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

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

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132 Citaten (Scopus)

Samenvatting

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. Copyright (C) 2000 Elsevier Science Ltd.

Originele taal-2Engels
Pagina's (van-tot)61-67
Aantal pagina's7
TijdschriftEuropean Journal of Cancer
Volume36
Nummer van het tijdschrift1
DOI's
StatusGepubliceerd - jan. 2000
Extern gepubliceerdJa

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