Table 1.
Baseline and demographic characteristics of all randomized patients
| Characteristic | 3-day treatment group | 5-day treatment group | Total |
|---|---|---|---|
| Age (years) | |||
| N | 36 | 99 | 135 |
| Mean (SD) | 49.2 (16.4) | 51.6 (14.78) | 51.0 (15.11) |
| Median | 49.2 | 54.7 | 54.1 |
| Age category, n (%) | |||
| ≥18–60 years | 25 (69.4) | 69 (69.7) | 94 (69.6) |
| ≥60 years | 11 (30.6) | 30 (30.3) | 41 (30.4) |
| Sex, n (%) | |||
| N | 36 | 99 | 135 |
| Men | 14 (38.9) | 65 (65.7) | 79 (58.5) |
| Women | 22 (61.1) | 34 (34.3) | 56 (41.5) |
| Race, n (%) | |||
| N | 36 | 99 | 135 |
| Han | 35 (97.2) | 99 (100.0) | 134 (99.3) |
| Others | 1 (2.8) | 0 (0.0) | 1 (0.7) |
| Body weight (kg) | |||
| N | 36 | 99 | 135 |
| Mean (SD) | 63.8 (9.19) | 63.1 (10.81) | 63.3 (10.37) |
| Duration of MDS (months) | |||
| N | 34 | 98 | 132 |
| Median (min–max) | 0.6 (0.1–26.6) | 0.7 (0.0–52.0) | 0.7 (0.0–52.0) |
| Patients with prior active MDS therapy, n | |||
| N | 24 | 44 | 68 (50%) |
| Chemotherapy | 8 | 13 | 21 (16%) |
| Biologica | 15 | 26 | 41 (30%) |
| Bone marrow transplant | 0 | 0 | 0 |
| FAB classification of MDS, n (%) | |||
| N | 36 | 99 | 135 |
| RA | 11 (30.6) | 16 (16.2) | 27 (20.0) |
| RARS | 0 (0.0) | 4 (4.0) | 4 (3.0) |
| RAEB | 18 (50.0) | 67 (67.7) | 85 (63.0) |
| RAEB-t | 4 (11.1) | 7 (7.1) | 11 (8.1) |
| CMML | 3 (8.3) | 5 (5.1) | 8 (5.9) |
| IPSS score, n (%)b | |||
| N | 36 | 99 | 135 |
| Intermediate-1 risk (0.5–1.0 points) | 18 (50.0) | 39 (39.4) | 57 (42.2) |
| Intermediate-2 risk (1.5–2.0 points) | 11 (30.6) | 47 (47.5) | 58 (43.0) |
| High risk (≥2.5 points) | 7 (19.4) | 13 (13.1) | 20 (14.8) |
| ECOG score, n (%) | |||
| N | 36 | 99 | 135 |
| 0 | 8 (22.2) | 11 (11.1) | 19 (14.1) |
| 1 | 20 (55.6) | 71 (71.7) | 91 (67.4) |
| 2 | 8 (22.2) | 17 (17.2) | 25 (18.5) |
CMML chronic myelomonocytic leukemia, ECOG Eastern Cooperative Oncology Group, FAB French–American–British, IPSS International Prognostic Scoring System, MDS myelodysplastic syndrome, RA refractory anemia, RAEB refractory anemia with excess blasts, RAEB-t refractory anemia with excess blasts in transformation, RARS refractory anemia with ringed sideroblasts, SD standard deviation
aGrowth factors, immunosuppressive agents, hormones
bDetermined by complete blood cell count, bone marrow assessment, and bone marrow cytogenetics within 30 days of randomization