Table 1.
Baseline characteristics
| All (n = 86) | TP53 cohort (n = 51) | Elderly cohort (n = 35) | |
|---|---|---|---|
| Age, median (range), y | 66 (33-85) | 62 (33-82) | 69 (63*-85) |
| ≥65, N (%) | 55 (64.0) | 21 (41.2) | 34 (97.1)* |
| Sex, N (%) | |||
| Female | 36 (41.9) | 20 (39.2) | 16 (45.7) |
| Male | 50 (58.1) | 31 (60.8) | 19 (54.3) |
| Prior treatment status, N (%) | |||
| Treatment-naïve | 53 (61.6) | 35 (68.6) | 18 (51.4) |
| Relapsed/refractory† | 33 (38.4) | 16 (31.4) | 17 (48.6) |
| Rai stage, N (%) | |||
| I/II | 28 (32.6) | 19 (37.3) | 9 (25.7) |
| III/IV | 58 (67.4) | 32 (62.7) | 26 (74.3) |
| Bulky adenopathy (≥5 cm), N (%)‡ | 31 (36.0) | 19 (37.3) | 12 (34.3) |
| Splenomegaly, N (% evaluable)§ | 74 (88.1) | 44 (88.0) | 30 (88.2) |
| IGHV unmutated, N (%)‖ | 57 (66.3) | 34 (66.7) | 23 (65.7) |
| TP53 aberration, N (%) | 54 (62.8) | 51 (100) | 0 (0) |
| Deletion 17p | 50 (58.1) | 47 (92.2) | 3 (8.6)¶ |
| TP53 mutation | 4 (4.7) | 4 (7.8) | 0 (0) |
| β2-microglobulin | |||
| Median (range), mg/dL | 4·0 (1.7-12.9) | 3.9 (1.7-12.3) | 4.4 (1.9-12.9) |
| >4 mg/dL, N (%) | 44 (51.2) | 24 (47.1) | 20 (57.2) |
*
One patient not meeting age requirement was removed from study.
†
Median number of prior therapies was 3 (range, 1-7).
‡
Target lymph nodes and spleen were assessed with CT scans.
§
Two patients had splenectomy. Normal spleen volume is less than 315 mL.
‖
Unmutated IGHV indicates a less than 2% change in IGHV sequence compared with germ line.
¶
Three patients had 7%-9% of nuclei with deletion 17p by fluorescence in situ hybridization; inclusion criteria for the TP53 cohort was more than 10% of nuclei with deletion 17p.