Table 1.
Baseline patients and disease characteristics
| Characteristic | ITACA‐S final data set (n = 1,100), n (%) | Translational study population (n = 256), n (%) | 5‐FU/LV arm (n = 123), n (%) | Sequential arm (n = 133), n (%) | p valuea |
|---|---|---|---|---|---|
| Age, yr | .49 | ||||
| Median | 62 | 63 | 62 | 63 | |
| IQR | 56–67 | 55–68 | 54–68 | 55–68 | |
| Sex | .42 | ||||
| M | 697 (64) | 174 (68) | 87 (71) | 87 (65) | |
| F | 403 (36) | 82 (32) | 36 (29) | 46 (35) | |
| ECOG PS | .99 | ||||
| 0 | 979 (90) | 228 (89) | 110 (89) | 118 (89) | |
| 1 | 115 (10) | 28 (11) | 13 (11) | 15 (11) | |
| NA | 6 | 0 | 0 | 0 | |
| Tumor grade | .89 | ||||
| 1–2 | 103 (30) | 77 (32) | 38 (32) | 39 (31) | |
| 3 | 243 (70) | 166 (68) | 79 (68) | 87 (69) | |
| NA | 754 | 13 | 6 | 7 | |
| Lauren histotype | .19 | ||||
| Diffuse | 340 (53) | 114 (49) | 60 (53) | 54 (44) | |
| Intestinal | 303 (47) | 121 (51) | 53 (47) | 68 (56) | |
| NA | 457 | 21 | 10 | 11 | |
| Tumor site of origin | .38 | ||||
| GC | 914 (86) | 217 (86) | 107 (88) | 110 (85) | |
| GEJ | 155 (14) | 34 (14) | 14 (12) | 20 (15) | |
| NA | 31 | 5 | 2 | 3 | |
| pT | .28 | ||||
| 1–2 | 243 (22) | 59 (23) | 32 (26) | 27 (20) | |
| 3–4 |
848 (78) 9 |
197 (77) | 91 (74) | 106 (80) | |
| Lymphnodal status | .97 | ||||
| Negative | 99 (9) | 21 (8) | 10 (8) | 11 (8) | |
| Positive | 988 (91) | 235 (92) | 113 (92) | 122 (92) | |
| NA | 13 | 0 | 0 | 0 | |
| MSI status | .51 | ||||
| MSS | NA | 232 (91) | 113 (92) | 119 (89) | |
| MSI‐high | NA | 24 (9) | 10 (8) | 14 (11) | |
| Inflammatory reaction | .58 | ||||
| Low | NA | 183 (77) | 91 (78) | 92 (75) | |
| High | NA | 55 (23) | 25 (22) | 30 (25) | |
| NA | ‐ | 18 | 7 | 11 | |
| Tumor PD‐L1 (IHC) | .43 | ||||
| <1% | NA | 163 (89) | 77 (91) | 86 (87) | |
| ≥1% | NA | 21 (11) | 8 (9) | 13 (13) | |
| NA | ‐ | 72 | 38 | 34 | |
| Stromal PD‐L1 (IHC) | .29 | ||||
| <1% | NA | 164 (89) | 78 (92) | 86 (87) | |
| ≥1% | NA | 20 (11) | 7 (8) | 13 (13) | |
| NA | ‐ | 72 | 38 | 34 |
a
The p value at Mann‐Whitney test, as appropriate, for numerical variables, and the chi‐square or Fisher test for categorical variables, respectively, to investigate the binary associations between patients and tumor characteristics and treatment arm.
Abbreviations: 5‐FU/LV, 5‐fluorouracile/leucovorin; ECOG PS, Eastern Cooperative Oncology Group Performance Status; F, female; GC, gastric cancer; GEJ, gastroesophageal junction; IHC, immunohistochemistry; IQR, interquartile range; M, male; MSI, microsatellite instability; NA, not assessed; PD‐L1, programmed death‐ligand 1.