Table 1.
Baseline patient characteristics for all patients treated as of December 31, 2013.
| 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