Phase II study of oral trofosfamide as palliative therapy in pretreated patients with metastatic soft-tissue sarcoma

This phase II study investigated the activity of continuously administered oral trofosfamide in chemotherapy-pretreated patients with metastatic soft- tissue sarcoma (STS). Trosfosfamide is an oxazaphosphorine with ifosfamide as the predominant metabolite. Eighteen patients with a median age of 60 ye ars were treated with trofosfamide given as continuous oral treatment. Star ting dose was 300 mg/day for 7 days and subsequently 150 mg/day, All patien ts had previously received at least one chemotherapy regimen including doxo rubicin and ifosfamide. Three patients achieved partial responses (18%) and nine a disease stabilization (53%) for an overall response rate of 18% (95 % CI: 0.5-35%). Median progression-free interval was 4 months (0-17 months) and median overall survival was 10 months (4-39+) months. Toxicity was gen erally mild, Only one WHO grade III nausea, but no other non-hematologic WH O grade III/IV toxicity occurred, Leukopenia WHO grade III/IV was observed in four patients (22%), No thrombocytopenia <50 000/mu l and no neutropenic infection was seen. Continuously administered oral trofosfamide is a well- tolerated palliative treatment in anthracycline/oxazaphosphorin-pretreated patients with advanced STS achieving responses and/or disease stabilization in up to 70% of patients. [(C) 1999 Lippincott Williams & Wilkins.].