Table III.
FCR on clinical trial – FCR-300 | Univariate | Multivariate (continuous) | ||||||
---|---|---|---|---|---|---|---|---|
N | Events | HR | 95% CI | P-value | HR | 95% CI | P-value | |
IGHV% | 203 | 105 | 0.84 | (0.78–0.91) | <0.001 | 0.82 | (0.76–0.90) | <0.001 |
β2M (mg/l) | 201 | 103 | 1.24 | (1.15–1.34) | <0.001 | |||
Cycles (n) | 203 | 105 | 0.66 | (0.58–0.75) | <0.001 | |||
Ag e≥65 years | ||||||||
No | 154 | 66 | ||||||
Yes | 49 | 39 | 2.92 | (1.96–4.35) | <0.001 | 1.92 | (1.23–3.01) | 0.004 |
β2M ≥ 4 mg/l | ||||||||
No | 116 | 45 | ||||||
Yes | 85 | 58 | 2.51 | (1.70–3.71) | <0.001 | |||
Cycles | ||||||||
1–3 | 22 | 19 | ||||||
4–5 | 27 | 18 | 0.52 | (0. 27–0.99) | 0.04 | 0.48 | (0.25–0.94) | 0.03 |
6 | 154 | 68 | 0.23 | (0.14–0.38) | <0.001 | 0.27 | (0.15–0.48) | <0.001 |
Other variables that were significantly associated with increased risk of death in univariate analysis but not in multivariate models were age >65 years, high β2M, elevated lactate dehydrogenase levels, ZAP70 positivity and undetectable 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; OS: overall survival.