Source:http://linkedlifedata.com/resource/pubmed/id/15160942
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
4
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pubmed:dateCreated |
2004-5-26
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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.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Apr
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pubmed:issn |
1042-8194
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
45
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
699-704
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pubmed:dateRevised |
2006-11-15
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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
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pubmed:year |
2004
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pubmed:articleTitle |
Phase I/II clinical study of topotecan and cytarabine in patients with myelodysplastic syndrome, chronic myelomonocytic leukemia and acute myeloid leukemia.
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pubmed:affiliation |
Department of Internal Medicine I, University of Cologne, Germany. martin.weihrauch@uni-koeln.de
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase II,
Clinical Trial, Phase I
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