Table II.
Univariate and multivariate analyses of PFS of CLL patients treated with frontline FCR
| FCR-300 Original | Univariate | Multivariate (continuous) | ||||||
|---|---|---|---|---|---|---|---|---|
| N | Events | HR | 95% CI | P-value | HR | 95% CI | P-value | |
| IGHV% | 203 | 148 | 0.81 | (0.76–0.87) | <0.001 | 0.80 | (0.75–0.86) | <0.001 |
| β2M (mg/l) | 201 | 146 | 1.17 | (1.09–1.27) | <0.001 | |||
| WBC ×109/l | 203 | 148 | 1.00 | (1.00–1.01) | 0.002 | |||
| Cycles (n) | 203 | 148 | 0.71 | (0.62–0.80) | <0.001 | |||
| Age ≥65 years | ||||||||
| No | 154 | 106 | ||||||
| Yes | 49 | 42 | 1.69 | (1.18–2.42) | 0.004 | |||
| β2M ≥ 4 mg/l | ||||||||
| No | 116 | 74 | ||||||
| Yes | 85 | 72 | 2.02 | (1.46–2.80) | <0.001 | |||
| WBC ≥ 200 ×109/l | ||||||||
| No | 190 | 132 | ||||||
| Yes | 21 | 19 | 2.45 | (1.50–3.98) | <0.001 | 2.30 | (1.40–3.77) | 0.001 |
| Cycles | ||||||||
| 1–3 | 22 | 21 | ||||||
| 4–5 | 27 | 19 | 0.36 | (0.19–0.68) | <0.001 | 0.28 | (0.15–0.52) | <0.001 |
| 6 | 154 | 108 | 0.29 | (0.18–0.47) | <0.001 | 0.24 | (0.15–0.39) | <0.001 |
Other variables that were significantly associated with increased risk of progression events in the univariate analysis but not in the multivariate models (and therefore not included in this table) were increased age, high β2 microglobin, elevated lactate dehydrogenase levels, and detectable minimal residual disease (not shown).
95% CI: 95% confidence interval; β2M; β2 microglobulin; CLL: chronic lymphocytic leukaemia; FCR: fludarabine, cyclophosphamide and rituximab; HR: Hazard ratio; PFS: progression-free survival; WBC: white blood cell count.