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Connective Tissue Oncology Society |
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| 2001 CTOS Annual Meeting Posters— Surgery IS THERE A ROLE
FOR ISOLATED LIMB PERFUSION IN UNRESECTABLE EXTREMITY SARCOMAS? OBJECTIVE: A number of recent studies from Europe have reported on the efficacy of isolated limb perfusion (ILP) in patients with unresectable extremity sarcomas. Unfortunately, these results have been difficult to reproduce in studies performed in the U.S. As systmeically deliverd doxorubicin has shown the most activity in patients with soft tissue sarcomas, we were interested in evaluating the use of doxorubicin delivered via ILP. We therefore undertook a Phase I trial of ILP with doxorubicin using the dosing previously reported from a phase I dose escalation trial from Italy. (Rossi et al. Cancer 73:2140-2146, 1999) METHODS: Seven patients have been entered in this Phase I trial; 6 patients have been perfused. the seventh patient was unable to be perfused secndary to inadequate venous access. There were 3 males and 3 females with a median age of 33 (range 19 - 75). The initial 3 patients were treated at a dose of 1.4 mg/kg for the lower extremty (LE) and 0.7 mg/kg for the upper extremity (UE). The dose was lowered 20% in the second 3 patients to 1.0mg/kg and 0.5mg/kg for the LE and UE respectively, secondary to toxicity seen in the first 3 patients. The perfusion was performed using a bubble oxygenator, roller pump in the standard, previously described manner. The perfusion with doxorubicin was performed for 60 minutes at normothermic temperatures (37°C). Patients were then evaluated for response to treatment using MRI scan at 6 weeks post perfusion. At that time patients underwent marginal excisions of the tumors. RESULTS: In the 6 patients thus far perfused, there have been no responses seen. Three patients had evidence of disease progression at the time of their 6 week MRI evaluation. There was one grade 3, and one grade 2 neurologic toxicity. Two patients have undergone amputation secondary to progression of disease. Two patients have had evidence of significant myonecrosis based on elevated CPK levels post-operatively (27,000 and 31,000) with significant post-operative limb dysfunction requiring extending physical therapy treatments. CONCLUSION: Thus far, there have been no responses observed in this study population. Additionally, there have been significant toxicities observed, as described above in the results section. The lack of responses seen to ILP with doxorubicin in this study, as well as the low response rates seen in other perfusion studies performed in the United States, makes it unlikely that there is a role for ILP in patients with unresectable extremity sarcomas.
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