Table 1.
Patients treated in the phase-III study versus real-world patient cohort
| Combi-v trial (dabrafenib/trametinib) [4] | CoBRIM trial (vemurafenib/cobimetinib) [17] | Real-world patients treated with BRAF-MEK inhibitors | |
|---|---|---|---|
| Patients; n | 352 | 247 | 435 |
| Median age; years (range) | 55 (18–91) | 56 (23–88) | 59 (19–91) |
| Male patients; n (%) | 208 (59) | 146 (59) | 229 (53) |
| ECOG PS; n (%) | |||
| 0 | 248/350 (71) | 184/243 (76) | 151 (35) |
| 1 | 102/350 (29) | 58/243 (24) | 151 (35) |
| ≥2 | 0 | 1/243 (<1) | 90 (21) |
| Unknown | 0 | 43 (10) | |
| Stage (AJCC 7th); n (%) | |||
| IVM1c | 221/351 (63) | 146 (59) | 378 (87) |
| IIIc, IVM1a, IVM1b | 130/351 (37) | 101 (41) | 57 (13) |
| Metastasis stage; n (%) | |||
| M0 | 14/351 (4) | 21 (9) | 31 (7) |
| M1a | 55/351 (16) | 40 (16) | 14 (3) |
| M1b | 61/351 (17) | 40 (16) | 12 (3) |
| M1c | 221/351 (63) | 146 (59) | 378 (87) |
| Number of disease sites; n (%) | |||
| <3 | 177/351 (50) | NA | 164 (38) |
| ≥3 | 174/351 (50) | NA | 271 (62) |
| Baseline LDH; n (%) | |||
| Above ULN | 118/351 (34) | 112/242 (46) | 215 (49) |
| ULN or less | 233/351 (66) | 130/242 (54) | 209 (48) |
| Unknown | – | _ | 11 (3) |
| BRAF mutation; n (%) | |||
| V600E | 312/346 (90) | 170 (69) | 361 (83) |
| V600K | 34/346 (10) | 24 (10) | 61 (14) |
| Not evaluated | 0 | 53 (21) | 0 |
| Other V600 | 0 | 0 | 13 (3) |
| Previous immunotherapy; n (%) | 61 (17) | NA | 0 |
| Type of BRAF-MEK inhibitors; n (%) | |||
| Dabrafenib + trametinib | 352 (100) | 0 | 372 (86) |
| Vemurafenib + cobimetinib | 0 | 247 (100) | 63 (14) |
| Enorafenib + binimetinib | 0 | 0 | 0 (0) |
| Other | 0 | 0 | 0 (0) |
AJCC, American Joint Committee on Cancer; ECOG PS, Eastern Cooperative Oncology Group Performance Score; LDH, lactate dehydrogenase.