Annals of Oncology Advance Access published online on June 1, 2005
Annals of Oncology, doi:10.1093/annonc/mdi229
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1 Departments of Surgery,, Institut Gustave Roussy, Villejuif, France
* To whom correspondence should be addressed. Background: The optimal dose of TNF- Patients and methods: Randomised phase II trial comparing hyperthermic ILP (38-40°) with melphalan and one of the four assigned doses of TNF- 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- Conclusion: At the range of TNF-
Received February 6, 2005
Revised March 31, 2005
Accepted April 7, 2005
Original article
Limb salvage with isolated perfusion for soft tissue sarcoma: could less TNF-
be better?
2 , Departments of Public Health,, Institut Gustave Roussy, Villejuif, France
3 , Departments of Multidisciplinary Oncology Center, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
4 Department of Surgery, Institut Bergonié, Bordeaux, France
5 , Departments of Radiotherapy,, Institut Gustave Roussy, Villejuif, France
6 , Departments of Radiology,, Institut Gustave Roussy, Villejuif, France
7 , Departments of Pathology,, Institut Gustave Roussy, Villejuif, France
8 , Departments ofNuclear Medicine, Institut Gustave Roussy, Villejuif, France
9 , Departments ofMedical Oncology, Institut Gustave Roussy, Villejuif, France
10 Department of Medical Oncology, Centre Léon Bérard, Lyon, France
S. Bonvalot, E-mail: bonvalot{at}igr.fr
Abstract 
delivered by isolated limb perfusion (ILP) in patients with locally advanced soft tissue sarcoma is still unknown.: 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.. 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. doses tested, there was no dose effect detected for the objective tumour response, but systemic toxicity was significantly correlated with higher TNF- doses. Efficacy and safety of low-dose TNF- could greatly facilitate ILP procedures in the near future..
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