Biological, hematologic, and clinical data of NK-AML patients
| A. Demographic data of the patients . | ||||
|---|---|---|---|---|
| Characteristics . | DAC (n = 103) . | DA (n = 124) . | P . | Total no. (N = 227) . |
| Median age (y) | 49 | 50 | .49* | 50 y‡ |
| NPM1(+/–)/FLT3-ITD(+/–)§ | ||||
| 1st N–/F– | 54 (54%) | 60 (49%) | .54† | 114 |
| 2nd N+/F– | 25 (25%) | 29 (24%) | .88† | 54 |
| 3rd N–/F+ | 3 (3%) | 11 (9%) | .09† | 14 |
| 4th N+/F+ | 19 (19%) | 22 (18%) | .89† | 41 |
| Median initial WBC (×106) | 33 | 21.2 | .88* | 28‡ |
| Sex | 55 F, 48 M | 72 F, 52 M | .48† | 127 F, 100 M |
| De novo AML | 101 (98%) | 113 (91%) | .03† | 214 |
| Sec MDS AML | 2 (2%) | 10 (8%) | .07† | 12 |
| Sec Th AML | 0 | 1 (0.8%) | .9† | 1 |
| FAB | ||||
| M0 | 8 (8%) | 8 (6%) | .8† | 16 |
| M1 | 28 (27%) | 35 (29%) | .86† | 63 |
| M2 | 25 (24%) | 34 (28%) | .59† | 59 |
| M4 | 36 (35%) | 27 (21%) | .03† | 63 |
| M5 | 5 (5%) | 20 (16%) | .07† | 25 |
| M6 | 1 (1%) | 0 (0%) | .45† | 1 |
| A. Demographic data of the patients . | ||||
|---|---|---|---|---|
| Characteristics . | DAC (n = 103) . | DA (n = 124) . | P . | Total no. (N = 227) . |
| Median age (y) | 49 | 50 | .49* | 50 y‡ |
| NPM1(+/–)/FLT3-ITD(+/–)§ | ||||
| 1st N–/F– | 54 (54%) | 60 (49%) | .54† | 114 |
| 2nd N+/F– | 25 (25%) | 29 (24%) | .88† | 54 |
| 3rd N–/F+ | 3 (3%) | 11 (9%) | .09† | 14 |
| 4th N+/F+ | 19 (19%) | 22 (18%) | .89† | 41 |
| Median initial WBC (×106) | 33 | 21.2 | .88* | 28‡ |
| Sex | 55 F, 48 M | 72 F, 52 M | .48† | 127 F, 100 M |
| De novo AML | 101 (98%) | 113 (91%) | .03† | 214 |
| Sec MDS AML | 2 (2%) | 10 (8%) | .07† | 12 |
| Sec Th AML | 0 | 1 (0.8%) | .9† | 1 |
| FAB | ||||
| M0 | 8 (8%) | 8 (6%) | .8† | 16 |
| M1 | 28 (27%) | 35 (29%) | .86† | 63 |
| M2 | 25 (24%) | 34 (28%) | .59† | 59 |
| M4 | 36 (35%) | 27 (21%) | .03† | 63 |
| M5 | 5 (5%) | 20 (16%) | .07† | 25 |
| M6 | 1 (1%) | 0 (0%) | .45† | 1 |
| B. Results of univariate analysis for all patients (N = 227) . | |||
|---|---|---|---|
| End point and variables . | DAC (n = 103) . | DA (n = 124) . | P . |
| CR rate, number of patients (%) | |||
| FLT3-ITD | |||
| NEG | 65/81 (80%) | 71/91 (78%) | .72† |
| POS | 19/22 (86%) | 20/33 (61%) | .04† |
| OS, number of patients, 4-y rate, % (SD) | |||
| FLT3-ITD | |||
| NEG | n = 81; 43% (6) | n = 91; 36% (5) | .6¶ |
| POS | n = 22; 37% (11) | n = 33; 14% (7) | .051¶ |
| OS censored at allograft, number of patients, 4-y rate, % (SD) | |||
| FLT3-ITD | |||
| NEG | n = 81; 37% (8) | n = 91; 28% (6) | .61¶ |
