Response and HSCT rates, OS, and EFS according to therapeutic approach in patients with sAML
| Variable . | Overall . | IC . | Non-IC . | HMA . | Clinical trial . | BSC . | P value . |
|---|---|---|---|---|---|---|---|
| Response, n (%) | 1489 (100) | 844 (100) | 303 (100) | 274 (100) | 68 (100) | ||
| ORR (CR + CRi) | 620 (41) | 467 (55) | 89 (30) | 43 (16) | 21 (31) | <.001 | |
| CR | 559 (37) | 437 (52) | 71 (23) | 33 (12) | 18 (26) | ||
| Cri | 61 (4) | 30 (4) | 18 (6) | 10 (4) | 3 (4) | ||
| PR | 118 (8) | 54 (6) | 30 (10) | 21 (8) | 13 (19) | ||
| Resistance | 562 (38) | 220 (26) | 138 (46) | 184 (67) | 20 (30) | ||
| Death | 189 (13) | 103 (12) | 46 (15) | 26 (9) | 14 (21) | ||
| HSCT in first CR/CRi, n (%)* | 584 (100) | 439 (100) | 83 (100) | 43 (100) | 19 (100) | ||
| Allogeneic HSCT rate, n (%) | 151 (26) | 130 (30) | 18 (22) | 0 (0) | 3 (16) | <.001 | |
| Autologous HSCT rate, n (%) | 51 (9) | 49 (11) | 2 (2) | 0 (0) | 0 (0) | ||
| No HSCT, n (%) | 382 (65) | 260 (59) | 63 (76) | 43 (100) | 16 (84) | ||
| OS, n (%) | 2310 (100)* | 876 (100) | 325 (100) | 328 (100) | 79 (100) | 544 (100) | |
| Median (CI 95%), mo | 5.6 (5.2-6.3) | 9.9 (8.9-11.4) | 5.5 (4.6-7.4) | 9.0 (7.6-10.6) | 7.7 (6.4-10.6) | 1.2 (1.0-1.5) | <.001 |
| 1 y (CI 95%) | 31.4 (29.3-33.4) | 44.4 (41.1-48.0) | 29.7 (24.9-35.5) | 40.3 (35.0-46.3) | 32.9 (22.8-47.5) | 6.5 (4.7-9.0) | |
| 5 y (CI 95%) | 8.2 (6.8-9.6) | 15.7 (13.0-18.9) | 6.4 (3.7-11.0) | 3.7 (1.8-7.6) | 7.1 (2.1-23.7) | NA (NA-NA) | |
| EFS, n (%) | 1394 (100) | 810 (100) | 288 (100) | 230 (100) | 66 (100) | NA | <.001 |
| Median (CI 95%), mo | 3.6 (3.2-4.0) | 4.1 (3.5-5.7) | 1.7 (1.5-2.1) | 4.8 (4.0-6.0) | 3.3 (1.9-5.9) | NA | |
| 1 y (CI 95%) | 22.2 (20.0-24.5) | 28.3 (25.3-31.7) | 13.7 (10.2-18.4) | 23.0 (18.2-29.2) | 10.3 (4.7-22.6) | NA | |
| 5 y (CI 95%) | 8.4 (6.8-10.0) | 11.3 (9.1-14.1) | 6.0 (3.6-9.7) | 2.5 (1.0-6.1) | 6.2 (2.1-17.9) | NA |
| Variable . | Overall . | IC . | Non-IC . | HMA . | Clinical trial . | BSC . | P value . |
|---|---|---|---|---|---|---|---|
| Response, n (%) | 1489 (100) | 844 (100) | 303 (100) | 274 (100) | 68 (100) | ||
| ORR (CR + CRi) | 620 (41) | 467 (55) | 89 (30) | 43 (16) | 21 (31) | <.001 | |
| CR | 559 (37) | 437 (52) | 71 (23) | 33 (12) | 18 (26) | ||
| Cri | 61 (4) | 30 (4) | 18 (6) | 10 (4) | 3 (4) | ||
| PR | 118 (8) | 54 (6) | 30 (10) | 21 (8) | 13 (19) | ||
| Resistance | 562 (38) | 220 (26) | 138 (46) | 184 (67) | 20 (30) | ||
| Death | 189 (13) | 103 (12) | 46 (15) | 26 (9) | 14 (21) | ||
| HSCT in first CR/CRi, n (%)* | 584 (100) | 439 (100) | 83 (100) | 43 (100) | 19 (100) | ||
| Allogeneic HSCT rate, n (%) | 151 (26) | 130 (30) | 18 (22) | 0 (0) | 3 (16) | <.001 | |
| Autologous HSCT rate, n (%) | 51 (9) | 49 (11) | 2 (2) | 0 (0) | 0 (0) | ||
| No HSCT, n (%) | 382 (65) | 260 (59) | 63 (76) | 43 (100) | 16 (84) | ||
| OS, n (%) | 2310 (100)* | 876 (100) | 325 (100) | 328 (100) | 79 (100) | 544 (100) | |
| Median (CI 95%), mo | 5.6 (5.2-6.3) | 9.9 (8.9-11.4) | 5.5 (4.6-7.4) | 9.0 (7.6-10.6) | 7.7 (6.4-10.6) | 1.2 (1.0-1.5) | <.001 |
| 1 y (CI 95%) | 31.4 (29.3-33.4) | 44.4 (41.1-48.0) | 29.7 (24.9-35.5) | 40.3 (35.0-46.3) | 32.9 (22.8-47.5) | 6.5 (4.7-9.0) | |
| 5 y (CI 95%) | 8.2 (6.8-9.6) | 15.7 (13.0-18.9) | 6.4 (3.7-11.0) | 3.7 (1.8-7.6) | 7.1 (2.1-23.7) | NA (NA-NA) | |
| EFS, n (%) | 1394 (100) | 810 (100) | 288 (100) | 230 (100) | 66 (100) | NA | <.001 |
| Median (CI 95%), mo | 3.6 (3.2-4.0) | 4.1 (3.5-5.7) | 1.7 (1.5-2.1) | 4.8 (4.0-6.0) | 3.3 (1.9-5.9) | NA | |
| 1 y (CI 95%) | 22.2 (20.0-24.5) | 28.3 (25.3-31.7) | 13.7 (10.2-18.4) | 23.0 (18.2-29.2) | 10.3 (4.7-22.6) | NA | |
| 5 y (CI 95%) | 8.4 (6.8-10.0) | 11.3 (9.1-14.1) | 6.0 (3.6-9.7) | 2.5 (1.0-6.1) | 6.2 (2.1-17.9) | NA |
NA, not applicable; ORR, overall response rate;
Data from patients in CR/CRi after front-line therapy. Global OS results includes all patients with sAML (2310 patients), but in 162 patients the therapeutic approach was not available. Including only patients with therapeutic approach available (2148 patients), the median OS was 8.9 mo (8.0-9.6), 1 y OS was 40% (38-43), and 5 y OS was 11% (9-13).