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TBI versus non-TBI regimens for de novo AML
95% CI: 0.75–1.23, P=0.15) and found none. We also exam- ined for differences in infection rates by transplant period and observed lower rate of fungal infection between 2012 and 2016 compared to the earlier period in patients who received TBI-containing (2% vs. 8%) and non-TBI (1% vs. 4%) regimens.
Subset analysis
In a subset analysis limited to patients who received Bu- Cy and Bu-Flu, we examined for an effect of anti-thymo- cyte globulin on grade 2-4 acute GvHD (HR 0.68, 95% CI: 0.44–1.03, P=0.07), grade 3-4 acute GvHD (HR 0.93, 95% CI: 0.51–1.70, P=0.82), chronic GvHD (HR 0.75, 95% CI:
0.50–1.12, P=0.16), non-relapse mortality (HR 1.09, 95% CI: 0.60–1.99, P=0.78), relapse (HR 1.07, 95% CI: 0.77–1.50, P=0.68), overall (HR 1.24, 95% CI: 0.90–1.72, P=0.19) and leukemia-free survival (HR 1.05, 95% CI: 0.78–1.40, P=0.75) and found none.
Discussion
To our knowledge this is the largest study to compare TBI and non-TBI intravenous Bu containing regimens in children and adolescents with de novo AML. Non-relapse mortality was higher with TBI regimens, and relapse was
Table 3A. Day-100 incidence of veno-occlusive disease and systemic infection. TBI-containing regimen
Non-TBI regimen Probability (95% CI)
15% (11-18)
30% (26-35) 30% (26-34) 2% (1-4)
Outcome N eval
VOD 197
Probability (95% CI)
8% (4-12)
47% (40-54)
43% (36-50)
6% (3-9)
N eval
422
425 425 425
P-value 0.03
<0.001 0.001 0.04
P-value 0.36
<0.001
0.26
Bacterial bloodstream infection
Viral bloodstream infection
Fungal bloodstream infection
199
199
199
TBI: total body irradiation;VOD: veno-occlusive disease; CI: Confidence Interval; eval: evaluated.
Table 3B. 3-year incidence of organ dysfunction in patients who were alive and in remission for at least 1-year post-transplant
Outcome
Interstitial pneumonitis / Idiopathic pneumonia syndrome
Endocrine dysfunction (gonadal
or growth hormone) Cardiac failure, renal failure
requiring dialysis
N eval
129
125
129
TBI-containing regimen Probability (95% CI)
5% (2-9)
24% (17-32)
5% (2-9)
N eval
267
265
267
Non-TBI regimen
Probability (95% CI)
7% (4-11)
8% (5-12)
3% (1-5)
Number of events: gonadal dysfunction TBI n=28 of 125; non-TBI n=29 of 265; growth hormone deficiency TBI n=14 of 129, non-TBI n=7 of 265; cardiac failure TBI n=3 of 129, non-TBI n=1 of 267; renal failure TBI n=4 of 129, non-TBI N=7 of 267.TBI: total body irradiation; CI: Confidence Interval; n: number; eval: evaluated.
AB
Figure 2. Leukemia-free survival and overall survival. (A) Probability of overall survival with total body irradiation (TBI)-containing and non-TBI regimens, (B) proba- bility of leukemia-free survival with TBI-containing and non-TBI regimens.
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