Table 1. Patient and Tumor Characteristics.
| Variable | No. (%) | ||
|---|---|---|---|
| All patients (n = 92) | Folfiri plus durvalumab (n = 47) | Folfiri plus durvalumab plus tremelimumab (n = 45) | |
| Age, median (range), y | 59.7 (24.7-83.3) | 59.3 (28.2-83.3) | 60.0 (24.7-82.6) |
| Sex | |||
| Female | 28 (30.4) | 14 (29.8) | 14 (31.1) |
| Male | 64 (69.6) | 33 (70.2) | 31 (68.9) |
| ECOG PSa | |||
| 0 | 31 (33.7) | 11 (23.4) | 20 (44.4) |
| 1 | 61 (66.3) | 36 (76.6) | 25 (55.6) |
| Body mass index, median (range), kg/m2 | 26.3 (16.6-48.4) | 26.0 (17.7-39.1) | 27.2 (16.6-48.4) |
| Primary tumor site | |||
| Gastroesophageal junction | 49 (53.3) | 27 (57.4) | 22 (48.9) |
| Stomach | 43 (46.7) | 20 (42.6) | 23 (51.1) |
| Tumour subtype (Lauren classification) | |||
| Intestinal type | 48 (56.5) | 24 (54.5) | 24 (58.5) |
| Diffuse type | 37 (43.5) | 20 (45.5) | 17 (41.5) |
| Unknown | 7 | 3 | 4 |
| ERBB2 status | |||
| Positive | 21 (23.1) | 11 (23.9) | 10 (22.2) |
| Negative | 70 (76.9) | 35 (76.1) | 35 (77.8) |
| Unknown | 1 | 1 | 0 |
| Microsatellite instability | |||
| Deficient | 4 (4.5) | 3 (6.4) | 1 (2.2) |
| Proficient | 85 (92.4) | 41 (87.2) | 44 (97.8) |
| Unknown | 3 | 3 | 0 |
| Time to metastatic disease | |||
| Metachronous | 32 (34.8) | 17 (36.2) | 15 (33.3) |
| Synchronous | 60 (65.2) | 30 (63.8) | 30 (66.7) |
| Resection of primary tumor | |||
| No | 67 (72.8) | 34 (72.3) | 33 (73.3) |
| Yes | 25 (27.2) | 13 (27.7) | 12 (26.7) |
| Type of disease | |||
| Locally advanced | 7 (7.6) | 4 (8.5) | 3 (6.7) |
| Metastatic | 85 (92.4) | 43 (91.5) | 42 (93.3) |
| Site of metastases | |||
| Liver | 37 (40.2) | 19 (40.4) | 18 (40.0) |
| Lung | 18 (19.6) | 9 (19.1) | 9 (20.0) |
| Peritoneal carcinomatosis | 33 (35.9) | 16 (34.0) | 17 (37.8) |
| Lymph nodes | 36 (39.1) | 19 (40.4) | 17 (37.8) |
| Prior first-line chemotherapy regimen | |||
| Doublet regimenb | 56 (60.9) | 33 (70.2) | 23 (51.1) |
| Triplet regimenc | 34 (37.0) | 13 (27.7) | 21 (46.7) |
| Single agent | 2 (2.2) | 1 (2.1) | 1 (2.2) |
| CPS PD-L1 | |||
| ≥5 | 18 (34.0) | 4 (19.0) | 14 (43.8) |
| <5 | 35 (66.0) | 17 (81.0) | 18 (56.2) |
| Unknown | 39 | 26 | 13 |
| TPS PD-L1 | |||
| ≥1 | 13 (24.5) | 5 (23.8) | 8 (25.0) |
| <1 | 40 (75.5) | 16 (76.2) | 24 (75.0) |
| Unknown | 39 | 26 | 13 |
Abbreviations: CPS, combined positive score; ECOG PS, Eastern Cooperative Oncology Group performance status; PD-L1, programmed cell death-ligand 1; TPS, tumor proportion score.
a
Significant difference between 2 groups.
b
Fluoropyrimidine plus platinum salt.
c
Fluoropyrimidine plus platinum salt plus taxane.