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.
P = .046.
P = .099.