Table 1.
Randomized | Non-Randomized | ||
---|---|---|---|
TMZ/DTIC (n=51) |
Selumetinib (n=50) |
Selumetinib (n=19) |
|
Age, Median (Range) | 62 (34–86) | 62 (32–86) | 63 (42–81) |
Gender | |||
Male (%) | 31 (62%) | 26 (52%) | 9 (47%) |
Female (%) | 20 (39%) | 24 (48%) | 10 (53%) |
Performance Status, Median (Range) | 0 (0–1) | 0 (0–1) | 0 (0–1) |
Stage | |||
M1a/b (%) | 3 (6%) | 2 (4%) | 0 (0%) |
M1c (%) | 48 (94%) | 48 (96%) | 19 (100%) |
Elevated Lactate Dehydrogenase† (%) | 30 (59%) | 25 (50%) | 14 (74%) |
Number of Prior Systemic Therapies, Median (Range) | 0 (0–2) | 0 (0–3) | 0 (0–2) |
Ipilimumab (%) | 11 (22%) | 8 (16%) | 4 (21%) |
Number of Prior Liver-Directed Therapies, Median (Range) | 0 (0–2) | 0 (0–2) | 0 (0–1) |
Radiofrequency Ablation (%) | 3 (6%) | 5 (10%) | 0 (0%) |
Chemoembolization (%) | 5 (10%) | 4 (8%) | 0 (0%) |
Immunoembolization (%) | 1 (2%) | 1 (2%) | 0 (0%) |
Other (%) | 2 (4%) | 4 (8%) | 1 (5.3%) |
Tumor Mutation | |||
GNAQ Mutant | 19 (37%) | 20 (40%) | 6 (32%) |
GNA11 Mutant | 25 (49%) | 21 (42%) | 8 (42%) |
Wild-type+ | 7 (14%) | 9 (18%) | 5 (26%) |
ECOG denotes Eastern Cooperative Oncology Group
Value exceeding institutional laboratory upper limit of normal range
Wild-type indicates wild-type for Q209 mutations in GNAQ/11