Table 1.

Patient demographics and baseline characteristics

Treatment group, n (%)
Selumetinib (n = 104)Temozolomide (n = 96)
Sex
 Male55 (52.9)65 (67.7)
 Female49 (47.1)31 (32.3)
Age, y
 Mean (range)57.1 (20–84)57.0 (28–84)
Racial origin
 Caucasian99 (95.2)91 (94.8)
 Non-Caucasiana3 (2.9)3 (3.0)
 Unknown2 (1.9)2 (2.1)
WHO performance status
 0 Normal activity67 (64.4)71 (74.0)
 1 restricted activity34 (32.7)23 (24.0)
 2 in-bed ≤ 50% of the time1 (1.0)2 (2.1)
 Unknown2 (1.9)0 (0)
AJCC staging
 Stage III3 (2.9)3 (3.1)
 Stage IV99 (95.2)92 (95.8)
  M1a/b40 (38.5)36 (37.5)
  M1c58 (55.8)54 (56.3)
  Unknown M status1 (1)2 (2.1)
 Unknown stage2 (1.9)1 (1.0)
Lactate dehydrogenase level at baseline
 <2 × ULN79 (76.0)79 (82.3)
 ≥2 × ULN17 (16.3)15 (15.6)
 Unknown8 (7.7)2 (2.1)
Tumor type
 Cutaneous75 (72.1)72 (75.0)
 Uveal7 (6.7)13 (13.5)
 Mucosal6 (5.8)0 (0.0)
 Unknown primary tumor16 (15.4)11 (11.5)
Mutation status
BRAF positive45 (43.3)28 (29.2)
NRAS positive10 (9.6)18 (18.8)
 Wild-type for both29 (27.9)28 (29.2)
 Unknownb20 (19.2)22 (22.9)
  • aThis group comprised Black, Hispanic, and Mediterranean patients.

  • bThis group comprised those patients where there was no result for both BRAF and NRAS mutation status or one of the mutation assays failed.