Table 1. Clinical characteristics of the patient cohort.
|
All patients |
Vemurafenib |
Dabrafenib |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Concomitant | Interrupted | Concomitant | Interrupted | Concomitant | Interrupted | ||||
| Number of patients | 87 | 68 | 59 | 51 | 28 | 17 | |||
| Mean age in years (range) | 53 (19–85) | 59 (18–83) | P=0.022 | 56 (19–85) | 58 (18–83) | P=0.683 | 48 (19–73) | 63 (40–80) | P=0.001 |
| Male | 53 (61%) | 43 (63%) | P=0.868 | 37 (63%) | 30 (59%) | P=0.699 | 16 (57%) | 13 (76%) | P=0.219 |
| Pts. with brain metastases | 54 (62%) | 44 (65%) | P=0.867 | 38 (64%) | 32 (63%) | P=1.000 | 16 (57%) | 12 (71%) | P=0.528 |
| Concomitant MEK-inhibitor | 8 (9%) | 7 (10%) | P=1.000 | 0 | 4 (8%) | P=0.043 | 8 (29%) | 3 (18%) | P=0.493 |
| LDH | P=0.213 | P=0.140 | P=0.710 | ||||||
| Elevated (>250 U l−1) | 42 (48%) | 23 (34%) | 35 (59%) | 20 (39%) | 7 (25%) | 3 (18%) | |||
| Normal (⩽250 U l−1) | 31 (36%) | 34 (50%) | 18 (31%) | 20 (39%) | 16 (57%) | 11 (65%) | |||
| Unknown | 14 (16%) | 11 (16%) | 6 (10%) | 11 (22%) | 5 (18%) | 3 (18%) | |||
| Number of pretreatments | P=0.145 | P=0.161 | P=0.589 | ||||||
| 0 | 51 (59%) | 41 (60%) | 37 (63%) | 31 (61%) | 14 (50%) | 10 (59%) | |||
| 1 | 25 (29%) | 19 (28%) | 15 (25%) | 15 (29%) | 10 (36%) | 4 (24%) | |||
| ≥2 | 11 (13%) | 2 (3%) | 7 (12%) | 1 (2%) | 4 (14%) | 1 (6%) | |||
| Unknown | 0 | 6 (9%) | 0 | 4 (8%) | 0 | 2 (12%) | |||
| ECOG | P=0.003 | P=0.008 | P=0.321 | ||||||
| 0 | 18 (21%) | 31 (46%) | 10 (17%) | 22 (43%) | 8 (29%) | 9 (53%) | |||
| 1 | 28 (32%) | 15 (22%) | 19 (32%) | 12 (24%) | 9 (32%) | 3 (18%) | |||
| ≥2 | 11(13%) | 5 (7%) | 8 (14%) | 2 (4%) | 3 (11%) | 3 (18%) | |||
| Unknown | 30 (34%) | 17 (25%) | 22 (37%) | 15 (29%) | 8 (29%) | 2 (12%) | |||
| Irradiated sites | P=0.757 | P=0.753 | P=0.750 | ||||||
| Whole-brain radiotherapy (WBRT) | 31 (36%) | 28 (41%) | 24 (41%) | 23 (45%) | 7 (25%) | 5 (29%) | |||
| Stereotactic radiotherapy (STX) brain | 23 (26%) | 16 (24%) | 14 (24%) | 9 (18%) | 9 (32%) | 7 (41%) | |||
| Bone metastases | 14 (16%) | 8 (12%) | 9 (15%) | 7 (14%) | 5 (18%) | 1 (6%) | |||
| Axillary lymph nodes | 7 (8%) | 7 (10%) | 3 (5%) | 6 (12%) | 4 (14%) | 1 (6%) | |||
| Mediastinal metastases | 5 (6%) | 1 (1%) | 4 (7%) | 1 (2%) | 1 (4%) | 0 | |||
| Soft tissue metastases | 4 (5%) | 5 (7%) | 3 (5%) | 3 (6%) | 1 (4%) | 2 (12%) | |||
| Others | 3 (3%) | 3 (4%) | 2 (3%) | 2 (4%) | 1 (4%) | 1 (6%) | |||
Abbreviations: ECOG=Eastern Cooperative Oncology Group; LDH=lactate dehydrogenase.