Response to therapy and mortality
| . | LDAC . | LDAC + volasertib . |
|---|---|---|
| No. of patients treated | 45 | 42 |
| Response to therapy, n (%) | ||
| Overall (CR + CRi)* | 6 (13.3) | 13 (31.0) |
| CR | 3 (6.7) | 6 (14.3) |
| CRi | 3 (6.7) | 7 (16.7) |
| Time to CR or CRi in days, median (range) | 64 (30-125) | 71 (29-158) |
| Death rate, cumulative events, n (%) | ||
| Day 0 | 0 (0) | 0 (0) |
| Day 30 | 4 (8.9) | 4 (9.5) |
| Day 60 | 8 (17.8) | 9 (21.4) |
| Day 90 | 15 (33.3) | 12 (28.6) |
| Response by ELN genetic group, n (%) | ||
| Favorable | 0/3 (0) | 1/1 (100) |
| Intermediate I/II | 5/25 (20) | 5/21 (24) |
| Adverse | 1/14 (7) | 5/14 (36) |
| Missing | 0/3 (0) | 2/6 (33) |
| Response by gene mutation, n (%) | ||
| NPM1 mutated | 4/7 (57) | 3/7 (43) |
| NPM1 wild-type | 2/33 (6) | 9/26 (35) |
| FLT3-ITD positive | 2/6 (33) | 1/5 (20) |
| FLT3-ITD negative | 4/33 (12) | 11/30 (37) |
| Response by Wheatley risk group, n (%) | ||
| Good | 0/1 (0) | 0/0 (0) |
| Standard | 3/14 (21) | 7/12 (58) |
| Poor | 3/30 (10) | 6/30 (20) |
| Response by WBC count, n (%) | ||
| <1 × 109/L | 0/2 (0) | 1/3 (33) |
| 1 × 109/L to <5 × 109/L | 3/22 (14) | 8/17 (47) |
| 5 × 109/L to 10 × 109/L | 1/5 (20) | 2/7 (29) |
| >10 × 109/L | 2/16 (13) | 2/15 (13) |
| Response by BM blast count, n (%) | ||
| <30% | 3/8 (38) | 3/8 (38) |
| 30-50% | 1/14 (7) | 3/11 (27) |
| >50% | 2/18 (11) | 7/20 (35) |
| Missing | 0/5 (0) | 0/3 (0) |
| . | LDAC . | LDAC + volasertib . |
|---|---|---|
| No. of patients treated | 45 | 42 |
| Response to therapy, n (%) | ||
| Overall (CR + CRi)* | 6 (13.3) | 13 (31.0) |
| CR | 3 (6.7) | 6 (14.3) |
| CRi | 3 (6.7) | 7 (16.7) |
| Time to CR or CRi in days, median (range) | 64 (30-125) | 71 (29-158) |
| Death rate, cumulative events, n (%) | ||
| Day 0 | 0 (0) | 0 (0) |
| Day 30 | 4 (8.9) | 4 (9.5) |
| Day 60 | 8 (17.8) | 9 (21.4) |
| Day 90 | 15 (33.3) | 12 (28.6) |
| Response by ELN genetic group, n (%) | ||
| Favorable | 0/3 (0) | 1/1 (100) |
| Intermediate I/II | 5/25 (20) | 5/21 (24) |
| Adverse | 1/14 (7) | 5/14 (36) |
| Missing | 0/3 (0) | 2/6 (33) |
| Response by gene mutation, n (%) | ||
| NPM1 mutated | 4/7 (57) | 3/7 (43) |
| NPM1 wild-type | 2/33 (6) | 9/26 (35) |
| FLT3-ITD positive | 2/6 (33) | 1/5 (20) |
| FLT3-ITD negative | 4/33 (12) | 11/30 (37) |
| Response by Wheatley risk group, n (%) | ||
| Good | 0/1 (0) | 0/0 (0) |
| Standard | 3/14 (21) | 7/12 (58) |
| Poor | 3/30 (10) | 6/30 (20) |
| Response by WBC count, n (%) | ||
| <1 × 109/L | 0/2 (0) | 1/3 (33) |
| 1 × 109/L to <5 × 109/L | 3/22 (14) | 8/17 (47) |
| 5 × 109/L to 10 × 109/L | 1/5 (20) | 2/7 (29) |
| >10 × 109/L | 2/16 (13) | 2/15 (13) |
| Response by BM blast count, n (%) | ||
| <30% | 3/8 (38) | 3/8 (38) |
| 30-50% | 1/14 (7) | 3/11 (27) |
| >50% | 2/18 (11) | 7/20 (35) |
| Missing | 0/5 (0) | 0/3 (0) |
OR, 2.91; P = .052.