EPIRUBICIN AND IFOSFAMIDE IN ADVANCED SOFT-TISSUE SARCOMAS

Background: To evaluate the feasibility, toxicity and efficacy of the combination of (IFO) ifosfamide and epirubicin (EPI) given at conventi onal doses for monochemotherapy, we started a phase II study in advanc ed/metastatic soft tissue sarcoma patients. Patients and methods: Trea tment consisted of: epirubicin 75 mg/m2 i.v. day 1; IFO 1.8 g/m2 days 1 to 5; MESNA 20% of the IFO dose at 4-hour intervals three times a da y during IFO administration. Cycles were given every 3-4 weeks for at least three cycles. Results: The overall response rate for non-viscera l sarcomas (51 pts) ws 31% (95% confidence limits +/- 13%). Among the 13 visceral sarcomas no response was seen for the leiomyosarcomas of t he gastrointestinal tract, whereas one complete and one partial remiss ion were observed for the uterine sarcomas. The duration of response w as 10 months (range 5-34+) for complete responses and 9 (range 4-42+) for partial responses. The median survival for responders is 18 months (range 2-60+) and for non-responders 10 months (range 1-33) (p < 0.00 4). Conclusions: This combination proved to be feasible and tolerable. The overall response rate does not appear to be superior to those wit h other standard treatments, but it should be pointed out that our pat ient population was totally unselected.