Table 1. Baseline Characteristics of the Intention-to-Treat Population.
| Characteristic | No. (%) | |
|---|---|---|
| Durvalumab plus tremelimumab (n = 119) | Best supportive care (n = 61) | |
| Age, median (range), y | 65 (39-87) | 64 (36-85) |
| Sex | ||
| Male | 74 (62) | 47 (77)a |
| Female | 45 (38) | 14 (23) |
| Race | ||
| White | 97 (82) | 54 (89)b |
| Asian | 16 (13) | 3 (5) |
| Other | 6 (5) | 6 (9) |
| ECOG performance status | ||
| 0 | 33 (28) | 17 (28) |
| 1 | 86 (72) | 44 (72) |
| Time from initial cancer diagnosis, median (range), mo | 44 (8-181) | 41 (8-152) |
| Presence of liver metastases | ||
| Yes | 80 (67) | 47 (77) |
| No | 39 (33) | 14 (23) |
| Prior systemic agents | ||
| Fluoropyrimidine | 119 (100) | 61 (100) |
| Irinotecan | 118 (99) | 58 (95) |
| Oxaliplatin | 104 (87) | 50 (82) |
| Anti-EGFR monoclonal antibody if appropriate | 42 (35) | 26 (43) |
| Bevacizumab | 94 (79) | 49 (80) |
| Regorafenib | 32 (27) | 15 (25) |
| TAS-102 | 0 | 0 |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; EGFR, estimated glomerular filtration rate; TAS-102, trifluridine/tipiracil.
a
P = .046.
b
P = .099.