Table I.
Demographics, baseline characteristics and disease state of patients.
| ESA-naïve |
Prior ESA-treated |
|
|---|---|---|
| n = 144 | n = 62 | |
| Sex, n (%) | ||
| Men | 72 (50) | 31 (50) |
| Race, n (%) | ||
| Caucasian | 124 (86) | 51 (82) |
| Other | 20 (14) | 11 (18) |
| Age, years | ||
| Mean (SD) | 75·0 (10·0) | 75·7 (9·3) |
| Median (Min, Max) | 76·0 (51, 93) | 76·5 (55, 94) |
| Baseline eEPO category, n (%) | ||
| Less than 100 mU/ml | 97 (67) | 40 (65) |
| 100 to less than 500 mU/ml | 30 (21) | 13 (21) |
| Greater than or equal to 500 mU/ml | 14 (10) | 7 (11) |
| Missing | 3 (2) | 2 (3) |
| FAB classification, n (%) | ||
| RA | 81 (56) | 38 (61) |
| RARS | 53 (37) | 20 (32) |
| RAEB | 10 (7) | 3 (5) |
| Missing | 0 (0) | 1 (2) |
| IPSS classification, n (%) | ||
| Low | 94 (65) | 44 (71) |
| Intermediate-1 | 44 (31) | 14 (23) |
| Missing | 6 (4) | 4 (6) |
| ECOG status, n (%) | ||
| 0 to 1 | 130 (90) | 55 (89) |
| 2 | 10 (7) | 3 (5) |
| Missing | 4 (3) | 4 (6) |
| Mean (SD) baseline haemoglobin, g/l | 97 (10) (n = 126) | 100 (11) (n = 49) |
| Absolute neutrophil count <1·5 × 109/l, n (%) | 22 (15) | 8 (13) |
| Platelets <100 × 109/l, n (%) | 23 (16) | 11 (18) |
| Cytogenetics, n (%) | ||
| Good | 115 (80) | 48 (77) |
| Intermediate | 14 (10) | 6 (10) |
| Poor | 6 (4) | 3 (5) |
| Unknown or not done | 9 (6) | 5 (8) |
| Transfusion-dependent, n (%)* | 2 (1) | 7 (11) |
| Mean (95% CI) baseline FACT-F score | 30·1 (27·7, 32·6) (n = 115) | 31·1 (27·6, 34·7) (n = 42) |
ESA, erythropoiesis-stimulating agent; Min, minimum; Max, maximum; eEPO, endogenous erythropoietin; FAB, French–American–British; RA, refractory anaemia; RARS, refractory anaemia with ringed sideroblasts; RAEB, refractory anaemia with excess blasts; IPSS, International Prognostic Scoring System; ECOG, Eastern Cooperative Oncology Group; FACT-F, Functional Assessment of Cancer Therapy-Fatigue.
*Patients who received at least three RBC transfusions in 3 months before screening were considered transfusion-dependent.