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Gemtuzumab ozogamicin as postremission treatment in AML at 60 years of age or more : results of a multicenter phase 3 study

Löwenberg, Bob and Beck, Joachim and Graux, Carlos and van Putten, Wim and Schouten, Harry C. and Verdonck, Leo F. and Ferrant, Augustin and Sonneveld, Pieter and Jongen-Lavrencic, Mojca and von Lilienfeld-Toal, Marie and Biemond Bart, J. and Vellenga, Edo and Breems, Dimitri and de Muijnck, Hilde and Schaafsma, Ron and Verhoef, Gregor and Döhner, Hartmut and Gratwohl, Alois and Pabst, Thomas and Ossenkoppele Gert, J. and Maertens, Johan and Dutch-Belgian Hemato-Oncology Cooperative Group, and German Austrian AML Study Group, . (2010) Gemtuzumab ozogamicin as postremission treatment in AML at 60 years of age or more : results of a multicenter phase 3 study. Blood, Vol. 115, H. 13. pp. 2586-2591.

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Official URL: http://edoc.unibas.ch/dok/A6004492

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Abstract

In older patients with acute myeloid leukemia (AML), the prevention of relapse has remained one of the major therapeutic challenges, with more than 75% relapses after complete remission. The anti-CD33 immunotoxin conjugate gemtuzumab ozogamicin (GO) has shown antileukemic remission induction activity in patients with relapsed AML. Patients with AML or refractory anemia with excess blasts in first complete remission attained after intensive induction chemotherapy were randomized between 3 cycles of GO (6 mg/m(2) every 4 weeks) or no postremission therapy (control) to assess whether GO would improve outcome. The 2 treatment groups (113 patients receiving GO vs 119 control patients) were comparable with regard to age (60-78 years, median 67 years), performance status, and cytogenetics. A total of 110 of 113 received at least 1 cycle of GO, and 65 of 113 patients completed the 3 cycles. Premature discontinuation was mainly attributable to incomplete hematologic recovery or intercurrent relapse. Median time to recovery of platelets 50 x 10(9)/L and neutrophils 0.5 x 10(9)/L after GO was 14 days and 20 days. Nonhematologic toxicities were mild overall, but there was 1 toxic death caused by liver failure. There were no significant differences between both treatment groups with regard to relapse probabilities, nonrelapse mortality, overall survival, or disease-free survival (17% vs 16% at 5 years). Postremission treatment with GO in older AML patients does not provide benefits regarding any clinical end points. The HOVON-43 study is registered at The Netherlands Trial Registry (number NTR212) and at http://www.controlled-trials.com as ISRCTN77039377.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Ehemalige Einheiten Medizinische Fächer (Klinik) > Hämatologie (Gratwohl)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Ehemalige Einheiten Medizinische Fächer (Klinik) > Hämatologie (Gratwohl)
UniBasel Contributors:Gratwohl, Alois A.
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:American Society of Hematology
ISSN:1528-0020
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:01 Feb 2013 08:46
Deposited On:01 Feb 2013 08:42

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