Ifosfamide/liposomal daunorubicin is a well tolerated and active first-line chemotherapy regimen in advanced soft tissue sarcoma -: Results of a Phase II study

BACKGROUND. The anthracycline/ifosfamide combination is the most effective chemotherapy in soft tissue sarcoma. To improve the tolerability and potential efficacy of this combination, the authors combined a moderate dose of continuous infusion ifosfamide with liposomal daunorubicin (L-Dauno). METHODS. In a single-arm, Phase 11 study, 40 patients with a median age of 57 years (range, 19-78 years) were enrolled. Of these, 35 patients were treated with first-line chemotherapy. The treatment regimen was comprised of ifosfamide at a dose of 5 g/m(2) over 24 hours and L-Dauno at a dose of too Mg/m(2) every 4 weeks with granulocyte-colony-stimulating factor support. RESULTS. Eleven (31%) of 35 anthracycline/ifosfamide-naive patients achieved a partial/complete response, 6 patients (17%) had stable disease, and 13 patients (37%) had disease progression. Three patients were not evaluable, and there were two intermittent deaths. The median time to disease progression was 6 months, the median overall survival was 14 months, and the median time to treatment failure was 15 months. Toxicity was tolerable. CONCLUSIONS. The combination of Ifostamide and L-Dauno was found to be a highly active chemotherapy regimen for first-line treatment of soft tissue sarcoma. Therefore, we believe randomized studies with this regimen are warranted. Cancer 2005;104:611-7. (c) 2005 American Cancer Society.