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Annals of Oncology 10:1211-1218, 1999
© 1999 European Society for Medical Oncology

research-article

A phase II study of cisplatin, ifosfamide and doxorubicin in operable primary, axial skeletal and metastatic osteosarcoma

P. A. Voûte1,, R. L. Souhami2, M. Nooij3, R. Somers4, H. Cortés-Funes5, J. W. van der Eijken6, J. Pringle7, P. C. W. Hogendoorn4, A. Kirkpatrick8, B. M. Uscinska9, M. van Glabbeke8, D. Machin10, S. Weeden9 The European Osteosarcoma Intergroup (EOI)

1Emma Kinderziekenhuis, Academic Medical Center Amsterdam, The Netherlands
2University College London Medical School London, UK
3Leiden University Medical Centre Leiden
4Antoni van Leeuwenhoek Ziekenhuis Amsterdam, The Netherlands
5Hospital Universidad 12 de Octubre Madrid, Spain
6Onze Lieve Vrouw Gasthuis Amsterdam, The Netherlands
7Royal National Orthopaedic Hospital London, UK
8EORTC Data Centre Brussels, Belgium
9Cancer Division, MRC Clinical Trials Unit London, UK
10NMRC Clinical Trials and Epidemiology Research Unit, Ministry of Health Singapore

Correspondence to: Prof. P. A. Voûte Emma Kinderziekenhuis, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

Background: Despite advances in the treatment of primary limb osteosarcoma, the outcome of patients with primary metastatic and axial skeletal disease remains poor. The European Osteosarcoma Intergroup have assessed a combination chemotherapy regimen consisting of ifosfamide (IFOS) 3 g/m2/dl–2, doxorubicin (DOX) 25 mg/m2/dl–3 i.v. bolus and cisplatin (CDDP) 100 mg/m2/dl.

Patients and methods: One hundred nine previously untreated patients with primary osteosarcoma were registered. Eligibility was confirmed in 103. At presentation, 45 eligible patients had metastatic disease, 15 axial skeletal primary tumours and 43 non-metastatic limb tumours.

Results: The major toxicities were myelosuppression (90%, grade 3 or 4) and nausea and vomiting (74%, grade 3 or 4).

Overall mean relative dose intensity (RDI) was 80% (88% CDDP, 75% IFOS, 81% DOX). Clinical response as measured by reduction in tumour volume occurred in 36% (95% confidence interval (95% CI): 27%–47%) of primary tumours. Response of pulmonary metastases to chemotherapy was seen in 33% (95% CI: 19%–49%). Good histological response (≥90% necrosis of the tumour) occurred in 33% (95% CI: 22%-45%) of resected tumours. Five-year survival was 62% in limb-non-metastatic, 41% in axial skeletal and 16% in limb metastatic patients.

Conclusions: This regimen is active in osteosarcoma but does not appear to be more active than the two-drug CDDP-DOX regimen currently recommended by EOI.

chemotherapy, osteosarcoma, relative dose intensity, survival, tumour response


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