Table 3.
Response to treatment overall and in post hoc analysis of subgroups.
| Patients assessed for response (Hi-FCR) | Overall response N (%) |
Complete response N (%) |
Partial response N (%) |
Stable disease N (%) |
Not evaluable/available N (%) |
|---|---|---|---|---|---|
| All patients (ITT, N = 100) | 76 (76.0) | 61 (61.0) | 15 (15.0) | 3 (3.0) | 21 (21.0)a |
| Treated patients (SP, N = 82) | 76 (92.7) | 61 (74.4) | 15 (18.3) | 3 (3.7) | 3 (3.7) |
| Patients with ≥ 3 cycles of FCR (N = 75) | 74 (98.7) | 61 (81.3) | 13 (17.3) | 1 (1.3) | 0 (0.0) |
| Two risk factors present (N = 58) | 44 (75.9) | 36 (62.1) | 8 (13.8) | 1 (1.7) | 13 (22.4) |
| Three risk factors present (N = 34) | 26 (76.5) | 20 (58.8) | 6 (17.6) | 2 (5.9) | 6 (17.6) |
| Four risk factors present (N = 8) | 6 (75.0) | 5 (62.5) | 1 (12.5) | 0 (0.0) | 2 (25.0) |
| LDT < 12 months (N = 58) | 43 (74.1) | 38 (65.5) | 5 (8.6) | 2 (3.4) | 13 (22.4) |
| TK > 10 U/L (N = 62) | 50 (80.6) | 38 (61.3) | 12 (19.4) | 2 (3.2) | 10 (16.1) |
| IGHV unmutated (N = 81) | 59 (72.8) | 45 (55.6) | 14 (17.3) | 3 (3.7) | 19 (23.5) |
| IGHV mutated (N = 19) | 17 (89.5) | 16 (84.2) | 1 (5.3) | 0 (0.0) | 2 (10.5) |
| Trisomy 12b (N = 25) | 18 (72.0) | 16 (64.0) | 2 (8.0) | 0 (0.0) | 7 (28.0) |
| Del(11q)b (N = 17) | 15 (88.2) | 12 (70.6) | 3 (17.6) | 0 (0.0) | 2 (11.8) |
| Del(17p)b (N = 4) | 2 (50.0) | 0 (0.0) | 2 (50.0) | 1 (25.0) | 1 (25.0) |
| No trisomy 12/del(11q)/del(17p) (N = 54) | 41 (75.9) | 33 (61.1) | 8 (14.8) | 2 (3.7) | 11 (20.4) |
aIncludes 18 patients who refused initiation of FCR therapy after stratification/randomization.
bAccording to Döhner et al. [24].