Patient and disease characteristics of the training cohort
| . | Total cohort (n = 154), n (%) . | CLL15 categories . | P value . | ||
|---|---|---|---|---|---|
| Low-risk group (n = 85), n (%) . | Intermediate-risk group (n = 31), n (%) . | High-risk group (n = 38), n (%) . | |||
| Male | 88 (57.1) | 47 (55.3) | 16 (51.6) | 25 (65.8) | .435 |
| Female | 66 (42.9) | 38 (44.7) | 15 (48.4) | 13 (34.2) | |
| Age, median (range) years | 70 (34-91) | 72 (34-91) | 69 (46-91) | 64 (44-85) | .05 |
| Binet stage | <.01 | ||||
| A | 116 (76.3) | 79 (92.9) | 24 (80) | 13 (35.1) | |
| B | 27 (17.8) | 6 (7.1) | 4 (13.3) | 17 (45.9) | |
| C | 9 (5.9) | 0 | 2 (6.7) | 7 (18.9) | |
| Missing, n | 2 | — | 1 | 1 | |
| Lymphocyte cell count, 109/L – median (range) | 16.8 (3.2-323) | 16.8 (3.2-238) | 15.6 (4.2-323) | 22.1 (7.9-207.4) | .18 |
| Missing, n | 38 | 3 | 7 | 28 | |
| β2-microglobulin | <.01 | ||||
| ≤3.5 mg/dL | 108 (74) | 68 (81.9) | 24 (85.7) | 16 (45.7) | |
| >3.5 mg/dL | 38 (26) | 15 (18.1) | 4 (14.3) | 19 (54.3) | |
| Missing, n | 8 | 2 | 3 | 3 | |
| CLL-IPI | <.01 | ||||
| Low (0-1) | 54 (43.9) | 38 (56.7) | 11 (42.3) | 5 (16.7) | |
| Intermediate (2-3) | 32 (20.8) | 16 (23.9) | 9 (34.6) | 7 (23.3) | |
| High (4-6) | 31 (20.1) | 12 (17.9) | 5 (19.2) | 14 (46.7) | |
| Very high (7-10) | 6 (3.9) | 1 (1.5) | 1 (3.8) | 4 (13.3) | |
| Missing, n | 31 | 18 | 5 | 8 | |
| CLL IPS-E | .785 | ||||
| Low (0) | 24 (27.3) | 16 (25.4) | 7 (36.8) | 1 (16.7) | |
| Intermediate (1) | 44 (50) | 32 (50.8) | 9 (47.4) | 3 (50) | |
| High (2-3) | 20 (22.7) | 15 (23.8) | 3 (15.8) | 2 (33.3) | |
| Missing, n | 28 | 16 | 5 | 7 | |
| IGHVmutational status | <.01 | ||||
| Mutated | 90 (62.5) | 58 (74.4) | 22 (71) | 10 (28.6) | |
| Unmutated | 54 (37.5) | 20 (25.6) | 9 (29) | 25 (71.4) | |
| Undetermined, n | 9 | 7 | — | 2 | |
| Missing, n | 1 | — | 1 | ||
| ZAP-70 | .121 | ||||
| <20% | 88 (74.6) | 54 (78.3) | 20 (80) | 14 (58.3) | |
| ≥20% | 30 (25.4) | 15 (21.7) | 5 (20) | 10 (41.7) | |
| Missing, n | 36 | 16 | 6 | 14 | |
| CD38 | .011 | ||||
| <30% | 117 (84.2) | 69 (90.8) | 24 (85.7) | 24 (68.6) | |
| ≥30% | 22 (15.8) | 7 (9.2) | 4 (14.3) | 11(31.4) | |
| Missing, n | 15 | 9 | 3 | 3 | |
| FISH analysis | |||||
| 17 deletion | 11 (7.9) | 6 (8.1) | 3 (10.3) | 2 (5.4) | |
| 11q deletion | 14 (10) | 8 (10.8) | 3 (10.3) | 3 (8.1) | |
