Phase II study of low-dose topotecan in myelodysplastic syndromes: a Hoosier Oncology Group (HOG) study.
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.
Vaena
Daniel A
DA
Division of Hematology-Oncology, Indiana Cancer Pavilion, Indiana University, 535 Barnhill Dr RT 473, Indianapolis, IN 46202, USA.
Walker
Paul
P
Pennington
Kenneth
K
Stephens
Anthony
A
Stender
Michael J
MJ
Yiannoutsos
Constantin T
CT
Young
Carol
C
Stoner
Cindy
C
Cripe
Larry D
LD
D000368:Aged; D000369:Aged, 80 and over; D000754:Anemia, Refractory, with Excess of Blasts / Q000175:diagnosis / Q000188:drug therapy; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004791:Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis / Q000188:drug therapy; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000175:diagnosis / Q000188:drug therapy*; D012074:Remission Induction; D019772:Topotecan / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D004791:Enzyme Inhibitors; D019772:Topotecan