Liposomal doxorubicin in the perfusional treatment of advanced soft tissue limb sarcoma

Liposome-containing doxorubicin has been employed in the treatment of advanced soft tissue limb sarcoma during hyperthermic perfusion. A phase I-II study was carried out starting with a standard dose of 10 mg//L of limb volume, the dosage was escalated with 2 mg for each triplet of patients. The maximum tolerable (MTD) dose was established as the amount able to cause a grade IV limb reaction at least in two out of three patients, the temperature level remained unchanged (41.5°C). The grade of limb reaction ranged between I-II (mild edema and erythema). Only in two patients treated with 18 mg/L of limb volume was a grade IV limb reaction observed, therefore MTD at a temperature of 41.5°C is 16 mg. A good tumor response was observed in 29% of the patients, partial response in 71%. The tumor shrinkage after perfusion permitted conservative surgery in 91% of the cases.