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Table 1 Design and characterístics of studies included in the meta-analysis

From: Efficacy and safety of Zolbetuximab plus chemotherapy for advanced CLDN18.2-positive gastric or gastro-oesophageal adenocarcinoma: a meta-analysis of randomized clinical trials

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)☨

  1. § Missing Lauren classification for 1 patient in Zolbetuximab plus CAPOX group. ☨ Missing Lauren classification for 1 patient in Zolbetuximab plus mFOLFOX6 group and 4 patients in placebo plus mFOLFOX6 group. CAPOX, Capecitabine and Oxaliplatin; CG, control group; EOX, Epirubicin, Oxaliplatin and Capecitabine; IG, intervention group; IQR, interquartile range; mFOLFOX6, 5-fluorouracil, folinic acid and oxaliplatin; NA, not available; NCT, National Clinical Trial