Table 1.
Clinical characteristics of patients included in the study
| Characteristics | Relapsed cases (n = 49) | Responders (n = 49) | Entire cohort (n = 98) | P value |
|---|---|---|---|---|
| Median age, y (range) | 66 (33-86) | 68 (46-85) | 67 (33-86) | ns |
| Male:female | 32:17 | 31:18 | 63:35 | ns |
| Median number of previous therapies | 2 | 1 | 2 | ns |
| Unmutated IGHV, n (%) | 28/35 (80) | 29/41 (70.7) | 57/76 (75) | ns |
| del(11q), n (%) | 14/45 (31) | 10/44 (22.7) | 24/89 (26.9) | ns |
| del(17p), n (%) | 21/46 (45.6) | 21/46 (45.6) | 42/92 (45.6) | ns |
| TP53 mutation, n (%) | 13/27 (48.1) | 8/38 (21) | 21/65 (32.3) | .03 |
| TP53 aberrations (del(17p) and/or TP53 mutations), n (%) | 25/46 (54.3) | 23/46 (50) | 48/92 (52.2) | ns |
| Best response to ibrutinib | ||||
| PR/PR-L | 44/49 | 35/49 | 79/98 | ns |
| CR | 5/49 | 14/49 | 19/98 | ns |
| Median duration of ibrutinib treatment, (range) (mo) | 36 (6-68) | 44 (18-87) | 40 (6-87) | ns |
| Follow-up | ||||
| Median follow-up, (range) (mo) | 43 (8-84) | 46 (18-87) | 44 (8-87) | ns |
| Median overall survival, (95% CI) (mo) | 58 (36-80) | NR | NR | P < .001 |
| Dead, n (%) | 25 (51) | 5 (10.2) | 30 (30.6) | P < .001 |
CI, confidence interval; CR, complete response; ns, not significant; NR, not reached PR, partial response; PR-L, partial response with lymphocytosis.