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. 2021 Dec 15;7(4):e29912. doi: 10.2196/29912

Table 5.

Summary of the COLUMBUS efficacy results along with the reported dermatologic adverse eventsa.

Study group Encorafenib plus binimetinib Encorafenib Vemurafenib
Overall survival

Value, median (months) 33.6 23.5 16.9

HRb 0.61c 0.76d N/Ae
Progression-free survival

Value, median (months) 14.9 9.6 7.3

HR 0.51c 0.68d N/A
Adverse events (all grade), % 98.4 99.5 100
Adverse events (grade ≥3), % 68.2 67.7 65.6
Dermatologic adverse events

Rash (all grade), % 16.1 20.8 30.1

Rash (grade ≥3), % 1.6 2.1 3.2

Pruritus (all grade), % 12.5 21.9 10.8

Pruritus (grade ≥3), % 0.5 0.5 0

Hyperkeratosis (all grade), % 15.1 40.1 29

Hyperkeratosis (grade ≥3), % 0.5 3.6 0

Dry skin (all grade), % 16.1 30.2 23.1

Dry skin (grade ≥3), % 0 0.5 0

Alopecia (all grade), % 14.6 56.3 37.6

Alopecia (grade ≥3), % 0 0 0

Palmoplantar erythrodysesthesia syndrome (all grade), % 7.3 51.6 14

Palmoplantar erythrodysesthesia syndrome (grade ≥3), % 0 13.5 1.1

Photosensitivity (all grade), % 3.6 3.6 25.3

Photosensitivity (grade ≥3), % 0.5 0 1.1

Palmoplantar keratoderma (all grade), % 9.9 26.6 17.7

Palmoplantar keratoderma (grade ≥3), % 0 2.1 1.1

Keratosis pilaris (all grade), % 4.7 3.6 25.3

Keratosis pilaris (grade ≥3), % 0.5 0 1.1

Papillomaf (all grade), % 7 10 19

Papillomaf (grade ≥3), % N/A N/A N/A

Squamous cell carcinomaf (all grade), % 3 8 17

Squamous cell carcinomaf (grade ≥3), % N/A N/A N/A

Basal cell carcinomaf (all grade), % 2 1 2

Basal cell carcinomaf (grade ≥3), % N/A N/A N/A

aAdapted from Ascierto et al [15] and Gogas et al [20].

bHR: hazard ratio.

cEncorafenib plus binimetinib versus vemurafenib.

dEncorafenib versus vemurafenib.

eN/A: not applicable.

fThese dermatologic adverse events were reported separately by Gogas et al [20] as all grade dermatologic adverse events with no further breakdown.