Table 1:
Patient and Disease Characteristics
| Number of patients (%) | |
|---|---|
| General Demographics | |
| Gender (male) | 84 (57.5) |
| Age (years; median, range) | 55, 18–85 |
| Race | |
| White | 128 (87.7%) |
| Unknown | 18 (12.3%) |
| Primary Site | |
| Cutaneous | 120 (82.2) |
| Acral | 3 (2.1) |
| Unknown primary | 23 (15.8) |
| BRAF Mutation Status | |
| BRAF V600E | 125 (85.6) |
| BRAF V600K | 9 (6.2) |
| BRAF (not specified) | 12 (8.2) |
| Other Mutation Status | 10 (6.8) |
| Stage (AJCC 8th Edition) | |
| III | 8 (5.5) |
| IV | 138 (94.5) |
| M Status | |
| M1a | 29 (19.9) |
| M1b | 30 (20.5) |
| M1c | 56 (38.4) |
| M1d | 23 (15.8) |
| Metastases | |
| Liver | 24 (16.4) |
| Bone | 24 (16.4) |
| Number of Organs Involved with Metastases | |
| 0–1 | 49 (33.6) |
| 2–3 | 78 (53.4) |
| 4+ | 11 (7.5) |
| ECOG | |
| 0 | 107 (73.3) |
| 1 | 35 (24.0) |
| 2 | 2 (1.4) |
| 3 | 1 (0.7) |
| Unknown | 1 (0.7) |
| LDH | |
| Normal | 90 (61.6) |
| 1–2x upper limit of normal | 24 (16.4) |
| >2x upper limit of normal | 5 (3.4) |
| unknown | 27 (18.5) |
| Treatment | |
| Systemic treatment prior to BRAF/MEK inhibitory therapy | 47 (32.2) |
| Pembrolizumab or nivolumab | 9 (6.2) |
| Ipilimumab | 10 (6.8) |
| Ipilimumab + nivolumab | 12 (8.2) |
| Interferon | 11 (7.5) |
| Chemotherapy | 9 (6.2) |
| Other (IL-2, Ebacadostat, Urelumab, Tremelilumab) | 12 (8.2) |
| BRAF monotherapy | 41 (28.1) |
| BRAF/MEK combination therapy | 105 (71.9) |
| BRAF/MEK Inhibitor Drug | |
| Dabrafenib | 6 (4.1) |
| Dabrafenib/trametinib | 92 (63.0) |
| Encorafenib/binimetinib | 9 (6.2) |
| Vemurafenib | 33 (22.6) |
| Vemurafenib/cobimetinib | 6 (4.1) |
| Duration on Therapy (months; median) | 62.0 |
| Reasons for Stopping Therapy (% of those who stopped therapy) | |
| Ongoing | 68 (46.6) |
| Progression | 10 (6.8) |
| Toxicity* | 25 (17.1) |
| Completion (physician/patient preference) | 38 (26.0) |
| Other** | 5 (3.4) |
| Best Investigator Assessed RECIST 1.1 Response to Therapy | |
| PD | 0 |
| SD | 4 (2.7) |
| PR | 38 (26.0) |
| CR | 104 (71.2) |
| Duration from Treatment Start to Date of Best Response (months; median) | 7.2 |
| Follow-up | |
| Follow-up Duration* (months, median) | 93.8 |
| Status at Last Follow-up | |
| Alive with no evidence of disease | 97 (66.4) |
| Alive with evidence of disease | 34 (23.3) |
| Died from melanoma | 12 (8.2) |
| Died from other cause | 3 (2.1) |
*
See Supplemental
**
from treatment start