Table 1 Comparison of patient characteristics in the full study populations and the biomarker study eligible populations
Discovery | Validation | |||
|---|---|---|---|---|
Full study population | Biomarker population | Full study population | Biomarker population | |
Number of patients | 250 | 150 | 328 | 210 |
Age, median (range) years | 53 (18–89) | 53 (18–89) | 57 (22–90) | 59 (22–90) |
Gender, n (%) | ||||
Male | 151 (60%) | 94 (63%) | 190 (58%) | 117 (56%) |
Female | 99 (40%) | 56 (37%) | 138 (42%) | 93 (44%) |
Objective Response, n (%) | ||||
Partial response | 16 (7%) | 20 (13%) | 36 (11%) | 28 (13%) |
Stable disease or progressive disease | 235 (93%) | 130 (87%) | 292 (89%) | 182 (87%) |
Grade of diarrhea | ||||
Any grade | 99 (39%) | 60 (40%) | 166 (51%) | 92 (44%) |
Grade 2–4 | 50 (20%) | 21 (14%) | 89 (27%) | 56 (27%) |
Grade 3–4 | 37 (15%) | 9 (6%) | 60 (18%) | 27 (13%) |
Prior chemotherapy | Yes | Yes | No | No |
One year survival n (%) | ||||
Patient alive at one year | 100 (40%) | 43 (29%) | 170 (52%) | 118 (56%) |
Patient deceased at one year | 150 (60%) | 107 (71%) | 158 (48%) | 92 (44%) |
Stages of Disease | ||||
IIIB and IIIC | 8 (3%) | 5 (3%) | 20 (6%) | 13 (6%) |
IV M1A | 27 (11%) | 16 (11%) | 46 (14%) | 35 (17%) |
IV M1B | 52 (21%) | 30 (20%) | 75 (23%) | 49 (23%) |
IV M1C | 164 (65%) | 99 (66%) | 187 (57%) | 113 (54%) |
Live in United States n (%) | ||||
U.S. | 114 (46%) | 62 (41%) | 62 (19%) | 44 (21%) |
Non-U.S. | 136 (54%) | 88 (59%) | 266 (81%) | 166 (795) |