| POS | n = 22; 37% (13) | n = 33; 5% (5) | .007¶ |
| B. Results of univariate analysis for all patients (N = 227) . | |||
|---|---|---|---|
| End point and variables . | DAC (n = 103) . | DA (n = 124) . | P . |
| CR rate, number of patients (%) | |||
| FLT3-ITD | |||
| NEG | 65/81 (80%) | 71/91 (78%) | .72† |
| POS | 19/22 (86%) | 20/33 (61%) | .04† |
| OS, number of patients, 4-y rate, % (SD) | |||
| FLT3-ITD | |||
| NEG | n = 81; 43% (6) | n = 91; 36% (5) | .6¶ |
| POS | n = 22; 37% (11) | n = 33; 14% (7) | .051¶ |
| OS censored at allograft, number of patients, 4-y rate, % (SD) | |||
| FLT3-ITD | |||
| NEG | n = 81; 37% (8) | n = 91; 28% (6) | .61¶ |
| POS | n = 22; 37% (13) | n = 33; 5% (5) | .007¶ |
| C. Multivariate analysis restricted to FLT3-ITD+ patients (N = 55) . | ||
|---|---|---|
| End point and variables . | Hazard ratio (95% CI) . | P . |
| CR | ||
| DAC vs DA | 0.25 (0.06-1.14) | .07‖ |
| Age (continuous) | 1.08 (1-1.16) | .04‖ |
| NPM1+ | 0.61 (0.14-2.62) | .5‖ |
| OS | ||
| DAC vs DA | 0.507 (0.257-1.001) | .05‖ |
| NPM1+ | 1.084 (0.52-2.262) | .83‖ |
| Age (continuous) | 1.018 (0.984-1.053) | .3‖ |
| OS censored at allograft | ||
| DAC vs DA | 0.36 (0.167-0.775) | .009‖ |
| NPM1+ | 1.074 (0.468-2.464) | .87‖ |
| Age (continuous) | 1.022 (0.988-1.058) | .21‖ |
| C. Multivariate analysis restricted to FLT3-ITD+ patients (N = 55) . | ||
|---|---|---|
| End point and variables . | Hazard ratio (95% CI) . | P . |
| CR | ||
| DAC vs DA | 0.25 (0.06-1.14) | .07‖ |
| Age (continuous) | 1.08 (1-1.16) | .04‖ |
| NPM1+ | 0.61 (0.14-2.62) | .5‖ |
| OS | ||
| DAC vs DA | 0.507 (0.257-1.001) | .05‖ |
| NPM1+ | 1.084 (0.52-2.262) | .83‖ |
| Age (continuous) | 1.018 (0.984-1.053) | .3‖ |
| OS censored at allograft | ||
| DAC vs DA | 0.36 (0.167-0.775) | .009‖ |
| NPM1+ | 1.074 (0.468-2.464) | .87‖ |
| Age (continuous) | 1.022 (0.988-1.058) | .21‖ |
CRR, complete remission rate; FAB, French American British classification; MDS, myelodysplastic syndrome; NPM1+), mutations in nucleophosmin gene; SD, standard deviation; sec MDS AML, secondary to MDS AML; sec Th AML, secondary to chemotherapy AML; WBC, white cells blood count.
A, Patients’ characteristics; B-C, early and long-term outcome by treatment arms in subgroups according to FLT3-ITD status.
Computed by the Mann-Whitney U test.
Computed by the Fisher exact test or χ2.
Median value for total patient group.
For 4 FLT3-ITD– patients, NPM1 status was not established.
Computed by log-rank test.
Computed by Cox regression analysis.