Table 1. Patient's characteristics and univariate association with PFS.
| ITT population (n=408) | Analysis set (n=139) | Median PFS (months) | Hazard rate (95% CI) | P-value | |
|---|---|---|---|---|---|
| Age⩾65 years | 31% (126/408) | 29% (40/139) | 55.2 | 1.12 (0.86–1.46) | 0.41 |
| Male | 74% (303/408) | 78% (109/139) | 54.2 | 1.51 (1.12–2.04) | 0.007 |
| ECOG 1/2 | 44% (174/395) | 47% (62/132) | 49.3 | 1.24 (0.97–1.60) | 0.09 |
| B-symptoms | 41% (167/407) | 35% (49/139) | 56.0 | 0.92 (0.71–1.20) | 0.52 |
| Binet C | 31% (126/407) | 32%(44/139) | 42.6 | 1.27 (0.97–1.65) | 0.08 |
| IGHV unmutated | 64% (197/310) | 71% (95/134) | 41.8 | 2.67 (1.92–3.72) | <0.001 |
| Deletion (13q)a | 34% (105/311) | 34% (44/131) | 77.5 | 0.50 (036–0.70) | <0.001 |
| Deletion (11q)a | 26% (80/311) | 31% (41/131) | 46.7 | 1.68 (1.25–2.26) | 0.001 |
| Trisomy 12a | 8% (24/311) | 8% (10/131) | 72.4 | 0.59 (0.34–1.01) | 0.051 |
| Deletion (17p)a | 7% (22/311) | 5% (7/131) | 11.3 | 3.91 (2.39–6.40) | <0.001 |
| TP53 mutation | 10% (31/313) | 8% (11/133) | 15.4 | 3.17 (2.09–4.82) | <0.001 |
| Deletion (17p) and/or TP53 mutation | 11% (34/305) | 8% (11/133) | 15.4 | 3.32 (2.21–4.99) | <0.001 |
| s-β2m⩾3.5 mg/l | 33%(106/318) | 30% (40/134) | 43.3 | 1.50 (1.13–2.00) | 0.005 |
| s-TK⩾10 U/l | 73% (232/318) | 78% (105/134) | 51.9 | 1.70 (1.21–2.39) | 0.002 |
| MRD level⩾10−4 to<10−2 | 24% (35/143) | 22% (31/139) | 38.4 | 2.8 (1.8–4.6)b | <0.001 |
| MRD level ⩾10−2 | 13% (18/143) | 13% (18/139) | 11.7 | 20.0 (10.4–38.6)b | <0.001 |
| iwCLL CR | 44% (180/408) | 49% (68/139) | 69.3 | 0.54 (0.42–0.70) | <0.001 |
Abbreviations: CI, confidence interval; CLL, chronic lymphocytic leukemia; CR, complete remission; ECOG, Eastern Cooperative Oncology Group; FCR, fludarabine, cyclophosphamide, and rituximab; ITT, intention-to-treat; MRD, minimal residual disease; PFS, progression free survival; s-β2m, β2-microglobulin; s-TK, serum levels of thymidine kinase.
Baseline characteristics and risks features of the CLL8 trial patients who received FCR are given for all patients in the intention-to-treat (ITT) population and in the subgroup of patients with sufficient data for risk classification according to the algorithm. Median PFS, hazard rates and significance of the association to PFS in univariate analysis are tabulated per risk feature. Hazard rates are computed in comparison with all other patients with available data on a particular risk feature, unless otherwise stated. MRD data are assessed in peripheral blood, 2 months after completion of therapy.
Chromosomal aberrations were assessed according to the Döhner hierarchical model.15
Compared with MRD levels<10−4 (MRD negativity according to iwCLL definition10).