Table 4.
Study group | Dabrafenib plus trametinib | Dabrafenib | |
Overall survival | |||
|
Value, median (months) | 25.1 | 18.7 |
|
HRb | 0.71c | N/Ad |
Progression-free survival | |||
|
Value, median (months) | 11.0 | 8.8 |
|
HR | 0.67c | N/A |
Adverse events (all grade), % | 87 | 90 | |
Adverse events (grade ≥3), % | 32 | 30 | |
Dermatologic adverse events | |||
|
Rash (all grade), % | 24 | 20 |
|
Rash (grade ≥3), % | 0 | <1 |
|
Dry skin (all grade), % | 9 | 14 |
|
Dry skin (grade ≥3), % | 0 | 0 |
|
Pruritus (all grade), % | 7 | 11 |
|
Pruritus (grade ≥3), % | 0 | 0 |
|
Alopecia (all grade), % | 5 | 26 |
|
Alopecia (grade ≥3), % | 0 | 0 |
|
Hyperkeratosis (all grade), % | 6 | 33 |
|
Hyperkeratosis (grade ≥3), % | 0 | <1 |
|
Skin papilloma (all grade), % | 1 | 18 |
|
Skin papilloma (grade ≥3), % | 0 | 0 |
|
Dermatitis acneiform (all grade), % | 8 | 3 |
|
Dermatitis acneiform (grade ≥3), % | 0 | 0 |
|
Squamous cell carcinoma (all grade), % | 3 | 9 |
|
Squamous cell carcinoma (grade ≥3), % | 3 | 9 |
|
New primary melanoma (all grade), % | <1 | 2 |
|
New primary melanoma (grade ≥3), % | <1 | <1 |
aAdapted from Long et al [14].
bHR: hazard ratio.
cDabrafenib plus trametinib versus trametinib.
dN/A: not applicable.