Table 4. Multivariate analysis of CLL-IPI risk factors for overall survival in relapsed/refractory CLL.
Multivariate analyses of CLL-IPI risk factors for overall survival are shown for all patients enrolled and treated on Study 115, Study 116, and Study 119, and for the idelalisib and comparator therapy subgroups.
| Relapsed/Refractory CLL | Idelalisib Subgroup | Comparator Subgroup | |||||
|---|---|---|---|---|---|---|---|
| Variable | Adverse factor | Hazard ratio (95% CI) | P value | Hazard ratio (95% CI) | P value | Hazard ratio (95% CI) | P value |
| Age | >65 years | 1.5 (1.18–1.91) | 0.001 | 1.89 (1.34–2.68) | 0.0003 | 1.14 (0.81–1.6) | 0.45 |
| Stage | Rai I-VI or Binet B-C |
1.29 (0.32–5.2) | 0.72 | 234475.12 (0-NR)1 | 0.98 | 0.73 (0.18–3.04) | 0.67 |
| B2M | >3.5mg/L | 2.64 (1.77–3.94) | <0.0001 | 2.22 (1.29–3.79) | 0.0038 | 3.44 (1.87–6.32) | <0.0001 |
| IGHV | Unmutated | 1.48 (1.06–2.07) | 0.0212 | 1.65 (1.02–2.68) | 0.0414 | 1.34 (0.84–2.14) | 0.2169 |
| del17p/TP53M | Deleted or mutated | 2.05 (1.63–2.58) | <0.0001 | 1.86 (1.34–2.58) | 0.0002 | 2.33 (1.68–3.24) | <0.0001 |
1
Unusually high estimate for hazard ratio is related to absence of death events (n=2, both censored) among patients in the idelalisib subgroup with the adverse factor (Rai I-VI or Binet B-C). B2M, beta-2 microglobulin; IGHV, immunoglobulin heavy chain variable region; del17p, deletion 17p; TP53M, TP53 mutation.