| 13q deletion | 77 (55) | 38 (51.4) | 21 (72.4) | 18 (48.6) | |
| Trisomy 12 | 26 (18.6) | 18 (24.3) | 5 (17.2) | 3 (8.1) | |
| Missing, n | 14 | 11 | 2 | 1 | |
| Complex karyotype (≥3 abnormalities) | .877 | ||||
| No | 63 (90) | 42 (89.4) | 14 (93.3) | 7 (87.5) | |
| Yes | 7 (10) | 5 (10.6) | 1 (6.7) | 1 (12.5) | |
| Missing, n | 84 | 38 | 16 | 30 | |
| TP53 mut | .009 | ||||
| No | 92 (92) | 61 (98.4) | 20 (83.3) | 11 (78.6) | |
| Yes | 8 (8) | 1 (1.6) | 4 (16.7) | 3 (21.4) | |
| Missing, n | 54 | 23 | 7 | 24 | |
| NOTCH1 mut | .351 | ||||
| No | 86 (82.7) | 49 (79) | 23 (92) | 14 (82.4) | |
| Yes | 18 (17.3) | 13 (21) | 2 (8) | 3 (17.6) | |
| Missing, n | 50 | 23 | 6 | 21 | |
| SF3B1 mut | .066 | ||||
| No | 92 (94.8) | 61 (98.4) | 21 (91.3) | 10 (83.3) | |
| Yes | 5 (5.2) | 1 (1.6) | 2 (8.7) | 2 (16.7) | |
| Missing, n | 57 | 23 | 8 | 26 | |
| MYD88 mut | .395 | ||||
| No | 85 (94.6) | 60 (96.8) | 21 (91.3) | 7 (87.5) | |
| Yes | 5 (5.4) | 2 (3.2) | 2 (8.7) | 1 (12.5) | |
| Missing, n | 61 | 23 | 8 | 30 | |
| Median follow-up, months (mo) | 43.8 | 43.6 | 43.8 | 45.9 | .61 |
| . | Total cohort (n = 154), n (%) . | CLL15 categories . | P value . | ||
|---|---|---|---|---|---|
| Low-risk group (n = 85), n (%) . | Intermediate-risk group (n = 31), n (%) . | High-risk group (n = 38), n (%) . | |||
| Male | 88 (57.1) | 47 (55.3) | 16 (51.6) | 25 (65.8) | .435 |
| Female | 66 (42.9) | 38 (44.7) | 15 (48.4) | 13 (34.2) | |
| Age, median (range) years | 70 (34-91) | 72 (34-91) | 69 (46-91) | 64 (44-85) | .05 |
| Binet stage | <.01 | ||||
| A | 116 (76.3) | 79 (92.9) | 24 (80) | 13 (35.1) | |
| B | 27 (17.8) | 6 (7.1) | 4 (13.3) | 17 (45.9) | |
| C | 9 (5.9) | 0 | 2 (6.7) | 7 (18.9) | |
| Missing, n | 2 | — | 1 | 1 | |
| Lymphocyte cell count, 109/L – median (range) | 16.8 (3.2-323) | 16.8 (3.2-238) | 15.6 (4.2-323) | 22.1 (7.9-207.4) | .18 |
| Missing, n | 38 | 3 | 7 | 28 | |
| β2-microglobulin | <.01 | ||||
| ≤3.5 mg/dL | 108 (74) | 68 (81.9) | 24 (85.7) | 16 (45.7) | |
| >3.5 mg/dL | 38 (26) | 15 (18.1) | 4 (14.3) | 19 (54.3) | |
| Missing, n | 8 | 2 | 3 | 3 | |
| CLL-IPI | <.01 | ||||
| Low (0-1) | 54 (43.9) | 38 (56.7) | 11 (42.3) | 5 (16.7) | |
| Intermediate (2-3) | 32 (20.8) | 16 (23.9) | 9 (34.6) | 7 (23.3) | |
| High (4-6) | 31 (20.1) | 12 (17.9) | 5 (19.2) | 14 (46.7) | |
