Patient characteristics at ibrutinib start
| . | All patients (N = 456) . | CA = 0 (n = 74) . | CA = 1-2 (n = 155) . | CA = 3-4 (n = 90) . | CA = 5-9 (n = 89) . | CA = 10-14 (n = 29) . | CA ≥15 (n = 19) . | P . |
|---|---|---|---|---|---|---|---|---|
| Age, median (range), y | 65 (26-91) | 64 (32-83) | 66 (37-88) | 64 (41-85) | 67 (26-83) | 66 (37-91) | 62 (53-76) | .58 |
| Sex, no. (%) | .78 | |||||||
| Male | 319 (70) | 53 (72) | 104 (67) | 68 (76) | 60 (67) | 20 (69) | 14 (74) | |
| Female | 137 (30) | 21 (28) | 51 (33) | 22 (24) | 29 (33) | 9 (31) | 5 (26) | |
| Rai stage, no. (%)* | .08 | |||||||
| Low (0-1) | 101 (24) | 22 (33) | 38 (27) | 19 (22) | 18 (21) | 3 (11) | 1 (5) | |
| Intermediate (2) | 69 (16) | 13 (19) | 20 (14) | 18 (21) | 9 (10) | 4 (15) | 5 (26) | |
| High risk (3-4) | 254 (60) | 32 (48) | 81 (58) | 49 (57) | 59 (69) | 20 (74) | 13 (68) | |
| Unknown | 32 | 7 | 16 | 4 | 3 | 2 | 0 | |
| Concomitant moAB, no. (%) | .82 | |||||||
| No | 382 (84) | 63 (85) | 134 (86) | 72 (80) | 74 (83) | 24 (83) | 15 (79) | |
| Yes | 74 (16) | 11 (15) | 21 (14) | 18 (20) | 15 (17) | 5 (17) | 4 (21) | |
| Previously treated, no. (%) | <.0001 | |||||||
| No | 101 (22) | 22 (30) | 52 (34) | 13 (14) | 8 (9) | 4 (14) | 2 (11) | |
| Yes | 355 (78) | 52 (70) | 103 (66) | 77 (86) | 81 (91) | 25 (86) | 17 (89) | |
| TN or no prior chemotherapy | 150 (33) | 30 (41) | 72 (46) | 26 (29) | 11 (12) | 7 (24) | 4 (21) | <.0001 |
| Previously treated with chemotherapy | 306 (67) | 44 (59) | 83 (54) | 64 (71) | 78 (88) | 22 (76) | 15 (79) | |
| Baseline ECOG PS score, no. (%) | .05 | |||||||
| 0 | 173 (39) | 33 (46) | 63 (43) | 32 (37) | 26 (30) | 10 (34) | 9 (47) | |
| 1 | 248 (56) | 34 (48) | 81 (55) | 52 (60) | 58 (67) | 15 (52) | 8 (42) | |
| 2 | 18 (4) | 4 (6) | 3 (2) | 2 (2) | 3 (3) | 4 (14) | 2 (11) | |
| Unknown | 17 | 3 | 8 | 4 | 2 | 0 | 0 | |
| Hemoglobin, g/dL | .22 | |||||||
| Median (range) | 11.1 (6.5-17.9) | 11.7 (7-17.9) | 11.4 (6.5-15.7) | 11.6 (7-16) | 10.7 (6.5-15.5) | 10.9 (7.9-14) | 11.5 (8.2-14) | |
| Unknown | 1 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Platelets, K/µL | .25 | |||||||
| Median (range) | 115 (7-528) | 112.5 (13-432) | 120.5 (0-528) | 121 (7-349) | 102 (8-429) | 97 (20-281) | 115 (35-313) | |
| Unknown | 1 | 0 | 1 | 0 | 0 | 0 | 0 | |
| WBC count, K/µL | .14 | |||||||
| Median (range) | 23.4 (0.7-547.5) | 24.1 (2.6-470.8) | 36.3 (1.2-547.5) | 22 (0.7-463.2) | 22.5 (0.9-345.8) | 18 (3.6-288.7) | 10.4 (2.4-195.6) | |
| Unknown | 1 | 0 | 1 | 0 | 0 | 0 | 0 | |
| LDH, no. (%) | .03 | |||||||
| ≤ULN | 171 (39) | 39 (55) | 57 (39) | 34 (38) | 29 (33) | 7 (25) | 5 (26) | |
| ≥ULN | 270 (61) | 32 (45) | 89 (61) | 55 (62) | 59 (67) | 21 (75) | 14 (74) | |
| Unknown | 15 | 3 | 9 | 1 | 1 | 1 | 0 | |
| FISH del(11q), no. (%) | <.0001 | |||||||
| No | 318 (70) | 69 (95) | 113 (73) | 49 (54) | 54 (61) | 21 (72) | 12 (63) | |
| Yes | 137 (30) | 4 (5) | 42 (27) | 41 (46) | 35 (39) | 8 (28) | 7 (37) | |
