Baseline demographic and disease characteristics of patients with CLL treated first line with targeted drugs or chemoimmunotherapy by the type of first line treatment
Primary data set . | |||||
---|---|---|---|---|---|
Parameters . | Venetoclax (n = 653) . | Ibrutinib (n = 68) . | Venetoclax + ibrutinib (n = 261) . | Idelalisib (n = 9) . | Total (N = 991) . |
Age, y | |||||
Median (range) | 65 (27-89) | 63 (32-82) | 60 (30-85) | 70 (44-77) | 64 (27-89) |
>65 y | 308 (47.2) | 26 (38.2) | 92 (35.2) | 6 (66.7) | 432 (43.6) |
Male sex | 472 (72.3) | 42 (61.8) | 171 (65.5) | 8 (88.9) | 693 (69.9) |
ECOG PS >0 | 234 (35.8) | 22 (32.4) | 80 (30.7) | 4 (44.4) | 340 (34.3) |
Binet stage B-C | 498 (76.3) | 53 (77.9) | 191 (73.2) | 8 (88.9) | 750 (75.7) |
CIRS score | |||||
Median (range) | 3 (0-23) | 3 (0-16) | 2 (0-7) | 2 (0-9) | 3 (0-23) |
>1 | 465 (71.2) | 53 (77.9) | 165 (63.2) | 6 (66.7) | 689 (69.5) |
>6 | 156 (23.9) | 11 (16.2) | 3 (1.1) | 1 (11.1) | 171 (17.3) |
Serum β2-microglobulin (mg/L) | |||||
Median (range) | 4.0 (1-16.2) | 3.9 (1.8-11.8) | 4.2 (1.3-12.5) | 5.2 (3.4-10.3) | 4.0 (1-16.2) |
>3.5 | 400 (61.3) | 43 (63.2) | 169 (64.8) | 8 (88.9) | 620 (62.6) |
Type according to hierarchical model, N (%) | |||||
del(17p) | 15 (2.3) | 9 (13.2) | 24 (9.2) | 0 (0.0) | 48 (4.8) |
del(11q) | 117 (17.9) | 14 (20.6) | 35 (13.4) | 2 (22.2) | 168 (17.0) |
Trisomy 12 | 111 (17.0) | 12 (17.6) | 35 (13.4) | 2 (22.2) | 160 (16.1) |
No del(17p)/del(11q)/trisomy12/del(13q) | 134 (20.5) | 16 (23.5) | 59 (22.6) | 2 (22.2) | 211 (21.3) |
del(13q) alone | 276 (42.3) | 17 (25.0) | 108 (41.4) | 3 (33.3) | 404 (40.8) |
Unmutated IGHV status | 386 (59.1) | 47 (69.1) | 151 (57.9) | 4 (44.4) | 588 (59.3) |
TP53 | |||||
Mutated | 23 (3.5) | 11 (16.2) | 38 (14.6) | 0 (0.0) | 72 (7.3) |
deleted and/or mutated | 24 (3.7) | 12 (17.6) | 39 (14.9) | 0 (0.0) | 75 (7.6) |
Secondary data set | |||||
Parameters | F/FCR (n = 466) | BR (n = 77) | CLB-rituximab (n = 263) | CLB-obinutuzumab (n = 450) | Total (n = 1256) |
Age, y | |||||
Median (range) | 59 (29-80) | 71 (66-84) | 73 (47-90) | 73 (39-89) | 68 (29-90) |
>65 y | 79 (17.0) | 77 (100.0) | 208 (79.1) | 366 (81.3) | 730 (58.1) |
Male sex | 333 (71.5) | 53 (68.8) | 161 (61.2) | 287 (63.8) | 834 (66.4) |
ECOG PS >0 | 159 (34.1) | 28 (36.4) | 173 (65.8) | 269 (59.8) | 629 (50.1) |
