RCTs | IMpassion130 | KEYNOTE-355 | IMpassion131 | ALICE | This study | Â | ||||
---|---|---|---|---|---|---|---|---|---|---|
Cohorts | ICT | CT | ICT | CT | ICT | CT | ICT | CT | ICT | CT |
Number of Participants | N = 902 | N = 847 | N = 651 | N = 68 | N = 2468 |  | ||||
451 (50%) | 451 (50%) | 566 (67%) | 281 (33%) | 1448 (60%) | 952 (40%) | 40 (59%) | 28 (41%) | 1488 (60%) | 980 (40%) | |
Age (median) | 55 (46–64) | 56 (47–65) | 53 (44–63) | 53 (43–63) |  |  | 58.5 (31–77) | 52.5 (28–74) |  |  |
Race | Â | Â | ||||||||
White | 308 (68%) | 301 (67%) | 384 (68%) | 195 (69%) | 246 (57%) | 128 (58%) | Â | Â | 1040 (70%) | 732 (70%) |
Asian | 85 (19%) | 76 (17%) | 123 (22%) | 52 (19%) | 123 (29%) | 66 (30%) | Â | Â | 378 (25%) | 235 (23%) |
African-American | 26 (6%) | 33 (7%) | 20 (4%) | 17 (6%) | 21 (5%) | 10 (5%) | Â | Â | 76 (5%) | 75 (7%) |
ECOG performance | Â | Â | ||||||||
0 | 256 (57%) | 270 (60%) | 332 (59%) | 173 (62%) | 262 (61%) | 130 (59%) | 27 (67.5%) | 21 (75.0%) | 877 (59%) | 594 (61%) |
1 | 193 (43%) | 179 (40%) | 232 (41%) | 108 (38%) | 169 (39%) | 90 (41%) | 13 (32.5%) | 7 (25.0%) | 552 (37%) | 357 (36%) |
PD-L1+ | 185 (41%) | 184 (41%) | 425 (75%) | 211 (75%) | 190 (44%) | 101 (46%) | 21 (52.5%) | 10 (35.7%) | 822 (55%) | 506 (52%) |
Metastatic disease | Â | Â | ||||||||
De novo metastasis | 404 (89.8%) | 408 (90.7%) | 167 (30%) | 84 (30%) | Â | Â | 10 (25.0%) | 8 (28.6%) | 581 (39%) | 493 (50%) |
Lymph node | 33 (7.3%) | 23 (5.1%) | 417 (74%) | 206 (73%) | Â | Â | 22 (55.0%) | 13 (46.4%) | 472 (32%) | 242 (25%) |
Bone | 145 (32.2%) | 141 (31.3%) | 169 (30%) | 85 (30%) | Â | Â | 17 (42.5%) | 16 (57.1%) | 331 (22%) | 242 (25%) |
Lung | 226 (50.1%) | 242 (53.7%) | 324 (57%) | 162 (58%) | Â | Â | 18 (45.0%) | 10 (35.7%) | 568 (38%) | 414 (42%) |
Liver | 126 (28%) | 118 (26%) | 171 (30%) | 78 (28%) | 118 (27%) | 61 (28%) | 12 (30.0%) | 13 (46.4%) | 427 (29%) | 270 (27%) |
Number of metastatic sites | ||||||||||
0–2 |  |  | 313 (55%) | 166 (59%) |  |  | 27 (67.5%) | 15 (53.6%) | 313 (21%) | 166 (17%) |
0–3 | 332 (74%) | 341 (76%) |  |  |  |  |  |  | 332 (22%) | 341 (35%) |
≥ 3 |  |  | 250 (44%) | 115 (41%) |  |  |  |  | 250 (17%) | 115 (12%) |
> 3 |  |  |  |  | 105 (24%) | 48 (22%) | 7 (17.5%) | 3 (10.7%) | 112 (7%) | 51 (5%) |
≥ 4 | 118 (26%) | 108 (24%) |  |  |  |  |  |  | 118 (8%) | 108 (11%) |
Previous chemo | 284 (63%) | 286 (63%) | 357 (63%) | 181 (64%) | 313 (48%) | 16 (40.0%) | 12 (43.0%) | 657 (44%) | 479(49%) | |
Prior taxane | 231 (51%) | 230 (51%) | 290 (51%) | 156 (56%) | 208 (48%) | 107 (49%) | Â | Â | 729 (50%) | 493 (52%) |
Prior anthracycline | 243 (54%) | 242 (54%) | 318 (56%) | 155 (55%) | 212 (49%) | 110 (50%) | 28 (70.0%) | 20 (71.4%) | 801(54%) | 527 (54%) |