Table 2.
Response to induction therapy, rates of allogeneic HCT, and efficacy outcomes
| AMLSG 16-10 | Historical controls | |||||
|---|---|---|---|---|---|---|
| All (N = 440) | 18-60 y (312) | 61-70 y (n = 128) | All (N = 415) | 18-60 y (n = 352) | 61-70 y (n = 63) | |
| Response to induction therapy | ||||||
| CR, % | 37.0 | 37.6 | 35.4 | 49.2 | 49.4 | 47.6 |
| CRi, % | 37.9 | 38.3 | 37.0 | 15.4 | 17.1 | 6.3 |
| CR/CRi, % | 74.9 | 75.9 | 72.4 | 64.6 | 66.5 | 54.0 |
| RD, % | 19.2 | 20.6 | 15.8 | 30.6 | 28.4 | 42.9 |
| ED/HD, % | 5.9 | 3.5 | 11.8 | 4.8 | 5.1 | 3.2 |
| Missing | 2 | 1 | 1 | — | — | — |
| Allogeneic HCT | ||||||
| HCT in CR/CRi, n (%) | 199 (45.2) | 150 (48.1) | 49 (38.3) | 94 (22.7) | 89 (25.3) | 5 (7.9) |
| MRD, n (%) | 51 (26) | 40 (27) | 11 (22) | 48 (51) | 46 (52) | 2 (40) |
| MUD, n (%) | 148 (74) | 110 (73) | 38 (78) | 46 (49) | 43 (48) | 3 (60) |
| Time to HCT, d (range) | 98 (49-202) | 98 (53-202) | 99 (49-186) | 135 (61-288) | 135 (61-237) | 148 (95-288) |
| Any HCT during disease course | 321 (72.9) | 241 (77.2) | 80 (62.5) | 237 (57.1) | 222 (63.1) | 15 (23.8) |
| Follow-up time | ||||||
| Median, mo | 40.4 | — | — | 76.3 | — | — |
| Outcomes | ||||||
| Median EFS, mo | 13.6 (10.4-17.9) | 14.5 (10.5-23.1) | 11.7 (8.5-17.7) | 5.3 (4.4-6.7) | 6.03 (5.03-7.1) | 2.53 (0.03-5.0) |
| 2-y EFS rate | 0.41 (0.36-0.46) | 0.43 (0.38-0.49) | 0.34 (0.27-0.44) | 0.21 (0.17-0.25) | 0.23 (0.19-0.28) | 0.10 (0.04-0.20) |
| Median OS-mo | 36.2 (24.6-57.3) | 57.3 (28.4-NA) | 22.7 (14.7-36.7) | 13.2 (11.9-15.7) | 14.9 (12.9-18.2) | 8.4 (7.1-11.7) |
| 2-y OS rate | 0.55 (0.50-0.60) | 0.57 (0.52-0.63) | 0.50 (0.41-0.59) | 0.38 (0.33-0.43) | 0.41 (0.36,0.47) | 0.18 (0.10-0.31) |
| 2-y CIR | 0.28 (0.23-0.33) | 0.24 (0.19-0.3) | 0.37 (0.27-0.47) | 0.57 (0.51-0.63) | 0.54 (0.48-0.61) | 0.74 (0.59-0.88) |
| 2-y CID | 0.20 (0.16-0.25) | 0.20 (0.15-0.26) | 0.19 (0.11-0.28) | 0.12 (0.08-0.15) | 0.12 (0.07-0.16) | 0.12 (0.01-0.23) |
CID, cumulative incidence of relapse; CIR, cumulative incidence of relapse; ED, early death; HD, hypoplastic death; MUD, matched-unrelated donor; RD, refractory disease.