Binet stage B-C | 352 (75.5) | 58 (75.3) | 205 (77.9) | 355 (78.9) | 970 (77.2) |
CIRS score | |||||
Median (range) | 1 (0-7) | 3 (0-6) | 8 (0-18) | 8 (0-28) | 6 (0-28) |
>1 | 188 (40.3) | 59 (76.6) | 255 (97.0) | 439 (97.6) | 941 (74.9) |
>6 | 2 (0.4) | 0 (0.0) | 188 (71.5) | 352 (78.2) | 542 (43.2) |
Serum β2-microglobulin, mg/L | |||||
Median (range) | 3.1 (1.2-12.3) | 4.7 (1.9-15.5) | 2.9 (0.2-17.8) | 3.5 (0.2-16.7) | 3.3 (0.2-17.8) |
>3.5 | 180 (38.6) | 61 (79.2) | 99 (37.6) | 222 (49.3) | 562 (44.7) |
Type according to hierarchical model, n (%) | |||||
del(17p) | 26 (5.6) | 0 (0.0) | 19 (7.2) | 31 (6.9) | 76 (6.1) |
del(11q) | 107 (23.0) | 14 (18.2) | 48 (18.3) | 76 (16.9) | 245 (19.5) |
Trisomy 12 | 53 (11.4) | 12 (15.6) | 42 (16.0) | 76 (16.9) | 183 (14.6) |
No del(17p)/del(11q)/trisomy12/del(13q) | 114 (24.5) | 15 (19.5) | 68 (25.9) | 116 (25.8) | 313 (24.9) |
del(13q) alone | 161 (34.5) | 36 (46.8) | 86 (32.7) | 151 (33.6) | 434 (34.6) |
Unmutated IGHV status | 294 (63.1) | 47 (61.0) | 171 (65.0) | 285 (63.3) | 797 (63.5) |
TP53 | |||||
Mutated | 27 (5.8) | 0 (0.0) | 21 (8.0) | 45 (10.0) | 93 (7.4) |
deleted and/or mutated | 30 (6.4) | 0 (0.0) | 29 (11.0) | 54 (12.0) | 113 (9.0) |
Primary data set . | |||||
---|---|---|---|---|---|
Parameters . | Venetoclax (n = 653) . | Ibrutinib (n = 68) . | Venetoclax + ibrutinib (n = 261) . | Idelalisib (n = 9) . | Total (N = 991) . |
Age, y | |||||
Median (range) | 65 (27-89) | 63 (32-82) | 60 (30-85) | 70 (44-77) | 64 (27-89) |
>65 y | 308 (47.2) | 26 (38.2) | 92 (35.2) | 6 (66.7) | 432 (43.6) |
Male sex | 472 (72.3) | 42 (61.8) | 171 (65.5) | 8 (88.9) | 693 (69.9) |
ECOG PS >0 | 234 (35.8) | 22 (32.4) | 80 (30.7) | 4 (44.4) | 340 (34.3) |
Binet stage B-C | 498 (76.3) | 53 (77.9) | 191 (73.2) | 8 (88.9) | 750 (75.7) |
CIRS score | |||||
Median (range) | 3 (0-23) | 3 (0-16) | 2 (0-7) | 2 (0-9) | 3 (0-23) |
>1 | 465 (71.2) | 53 (77.9) | 165 (63.2) | 6 (66.7) | 689 (69.5) |
>6 | 156 (23.9) | 11 (16.2) | 3 (1.1) | 1 (11.1) | 171 (17.3) |
Serum β2-microglobulin (mg/L) | |||||
Median (range) | 4.0 (1-16.2) | 3.9 (1.8-11.8) | 4.2 (1.3-12.5) | 5.2 (3.4-10.3) | 4.0 (1-16.2) |
>3.5 | 400 (61.3) | 43 (63.2) | 169 (64.8) | 8 (88.9) | 620 (62.6) |
Type according to hierarchical model, N (%) | |||||
del(17p) | 15 (2.3) | 9 (13.2) | 24 (9.2) | 0 (0.0) | 48 (4.8) |
