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- Title:
Allogeneic transplantation as post-remission therapy for cytogenetically high-risk acute myeloid leukemia: landmark analysis from a single prospective multicenter trial.
- Document type:
- Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
- Author(s):
- Stelljes, M; Beelen, DW; Braess, J; Sauerland, MC; Heinecke, A; Berning, B; Kolb, HJ; Holler, E; Schwerdtfeger, R; Arnold, R; Spiekermann, K; Müller-Tidow, C; Serve, HL; Silling, G; Hiddemann, W; Berdel, WE; Büchner, T; Kienast, J
- Abstract:
- Background Allogeneic hematopoietic cell transplantation is considered the preferred post-remission therapy in patients with acute myeloid leukemia cytogenetically defined as being at high risk. To substantiate evidence for allogeneic hematopoietic cell transplantation in first complete remission in these high-risk patients we performed a landmark analysis within a single prospective multicenter treatment trial. DESIGN AND METHODS: By the time of analysis, 2,347 patients had been accrued into the AMLCG 99 trial between 1999 - 2007. Out of this population, 243 patients under 60 years old fulfilled the criteria for high-risk cytogenetics. Landmark analyses were performed with a control cohort, who remained in first complete remission at least the median time from complete remission to transplantation in the intervention group. RESULTS: After standardized induction therapy, 111 patients under 60 years old achieved complete remission. A matched allogeneic donor was identified for 59 patients (30 sibling donors, 29 unrelated donors). Fifty-five patients received an allogeneic hematopoietic cell transplant after a median time of 88 days in first complete remission. Of the remaining 56 patients, 21 relapsed within 90 days after achieving first complete remission and for 7 patients with relevant comorbidities no donors search was initiated, leaving 28 patients given conventional post-remission therapy as the control cohort. The median follow-up of surviving patients was 60.4 months. Patients with an allogeneic donor had substantially better 5-year overall and relapse-free survival rates than the control group (48% versus 18%, P=0.004 and 39% versus 10%, P<0.001, respectively). A survival benefit from transplantation was evident regardless of donor type, age and monosomal karyotype. Conclusions Beyond evidence available for subgroups of high-risk patients, the findings of this study establish in a broader manner that allogeneic hematopoietic cell transplantation is a preferable consolidation treatment for patients with acute myeloid leukemia and high-risk cytogenetics. The study was registered at Clinicaltrials.gov as NCT00266136.
- Journal title abbreviation:
- Haematologica
- Year:
- 2011
- Journal volume:
- 96
- Journal issue:
- 7
- Pages contribution:
- 972-9
- Language:
- eng
- Fulltext / DOI:
- doi:10.3324/haematol.2011.041004
- Pubmed ID:
- http://view.ncbi.nlm.nih.gov/pubmed/21459795
- Print-ISSN:
- 0390-6078
- TUM Institution:
- III. Medizinische Klinik und Poliklinik (Hämatologie / Onkologie)
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