title: Phase II study of oral trofosfamide as palliative therapy in pretreated patients with metastatic soft-tissue sarcoma.
abstract: 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 years were treated with trofosfamide given as continuous oral treatment. Starting dose was 300 mg/day for 7 days and subsequently 150 mg/day. All patients had previously received at least one chemotherapy regimen including doxorubicin 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 generally mild. Only one WHO grade III nausea, but no other non-hematologic WHO grade III/IV toxicity occurred. Leukopenia WHO grade III/IV was observed in four patients (22%). No thrombocytopenia <50,000/microl 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.
authors.affiliation: Department of Internal Medicine, University of Tübingen Medical School, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Kollmannsberger
authors.forename: W
authors.initials: W
authors.lastname: Brugger
authors.forename: J T
authors.initials: JT
authors.lastname: Hartmann
authors.forename: F
authors.initials: F
authors.lastname: Maurer
authors.forename: P
authors.initials: P
authors.lastname: Böhm
authors.forename: L
authors.initials: L
authors.lastname: Kanz
authors.forename: C
authors.initials: C
authors.lastname: Bokemeyer
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010166:Palliative Care; D012509:Sarcoma / Q000188:drug therapy*
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003520:Cyclophosphamide; C003726:trofosfamide