HER2 status (solid tumors — gastric/GEJ/CRC scoring)

Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.

ID	`BIO-HER2-SOLID`
Тип	Біомаркер
Синоніми	ERBB2HER-2/neuHER2 IHC + ISHСтатус HER2 (солідні пухлини)
Статус	переглянуто 2026-04-26
Хвороби	Не вказано
Джерела	`SRC-ESMO-GASTRIC-2024` `SRC-NCCN-COLON-2025` `SRC-NCCN-GASTRIC-2025`

Дані про біомаркер

Тип біомаркера	protein_expression_ihc
Вимірювання	MethodIHC (4B5 / HercepTest), reflex ISH (FISH/CISH/SISH) for IHC 2+. Solid-tumor scoring uses gastric criteria (Hofmann 2008) — basolateral / lateral membranous staining ≥10% (vs breast 2018 ASCO/CAP). UnitsIHC 0 \| 1+ \| 2+ \| 3+; ISH HER2/CEP17 ratio with cutoff ≥2.0
Пов’язані біомаркери	Не вказано

Де використовується

Algorithms

ALGO-ESOPH-METASTATIC-1L - ALGO-ESOPH-METASTATIC-1L

Diseases

DIS-CHOLANGIOCARCINOMA - Cholangiocarcinoma (bile duct cancer)
DIS-SALIVARY - Salivary gland carcinoma

Indications

IND-BREAST-BRCA-MET-TALAZOPARIB - IND-BREAST-BRCA-MET-TALAZOPARIB
IND-BREAST-BRCA-POS-MET-PARPI - IND-BREAST-BRCA-POS-MET-PARPI
IND-BREAST-HER2-LOW-2L-DATO-DXD - IND-BREAST-HER2-LOW-2L-DATO-DXD
IND-BREAST-HER2-POS-3L-TUCATINIB - IND-BREAST-HER2-POS-3L-TUCATINIB
IND-BREAST-HER2-POS-EARLY-NEOADJUVANT - IND-BREAST-HER2-POS-EARLY-NEOADJUVANT
IND-BREAST-HER2-POS-MAINT-TRAST - IND-BREAST-HER2-POS-MAINT-TRAST
IND-BREAST-HER2-POS-MET-1L-THP - IND-BREAST-HER2-POS-MET-1L-THP
IND-BREAST-HER2-POS-MET-2L-TDXD - IND-BREAST-HER2-POS-MET-2L-TDXD
IND-BREAST-HR-POS-1L-INAVOLISIB - IND-BREAST-HR-POS-1L-INAVOLISIB
IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB - IND-BREAST-HR-POS-2L-AKT-CAPIVASERTIB
IND-BREAST-HR-POS-2L-DATO-DXD - IND-BREAST-HR-POS-2L-DATO-DXD
IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT - IND-BREAST-HR-POS-2L-ESR1-ELACESTRANT
IND-BREAST-HR-POS-2L-FUL-EVEROLIMUS - IND-BREAST-HR-POS-2L-FUL-EVEROLIMUS
IND-BREAST-HR-POS-2L-PIK3CA-ALPELISIB - IND-BREAST-HR-POS-2L-PIK3CA-ALPELISIB
IND-BREAST-HR-POS-2L-T-DXD-HER2-LOW - IND-BREAST-HR-POS-2L-T-DXD-HER2-LOW
IND-BREAST-HR-POS-3L-POST-CDK46I-POST-AKT - IND-BREAST-HR-POS-3L-POST-CDK46I-POST-AKT
IND-BREAST-HR-POS-EARLY-ADJ-CDK46I - IND-BREAST-HR-POS-EARLY-ADJ-CDK46I
IND-BREAST-HR-POS-EARLY-ADJ-RIBOCICLIB - IND-BREAST-HR-POS-EARLY-ADJ-RIBOCICLIB
IND-BREAST-HR-POS-MAINT-CDK46I - IND-BREAST-HR-POS-MAINT-CDK46I
IND-BREAST-HR-POS-MET-1L-CDKI - IND-BREAST-HR-POS-MET-1L-CDKI
IND-BREAST-TNBC-2L-BRCA-OLAPARIB - IND-BREAST-TNBC-2L-BRCA-OLAPARIB
IND-BREAST-TNBC-2L-BRCA-TALAZOPARIB - IND-BREAST-TNBC-2L-BRCA-TALAZOPARIB
IND-BREAST-TNBC-2L-DATO-DXD - IND-BREAST-TNBC-2L-DATO-DXD
IND-BREAST-TNBC-2L-SACITUZUMAB - IND-BREAST-TNBC-2L-SACITUZUMAB
IND-BREAST-TNBC-2L-T-DXD-HER2-LOW - IND-BREAST-TNBC-2L-T-DXD-HER2-LOW
IND-BREAST-TNBC-3L-POST-SACI-POST-T-DXD - IND-BREAST-TNBC-3L-POST-SACI-POST-T-DXD
IND-BREAST-TNBC-EARLY-NEOADJUVANT - IND-BREAST-TNBC-EARLY-NEOADJUVANT
IND-CHOLANGIO-2L-HER2-ZANIDATAMAB - IND-CHOLANGIO-2L-HER2-ZANIDATAMAB
IND-CRC-METASTATIC-2L-HER2-AMP-T-DXD - IND-CRC-METASTATIC-2L-HER2-AMP-T-DXD
IND-CRC-METASTATIC-2L-HER2-AMP-TUCATINIB - IND-CRC-METASTATIC-2L-HER2-AMP-TUCATINIB
IND-ESOPH-METASTATIC-1L-HER2-TRASTUZUMAB-CHEMO - IND-ESOPH-METASTATIC-1L-HER2-TRASTUZUMAB-CHEMO
IND-ESOPH-METASTATIC-2L-HER2-POSITIVE-T-DXD - IND-ESOPH-METASTATIC-2L-HER2-POSITIVE-T-DXD
IND-ESOPH-OLIGOMET-SYSTEMIC-PLUS-LOCAL - IND-ESOPH-OLIGOMET-SYSTEMIC-PLUS-LOCAL
IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB - IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB
IND-GASTRIC-METASTATIC-1L-FGFR2B-BEMARITUZUMAB - IND-GASTRIC-METASTATIC-1L-FGFR2B-BEMARITUZUMAB
IND-GASTRIC-METASTATIC-1L-HER2-TOGA - IND-GASTRIC-METASTATIC-1L-HER2-TOGA
IND-GASTRIC-METASTATIC-1L-PDL1-CHEMO-ICI - IND-GASTRIC-METASTATIC-1L-PDL1-CHEMO-ICI
IND-GASTRIC-METASTATIC-2L-HER2-TDXD - IND-GASTRIC-METASTATIC-2L-HER2-TDXD
IND-GASTRIC-METASTATIC-2L-RAMUCIRUMAB-PACLITAXEL - IND-GASTRIC-METASTATIC-2L-RAMUCIRUMAB-PACLITAXEL
IND-GASTRIC-OLIGOMET-SYSTEMIC-PLUS-LOCAL - IND-GASTRIC-OLIGOMET-SYSTEMIC-PLUS-LOCAL
... 2 ще

