Table 1.
Main patients’ characteristics prior to venetoclax treatment.
| Variable | All Patients | Azacitidine + Venetoclax | Decitabine + Venetoclax | Low-Dose Cytarabine + Venetoclax | ||||
|---|---|---|---|---|---|---|---|---|
| n (%) | Median (Range) | n (%) | Median (Range) | n (%) | Median (Range) | n (%) | Median (Range) | |
| Total | 51 (100) | 30 (58.8) | 15 (29.4) | 6 (11.8) | ||||
| Sex (male), n (%) | 33 (64.7) | 19 (63.3) | 10 (66.7) | 4 (66.7) | ||||
| Age, median (range) | 51 | 68 (25–82) | 30 | 67 (41–76) | 15 | 64 (25–82) | 6 | 74 (71–77) |
| ≥65 y, n (%) | 34 (66.6) | 21 (70) | 7 (46.7) | 6 (100) | ||||
| Secondary AML | 20/50 (40) | 11/30 (36.7) | 7/15 (46.7) | 2/5 (40) | ||||
| MDS | 13/20 (65) | 6/ | 5 | 2 | ||||
| MPNs | 2/20 (10) | 1 | 1 | 0 | ||||
| t-AML | 6/20 (30) | 5 | 1 | 0 | ||||
| ECOG performance status | 50 | 30 | 9 | 5 | ||||
| 0 | 10 (20) | 7 (23.3) | 5 (55.6) | 3 (60) | ||||
| 1 | 14 (28) | 18 (60) | 3 (33.3) | 2 (40) | ||||
| ≥2 | 26 (52) | 5 (16.7) | 1 (11.1) | 0 | ||||
| WBC count (×109/L) | 48 | 2 (0–640) | 29 | 3.0 (0–110) | 13 | 1.0 (0–640) | 6 | 3.5 (1.0–20) |
| Hemoglobin (g/dL) | 48 | 8.0 (6–13) | 29 | 9.0 (7.0–13) | 13 | 8.0 (6.0–10.0) | 6 | 8.5 (7.0–10.0) |
| Bone marrow blast count, % | 44 | 36.5 (0–95) | 28 | 29 (2–92) | 10 | 45 (0–95) | 6 | 39 (24–86) |
| ≥50% | 16 (36.4) | 8 (28.6) | 5 (50) | 3 (50) | ||||
| FAB subtype | 43 | 30 | 15 | 6 | ||||
| M0/M6/M7 | 9 (21) | 5 (16.7) | 4 (26.7) | 0 | ||||
| M1/M2 | 10 (23) | 5 (16.7) | 3 (20) | 2 (33.3) | ||||
| M4/M5 | 11 (25.5) | 6 (20) | 3 (20) | 2 (33.3) | ||||
| Other | 13 (30) | 14 (19.8) | 5 (33.3) | 2 (33.3) | ||||
| Myelodysplasia-related changes AML | 34 (66.7) | 19 (63.3) | 12 (80) | 3 (50) | ||||
| Cytogenetics | 44 | 26 | 13 | 5 | ||||
| Favorable/Intermediate | 24 (54.5) | 14 (53.8) | 6 (46.2) | 4 (80) | ||||
| Adverse | 20 (45.5) | 12 (36.2) | 7 (53.8) | 1 (20) | ||||
| MRC risk stratification | 42 | 26 | 12 | 4 | ||||
| Favorable/intermediate | 20(47.6) | 12 (46.2) | 5 (41.7) | 3 (75) | ||||
| Adverse | 22 (52.4) | 14 (53.8) | 7 (58.3) | 1 (25) | ||||
| ELN 2017 risk stratification | 36 | 23 | 10 | 3 | ||||
| Favorable/intermediate | 5 (14) | 3 (139) | 1 (10) | 1 (33.3) | ||||
| Adverse | 31 (86) | 20 (87) | 9 (90) | 2 (66.7) | ||||
| Somatic mutations | ||||||||
| NPM1 | 6/41 (15) | 3/27 (11.1) | 2/11 (18.2) | 1/3 (33.3) | ||||
| FLT3-ITD | 5/41 (12) | 4/27 (14.8) | 1/11 (9.1) | 0/3 (0) | ||||
| P53 | 8/29 (27) | 6/20 (30) | 2/7 (28.6) | 0/2 (0) | ||||
| IDH1/2 | 9/27 (29) | 6/18 (33.3) | 1/7 (14.3) | 1/2 (50) | ||||
| First-line treatment | ||||||||
| Intensive chemotherapy, n = 35 | 35 (69) | 22 (73.3) | 11 (73.3) | 2 (33.3) | ||||
| LDAC-based regimen, n = 4 | 4 (8) | 2 (6.7) | 1 (6.7) | 1 (7.8) | ||||
| HMAs, n = 12 | 12 (23) | 6 (20.0) | 3 (20) | 12 (23.5) | ||||
| HMAs at any line prior to venetoclax, n = 26 | 26 (51) | 10 (33.3) | 10 (66.7) | 6 (100) | ||||
| Previous stem cell transplant, n = 12 | 12 (23) | 8 (26.7) | 4 (28.6) | 0 (0) | ||||
| Median number of previous lines (range) | 1 (1–4) | 2 (1–4) | 2 (1–3) | |||||
| AML status | ||||||||
| Refractory | 22 (43.1) | 16 (53.3) | 5 (33.3) | 1 (16.7) | ||||
| Relapse 1 | 23 (45.1) | 12 (40.0) | 8 (53.3) | 3 (50.0) | ||||
| Relapse ≥ 2 | 6 (11.8) | 2 (6.7) | 2 (13.3) | 2 (33.3) | ||||
| Refractory to any line prior VEN | 30 (58.8) | 18 (60.0) | 10 (66.7) | 2 (33.3) | ||||
| Refractory to prior HMAs | 17 (33.3) | 7 (23.3) | 8 (53.3) | 2 (33.3) | ||||
Abbreviations: AML, acute myeloid leukemia; ELN, European LeukemiaNet; ECOG, Eastern Cooperative Oncology Group scale; FAB, French-American-British; FLT3-ITD, fms-related receptor tyrosine kinase 3 internal tandem duplications; HMAs, hypomethilating agents; LDAC, low-dose cytarabine; MDS, myelodysplastic syndrome; MPNs, myeloproliferative neoplasms; MRC, Medical Research Council; NMP1, nucleophosmin 1; t-AML, therapy-related acute myeloid leukemia; VEN, venetoclax; WBC, white blood cell.