| Unknown | 1 | 1 | 0 | 0 | 0 | 0 | 0 | |
| FISH trisomy 12, no. (%) | <.0001 | |||||||
| No | 355 (78) | 72 (99) | 107 (69) | 69 (77) | 73 (82) | 21 (72) | 13 (68) | |
| Yes | 99 (22) | 1 (1) | 47 (31) | 21 (23) | 16 (18) | 8 (28) | 6 (32) | |
| Unknown | 2 | 1 | 1 | 0 | 0 | 0 | 0 | |
| FISH del(13q), no. (%) | .06 | |||||||
| No | 229 (50) | 39 (53) | 92 (59) | 40 (44) | 36 (40) | 14 (48) | 8 (42) | |
| Yes | 227 (50) | 35 (47) | 63 (41) | 50 (56) | 53 (60) | 15 (52) | 11 (58) | |
| FISH del(17p), no. (%) | <.0001 | |||||||
| No | 319 (70) | 72 (97) | 132 (85) | 70 (78) | 35 (39) | 6 (21) | 4 (21) | |
| Yes | 137 (30) | 2 (3) | 23 (15) | 20 (22) | 54 (61) | 23 (79) | 15 (79) | |
| IGHV, no. (%) | <.0001 | |||||||
| Mutated | 99 (25) | 29 (46) | 36 (27) | 19 (23) | 10 (14) | 5 (19) | 0 (0) | |
| Unmutated | 295 (75) | 34 (54) | 96 (73) | 64 (77) | 62 (86) | 21 (81) | 18 (100) | |
| Unknown or not tested | 62 | 11 | 23 | 7 | 17 | 3 | 1 | |
| Presence of structural abnormality, no. (%) | <.0001 | |||||||
| No | 169 (37) | 74 (100) | 85 (55) | 10 (11) | 0 (0) | 0 (0) | 0 (0) | |
| Yes | 287 (63) | 0 (0) | 70 (45) | 80 (89) | 89 (100) | 29 (100) | 19 (100) | |
| Balanced rearrangement only | 30 (7) | 0 (0) | 19 (12) | 11 (12) | 0 (0) | 0 (0) | 0 (0) | |
| Unbalanced rearrangement only | 184 (40) | 0 (0) | 49 (32) | 48 (53) | 57 (64) | 20 (69) | 10 (53) | |
| Both | 73 (16) | 0 (0) | 2 (1) | 21 (23) | 32 (36) | 9 (31) | 9 (47) |
| . | All patients (N = 456) . | CA = 0 (n = 74) . | CA = 1-2 (n = 155) . | CA = 3-4 (n = 90) . | CA = 5-9 (n = 89) . | CA = 10-14 (n = 29) . | CA ≥15 (n = 19) . | P . |
|---|---|---|---|---|---|---|---|---|
| Age, median (range), y | 65 (26-91) | 64 (32-83) | 66 (37-88) | 64 (41-85) | 67 (26-83) | 66 (37-91) | 62 (53-76) | .58 |
| Sex, no. (%) | .78 | |||||||
| Male | 319 (70) | 53 (72) | 104 (67) | 68 (76) | 60 (67) | 20 (69) | 14 (74) | |
| Female | 137 (30) | 21 (28) | 51 (33) | 22 (24) | 29 (33) | 9 (31) | 5 (26) | |
| Rai stage, no. (%)* | .08 | |||||||
| Low (0-1) | 101 (24) | 22 (33) | 38 (27) | 19 (22) | 18 (21) | 3 (11) | 1 (5) | |
| Intermediate (2) | 69 (16) | 13 (19) | 20 (14) | 18 (21) | 9 (10) | 4 (15) | 5 (26) | |
| High risk (3-4) | 254 (60) | 32 (48) | 81 (58) | 49 (57) | 59 (69) | 20 (74) | 13 (68) | |
| Unknown | 32 | 7 | 16 | 4 | 3 | 2 | 0 | |
| Concomitant moAB, no. (%) | .82 | |||||||
| No | 382 (84) | 63 (85) | 134 (86) | 72 (80) | 74 (83) | 24 (83) | 15 (79) | |
| Yes | 74 (16) | 11 (15) | 21 (14) | 18 (20) | 15 (17) | 5 (17) | 4 (21) | |
| Previously treated, no. (%) | <.0001 | |||||||
| No | 101 (22) | 22 (30) | 52 (34) | 13 (14) | 8 (9) | 4 (14) | 2 (11) | |
| Yes | 355 (78) | 52 (70) | 103 (66) | 77 (86) | 81 (91) | 25 (86) | 17 (89) | |
| TN or no prior chemotherapy | 150 (33) | 30 (41) | 72 (46) | 26 (29) | 11 (12) | 7 (24) | 4 (21) | <.0001 |
| Previously treated with chemotherapy | 306 (67) | 44 (59) | 83 (54) | 64 (71) | 78 (88) | 22 (76) | 15 (79) | |