Questionnaires

QUEST-BREAST-1L-STUB - Invasive breast cancer — first line
QUEST-CRC-1L-STUB - Colorectal carcinoma — first line
QUEST-GASTRIC-1L-STUB - Gastric and gastroesophageal junction adenocarcinoma — first line
QUEST-NSCLC-1L-STUB - Non-small cell lung cancer — first line

Tests

TEST-HER2-IHC-FISH - HER2 IHC + reflex FISH on tumor

Біомаркер

BIO-CLDN18-2 - Claudin-18.2 expression (CLDN18.2)
BIO-ESTROGEN-RECEPTOR - Estrogen receptor (ER)
BIO-FGFR2B-IHC - FGFR2b protein expression by IHC (membranous staining)
BIO-HER2-LOW - HER2-low (breast — IHC 1+ OR IHC 2+ ISH-negative)
BIO-HER2-ULTRALOW - HER2-ultralow (breast — IHC > 0 < 1+; faint/incomplete membrane staining ≤10%)

Клінічна застосовність

BMA-HER2-AMP-CHOLANGIO - HER2-amplified biliary tract cancer (~5-15% overall; enriched in gallbladder + extrahepat...
BMA-HER2-AMP-CRC - HER2-amplified metastatic colorectal cancer (~3-5% in RAS/BRAF-WT population): tucatinib...
BMA-HER2-AMP-ESOPHAGEAL - HER2-positive esophageal/GEJ adenocarcinoma scored by gastric criteria: trastuzumab + che...
BMA-HER2-AMP-GASTRIC - HER2-positive gastric/GEJ adenocarcinoma (~15-20%): trastuzumab + chemotherapy is standar...

Тривожна ознака

RF-BREAST-HIGH-RISK-BIOLOGY - Germline or somatic BRCA1/2 mutation, PIK3CA mutation, ESR1 mutation, HER2-amplification,...
RF-CHOLANGIOCARCINOMA-HIGH-RISK-BIOLOGY - Actionable molecular alteration in cholangiocarcinoma — FGFR2 fusion / rearrangement, IDH...
RF-CRC-HER2-AMP-ACTIONABLE - HER2 amplification in metastatic colorectal cancer — IHC 3+ OR (IHC 2+ AND ISH amplified,...
RF-SALIVARY-HIGH-RISK-BIOLOGY - Salivary gland carcinoma with actionable molecular driver: ETV6-NTRK3 fusion (mammary ana...