| Very high (7-10) | 6 (3.9) | 1 (1.5) | 1 (3.8) | 4 (13.3) | |
| Missing, n | 31 | 18 | 5 | 8 | |
| CLL IPS-E | .785 | ||||
| Low (0) | 24 (27.3) | 16 (25.4) | 7 (36.8) | 1 (16.7) | |
| Intermediate (1) | 44 (50) | 32 (50.8) | 9 (47.4) | 3 (50) | |
| High (2-3) | 20 (22.7) | 15 (23.8) | 3 (15.8) | 2 (33.3) | |
| Missing, n | 28 | 16 | 5 | 7 | |
| IGHVmutational status | <.01 | ||||
| Mutated | 90 (62.5) | 58 (74.4) | 22 (71) | 10 (28.6) | |
| Unmutated | 54 (37.5) | 20 (25.6) | 9 (29) | 25 (71.4) | |
| Undetermined, n | 9 | 7 | — | 2 | |
| Missing, n | 1 | — | 1 | ||
| ZAP-70 | .121 | ||||
| <20% | 88 (74.6) | 54 (78.3) | 20 (80) | 14 (58.3) | |
| ≥20% | 30 (25.4) | 15 (21.7) | 5 (20) | 10 (41.7) | |
| Missing, n | 36 | 16 | 6 | 14 | |
| CD38 | .011 | ||||
| <30% | 117 (84.2) | 69 (90.8) | 24 (85.7) | 24 (68.6) | |
| ≥30% | 22 (15.8) | 7 (9.2) | 4 (14.3) | 11(31.4) | |
| Missing, n | 15 | 9 | 3 | 3 | |
| FISH analysis | |||||
| 17 deletion | 11 (7.9) | 6 (8.1) | 3 (10.3) | 2 (5.4) | |
| 11q deletion | 14 (10) | 8 (10.8) | 3 (10.3) | 3 (8.1) | |
| 13q deletion | 77 (55) | 38 (51.4) | 21 (72.4) | 18 (48.6) | |
| Trisomy 12 | 26 (18.6) | 18 (24.3) | 5 (17.2) | 3 (8.1) | |
| Missing, n | 14 | 11 | 2 | 1 | |
| Complex karyotype (≥3 abnormalities) | .877 | ||||
| No | 63 (90) | 42 (89.4) | 14 (93.3) | 7 (87.5) | |
| Yes | 7 (10) | 5 (10.6) | 1 (6.7) | 1 (12.5) | |
| Missing, n | 84 | 38 | 16 | 30 | |
| TP53 mut | .009 | ||||
| No | 92 (92) | 61 (98.4) | 20 (83.3) | 11 (78.6) | |
| Yes | 8 (8) | 1 (1.6) | 4 (16.7) | 3 (21.4) | |
| Missing, n | 54 | 23 | 7 | 24 | |
| NOTCH1 mut | .351 | ||||
| No | 86 (82.7) | 49 (79) | 23 (92) | 14 (82.4) | |
| Yes | 18 (17.3) | 13 (21) | 2 (8) | 3 (17.6) | |
| Missing, n | 50 | 23 | 6 | 21 | |
| SF3B1 mut | .066 | ||||
| No | 92 (94.8) | 61 (98.4) | 21 (91.3) | 10 (83.3) | |
| Yes | 5 (5.2) | 1 (1.6) | 2 (8.7) | 2 (16.7) | |
| Missing, n | 57 | 23 | 8 | 26 | |
| MYD88 mut | .395 | ||||
| No | 85 (94.6) | 60 (96.8) | 21 (91.3) | 7 (87.5) | |
| Yes | 5 (5.4) | 2 (3.2) | 2 (8.7) | 1 (12.5) | |
| Missing, n | 61 | 23 | 8 | 30 | |
| Median follow-up, months (mo) | 43.8 | 43.6 | 43.8 | 45.9 | .61 |
P values are for comparisons across the 3 risk groups determined by the CLL15 score.
CLL-IPI, International Prognostic Index for CLL; FISH, fluorescence in situ hybridization.