Background: To evaluate the feasibility, toxicity and efficacy of the combination of (IFO) ifosfamide and epirubicin (EPI) given at conventional doses for monochemotherapy, we started a phase II study in advanced/metastatic soft tissue sarcoma patients.
Patients and methods: Treatment 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 day during IFO administration. Cycles were given every 3-4 weeks for at least three cycles.
Results: The overall response rate for non-visceral sarcomas (51 pts) was 31% (95% confidence limits +/- 13%). Among the 13 visceral sarcomas no response was seen for the leiomyosarcomas of the gastrointestinal tract, whereas one complete and one partial remission were observed for the uterine sarcomas. The duration of response was 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 < 0.004).
Conclusions: This combination proved to be feasible and tolerable. The overall response rate does not appear to be superior to those with other standard treatments, but it should be pointed out that our patient population was totally unselected.