Table 3. The relevance of clinicobiological prognostic factors according to the three cytosine derivative subgroups in the validation cohort.
| Prognostic factors and clinical outcome | Global | Partial | Normal | Statistics (p) |
|---|---|---|---|---|
| Age at diagnosis - median [range] | 62.5 [43–77] | 62.5 [33–83] | 67.4 [60–77] | ns |
| Age at study entry - median [range] | 67.4 [45–85] | 66.9 [33–87] | 74.5 [61.89] | ns |
| Binet stage - number of patients (%) | ns | |||
| A | 11/22 (50%) | 15/26 (57.7%) | 8/8 (100%) | |
| B and C | 11/22 (50%) | 11/26 (42.3%) | 0/8 (0%) | |
| Lymphocytosis (Giga/L) - median (±SEM) | 37.36 (± 11.96) | 28.01 (± 5.01) | 17.82 (± 3.55) | 0.03 |
| Lymphocyte doubling time from diagnosis (months)* | 12 | 14.5 | 48 | ns |
| IGHV mutational status - number of patients (%) | ns | |||
| Unmutated (≥ 98% homology) | 5 (10.42%) | 2 (4.17%) | 3 (6.25%) | |
| Mutated (< 98% homology) | 14 (29.17%) | 14 (29.17%) | 10 (20.83%) | |
| Cytogenetic risk category - number of patients (%) | 0.005 | |||
| Low risk - Isolated del(13q) | 7/17 (41.2%) | 11/20 (55%) | 5/8 (62.5%) | |
| Intermediate risk- Trisomy 12, normal karyotype and FISH | 0/17 (0%) | 5/20 (25%) | 3/8 (37.5%) | |
| High risk - del(11q), del(17p), complex karyotype | 10/17 (58.8%) | 4/20 (20%) | 0/8 (0%) | |
| CD38 > 30% - number of patients (%) | 5/20 (25%) | 7/25 (28%) | 2/8 (25%) | ns |
| 5-mCyt Index - median (± SEM) | 0.88 (± 0.02) | 0.98 (± 0.03) | 1.07 (± 0.03) | p < 0.0001 |
| 5-hmCyt Index - median (± SEM) | 0.18 (± 0.007) | 0.21 (± 0.003) | 0.21 (± 0.003) | p < 0.0001 |
| 5-CaCyt Index - median (± SEM) | 0.60 (± 0.01) | 0.65 (± 0.01) | 0.63 (± 0.01) | ns |
| Progression free survival - median (months)* | 48 | 90 | Undefined | 0.03 |
| Treatment free survival - median (months)* | 60 | 92 | Undefined | 0.03 |
Abbreviations: ns, not significant; IGHV, immunoglobulin heavy chain variable region; FISH, fluorescence in situ hybridization; 5mCyt, 5-methylcytosine; 5-hmCyt, 5-hydroxymethylcytosine; 5-CaCyt, 5-carboxylcytosine; *, Kaplan-Meyer survival analysis. Statistical analysis was assessed using One-Way Anova test, Fisher’s exact test, or Log-rank analysis.