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Gemtuzumab ozogamicin as postconsolidation therapy does not prevent relapse in children with AML: results from NOPHO-AML 2004.
- Source :
-
Blood [Blood] 2012 Aug 02; Vol. 120 (5), pp. 978-84. Date of Electronic Publication: 2012 Jun 22. - Publication Year :
- 2012
-
Abstract
- There are no data on the role of postconsolidation therapy with gemtuzumab ozogamicin (GO; Mylotarg) in children with acute myeloid leukemia (AML). The NOPHO-AML 2004 protocol studied postconsolidation randomization to GO or no further therapy. GO was administered at 5 mg/m(2) and repeated after 3 weeks. We randomized 120 patients; 59 to receive GO. Survival was analyzed on an intention-to-treat basis. The median follow-up for patients who were alive was 4.2 years. Children who received GO showed modest elevation of transaminase and bilirubin without signs of veno-occlusive disease. Severe neutropenia followed 95% and febrile neutropenia 40% of the GO courses. Only a moderate decline in platelet count and a minor decrease in hemoglobin occurred. Relapse occurred in 24 and 25 of those randomized to GO or no further therapy. The median time to relapse was 16 months versus 10 months (nonsignificant). The 5-year event-free survival and overall survival was 55% versus 51% and 74% versus 80% in those randomized to receive GO or no further therapy, respectively. Results were similar in all subgroups. In conclusion, GO therapy postconsolidation as given in this trial was well tolerated, showed a nonsignificant delay in time to relapse, but did not change the rate of relapse or survival (clinicaltrials.gov identifier NCT00476541).
- Subjects :
- Aminoglycosides adverse effects
Antibodies, Monoclonal, Humanized adverse effects
Antineoplastic Agents adverse effects
Antineoplastic Agents therapeutic use
Child
Child, Preschool
Consolidation Chemotherapy
Disease-Free Survival
Female
Gemtuzumab
Humans
Infant
Infant, Newborn
Leukemia, Myeloid, Acute mortality
Leukemia, Myeloid, Acute pathology
Male
Secondary Prevention
Survival Analysis
Time Factors
Treatment Outcome
Aminoglycosides therapeutic use
Antibodies, Monoclonal, Humanized therapeutic use
Leukemia, Myeloid, Acute drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0020
- Volume :
- 120
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Blood
- Publication Type :
- Academic Journal
- Accession number :
- 22730539
- Full Text :
- https://doi.org/10.1182/blood-2012-03-416701