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The phase III randomized European Organization for Research and Treatment of Cancer-Gruppo Italiano Malattie Ematologiche dell’ Adulto (EORTC-GIMEMA) AML-10 trial assessed the impact of the type of induction and stem cell transplantation in younger patients with acute myeloid leukemia (AML).1 The trial was amended to include a second randomization to compare autologous hematopoietic stem cell transplantation (auto-HSCT) with peripheral blood stem cells (APBSCT) and auto-HSCT with bone marrow (ABMT) in patients in first complete remission (CR) following intensive chemotherapy who did not have a human leukocyte antigen identical sibling donor available.2
Here, we summarize the long-term follow-up data from the second randomization of the EORTC-GIMEMA AML-10 trial published by Baron et al.2 in American Journal of Hematology.
Figure 1. A 5-, B 10-, and C 15-year DFS, CIR, and OS rates from the second randomization in the AML-10 trial*
ABMT, autologous hematopoietic stem cell transplantation with bone marrow; APBSCT, autologous hematopoietic stem cell transplantation with peripheral blood stem cells; CIR, cumulative incidence of relapse; DFS, disease-free survival; OS, overall survival.
*Data from Baron, et al.2
Figure 2. 15-year DFS, CIR, and OS rate among patients alive and still in first CR 5 years postrandomization in the AML-10 trial*
ABMT, autologous hematopoietic stem cell transplantation with bone marrow; APBSCT, autologous hematopoietic stem cell transplantation with peripheral blood stem cells; CIR, cumulative incidence of relapse; DFS, disease-free survival; OS, overall survival.
*Data from Baron, et al.2
Table 1. Multivariable analysis for DFS, CIR, and OS in the AML-10 trial*
CI, confidence interval; CIR, cumulative incidence of relapse; DFS, disease-free survival; H, highest count of CD34+ cells ×106/kg body weight during a single apheresis; HR, hazard ratio; MRC, Medical Research Council; OS, overall survival. |
||||||
Variable |
DFS |
CIR |
OS |
|||
---|---|---|---|---|---|---|
HR (95% CI) |
p value |
HR (95% CI) |
p value |
HR (95% CI) |
p value |
|
MRC: Intermediate vs favorable |
2.69 (1.63–4.45) |
0.0001 |
2.63 (1.53–4.53) |
0.0005 |
2.66 (1.55–4.58) |
0.0004 |
MRC: Adverse vs favorable |
5.90 (2.94–11.80) |
<0.0001 |
7.02 (3.39–14.53) |
<0.0001 |
6.98 (3.37–14.5) |
<0.0001 |
Sex: male vs female |
1.41 (1.04–1.91) |
0.029 |
1.33 (0.96–1.85) |
0.085 |
1.36 (0.98–1.88) |
0.064 |
CD34 cell harvest: H ≥7 vs H <1 |
3.11 (1.64–5.87) |
0.0005 |
4.48 (2.10–9.54) |
0.0001 |
2.35 (1.24–4.44) |
0.0086 |
|
References
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