Table I.
Baseline characteristics of patients with CLL treated with frontline FCR FCR-300 clinical trial and FCR-based therapies (off-protocol)
| Characteristic | Measure/Category | FCR-300 clinical trial (n=203) | FCR-based therapy (control group) (n=332) |
|---|---|---|---|
| Age, years | Median (range) | 57 (17–85) | 58 (28–84) |
| Age (≥65 years) | n (%) | 49 (24) | 68 (21) |
| Gender | Male/Female (n) | 151/52 | 220/112 |
| Rai stage | (0, 1, 2/3, 4) n (%) | 134 (66)/69 (34) | 217 (65)/115 (35) |
| WBC, ×109/l | Median (range) | 81.5 (2.1–407.8) | 84.2 (1.4–541) |
| Hb, g/l | Median (range) | 125 (61–187) | 125 (23–165) |
| Platelet count, ×109/l | Median (range) | 156 (34–406) | 147 (10–420) |
| β2M (mg/l) | (</≥ 4 mg/l) n (%) | 116 (57)/85 (42) | 220 (67)/111 (33) |
| Number of cycles |
1–3 4–5 6 |
22 30 159 |
77 84 232 |
| Progressed | n (%) | 132 (65) | 158 (48) |
| Died | n (%) | 105 (52) | 64 (20) |
| Follow-up, years | Median (range) | 10.7 (0.1–15.5) | 5.6 (0.2–12.1) |
β2M; β2 microglobulin; CLL: chronic lymphocytic leukaemia; FCR: fludarabine, cyclophosphamide and rituximab; Hb: haemoglobin concentration; WBC: white blood cell count.