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. 2018 Feb 26;131(21):2357–2366. doi: 10.1182/blood-2017-12-820910

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.