TABLE 1.
Patient demographic and baseline characteristics.
| Characteristics | Subgroup | Standard dosing arm (n = 94) | Extended dosing arm (n = 97) | p value |
|---|---|---|---|---|
| Age (years) | Median (range) | 57.00 (20–79) | 57.00 (27–84) | 0.9551 |
| >65 | 21 (22.34%) | 22 (22.68%) | ||
| Gender | Male | 62 (65.96%) | 60 (61.86%) | 0.5552 |
| Female | 32 (34.04%) | 37 (38.14%) | ||
| ECOG performance status score | 0 | 18 (19.15%) | 22 (22.68%) | 0.6201 |
| 1 | 62 (65.96%) | 59 (60.82%) | ||
| 2 | 14 (14.89%) | 16 (16.49%) | ||
| MDS subtype (WHO classification) | RCUD | 3 (3.19%) | 1 (1.03%) | 0.3989a |
| RARS | 2 (2.13%) | 4 (4.12%) | ||
| RCMD | 20 (21.28%) | 18 (18.56%) | ||
| RAEB‐1 | 33 (35.11%) | 26 (26.80%) | ||
| RAEB‐2 | 36 (38.30%) | 45 (46.39%) | ||
| 5q‐ | 0 | 2 (2.06%) | ||
| Lost | 0 | 1 (1.03%) | ||
| IPSS | Intermediate‐1 | 39 (41.49%) | 35 (36.08%) | 0.3960 |
| Intermediate‐2 | 37 (39.36%) | 40 (41.24%) | ||
| High risk | 18 (19.15%) | 21 (21.65%) | ||
| Lost | 0 | 1 (1.03%) | ||
| Comorbidities | No | 39 (41.49%) | 37 (38.14%) | 0.5164 |
| Yes | 54 (57.45%) | 60 (61.86%) | ||
| Lost | 1 (1.06%) | 0 |
Note: MDS subtype was based on the WHO Classification.
Abbreviations: ECOG, Eastern Cooperative Oncology Group; IPSS, International Prognostic Scoring System; MDS, myelodysplastic syndrome; RAEB, refractory anemia with excess blasts; RARS, refractory anemia with ring sideroblasts; RCMD, refractory anemia with multilineage dysplasia; RCUD, refractory cytopenia with unilineage dysplasia.