Study | Design/NCT | Intervention treatment | Follow-up (median) | Number of participants IG/CG, n | Median age (IQR or range) IG/CG, years | Male IG/CG, no. (%) | Primary site, n (%) | Organs with metastases, n (%) | Lauren classification, n (%) | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|
IG | CG | IG | CG | IG | CG | |||||||
FAST 2021 [35] | Phase II/ NCT01630083 | Zolbetuximab plus EOX | 54.7 months | 77/84 | 59 (range 22–77)/ 57 (range 24–73) | 47 (61.0)/ 56 (66.7) | Stomach: 62 (80.5) GEJ: 13 (16.9) Oesophagus: 2 (2.6) | Stomach: 68 (81.0) GEJ: 12 (14.3) Oesophagus: 4 (4.8) | NA | NA | Diffuse 35 (45.5) Intestinal 26 (33.8) Mixed 10 (13.0) Unknown 6 (7.8) | Diffuse 38 (45.2) Intestinal 27 (32.1) Mixed 11 (13.1) Unknown 8 (9.5) |
GLOW 2023 [36] | Phase III/ NCT03653507 | Zolbetuximab plus CAPOX | 12.62 months | 254/253 | 61.0 (range 22–82)/ 59.0 (range 21–83) | 159 (62.6)/ 156 (61.7) | Stomach: 219 (86.2) GEJ: 35 (13.8) | Stomach: 209 (82.6) GEJ: 44 (17.4) | 0–2: 189 (74.4) ≥ 3: 65 (25.6) | 0–2: 188 (74.3) ≥ 3: 65 (25.7) | Diffuse 87 (34.4) Intestinal 36 (14.2) Mixed 20 (7.9) Unknown 76 (30.0) Other 34 (13.4)§ | Diffuse 100 (39.5) Intestinal 41 (16.2) Mixed 21 (8.3) Unknown 64 (25.3) Other 27 (10.7)§ |
SPOTLIGHT 2023 [37] | Phase III/ NCT03504397 | Zolbetuximab plus mFOLFOX6 | NA | 283/282 | 62·0 (IQR 51·0–69·0)/ 60·0 (IQR 50·0–69·0) | 176 (62)/ 175 (62) | Stomach: 219 (77) GEJ: 64 (23) | Stomach: 210 (74) GEJ: 72 (26) | 0–2: 219 (77) ≥ 3: 64 (23) | 0–2: 219 (78) ≥ 3: 63 (22) | Diffuse 82 (29) Intestinal 70 (25) Mixed 31 (11) Unknown 49 (17) Other 50 (18)☨ | Diffuse 117 (41) Intestinal 66 (23) Mixed 13 (5) Unknown 40 (14) Other 42 (15)☨ |