Table 2.
Outcome analysis
| Characteristic | All patients (N = 655) | Relapsed AML (n = 365) | Refractory AML (n = 290) | Bridging to alloSCT (n = 63) | P |
|---|---|---|---|---|---|
| Response (n = 638), n (%) | Relapsed vs refractory = .0248, alloSCT vs no alloSCT < .0001 | ||||
| CR | 70 (11) | 41 (11.6) | 29 (10.2) | 18 (28.6) | |
| CRi | 34 (5.3) | 25 (7.1) | 9 (3.2) | 15 (23.8) | |
| HI | 54 (8.5) | 21 (5.9) | 33 (11.6) | 2 (3.2) | |
| SD | 47 (7.4) | 24 (6.8) | 23 (8.1) | 8 (12.7) | |
| PD | 433 (67.9) | 242 (68.6) | 191 (67.0) | 20 (31.7) | |
| OS based on response (n = 621), median (95% CI), mo | 6.7 (6.1-7.3) | 6.2 (5.6-7.4) | 7 (6.4-8.9) | 12.5 (9.7-17) | Relapsed vs refractory = .47, alloSCT vs no alloSCT < 0.0001 |
| CR | 25.3 (17-30.2) | 23.9 (16.8-46.2) | 25.3 (16.7-Inf) | 17.7 (15.3-Inf) | |
| CRi | 14.6 (9.5-32) | 11.7 (9.5-Inf) | 16.1 (8.9-Inf) | 11.7 (9.5-Inf) | |
| HI | 11.7 (9.4-14.6) | 9.4 (7.8-46.5) | 11.7 (9.7-14.9) | 9.4 (NA) | |
| SD | 10.4 (8.7-14) | 8.7 (5.8-16.4) | 10.6 (9.1-17.7) | 16.4 (10.6-Inf) | |
| PD | 4.5 (4.1-5.3) | 4.7 (3.9-5.6) | 4.4 (3.8-5.9) | 6.7 (4.5-16.6) | |
| OS based on HMA used (n = 621), median (95% CI), mo | |||||
| Azacitidine | 6.8 (6-8.5) | 6.3 (5.3-8.4) | 7.5 (6.5-9.4) | 16.1 (9.5-Inf) | Relapsed vs refractory = 0.532, alloSCT vs no alloSCT = 0.0237 |
| Decitabine | 6.2 (5.3-7.3) | 6.2 (5.3-8.4) | 6.5 (4.4-7.7) | 11.7 (9.3-17.7) | Relapsed vs refractory = 0.969, alloSCT vs no alloSCT < 0.0001 |
| Duration of response (n = 62), median (range), mo | 8.5 (1-84) | 10 (1-84) | 5 (2-36.9) | 5 (1-36.9) | Relapsed vs refractory = .3112, alloSCT vs no alloSCT = .4014 |
| Reason for discontinuation of HMA (n = 492), n (%) | Relapsed vs refractory = .0905, alloSCT vs no alloSCT < .0001 | ||||
| Intolerance | 31 (6.3) | 18 (6.4) | 13 (6.2) | 2 (3.2) | |
| No response | 136 (27.6) | 65 (23) | 71 (33.8) | 8 (12.7) | |
| Progression of disease | 273 (55.5) | 170 (60.3) | 103 (49) | 24 (38.1) | |
| End of protocol | 45 (9.1) | 25 (8.9) | 20 (9.5) | 29 (46) | |
| Ongoing treatment, n (%) | 7 (1.4) | 4 (1.4) | 3 (1.4) | 0 (0) | |
| Number of lines of therapy after HMA failure (n = 612), median (range) | 0 (0-6) | 0 (0-5) | 0 (0-6) | 1 (0-6) | Relapsed vs refractory = .6315, alloSCT vs no alloSCT = .0004 |
| AlloSCT after HMA therapy (n = 629), n (%) | 37 (5.6) | 16 (43.2) | 21 (56.8) | — | Relapsed vs refractory = .5108 |
Inf, infinity; NA, not applicable.