Table 2.
Characteristic of the outcomes of first-line treatment with vemurafenib (V) versus vemurafenib + cobimetinib (V + C) in the study groups
| Factors | V | V + C | p-value |
|---|---|---|---|
| Duration of treatment | |||
| Median (range) months | 5.3 (0.7–93.1)* | 8.4 (0.4–98.5)* | 0.0001 |
| Best overall tumor response | |||
| CR | 8 (7%) | 15 (10%) | 0.7226 |
| PR | 62 (52%) | 72 (46%) | |
| SD | 31 (26%) | 44 (28%) | |
| PD | 18 (15%) | 25 (16%) | |
| ORR (CR+PR) | 70 (59%) | 87 (56%) | 0.6120 |
| DCR (CR+PR+SD) | 101 (85%) | 131 (84%) | 0.8386 |
| Reason for end of therapy | |||
| Continuing first line | 1 (1%) | 16 (10%) | |
| Progression | 107 (90%) | 109 (70%) | |
| Death | 5 (4%) | 14 (9%) | |
| Complications | 5 (4%) | 15 (10%) | |
| Consent withdrawal | 1 (1%) | 2 (1%) | 0.0003 |
| Dose changes | |||
| Dose reduction |
Once: 17 (14%) Twice: 1 (15) |
Once: 23 (15%) Twice: 4 (3%) Only V: 2 (1%) |
|
| Interruption in treatment | 27 (23%) |
V + C: 40 (26%) Only C: 4 (3%) |
|
| Treatment discontinuation | 5 (4%) | 15 (10%) | |
| Second-line treatment | |||
| None | 67 (56%) | 88 (56%) | 0.0962 |
| Immunotherapy | 40 (34%) | 62 (40%) | |
| Anti-PD-1/anti-CTLA-4 | 13 (11%)/27 (23%) | 56 (36%)/6 (4%) | |
| Chemotherapy | 12 (10%) | 6 (4%) | |
CR complete response, DCR disease control rate, ORR overall response rate, OS overall survival, PD progressive disease, PFS progression-free survival, PR partial response, SD stable disease
*Data based on the last follow-up