Table 1:
Clinical characteristics for CLL and HC MBL by cohorts and overall
| Cohorts | CLL discovery cohort | CLL validation Cohort 1 | CLL Validation Cohort 2 | CLL overall | HC MBL | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| (N=152) | (N=175) | (N=118) | (N=445) | (N=112) | |||||||
| Clinical characteristic | N | % | N | % | N | % | N | % | N | % | |
| Gender | female | 48 | 31.6% | 41 | 23.4% | 32 | 27.1% | 121 | 27.2% | 39 | 34.8% |
| male | 104 | 68.4% | 134 | 76.6% | 86 | 72.9% | 324 | 72.8% | 73 | 65.2% | |
| Age | Median (range) | 62 | (28–87) | 60 | (31–86) | 62 | (36–87) | 61 | (28–87) | 66 | (43–87) |
| Rai stage risk group | Rai 0 | 111 | 73.0% | 75 | 43.1% | 69 | 59.0% | 255 | 57.5% | - | - |
| Rai I–II | 35 | 23.0% | 80 | 46.0% | 39 | 33.3% | 154 | 34.8% | - | - | |
| Rai III–IV | 6 | 4.0% | 19 | 10.9% | 9 | 7.7% | 34 | 7.7% | - | - | |
| Missing | 1 | 1 | 2 | - | - | ||||||
| FISH* | 13q deletion | 82 | 56.2% | 67 | 39.4% | 53 | 48.7% | 202 | 47.5% | 58 | 51.8% |
| Trisomy 12 | 14 | 9.6% | 30 | 17.6% | 14 | 12.8% | 58 | 13.6% | 11 | 9.8% | |
| 11q deletion | 11 | 7.5% | 30 | 17.6% | 10 | 9.2% | 51 | 12.0% | 9 | 8.0% | |
| 17p deletion | 6 | 4.1% | 12 | 7.1% | 8 | 7.3% | 26 | 6.1% | 4 | 3.6% | |
| Normal | 33 | 22.6% | 31 | 18.2% | 24 | 22.0% | 88 | 20.7% | 30 | 26.8% | |
| Missing | 6 | 5 | 9 | 20 | |||||||
| TP53 | Mutated | 12 | 7.9% | 22 | 7.8% | 13 | 11.0% | 43 | 9.7% | 7 | 6.2% |
| Unmutated | 140 | 92.1% | 261 | 92.2% | 105 | 89.0% | 402 | 90.3% | 105 | 93.8% | |
| IGHV | Mutated | 99 | 65.1% | 61 | 35.7% | 58 | 51.3% | 218 | 50.0% | 85 | 75.9% |
| Unmutated | 53 | 34.9% | 110 | 64.3% | 55 | 48.7% | 218 | 50.0% | 27 | 24.1% | |
| mutation status | Missing | 4 | 5 | 9 | |||||||
| Beta-2 microglobulin | ≤3.5 mg/L | 127 | 83.6% | 123 | 70.3% | 91 | 78.4% | 341 | 77.0% | 99 | 88.4% |
| >3.5 mg/L | 25 | 16.4% | 52 | 29.7% | 25 | 21.6% | 102 | 23.0% | 13 | 11.6% | |
| Missing | 2 | 2 | |||||||||
| CLL-IPI** | Low risk (0–1) | 77 | 50.8% | 47 | 27.0% | 39 | 36.8% | 163 | 37.7% | 68 | 60.7% |
| Intermediate risk (2–3) | 44 | 28.9% | 62 | 35.6% | 39 | 36.8% | 145 | 33.6% | 30 | 26.8% | |
| High risk (4–6) | 25 | 16.4% | 48 | 27.6% | 20 | 18.9% | 93 | 21.5% | 14 | 12.5% | |
| Very high risk (7–10) | 6 | 3.9% | 17 | 9.8% | 8 | 7.5% | 31 | 7.2% | 0 | 0.0% | |
| Missing | 1 | 12 | 13 | ||||||||
| B cell count × 109/L | Median (range) | 11.6 | (2.2–145) | 24.9 | (5.2–235) | 10.9 | (3.4–395) | 15.1 | (2.2–395) | 3.2 | (0.6–5.0) |
| Missing | 5 | 28 | 25 | 58 | 4 | ||||||
| ALC × 109/L | Median (range) | 16.6 | (3.4–183) | 35.2 | (1.9–317) | 17.3 | (2.6–386) | 23.5 | (1.9–386) | 6.12 | (2.35–12.6) |
| Missing | 1 | 0 | 1 | 2 | 0 | ||||||
CLL, chronic lymphocytic leukemia; HC MBL, high-count monoclonal B-cell lymphocytosis; CLL-IPI, CLL international prognostic index; ALC, absolute lymphocyte count
*
cases with >1 FISH abnormality were counted for the worse abnormality.
**
HC MBL were scored as 0 points for Rai stage.