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Table. 3.

Table. 3.

Patient subgroup according to established and potential biomarkers of targeted therapies in gastric cancer

Biomarker* Established/in clinical trials N Specifications
ERBB2 amplification First line: trastuzumab+chemotherapy
Third line: trastuzumab, deruxtecan
NCT05190445, NCT05152147, NCT02465060, NCT04143711
4 (4/81, 4.9%) Assay A: 1/49, 2.0%
Assay B: 3/32, 9.4%
FGFR2 amplification NCT05019794, NCT04189445 5 (5/81, 6.2%) Assay A: 1/49, 2.0%
Assay B: 4/32, 12.5%
FGFR1 amplification NCT05019794, NCT04189445 1 (1/81, 1.2%) Assay A: 0/49, 0.0%
Assay B: 1/32, 3.1%
EGFR amplification NCT04077255, NCT04739202 3 (3/81, 3.7%) Assay A: 2/49, 4.1%
Assay B: 1/32, 3.1%
CCNE1 amplification NCT05252416 3 (3/32, 9.4%) -
RAS mutation or amplification NCT02465060 12 (9/81, 11.1%; 3/32, 9.4%) Assay A: 5/49, 10.2%
Assay B: 4/32, 12.5%
9 mutations (8 KRAS, 1 NRAS)
3 KRAS amplifications
TP53 mutation NCT03641313 31 (31/81, 38.3%) Assay A: 17/49, 34.7%
Assay B: 14/32, 43.8%
35 mutations in 31 patients
PIK3CA mutation or amplification NCT04526470, NCT04739202, NCT02465060 2 (2/81, 2.5%) Assay A: 1/49, 2.0%
Assay B: 1/32, 3.1%
2 mutations
No amplification
ARID1A mutation NCT05379972 3 (3/32, 9.4%) 4 mutations from 3 patients
MET amplification NCT04923932, NCT05620628, NCT05439993, NCT03993873, NCT02465060 3 (3/81, 3.7%) Assay A: 3/49, 6.1%
Assay B: 0/32, 0.0%
TSC2 null NCT02465060 1 (1/32, 3.1%) p.Phe471LeufsTer14 from #69 patient

*Biomarkers first described in Nakamura, et al. [15] and Lee, et al. [12].

CCNE1 amplification, KRAS amplification, PIK3CA amplification, ARID1A mutation, and TSC2 null were only evaluated in the 32 patients tested using assay B (AlphaLiquid 100 kit).

Phase II or III clinical trials with “active, not recruiting” or “recruiting” status are listed.

Abbreviation: NCT, national clinical trial.

Ann Lab Med 2024;44:164~173 https://doi.org/10.3343/alm.2023.0187

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