Table I.
Baseline patient characteristics.
| AML (n = 23) | MDS (n = 16) | Total (n = 39) | |
|---|---|---|---|
| Age (years) | |||
| n | 23 | 16 | 39 |
| Median | 70 | 73 | 71 |
| Range | (61.0-86.0) | (61.0-87.0) | (61.0-87.0) |
| Gender | |||
| Female | 12 (52.2%) | 6 (37.5%) | 18 (46.2%) |
| Male | 11 (47.8%) | 10 (62.5%) | 21 (53.8%) |
| ECOG performance score | |||
| 0 | 4 (17.4%) | 4 (25.0%) | 8 (20.5%) |
| 1 | 12 (52.2%) | 11 (68.8%) | 23 (59.0%) |
| 2 | 7 (30.4%) | 1 (6.3%) | 8 (20.5%) |
| Race | |||
| White | 23 (100.0%) | 16 (100.0%) | 39 (100.0%) |
| Months from bone marrow diagnosis to on-study | |||
| n | 23 | 16 | 39 |
| Median | 1.1 | 17.6 | 8.7 |
| Range | (–0.4-42.4) | (0.4-87.9) | (–0.4-87.9) |
| Associated diseases | |||
| Yes | 7 (30.4%) | 1 (6.3%) | 8 (20.5%) |
| No | 16 (69.6%) | 15 (93.8%) | 31 (79.5%) |
| Complication hemorrhage within last 3 months | |||
| Yes | 1 (4.3%) | 0 (0.0%) | 1 (2.6%) |
| No | 22 (95.7%) | 16 (100.0%) | 38 (97.4%) |
| Infection within last 3 months | |||
| Yes | 11 (47.8%) | 1 (6.3%) | 12 (30.8%) |
| No | 12 (52.2%) | 15 (93.8%) | 27 (69.2%) |
| Hematopoietic diagnosis WHO | |||
| Not WHO AML classified at diagnosis, relapsed | 1 (4.3%) | 0 (0.0%) | 1 (2.6%) |
| AML with t(8;21)(q22;q22), (AML1/ETO) | 1 (4.3%) | 0 (0.0%) | 1 (2.6%) |
| AML with abnormal bone marrow eosinophils | 1 (4.3%) | 0 (0.0%) | 1 (2.6%) |
| Following MDS or MDS/MPD | 3 (13.0%) | 0 (0.0%) | 3 (7.7%) |
| Alkylating agent/radiation-related type | 1 (4.3%) | 0 (0.0%) | 1 (2.6%) |
| AML without maturation | 4 (17.4%) | 0 (0.0%) | 4 (10.3%) |
| AML with maturation | 7 (30.4%) | 0 (0.0%) | 7 (17.9%) |
| Acute myelomonocytic leukemia | 4 (17.4%) | 0 (0.0%) | 4 (10.3%) |
| Acute monoblastic/acute monocytic leukemia | 1 (4.3%) | 0 (0.0%) | 1 (2.6%) |
| Refractory cytopenia with multilineage dysplasia | 0 (0.0%) | 2 (12.5%) | 2 (5.1%) |
| Refractory anemia with excess blasts-1 (RAEB-1) | 0 (0.0%) | 5 (31.3%) | 5 (12.8%) |
| Refractory anemia with excess blasts-2 (RAEB-2) | 0 (0.0%) | 3 (18.8%) | 3 (7.7%) |
| Myelodysplastic syndrome, unclassified (MDS-U) | 0 (0.0%) | 6 (37.5%) | 6 (15.4%) |
| Prior stem transplant | |||
| No | 23 (100.0%) | 16 (100.0%) | 39 (100.0%) |
| Cytogenetic risk group | |||
| 4 (17.4%) | 3 (18.8%) | 7 (17.9%) | |
| Intermediate | 8 (34.8%) | 6 (37.5%) | 14 (35.9%) |
| High | 9 (39.1%) | 7 (43.8%) | 16 (41.0%) |
| Other | 2 (8.7%) | 0 (0.0%) | 2 (5.1%) |
| Stage of treatment | |||
| De novo AML | 11 (47.8%) | ||
| Relapsed/refractory disease | 12 (52.2%) | ||
| IPSS risk group | |||
| Intermediate-2 | 10 (62.5%) | ||
| High risk | 6 (37.5%) |
ECOG, Eastern Cooperative Oncology Group; WHO, World Health Organization; AML, acute myeloid leukemia; MDS, myelodysplastic syndrome; MPD, myeloproliferative disorder; IPSS, International Prognostic Scoring System.