Table 1.
Demography and baseline characteristics by diagnosis of AML
| Characteristic | Overall population | de novo AML | Secondary AML | |||
|---|---|---|---|---|---|---|
| Glasdegib + LDAC n = 78 |
LDAC alone n = 38 |
Glasdegib + LDAC n = 38 |
LDAC alone n = 18 |
Glasdegib + LDAC n = 40 |
LDAC alone n = 20 |
|
| Sex, n (%) | ||||||
| Female | 19 (24.4) | 15 (39.5) | 10 (26.3) | 8 (44.4) | 9 (22.5) | 7 (35.0) |
| Male | 59 (75.6) | 23 (60.5) | 28 (73.7) | 10 (55.6) | 31 (77.5) | 13 (65.0) |
| Age, years, n (%) | ||||||
| Mean (SD) | 76.4 (6.0) | 74.8 (4.9) | 76.6 (5.8) | 74.6 (5.1) | 76.2 (6.3) | 74.9 (4.9) |
| Median (range) | 77.0 (64–92) | 76.0 (58–83) | 77.0 (64–87) | 75.5 (58–80) | 76.0 (65–92) | 76.0 (65–83) |
| Secondary AML, n (%) | ||||||
| Prior hematologic disease | 34 (43.6) | 19 (50.0) | – | – | 34 (85.0) | 19 (95.0) |
| MDS | 29 (37.2) | 15 (39.5) | – | – | 29 (72.5) | 15 (75.0) |
| Other | 5 (6.4) | 4 (10.5) | – | – | 5 (12.5) | 4 (20.0) |
| Chemotherapy/ radiotherapy | 6 (7.7) | 1 (2.6) | – | – | 6 (15.0) | 1 (5.0) |
| Prior therapy with MDS drug, n (%) | ||||||
| Azacitidine | 10 (12.8) | 5 (13.2) | – | – | 10 (25.0) | 5 (25.0) |
| Decitabine | 1 (1.3) | 1 (2.6) | – | – | 1 (2.5) | 1 (5.0) |
| Duration since diagnosis, median, months | 0.6 | 0.5 | 0.5 | 0.5 | 0.6 | 0.6 |
| First-line AML non-intensive population criteria, n (%) | ||||||
| Age ≥ 75 years | 48 (61.5) | 23 (60.5) | 25 (65.8) | 12 (66.7) | 23 (57.5) | 11 (55.0) |
| ECOG PS = 2 | 41 (52.6) | 18 (47.4) | 18 (47.4) | 8 (44.4) | 23 (57.5) | 10 (50.0) |
| sCr > 1.3 mg/dL | 15 (19.2) | 5 (13.2) | 7 (18.4) | 4 (22.2) | 8 (20.0) | 1 (5.0) |
| Severe cardiac disease | 52 (66.7) | 20 (52.6) | 29 (76.3) | 9 (50.0) | 23 (57.5) | 11 (55.0) |
| Cytogenetic risk, n (%)a | ||||||
| Good/intermediate | 53 (67.9) | 22 (57.9) | 25 (65.8) | 14 (77.8) | 28 (70.0) | 8 (40.0) |
| Poor | 25 (32.1) | 16 (42.1) | 13 (34.2) | 4 (22.2) | 12 (30.0) | 12 (60.0) |
| ELN risk stratification for AML, n (%) [22] | ||||||
| Favorable | 5 (6.4) | 3 (7.9) | 3 (7.9) | 2 (11.1) | 2 (5.0) | 1 (5.0) |
| Intermediate I | 27 (34.6) | 11 (28.9) | 13 (34.2) | 5 (27.8) | 14 (35.0) | 6 (30.0) |
| Intermediate II | 21 (26.9) | 8 (21.1) | 9 (23.7) | 7 (38.9) | 12 (30.0) | 1 (5.0) |
| Adverse | 25 (32.1) | 16 (42.1) | 13 (34.2) | 4 (22.2) | 12 (30.0) | 12 (60.0) |
| Mutations, n (%)b | ||||||
| FLT3 | 5 (6.4) | 0 | 3 (7.9) | 0 | 2 (5.0) | 0 |
| IDH1 or IDH2 | 19 (24.3) | 6 (15.8) | 14 (29.2) | 2 (11.1) | 5 (12.5) | 4 (20.0) |
| NPM1 | 5 (6.4) | 1 (2.6) | 3 (7.9) | 1 (5.6) | 2 (5.0) | 0 |
| White blood cell count (103/mm3) | ||||||
| Median (range) | 2.7 (0.4–5850.0) | 3.8 (1.2–1370.0) | 2.7 (0.4–28.0) | 4.0 (1.6–27.9) | 2.7 (0.5–5850.0) | 3.7 (1.2–1370.0) |
| Hemoglobin (g/dL) | ||||||
| Median (range) | 8.7 (6.9–13.8) | 9.0 (6.9–13.4) | 8.8 (6.9–13.8) | 9.2 (7.4–12.4) | 8.7 (7.3–12.2) | 8.9 (6.9–13.4) |
| Platelet count (103/mm3) | ||||||
| Median (range) | 42.0 (7.0–35,000.0) | 26.5 (3.0–23,000.0) | 55.0 (10.0–258.0) | 34.0 (11.0–199.0) | 30.0 (7.0–35,000.0) | 22.0 (3.0–23,000.0) |
| Bone marrow blasts, % | ||||||
| Median (range) | 41.0 (16.0–99.0) | 46.0 (13.0–95.0) | 47.5 (20.8–99.0) | 50.5 (20.0–87.0) | 38.0 (16.0–95.0) | 43.0 (13.0–95.0) |
AML, acute myeloid leukemia; ECOG PS, Eastern Cooperative Oncology Group performance status; ELN, European LeukemiaNet; LDAC, low-dose cytarabine; MDS, myelodysplastic syndromes; sCr, serum creatinine; SD, standard deviation
aFor AML, good/intermediate cytogenetic risk = favorable, Intermediate I and Intermediate II risk groups; poor cytogenetic risk = adverse risk group
bBaseline gene mutations were determined in 58/78 glasdegib/LDAC patients (de novo AML, n = 30; secondary AML, n = 28) and 25/38 LDAC alone patients (de novo AML, n = 11; secondary AML, n = 14)