TABLE 1.
Baseline characteristics.
| Aza-venetoclax cohort N = 27 |
Historical cohort N = 95 |
|
|---|---|---|
| Median age, years (range) | 70 (59–81) | 73 (39–91) |
| Sex, n (%) | ||
| Male | 16 (59) | 50 (53) |
| Female | 11 (41) | 45 (47) |
| WHO classification | ||
| Single-lineage dysplasia | - | 4 (4) |
| Multi-lineage dysplasia | - | 12 (13) |
| MDS with isolated del(5q) | - | 2 (2) |
| MDS-EB 1 | 2 (7.4) | 22 (23) |
| MDS EB 2 | 3 (11.1) | 28 (30) |
| Unclassifiable | - | 1 (1) |
| CMML | - | 2 (2) |
| AML de novo | 12 (44.4) | 24 (25) |
| AML post-MDS | 10 (37.1) | - |
| IPSS-R risk, n (%) | ||
| Very low | - | - |
| Low | 1 (4) | 14 (15) |
| Intermediate | - | 21 (22) |
| High | 9 (33) | 26 (27) |
| Very high | 5 (18) | 3 (3) |
| Not evaluable | - | 7 (7) |
| ELN risk, n (%) | ||
| Favorable | 7 (26) | - |
| Intermediate | 4 (15) | - |
| Unfavorable | (1 4) | - |
| Not evaluable | - | 24 (26) |
| Cytogenetic risk, n (%) | ||
| Very good | - | - |
| Good | 6 (22) | 45 (47) |
| Intermediate | 8 (30) | 5 (5.3) |
| Poor | 1 4) | 2 (2.1) |
| Very poor | 3 (11) | 2 (2.1) |
| Not evaluable | 9 (33) | 41 (43) |
| Median % blasts (range) | 32 (0–70) | 11 (0–90) |
| First-line therapy | ||
| Azacytidine, n (%) | 12 (44) | 75 (79) |
| Azacytidine + venetoclax | 9 (33) | - |
| Lenalidomide, n (%) | 1 (4) | 6 (6) |
| Decitabine | 3 (11) | - |
| Standard chemotherapy | 2 (8) | 5 (5) |
| Supportive | - | 9 (10) |
| Second-line therapy | 17/27 | 20/95 |
| Azacytidine | - | 11 (55) |
| Azacytidine + lenalidomide | - | 2 (10) |
| Azacytidine + venetoclax | 12 (71) | 1 (5) |
| Decitabine | 1 (6) | 1 (5) |
| Standard chemotherapy | 1 (6) | 2 (10) |
| Venetoclax | 3 (17) | - |
| Others | - | 3 (15) |
| HSCT | 3 (11) | 6 (6) |
| Median Hb, g/dL (range) | 9 (6–13) | 9.1 (5.1–14.4) |
| Median ANC, cells/µl (range) | 1,015 (30–20,850) | 1,677 (120–21,490) |
| Median platelets/µl (range) | 62,500 (6,000–216,000) | 68,000 (6,000–982,000) |
Abbreviations: WHO, world health organization; MDS, myelodysplastic syndrome; EB, excess of blast; CMML, chronic myelomonocytic leukemia; AML, acute myeloid leukemia; IPSS-R, international prognostic scoring system revised; ELN, european leukemia net; HSCT, hematopoietic stem cell transplantation; Hb, hemoglobin; ANC, absolute neutrophil count.