Sobuzoxane (MST-16), a topoisomerase II inhibitor, is an orally administered bis(2,6-dioxopiperazine) analog prodrug that is converted to the active metabolite ICRF-154.112 MST-16 has been administered to 24 patients with ATL (13 acute, 8 lymphoma, and 2 chronic) in a dose-escalating phase I/II study.113 Median age was 55 years (range 41-76 years). Twenty-five percent of patients had been previously treated. Of the 23 evaluable patients, OR rate was 43.5% (CR

8.7%; PR 34.8%); all responses occurred in previously untreated patients. Responses were observed mostly in patients who received MST-16 at doses of 1200-1600 mg/day. Median duration of responses was 282 days and 41 days for patients who achieved a CR and PR, respectively. Common grade 3 or 4 toxicities included reversible leukopenia (80%) and anemia (26.1%).

Based on the findings of the phase I/II study, MST-16 has been evaluated at a dose of 1600 mg/day.114 Preliminary results in six patients with ATL (subtype not specified) have been presented.114 Median age was 47 years (range 41-76 years). Only one patient had received prior therapy. Overall response rate was 66.7% (CR 33.3%; PR 33.3%) with a median response duration of 5 months. The major toxicity was myelo-suppression.

0 0

Post a comment