del(11q) | 117 (17.9) | 14 (20.6) | 35 (13.4) | 2 (22.2) | 168 (17.0) |
Trisomy 12 | 111 (17.0) | 12 (17.6) | 35 (13.4) | 2 (22.2) | 160 (16.1) |
No del(17p)/del(11q)/trisomy12/del(13q) | 134 (20.5) | 16 (23.5) | 59 (22.6) | 2 (22.2) | 211 (21.3) |
del(13q) alone | 276 (42.3) | 17 (25.0) | 108 (41.4) | 3 (33.3) | 404 (40.8) |
Unmutated IGHV status | 386 (59.1) | 47 (69.1) | 151 (57.9) | 4 (44.4) | 588 (59.3) |
TP53 | |||||
Mutated | 23 (3.5) | 11 (16.2) | 38 (14.6) | 0 (0.0) | 72 (7.3) |
deleted and/or mutated | 24 (3.7) | 12 (17.6) | 39 (14.9) | 0 (0.0) | 75 (7.6) |
Secondary data set | |||||
Parameters | F/FCR (n = 466) | BR (n = 77) | CLB-rituximab (n = 263) | CLB-obinutuzumab (n = 450) | Total (n = 1256) |
Age, y | |||||
Median (range) | 59 (29-80) | 71 (66-84) | 73 (47-90) | 73 (39-89) | 68 (29-90) |
>65 y | 79 (17.0) | 77 (100.0) | 208 (79.1) | 366 (81.3) | 730 (58.1) |
Male sex | 333 (71.5) | 53 (68.8) | 161 (61.2) | 287 (63.8) | 834 (66.4) |
ECOG PS >0 | 159 (34.1) | 28 (36.4) | 173 (65.8) | 269 (59.8) | 629 (50.1) |
Binet stage B-C | 352 (75.5) | 58 (75.3) | 205 (77.9) | 355 (78.9) | 970 (77.2) |
CIRS score | |||||
Median (range) | 1 (0-7) | 3 (0-6) | 8 (0-18) | 8 (0-28) | 6 (0-28) |
>1 | 188 (40.3) | 59 (76.6) | 255 (97.0) | 439 (97.6) | 941 (74.9) |
>6 | 2 (0.4) | 0 (0.0) | 188 (71.5) | 352 (78.2) | 542 (43.2) |
Serum β2-microglobulin, mg/L | |||||
Median (range) | 3.1 (1.2-12.3) | 4.7 (1.9-15.5) | 2.9 (0.2-17.8) | 3.5 (0.2-16.7) | 3.3 (0.2-17.8) |
>3.5 | 180 (38.6) | 61 (79.2) | 99 (37.6) | 222 (49.3) | 562 (44.7) |
Type according to hierarchical model, n (%) | |||||
del(17p) | 26 (5.6) | 0 (0.0) | 19 (7.2) | 31 (6.9) | 76 (6.1) |
del(11q) | 107 (23.0) | 14 (18.2) | 48 (18.3) | 76 (16.9) | 245 (19.5) |
Trisomy 12 | 53 (11.4) | 12 (15.6) | 42 (16.0) | 76 (16.9) | 183 (14.6) |
No del(17p)/del(11q)/trisomy12/del(13q) | 114 (24.5) | 15 (19.5) | 68 (25.9) | 116 (25.8) | 313 (24.9) |
del(13q) alone | 161 (34.5) | 36 (46.8) | 86 (32.7) | 151 (33.6) | 434 (34.6) |
Unmutated IGHV status | 294 (63.1) | 47 (61.0) | 171 (65.0) | 285 (63.3) | 797 (63.5) |
TP53 | |||||
Mutated | 27 (5.8) | 0 (0.0) | 21 (8.0) | 45 (10.0) | 93 (7.4) |
deleted and/or mutated | 30 (6.4) | 0 (0.0) | 29 (11.0) | 54 (12.0) | 113 (9.0) |
BR, bendamustine-rituximab; CLB, chlorambucil; F/FCR, fludarabine/fludarabine-cyclophosphamide-rituximab.