Table 2 Univariate analysis on transplanted patients.

From: Myeloablative conditioning with thiotepa-busulfan-fludarabine does not improve the outcome of patients transplanted with active leukemia: final results of the GITMO prospective trial GANDALF-01

 

OS HR (95% CI)

OS P value

CIR HR (95% CI)

CIR P value

NRM HR (95% CI)

NRM P value

Age (years)

1.01 (1–1.03)

0.0907

0.99 (0.97–1.01)

0.38

1.03 (1–1.06)

0.077

Sex

  Female

1

 

1

 

1

 

  Male

1.19 (0.76–1.87)

0.4504

0.7 (0.4–1.23)

0.21

1.64 (0.79–3.4)

0.18

Previous autologous transplant

0.98 (0.45–2.14)

0.9655

0.81 (0.32–2.1)

0.67

1.08 (0.35–3.34)

0.9

Diagnosis

  Acute Myeloid Leukemia

1

 

1

 

1

 

  Acute Lymphoblastic Leukemia

0.88 (0.32–2.4)

0.7987

1.51 (0.38–6.09)

0.56

0.49 (0.07–3.27)

0.46

Clinical history

  Primary refractory

1

 

1

 

1

 

  Relapsed

0.97 (0.62–1.53)

0.9058

1.88 (1.06–3.34)

0.03

0.53 (0.25–1.13)

0.1

Cytogenetics

  low risk

3.57 (1.08–11.82)

0.037

0 (0–0)

<0.0001

7.7 (3.03–19.56)

<.0001

  Intermediate risk

1

 

1

 

1

 

  High risk

1.36 (0.82–2.26)

0.2299

0.78 (0.4–1.51)

0.46

1.84 (0.82–4.12)

0.14

  Unknown

1.38 (0.7–2.72)

0.3506

1.02 (0.44–2.37)

0.96

1.46 (0.45–4.69)

0.53

Molecular biology

  FLT3-ITD mutated

1.25 (0.72–2.17)

0.4243

1.82 (0.87–3.83)

0.11

0.59 (0.23–1.49)

0.27

  NPM1 mutated

0.84 (0.48–1.45)

0.5266

1.29 (0.65–2.56)

0.47

0.64 (0.27–1.51)

0.31

Sorror score

  0

1

 

1

 

1

 

  1

1.99 (1.18–3.34)

0.0094

0.88 (0.47–1.64)

0.69

3.41 (1.27–9.18)

0.015

  2

2.4 (1.13–5.1)

0.0225

0.98 (0.41–2.32)

0.96

3.12 (0.85–11.52)

0.088

  3

4.93 (1.83–13.26)

0.0016

0.25 (0.04–1.69)

0.15

11.04 (2.73–44.68)

0.0008

Blasts in the peripheral blood (%)

1 (0.99–1.01)

0.4927

1 (0.99-1.01)

0.94

1 (0.99–1.01)

0.87

Platelets ×109/L

1 (1–1)

0.6866

1 (1-1)

0.86

1 (1–1)

0.99

Ferritin ng/mL

1 (1–1)

0.019

1 (1-1)

0.7

1 (1–1)

0.38

Albumin mg/dL

0.99 (0.98–1.01)

0.3046

1 (0.99–1.02)

0.56

0.99 (0.97–1.01)

0.34

Donor type

  URD

1.43 (0.89–2.32)

0.1404

0.83 (0.46–1.5)

0.54

1.78 (0.84–3.8)

0.13

  CB

1.1 (0.42–2.86)

0.8467

1.42 (0.46–4.43)

0.54

0.62 (0.07–5.27)

0.67

  Haploidentical

1

 

1

 

1

 

Female donor for male recipient

0.82 (0.47–1.44)

0.4936

0.68 (0.33–1.42)

0.3

1.11 (0.5–2.46)

0.79

HSC source

  BM

1

 

1

 

1

 

  PBSC

1.22 (0.77–1.96)

0.3971

0.75 (0.42–1.36)

0.35

1.58 (0.77–3.27)

0.21

  CB

0.99 (0.39–2.56)

0.9901

1.37 (0.44–4.2)

0.59

0.56 (0.07–4.69)

0.6

CMV serostatus

 R CMV+/D CMV+

1

 

1

 

1

 

 R CMV+/D CMV−

0.9 (0.54–1.48)

0.6675

0.99 (0.54–1.81)

0.96

0.86 (0.38–1.95)

0.71

 R CMV−/D CMV+

0.79 (0.31–2.01)

0.6225

1.37 (0.46–4.04)

0.57

0.42 (0.06–3.11)

0.4

 R CMV−/D CMV−

0.89 (0.27–2.89)

0.8444

0.4 (0.04–3.9)

0.43

1.68 (0.38–7.4)

0.49

 Acute GvHDa

1.24 (0.74–2.05)

0.41

0.74 (0.40–1.37)

0.34

1.61 (0.70–3.73)

0.26

 Chronic GvHDa

1.08 (0.50–2.33)

0.84

1.22 (0.50–2.99)

0.66

0.95 (0.26–3.48)

0.94

  1. Bold values indicate statistically significant results.
  2. OS overall survival, HR hazard risk, CIR cumulative incidence of relapse, NRM non-relapse mortality, URD unrelated donor, CB cord blood, HSC hematopoietic stem cell source, BM bone marrow, PBSC peripheral blood stem cells, CMV cytomegalovirus, R recipient, D donor, TBF thiotepa, busulfan, fludarabine, GVHD graft-versus-host disease.
  3. aTime-dependent variable.
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