Oosterom, J A Radford, L Svancárová, K Krzemienlecki, C Hermans, M van Glabbeke, J W Oosterhuis, J Verweij
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 36 Issue 1 Pg. 61-7 (Jan 2000) ISSN: 0959-8049 [Print] England
• PMID: 10741296 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Antineoplastic Agents, Alkylating
• Ifosfamide

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Alkylating (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Humans
• Ifosfamide (administration & dosage, adverse effects)
• Male
• Middle Aged
• Patient Compliance
• Sarcoma (drug therapy, mortality)
• Survival Analysis