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

Löwenberg, Bob; Beck, Joachim; Graux, Carlos; van Putten, Wim; Schouten, Harry C; Verdonck, Leo F; Ferrant, Augustin; Sonneveld, Pieter; Jongen-Lavrencic, Mojca; von Lilienfeld-Toal, Marie; Biemond, Bart J; Vellenga, Edo; Breems, Dimitri; de Muijnck, Hilde; Schaafsma, Ron; Verhoef, Gregor; Döhner, Hartmut; Gratwohl, Alois; Pabst, Thomas; Ossenkoppele, Gert J; ... (2010). Gemtuzumab ozogamicin as postremission treatment in AML at 60 years of age or more: results of a multicenter phase 3 study. Blood, 115(13), pp. 2586-91. Washington, D.C.: American Society of Hematology 10.1182/blood-2009-10-246470

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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.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Medical Oncology
UniBE Contributor:	Pabst, Thomas Niklaus
ISSN:	0006-4971
Publisher:	American Society of Hematology
Language:	English
Submitter:	Factscience Import
Date Deposited:	04 Oct 2013 14:09
Last Modified:	02 Mar 2023 23:20
Publisher DOI:	10.1182/blood-2009-10-246470
PubMed ID:	20103782
Web of Science ID:	000276201000007
URI:	https://boris.unibe.ch/id/eprint/1088 (FactScience: 201835)