Final multivariate analysis of the effects of various prognostic factors on PFS and OS
| Characteristic . | Adverse factor . | HR . | 95% CI . | P value . |
|---|---|---|---|---|
| PFS (N = 500; 348 [42.6%] events) | ||||
| Study treatment | FC | 1.976 | 1.59-2.45 | <.001 |
| Serum thymidine kinase level | ≥10 U/L | 1.362 | 1.10-1.77 | .020 |
| IGHV mutational status | UNM | 1.719 | 1.33-2.23 | <.001 |
| Cytogenetic subgroup | Del(11q) | 1.546 | 1.22-1.97 | <.001 |
| Cytogenetic subgroup | Del(17p) | 2.916 | 1.78-4.78 | <.001 |
| TP53 mutational status | Mutated | 2.123 | 1.40-3.22 | <.001 |
| SF3B1 mutational status | Mutated | 1.346 | 1.04-1.75 | .026 |
| OS (N = 500; 173 [21.2%] events) | ||||
| Study treatment | FC | 1.538 | 1.14-2.08 | .006 |
| Age | ≥65 y | 1.423 | 1.04-1.20 | .018 |
| ECOG | >0 | 1.622 | 1.20-2.21 | .002 |
| Serum β2- microglobulin level | ≥3.5 mg/L | 1.473 | 1.07-2.03 | .014 |
| Serum thymidine kinase level | ≥10 U/L | 1.864 | 1.20-2.90 | .003 |
| IGHV mutational status | UNM | 2.059 | 1.39-3.05 | <.001 |
| Cytogenetic subgroup | Del(17p) | 2.715 | 1.60-4.60 | <.001 |
| TP53 mutational status | Mutated | 3.014 | 1.89-4.80 | <.001 |
| Characteristic . | Adverse factor . | HR . | 95% CI . | P value . |
|---|---|---|---|---|
| PFS (N = 500; 348 [42.6%] events) | ||||
| Study treatment | FC | 1.976 | 1.59-2.45 | <.001 |
| Serum thymidine kinase level | ≥10 U/L | 1.362 | 1.10-1.77 | .020 |
| IGHV mutational status | UNM | 1.719 | 1.33-2.23 | <.001 |
| Cytogenetic subgroup | Del(11q) | 1.546 | 1.22-1.97 | <.001 |
| Cytogenetic subgroup | Del(17p) | 2.916 | 1.78-4.78 | <.001 |
| TP53 mutational status | Mutated | 2.123 | 1.40-3.22 | <.001 |
| SF3B1 mutational status | Mutated | 1.346 | 1.04-1.75 | .026 |
| OS (N = 500; 173 [21.2%] events) | ||||
| Study treatment | FC | 1.538 | 1.14-2.08 | .006 |
| Age | ≥65 y | 1.423 | 1.04-1.20 | .018 |
| ECOG | >0 | 1.622 | 1.20-2.21 | .002 |
| Serum β2- microglobulin level | ≥3.5 mg/L | 1.473 | 1.07-2.03 | .014 |
| Serum thymidine kinase level | ≥10 U/L | 1.864 | 1.20-2.90 | .003 |
| IGHV mutational status | UNM | 2.059 | 1.39-3.05 | <.001 |
| Cytogenetic subgroup | Del(17p) | 2.715 | 1.60-4.60 | <.001 |
| TP53 mutational status | Mutated | 3.014 | 1.89-4.80 | <.001 |
Variables included in the model applying backward selection (complete case analysis): type of therapy (FC/FCR), age, sex, disease stage, ECOG performance status, B symptoms, white blood cell count, s-TK, s-β2m, del(11q), trisomy 12, del(13q), del(17p), IGHV mutation status, TP53 mutation status [irrespective del(17p)], NOTCH1 mutation status, and SF3B1 mutation status (N = 507).