Table 4.
Recovery of ANC, hemoglobin, and platelets, and rates of transfusions in patients with AML (overall population)
| Glasdegib + LDAC | LDAC alone | Glasdegib + LDAC | LDAC alone | |
| n = 72 | n = 32 | n = 72 | n = 32 | |
| ANC | ≥ 1000/μL | ≥ 500/μL | ||
| All patients with recovery, n (%) | 49 (68.1) | 20 (62.5) | 58 (80.6) | 24 (57.1) |
| Recovery at ≥ 2 consecutive visits, n (%) | 40 (55.6) | 12 (37.5) | 47 (65.3) | 17 (53.1) |
| Baseline ANC < threshold, n (%)a | 22 (30.5) | 5 (15.6) | 18 (25.0) | 1 (3.1) |
| Median time to first recovery, days (range) | 27 (7–114) | 13 (8–70) | 16 (3–143) | 11 (8–119) |
| Achieved recovery during cycle 2/1, n (%)b | 30 (41.7) | 10 (31.3) | 49 (68.1) | 22 (68.8) |
| Hemoglobin | 10 g/dL | ≥ 9 g/dL | ||
| All patients with recovery, n (%) | 43 (59.7) | 18 (56.3) | 64 (88.9) | 22 (68.8) |
| Recovery at ≥2 consecutive visits, n (%) | 23 (31.9) | 7 (21.9) | 44 (61.1) | 13 (40.6) |
| Baseline hemoglobin < threshold, n (%)a | 19 (26.4) | 4 (12.5) | 24 (33.3) | 2 (6.3) |
| Median time to first recovery, days (range) | 22 (6–129) | 33 (9–140) | 14 (4–172) | 22 (2–85) |
| Achieved recovery during cycle 1, n (%) | 31 (43.1) | 11 (34.4) | 57 (79.2) | 20 (62.5) |
| Platelets | ≥ 100,000/μL | ≥50,000/µL | ||
| All patients with recovery, n (%) | 36 (50.0) | 7 (21.9) | 49 (68.1) | 13 (40.6) |
| Recovery at ≥2 consecutive visits, n (%) | 30 (41.7) | 4 (12.5) | 38 (52.8) | 8 (25.5) |
| Baseline platelets < threshold, n (%)a | 20 (27.8) | 2 (6.25) | 15 (20.8) | 3 (9.4) |
| Median time to first recovery, days (range) | 30 (6–171) | 26 (2–56) | 26 (4–141) | 24 (2–119) |
| Achieved recovery during cycle 1, n (%) | 24 (33.3) | 6 (18.8) | 40 (55.6) | 11 (34.4) |
| Transfusion rates |
Glasdegib + LDAC n = 75 |
LDAC alone n = 36 |
||
| Proportion independent, n (%)c | ||||
| No transfusions | 22 (29.3) | 2 (5.6) | ||
| PRBC transfusions | 25 (33.3) | 3 (8.3) | ||
| Platelet transfusion | 32 (42.7) | 4 (11.1) | ||
| Exposure-adjusted rate | ||||
| Any transfusion | 0.0696 | 0.1555 | ||
| PRBC transfusion | 0.0423 | 0.0789 | ||
| Platelet transfusion | 0.0273 | 0.0766 | ||
AML, acute myeloid leukemia; ANC, absolute neutrophil count; LDAC, low-dose cytarabine; PRBC, packed red blood cell
aRequires measurement at ≥ 2 consecutive visits
bCycle 2 for ANC ≥ 1000/μL and cycle 1 for ANC ≥ 500/μL
cRequired no PRBC or platelet transfusions for ≥ 8 weeks