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PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2004-5-26
pubmed:abstractText
Topotecan, a topoisomerase-I inhibitor is an active drug in the treatment of AML and MDS. To evaluate its toxicity and efficacy in a combination regimen with cytarabine, we conducted a clinical phase I/II trial in patients with relapsed acute myeloid leukemia (AML) or relapsed or newly diagnosed MDS RAEB, RAEB-t or CMML. Twenty-one patients (11 AML, 10 MDS/CMML) entered the study and were treated with 1.25 mg/m2 topotecan as continuous intravenous infusion daily for 5 days and cytarabine 1.0 g/m2 by infusion over 2 h daily for 5 days (TA). Cycles were repeated on day 28. The median observation time was 131 weeks (range: 36-196 weeks). A total of 37 cycles of TA were administered. In 1 patient, the dose of TA had to be reduced and in 1 patient, there was a treatment delay for the second cycle, both because of hematologic toxicity. The most frequent non-hematologic side-effect of TA was fever, which occurred in 17 patients (89%) with temperatures over 38 degrees C. None of the patients died due to any treatment-related toxicities, but 2 patients (10%) died within 1 month due to disease progression. A CR was achieved in 7 patients (33%), 3 of whom were MDS and 4 AML. A partial remission was reported in 8 patients (38%), no change of disease in 2 patients (10%) and progressive disease in 4 patients (19%). The median remission duration was 18 weeks (range 2-161 weeks) for MDS patients and 11 weeks (range 2-49 weeks) for AML patients. The time to progression for patients of 60 years and older (n = 10) was 16 weeks (range 2-49 weeks) and the survival was 32 weeks (range 2-119 weeks). TA is a feasible and efficacious chemotherapeutic combination for the treatment of MDS RAEB, RAEB-t, CMML and AML. For patients of 60 years and older, this regimen is also a safe option.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Apr
pubmed:issn
1042-8194
pubmed:author
pubmed:issnType
Print
pubmed:volume
45
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
699-704
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:15160942-Acute Disease, pubmed-meshheading:15160942-Adult, pubmed-meshheading:15160942-Aged, pubmed-meshheading:15160942-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:15160942-Blood Cell Count, pubmed-meshheading:15160942-Cytarabine, pubmed-meshheading:15160942-Disease-Free Survival, pubmed-meshheading:15160942-Female, pubmed-meshheading:15160942-Hemoglobinometry, pubmed-meshheading:15160942-Humans, pubmed-meshheading:15160942-Leukemia, Myeloid, pubmed-meshheading:15160942-Leukemia, Myelomonocytic, Chronic, pubmed-meshheading:15160942-Male, pubmed-meshheading:15160942-Middle Aged, pubmed-meshheading:15160942-Myelodysplastic Syndromes, pubmed-meshheading:15160942-Remission Induction, pubmed-meshheading:15160942-Survival Analysis, pubmed-meshheading:15160942-Topotecan, pubmed-meshheading:15160942-Treatment Outcome
pubmed:year
2004
pubmed:articleTitle
Phase I/II clinical study of topotecan and cytarabine in patients with myelodysplastic syndrome, chronic myelomonocytic leukemia and acute myeloid leukemia.
pubmed:affiliation
Department of Internal Medicine I, University of Cologne, Germany. martin.weihrauch@uni-koeln.de
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase II, Clinical Trial, Phase I