Oral trofosfamide: an active and well-tolerated maintenance therapy for adult patients with advanced bone and soft tissue sarcomas. Results of a retrospective analysis.

OBJECTIVES: Aim of this study was to evaluate the feasibility and toxicity of oral trofosfamide given as maintenance therapy to adult patients with bone and soft tissue sarcomas following first or later line induction chemotherapy, and to determine the clinical efficacy in terms of impact on progression-free and overall survival.

PATIENTS AND METHODS: 49 patients with locally advanced or metastatic high-grade soft tissue and bone sarcomas were identified retrospectively according to the inclusion criteria of the analysis. They were treated with oral trofosfamide at a dose of 100-150 mg per day continuously. All patients were pretreated with one or more lines of chemotherapy resulting in partial remission or stable disease. Patients were treated until progression of disease or unacceptable toxicity occurred. Progression- free and overall survival were measured from the beginning of maintenance therapy.

RESULTS: Median follow-up for all patients was 33 months (range 10-98). Toxicity was mild and predominantly hematologic. Only 1 patient had to stop treatment due to renal toxicity. The median progression-free survival was 7 months with 27% of patients continuing maintenance treatment at 1 year. Median overall survival is 14 months. Patients with metastatic disease showed a median survival of 23 months from diagnosis of metastases. 3 patients with stable disease following induction chemotherapy reached partial remission while under trofosfamide maintenance.

CONCLUSION: Oral maintenance therapy with trofosfamide is well-tolerated and seems to prolong progression-free and overall survival compared to the course of advanced soft tissue and bone sarcomas without maintenance chemotherapy.