Three-year safety of ibrutinib in patients with CLL and SLL
| . | TN ≥65 years (n = 31) . | R/R (n = 101) . | All patients (N = 132) . |
|---|---|---|---|
| Median treatment duration, months (range) | 30 (0.3-44) | 23 (0.3-45) | 25 (0.3-45) |
| Treatment duration | |||
| ≤1 years | 5 (16) | 24 (24) | 29 (22) |
| >1-2 years | 1 (3) | 31 (31) | 32 (24) |
| >2-3 years | 15 (48) | 33 (33) | 48 (36) |
| >3 years | 10 (32) | 13 (13) | 23 (17) |
| Grade ≥3 AEs | |||
| Hematologic | 4 (13) | 32 (32) | 36 (27) |
| Nonhematologic | 18 (58) | 83 (82) | 101 (77) |
| Infections | 4 (13) | 52 (51) | 56 (42) |
| Dose reductions | |||
| ≤1 years | 1/31 (3) | 10/101 (10) | 11/132 (8) |
| >1-2 years | 1/26 (4) | 0/77 (0) | 1/103 (1) |
| >2-3 years | 0/25 (0) | 1/46 (2) | 1/71 (1) |
| >3-4 years | 0/10 (0) | 0/13 (0) | 0/23 (0) |
| Patients rolled over to long-term extension study (PCYC-1103) | 26 (84) | 69 (68) | 95 (72) |
| Patients remaining on ibrutinib treatment | 25 (81) | 54 (53) | 79 (60) |
| Primary reasons for discontinuation | |||
| Disease progression | 1 (3) | 21 (21) | 22 (17) |
| AE | 3 (10) | 12 (12) | 15 (11) |
| Consent withdrawal | 2 (6) | 4 (4) | 6 (5) |
| Investigator decision | 0 | 9 (9)* | 9 (7) |
| Other | 0 | 1 (1) | 1 (1) |
| Death on study† | 1 (3) | 13 (13) | 14 (11) |
| . | TN ≥65 years (n = 31) . | R/R (n = 101) . | All patients (N = 132) . |
|---|---|---|---|
| Median treatment duration, months (range) | 30 (0.3-44) | 23 (0.3-45) | 25 (0.3-45) |
| Treatment duration | |||
| ≤1 years | 5 (16) | 24 (24) | 29 (22) |
| >1-2 years | 1 (3) | 31 (31) | 32 (24) |
| >2-3 years | 15 (48) | 33 (33) | 48 (36) |
| >3 years | 10 (32) | 13 (13) | 23 (17) |
| Grade ≥3 AEs | |||
| Hematologic | 4 (13) | 32 (32) | 36 (27) |
| Nonhematologic | 18 (58) | 83 (82) | 101 (77) |
| Infections | 4 (13) | 52 (51) | 56 (42) |
| Dose reductions | |||
| ≤1 years | 1/31 (3) | 10/101 (10) | 11/132 (8) |
| >1-2 years | 1/26 (4) | 0/77 (0) | 1/103 (1) |
| >2-3 years | 0/25 (0) | 1/46 (2) | 1/71 (1) |
| >3-4 years | 0/10 (0) | 0/13 (0) | 0/23 (0) |
| Patients rolled over to long-term extension study (PCYC-1103) | 26 (84) | 69 (68) | 95 (72) |
| Patients remaining on ibrutinib treatment | 25 (81) | 54 (53) | 79 (60) |
| Primary reasons for discontinuation | |||
| Disease progression | 1 (3) | 21 (21) | 22 (17) |
| AE | 3 (10) | 12 (12) | 15 (11) |
| Consent withdrawal | 2 (6) | 4 (4) | 6 (5) |
| Investigator decision | 0 | 9 (9)* | 9 (7) |
| Other | 0 | 1 (1) | 1 (1) |
| Death on study† | 1 (3) | 13 (13) | 14 (11) |