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Limb salvage with isolated perfusion for soft tissue sarcoma: could less TNF-α be better?

Bonvalot, S. ; Laplanche, A. ; Lejeune, F. ; Stoeckle, E. ; Le Péchoux, C. ; Vanel, D. ; Terrier, P. ; Lumbroso, J. ; Ricard, M. ; Antoni, G. ; Cavalcanti, A. ; Robert, C. ; Lassau, N. ; Blay, J. Y. ; Le Cesne, A.

In: Annals of Oncology, 2005, vol. 16, no. 7, p. 1061-1068

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    Title
    • Limb salvage with isolated perfusion for soft tissue sarcoma: could less TNF-α be better?
    Author
    • Bonvalot, S.. Departments of
    • Laplanche, A.. Public Health
    • Lejeune, F.. Multidisciplinary Oncology Center, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
    • Stoeckle, E.. Department of Surgery, Institut Bergonié, Bordeaux, France
    • Le Péchoux, C.. Radiotherapy
    • Vanel, D.. Radiology
    • Terrier, P.. Pathology
    • Lumbroso, J.. Nuclear Medicine and
    • Ricard, M.. Nuclear Medicine and
    • Antoni, G.. Public Health
    • Cavalcanti, A.. Departments of
    • Robert, C.. Medical Oncology, Institut Gustave Roussy, Villejuif, France
    • Lassau, N.. Radiology
    • Blay, J. Y.. Department of Medical Oncology, Centre Léon Bérard, Lyon, France
    • Le Cesne, A.. Medical Oncology, Institut Gustave Roussy, Villejuif, France
    Document Type
    • Postprint
    Language
    • English
    Published in
    • Annals of Oncology, 2005, vol. 16, no. 7, p. 1061-1068. Oxford University Press
    Other Version
    OAI-PMH Identifier
    • oai:doc.rero.ch:303937
    Summary
    Background: The optimal dose of TNF-α delivered by isolated limb perfusion (ILP) in patients with locally advanced soft tissue sarcoma is still unknown. Patients and methods: Randomised phase II trial comparing hyperthermic ILP (38-40°) with melphalan and one of the four assigned doses of TNF-α: 0.5 mg, 1 mg, 2 mg, and 3/4 mg upper/lower limb. The main end point was objective tumour response on MRI. Secondary end points were histological response, rate of amputation and toxicity. Resection of the remnant tumour was performed 2-3 months after ILP. The sample size was calculated assuming a linear increase of 10% in the objective response rates between each dose level group. Results: One hundred patients (25 per arm) were included. Thirteen per cent of patients had a systemic leakage with a cardiac toxicity in six patients correlated with high doses of TNF-α. Objective tumour responses were: 68%, 56%, 72% and 64% in the 0.5 mg, 1 mg, 2 mg and 3 or 4 mg arms, respectively (NS). Sixteen per cent of patients were not operated, 71% had a conservative surgery and 13% were amputated with no difference between the groups. With a median follow-up of 24 months, the 2 year overall and disease-free survival rates (95% CI) were 82% (73% to 89%) and 49% (39% to 59%), respectively. Conclusion: At the range of TNF-α doses tested, there was no dose effect detected for the objective tumour response, but systemic toxicity was significantly correlated with higher TNF-α doses. Efficacy and safety of low-dose TNF-α could greatly facilitate ILP procedures in the near future