pISSN 2234-3806
eISSN 2234-3814

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