Leukemia research · 2004
Phase II study of low-dose topotecan in myelodysplastic syndromes: a Hoosier Oncology Group (HOG) study.
Клиническое исследованиеКлиническое исследование II фазыСтатьяНазвание и аннотация: Перевод в очереди
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Vaena Daniel A, Walker Paul, Pennington Kenneth, Stephens Anthony, Stender Michael J, Yiannoutsos Constantin T, Young Carol, Stoner Cindy, Cripe Larry D, Hoosier Oncology Group
Аннотация
Topotecan has demonstrable activity in high-risk MDS and CMMoL. However, the significant toxicity of topotecan administered at a dose of 2mg/m2 i.v. daily for 5 days as a continuous infusion limits its use in older patients. Therefore, we studied topotecan 1.5mg/m2 per day i.v. over 2 h for three consecutive days in 20 patients with high-risk MDS (12 RAEB; 4 RAEB-T; 4 CMMoL). Cycles were given every 4-6 weeks. Fifteen patients were evaluable for response. Only one patient achieved a durable complete remission (CR). There were three deaths within the first cycle of therapy. Severe myelosuppression was the most common toxicity. Grades 3-4 infections were documented in four patients. We conclude that topotecan administered at this dose and schedule has no clinically significant activity.