| Baseline ECOG PS score, no. (%) | .05 | |||||||
| 0 | 173 (39) | 33 (46) | 63 (43) | 32 (37) | 26 (30) | 10 (34) | 9 (47) | |
| 1 | 248 (56) | 34 (48) | 81 (55) | 52 (60) | 58 (67) | 15 (52) | 8 (42) | |
| 2 | 18 (4) | 4 (6) | 3 (2) | 2 (2) | 3 (3) | 4 (14) | 2 (11) | |
| Unknown | 17 | 3 | 8 | 4 | 2 | 0 | 0 | |
| Hemoglobin, g/dL | .22 | |||||||
| Median (range) | 11.1 (6.5-17.9) | 11.7 (7-17.9) | 11.4 (6.5-15.7) | 11.6 (7-16) | 10.7 (6.5-15.5) | 10.9 (7.9-14) | 11.5 (8.2-14) | |
| Unknown | 1 | 0 | 1 | 0 | 0 | 0 | 0 | |
| Platelets, K/µL | .25 | |||||||
| Median (range) | 115 (7-528) | 112.5 (13-432) | 120.5 (0-528) | 121 (7-349) | 102 (8-429) | 97 (20-281) | 115 (35-313) | |
| Unknown | 1 | 0 | 1 | 0 | 0 | 0 | 0 | |
| WBC count, K/µL | .14 | |||||||
| Median (range) | 23.4 (0.7-547.5) | 24.1 (2.6-470.8) | 36.3 (1.2-547.5) | 22 (0.7-463.2) | 22.5 (0.9-345.8) | 18 (3.6-288.7) | 10.4 (2.4-195.6) | |
| Unknown | 1 | 0 | 1 | 0 | 0 | 0 | 0 | |
| LDH, no. (%) | .03 | |||||||
| ≤ULN | 171 (39) | 39 (55) | 57 (39) | 34 (38) | 29 (33) | 7 (25) | 5 (26) | |
| ≥ULN | 270 (61) | 32 (45) | 89 (61) | 55 (62) | 59 (67) | 21 (75) | 14 (74) | |
| Unknown | 15 | 3 | 9 | 1 | 1 | 1 | 0 | |
| FISH del(11q), no. (%) | <.0001 | |||||||
| No | 318 (70) | 69 (95) | 113 (73) | 49 (54) | 54 (61) | 21 (72) | 12 (63) | |
| Yes | 137 (30) | 4 (5) | 42 (27) | 41 (46) | 35 (39) | 8 (28) | 7 (37) | |
| Unknown | 1 | 1 | 0 | 0 | 0 | 0 | 0 | |
| FISH trisomy 12, no. (%) | <.0001 | |||||||
| No | 355 (78) | 72 (99) | 107 (69) | 69 (77) | 73 (82) | 21 (72) | 13 (68) | |
| Yes | 99 (22) | 1 (1) | 47 (31) | 21 (23) | 16 (18) | 8 (28) | 6 (32) | |
| Unknown | 2 | 1 | 1 | 0 | 0 | 0 | 0 | |
| FISH del(13q), no. (%) | .06 | |||||||
| No | 229 (50) | 39 (53) | 92 (59) | 40 (44) | 36 (40) | 14 (48) | 8 (42) | |
| Yes | 227 (50) | 35 (47) | 63 (41) | 50 (56) | 53 (60) | 15 (52) | 11 (58) | |
| FISH del(17p), no. (%) | <.0001 | |||||||
| No | 319 (70) | 72 (97) | 132 (85) | 70 (78) | 35 (39) | 6 (21) | 4 (21) | |
| Yes | 137 (30) | 2 (3) | 23 (15) | 20 (22) | 54 (61) | 23 (79) | 15 (79) | |
| IGHV, no. (%) | <.0001 | |||||||
| Mutated | 99 (25) | 29 (46) | 36 (27) | 19 (23) | 10 (14) | 5 (19) | 0 (0) | |
| Unmutated | 295 (75) | 34 (54) | 96 (73) | 64 (77) | 62 (86) | 21 (81) | 18 (100) | |
| Unknown or not tested | 62 | 11 | 23 | 7 | 17 | 3 | 1 | |
| Presence of structural abnormality, no. (%) | <.0001 | |||||||
| No | 169 (37) | 74 (100) | 85 (55) | 10 (11) | 0 (0) | 0 (0) | 0 (0) | |
| Yes | 287 (63) | 0 (0) | 70 (45) | 80 (89) | 89 (100) | 29 (100) | 19 (100) | |
| Balanced rearrangement only | 30 (7) | 0 (0) | 19 (12) | 11 (12) | 0 (0) | 0 (0) | 0 (0) | |
| Unbalanced rearrangement only | 184 (40) | 0 (0) | 49 (32) | 48 (53) | 57 (64) | 20 (69) | 10 (53) | |
| Both | 73 (16) | 0 (0) | 2 (1) | 21 (23) | 32 (36) | 9 (31) | 9 (47) |
CA, cytogenetic abnormalities; del(11q), deletion of 11q; del(13q), deletion of 13q; ULN, upper limit of normal.
Rai stage calculated at diagnosis.