Table 1.

Clinical characteristics of patients included in the study

CharacteristicsRelapsed 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 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 
CharacteristicsRelapsed 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 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.

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