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Long-term follow-up of the EORTC-GINEMA AML-10 trial

By Dylan Barrett

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Mar 6, 2024

Learning objective: After reading this article, learners will be able to cite a new development in the treatment of patients with acute myeloid leukemia.


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.

Study design and patient population2

  • 292 patients were randomized to receive either APBSCT (n = 146) or ABMT (n = 146).
    • Among the patients randomized to receive APBSC, 104 received APBSCT, and 6 received ABMT.
    • Of the patients randomized to ABMT, 71 received ABMT, 17 received APBSCT, and 22 received ABMT followed by APBSCT rescue.
  • The median age was 44 years (range, 15–60 years), and patient characteristics were comparable between treatment groups.
  • While 22.3% of patients were not assessable, 19.9%, 51.4%, and 6.5% of patients were classified as favorable, intermediate, and adverse risk, respectively, according to the UK Medical Research Council classification.
  • Median follow-up was 15.7 years and 16.0 years for the APBSCT and ABMT groups, respectively.

Key findings2

  • The 5-, 10-, and 15-year disease-free survival (p = 0.48), cumulative incidences of relapse (p = 0.45), and overall survival (p = 0.52) rates from the second randomization were similar between treatment groups (Figure 1).

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

  • The 15-year disease-free survival, cumulative incidences of relapse, and overall survival rates among patients alive and still in first CR 5 years postrandomization were comparable between treatment arms Figure 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

  • The 15-year cumulative incidence of death without relapse from randomization was 6.7% in the APBSCT group and 8.0% in the ABMT group.
  • Multivariable analysis showed that cytogenetic adverse and intermediate risk, male sex, and higher CD43+ cell count (≥7×106 CD34+ cells/kg) in the apheresis product were associated with worse survival outcomes (Table 1).

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.
*Adapted from Baron, et al.2

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

 

Key learnings

  • Long-term outcomes were comparable between patients receiving APBSCT and ABMT.
  • Among patients in first CR 5-years postrandomization, approximately 10–15% of patients died in the following 10 years, highlighting the need for long-term monitoring of patients who undergo auto-HSCT.
  • Cytogenetic risk groups and CD34+ cell counts were predictive of long-term outcomes in this study.

References

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