Phase II study of low-dose topotecan in myelodysplastic syndromes: a Hoosier Oncology Group (HOG) study.

Abstract

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.

• Authors: Daniel A Vaena, Paul Walker, Kenneth Pennington, Anthony Stephens, Michael J Stender, Constantin T Yiannoutsos, Carol Young, Cindy Stoner, Larry D Cripe, Hoosier Oncology Group
• Journal: Leukemia research (Leuk Res) Vol. 28 Issue 1 Pg. 49-52 (Jan 2004) ISSN: 0145-2126 [Print] England
• PMID: 14630080 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents
• Enzyme Inhibitors
• Topotecan

Topics

• Aged
• Aged, 80 and over
• Anemia, Refractory, with Excess of Blasts (diagnosis, drug therapy)
• Antineoplastic Agents (administration & dosage, adverse effects)
• Drug Administration Schedule
• Enzyme Inhibitors (administration & dosage, adverse effects)
• Humans
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive (diagnosis, drug therapy)
• Middle Aged
• Myelodysplastic Syndromes (diagnosis, drug therapy)
• Remission Induction
• Topotecan (administration & dosage, adverse effects)
• Treatment Outcome