Table 1.
Baseline characteristics (intention-to-treat population).
| Parameter | High risk | Low risk | Total N (%) |
|
|---|---|---|---|---|
| Hi-FCR N (%) |
Hi-W&W N (%) |
Lo-W&W N (%) |
||
| All patients | 100 | 101 | 599 | 800 |
| Germany | 59 (59.0) | 60 (59.4) | 295 (49.2) | 414 (51.8) |
| France | 41 (41.0) | 41 (40.6) | 304 (50.8) | 386 (48.3) |
| Median age (range) | 58 (33–77) | 60 (40–81) | 59 (27–81) | 59 (27–81) |
| Age ≤ 60 years | 58 (58.0) | 54 (53.5) | 335 (55.9) | 447 (55.9) |
| Age > 70 years | 10 (10.0) | 15 (14.5) | 59 (9.8) | 84 (10.5) |
| Male sex | 69 (69.0) | 78 (77.2) | 366 (61.1) | 513 (64.1) |
| ≥1 comorbidity (CIRSa, N = 765) | 54 (54.0) | 61 (60.4) | 354 (62.8) | 469 (61.3) |
| >6 comorbidities (CIRSa, N = 765) | 2 (2.0) | 4 (4.0) | 6 (1.1) | 12 (1.6) |
| ECOGb 0–1 (N = 751) | 94 (98.9) | 100 (100.0) | 554 (98.9) | 748 (99.1) |
| B symptoms (N = 762) | 8 (8.1) | 9 (9.1) | 25 (4.4) | 42 (5.5) |
| Clinical lymphadenopathy > 1 cm (N = 772) | 48 (48.0) | 49 (48.5) | 159 (27.8) | 256 (33.2) |
| Radiologic lymphadenopathy > 1 cm (N = 772) | 49 (49.0) | 41 (40.6) | 130 (22.8) | 220 (28.5) |
| Median WBC, ×10E3/µl (range, N = 766) | 28 (7.2–220.0) | 30 (0.1–165.6) | 18 (5.8–239.8) | 20 (0.1–239.8) |
| TK > 10 U/L (N = 795) | 62 (62.0) | 52 (52.0) | 40 (6.7) | 154 (19.4) |
| LDT < 12 months (N = 799) | 58 (58.0) | 48 (47.5) | 71 (11.9) | 177 (22.2) |
| IGHV unmutated (N = 783) | 81 (81.0) | 82 (82.0) | 57 (9.8) | 220 (28.1) |
| Cytogenetics (N = 795)c | 100 | 100 | 595 | 795 |
| Trisomy 12 (n, %) | 25 (25.0) | 24 (24.0) | 18 (3.0) | 67 (8.4) |
| Del(11q) (n, %) | 17 (17.0) | 35 (35.0) | 3 (0.5) | 55 (6.9) |
| Del(17p) (n, %) | 4 (4.0) | 9 (9.0) | 5 (0.8) | 18 (2.3) |
| Not del(17p)/del(11q)/trisomy 12 | 54 (54.0) | 32 (32.0) | 569 (95.6) | 655 (82.4) |
| Total risk factors (N = 799) | 100 | 100 | 599 | 799 |
| 0 | 0 (0.0) | 0 (0.0) | 395 (65.9) | 395 (49.4) |
| 1 | 0 (0.0) | 1 (1.0)d | 202 (33.7) | 203 (25.4) |
| 2 | 58 (58.0) | 55 (55.0) | 2 (0.3)d | 115 (14.4) |
| 3 | 34 (34.0) | 36 (36.0) | 0 (0.0) | 70 (8.8) |
| 4 | 8 (.0) | 8 (8.0) | 0 (0.0) | 16 (2.0) |
aCumulative illness rating scale [32].
bECOG = performance status scale according to the Eastern Cooperative Group [33].
cAccording to Döhner et al. [24].
dThree patients were allocated to the incorrect risk stratum according to their risk profile presented here. Two of those cases (one Hi-W&W and one Lo-W&W) were caused by entry/capture errors for assigned risk factors in the database; and, these patients were stratified in the correct risk subset. Only one Lo-W&W patient was truly misstratified as a low-risk case, despite the fact that two risk factors had been found present by central diagnostics.