Table 1.
Patient characteristics
| All patients | Treatment | ||||
|---|---|---|---|---|---|
| Ibrutinib | Acalabrutinib | iFCR | Ibrutinib + umbralisib | ||
| No. of patients | 217 | 122 | 21 | 57 | 17 |
| Age at initiation of BTKi, median (range), y | 65.1 (38.2-85.9) | 69.3 (43.5-83.2) | 68.4 (49.1-83.7) | 55.0 (38.2-66.0) | 67.9 (48.4-85.9) |
| Sex, n (%) | |||||
| Male | 137 (63) | 78 (64) | 14 (67) | 34 (60) | 11 (65) |
| FISH cytogenetic abnormality (hierarchical), n (%) | |||||
| 17p13.1 deletion | 52 (24) | 39 (32) | 7 (33) | 3 (5) | 3 (18) |
| 11q22.3 deletion | 46 (21) | 24 (20) | 4 (19) | 11 (19) | 7 (41) |
| 13q14 deletion | 101 (47) | 44 (36) | 13 (62) | 33 (58) | 11 (65) |
| Trisomy 12 | 55 (25) | 38 (31) | 4 (19) | 8 (14) | 5 (29) |
| None | 76 (35) | 29 (24) | 5 (24) | 38 (67) | 4 (24) |
| Complex karyotype, n (%) | 47 (22) | 30 (25) | 5 (24) | 5 (9) | 7 (41) |
| TP53 mutated, n (%) | 41 (22) | 30 (30) | 6 (38) | 1 (2) | 4 (24) |
| No. evaluable | 188 | 100 | 16 | 55 | 17 |
| Unmutated IGHV, n (%) | 139 (70) | 78 (72) | 17 (81) | 31 (58) | 13 (87) |
| No. evaluable | 198 | 109 | 21 | 53 | 15 |
| Total no. of prior therapies before BTKi initiation, n (%) | |||||
| Median (range) | 0 (0-6) | 1 (0-6) | 1 (0-3) | 0 (NA) | 1 (1-5) |
| 0 | 127 (59) | 60 (49) | 10 (48) | 57 (100) | 0 (0) |
| 1 | 40 (18) | 25 (20) | 5 (24) | 0 (0) | 10 (59) |
| 2 | 21 (10) | 12 (10) | 3 (14) | 0 (0) | 6 (35) |
| 3 | 14 (6) | 11 (9) | 3 (14) | 0 (0) | 0 (0) |
| 4-6 | 15 (7) | 14 (11) | 0 (0) | 0 (0) | 1 (6) |
| Type of prior therapy before BTKi initiation, n = 90, n (%) | |||||
| Purine analog | 57 (63) | 39 (63) | 9 (82) | NA | 9 (53) |
| Alkylator | 70 (78) | 49 (79) | 9 (82) | NA | 12 (71) |
| CD20 mAb | 82 (91) | 57 (92) | 11 (100) | NA | 14 (82) |
| BCR-pathway inhibitor | 7 (8) | 4 (6) | 0 (0) | NA | 3 (18) |
| BCL-2 inhibitor | 4 (4) | 2 (3) | 1 (9) | NA | 1 (6) |
| Duration of BTKi therapy, median (range), mo | 22.7 (1.0-69.8) | 21.4 (1.0-69.8) | 42.0 (4.3-46.9) | 17.6 (2.9-50.5) | 33.1 (9.2-48.9) |
| Ongoing BTKi therapy at time of data cutoff, n (%) | 124 (57) | 61 (50) | 17 (81) | 34 (60) | 12 (71) |
| PJP prophylaxis, n (%) | |||||
| TMP-SMX | 98 (45) | 37 (30) | 9 (43) | 41 (72) | 11 (65) |
| Atovaquone | 32 (15) | 9 (7) | 3 (14) | 15 (26) | 5 (29) |
| None | 87 (40) | 76 (62) | 9 (43) | 1 (2) | 1 (6) |
BCL2, B-cell leukemia/lymphoma-2; BCR, B-cell receptor; FISH, fluorescence in situ hybridization; iFCR, ibrutinib and fludarabine/cyclophosphamide/rituximab; mAb, monoclonal antibody; NA, not applicable; TMP-SMX, trimethoprim-sulfamethoxazole.