Abstract | BACKGROUND: DESIGN AND METHODS: HLA-typed patients with high-risk acute myeloid leukemia, who achieved first complete remission (n = 247), were included in this analysis. All patients received double induction and consolidation. Based on the availability of a matched-sibling donor, patients were allocated by genetic chance to allogeneic stem cell transplantation (n = 61) or chemotherapy-only (i.e. intensification and maintenance therapy; n = 186). The main analysis was done on an intention-to-treat basis according to this allocation. RESULTS: Intention-to-treat analysis did not show a significantly different 5-year disease-free survival (49 ± 6% versus 45 ± 4%, P(log rank) = 0.44) or overall survival (68 ± 6% versus 57 ± 4%, P(log rank) = 0.17) between the matched-sibling donor and no-matched-sibling donor groups, whereas late adverse effects occurred more frequently after allogeneic stem cell transplantation (72.5% versus 31.8%, P(Fischer)<0.01). These results were confirmed by as-treated analysis corrected for the time until transplantation (5-year overall survival: 72 ± 8% versus 60 ± 4%, P(Mantel-Byar) 0.21). Subgroup analysis demonstrated improved survival rates for patients with 11q23 aberrations allocated to allogeneic stem cell transplantation (5-year overall survival: 94 ± 6% versus 52 ± 7%, P(log-rank) = 0.01; n = 18 versus 49) in contrast to patients without 11q23 aberrations (5-year overall survival: 58 ± 8% versus 55 ± 5%, P(log-rank) = 0.66). CONCLUSIONS:
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Authors | Jan-Henning Klusmann, Dirk Reinhardt, Martin Zimmermann, Bernhard Kremens, Josef Vormoor, Michael Dworzak, Ursula Creutzig, Thomas Klingebiel |
Journal | Haematologica
(Haematologica)
Vol. 97
Issue 1
Pg. 21-9
(Jan 2012)
ISSN: 1592-8721 [Electronic] Italy |
PMID | 21933851
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Topics |
- Adolescent
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Child
- Child, Preschool
- Female
- Graft vs Host Disease
(complications)
- Hematopoietic Stem Cell Transplantation
(adverse effects)
- Humans
- Infant
- Infant, Newborn
- Leukemia, Myeloid, Acute
(complications, mortality, therapy)
- Male
- Remission Induction
- Siblings
- Survival Analysis
- Tissue Donors
- Transplantation, Homologous
- Treatment Outcome
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