Table 3.
Impacts of clinical parameters on response and outcome after treatment with azacitidine for posttransplant AML and MDS relapse—univariate and multivariate Analysis (n = 151).
| Variable | Overall Survival | Response | ||||
|---|---|---|---|---|---|---|
| 2-y OS after Initiation of Aza (%) |
p | CR Rate after Initiation of Aza (%) |
p | |||
| Uni-variate | Multi-variate | Uni-variate | Multi-variate | |||
|
Age ≥60 y <60 y |
32.7 ± 8 41.8 ± 6 |
0.16 |
- |
33 56 |
0.13 |
ns |
|
Gender Female Male |
27.9 ± 7 45.5 ± 8 |
0.07 |
ns |
35 46 |
0.24 |
- |
|
Diagnosis AML MDS |
29.3 ± 6 49.4 ± 8 |
0.03 |
ns |
41 47 |
0.59 |
- |
|
Karyotype Abnormal Normal |
35.1 ± 6 44.7 ± 8 |
0.28 |
- |
35 48 |
0.12 |
ns |
|
Karyotype Complex Not complex |
26.1 ± 9 41.2 ± 6 |
0.16 |
ns |
28 43 |
0.09 |
ns |
|
Molecular/genetic risk * High Low/int |
42.6 ± 7 27.5 ± 8 |
0.17 | - |
34 46 |
0.21 | - |
| Disease status at transplant | ||||||
| No CR | 38.5 ± 6 | 0.3 | - | 36 | 0.08 | ns |
| CR | 45.8 ± 9 | 52 | ||||
|
Donor Related Unrelated |
37.7 ± 11 39.4 ± 5 |
0.84 |
- |
44 40 |
0.84 |
- |
|
HLA-Match Mismatched Matched |
36.2 ± 9 38 ± 6 |
0.51 |
- |
29 45 |
0.09 |
ns |
|
Conditioning || RIC Standard dose |
30.1 ± 6 51.2 ± 8 |
0.12 |
ns |
36 50 |
0.12 |
ns |
|
Type of relapse Hematologic Molecular |
29 ± 6 54.6 ± 9 |
0.0004 |
0.002 |
28 61 |
<0.0001 |
0.0001 |
|
Time until relapse <6 months ≥6 months |
31.4 ± 6 50.5 ± 8 |
0.007 |
0.026 |
33 52 |
0.02 |
ns |
|
BM blasts at relapse >7% (median) ≤7% |
32 ± 7 46.8 ± 7 |
0.001 | ns |
26 56 |
0.0005 | ns |
Note: * for MDS IPSS-R risk cytogenetics [20] were applied and very good, good and intermediate risk categories were assigned to low/intermediate group, whereas poor and very poor risk categories were included into high risk group; for AML ELN cytogenic risk classification (19) was applied and favorable and intermediate risk categories were assigned to low/intermediate risk group, whereas adverse risk category was included into high risk group; || according to Bacigalupo et al. [22]; - indicates that the respective parameter was not included into multivariate model; AML, acute myeloid leukemia; Aza, Azacitidine; BM, bone marrow; CR, complete remission; HLA, human leukocyte antigen; int, intermediate; MDS, myelodysplastic syndrome; ns, no statistical significance; OS, overall survival; RFS, relapse-free survival; RIC, reduced intensity conditioning; y, years.