Cetuximab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-CETUXIMAB |
|---|---|
| Тип | Препарат |
| Синоніми | ErbituxЦетуксимаб |
| Статус | переглянуто 2026-04-26 | очікує клінічного підпису |
| Хвороби | DIS-CRC DIS-HNSCC |
| Джерела | SRC-ESMO-COLON-2024 SRC-NCCN-COLON-2025 |
Дані про препарат
| Клас | Anti-EGFR chimeric IgG1 monoclonal antibody |
|---|---|
| Механізм дії | Chimeric (mouse Fv / human IgG1) monoclonal antibody binding the extracellular domain of the epidermal growth factor receptor (EGFR/HER1) with high affinity, competitively blocking binding of endogenous ligands (EGF, TGF-α). Inhibits ligand-induced receptor dimerization and downstream RAS-RAF-MAPK + PI3K-AKT signaling. IgG1 backbone enables ADCC. Effective ONLY in RAS wild-type mCRC (mutant KRAS / NRAS bypass EGFR signaling); BRAF V600E mutants are also intrinsically resistant. Left-sided primary tumor location is a positive predictor of benefit (CALGB-80405, FIRE-3 subgroup). |
| Типове дозування | mCRC: 400 mg/m² IV loading dose over 2 h, then 250 mg/m² IV weekly over 1 h. Alternative q2w schedule: 500 mg/m² IV q14d (non-inferior in CRC; aligns with FOLFOX/FOLFIRI). Head and neck (with RT): 400 mg/m² loading 1 wk pre-RT, then 250 mg/m² weekly during RT (typically 7-8 weeks). Head and neck (recurrent/metastatic with platinum + 5-FU): 400 mg/m² loading, then 250 mg/m² weekly. BRAF V600E mCRC (BEACON regimen): 400 mg/m² loading, then 250 mg/m² weekly with encorafenib 300 mg PO daily. Premedication: H1 antihistamine (diphenhydramine 50 mg IV) ± H2 blocker before each infusion; consider corticosteroid for first infusion. |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | True |
| Остання перевірка для України | 2026-04-27 |
Застереження
- Severe infusion reactions (~3% Grade 3-4; higher in southeastern US — preformed IgE to galactose-α-1,3-galactose; tick-bite association)
- Cardiopulmonary arrest and sudden death — observed with cetuximab + radiation in head and neck (~2%); careful electrolyte monitoring (Mg, K, Ca)
Нотатки
Mandatory pre-treatment testing in mCRC: extended RAS panel (KRAS exons 2-4 + NRAS exons 2-4) + BRAF V600E + tumor sidedness. Left- sided RAS-WT BRAF-WT → strong cetuximab benefit; right-sided WT → bevacizumab preferred (CALGB-80405). Rash management: doxycycline 100 mg BID prophylaxis (STEPP study) reduces severe rash; topical clindamycin / metronidazole for established rash; sunscreen + skin emollient. Monitor Mg weekly; replace IV when serum Mg <1.0 mg/dL. Premedicate aggressively in regions with high α-Gal IgE prevalence; consider serum α-Gal IgE screening in highest-risk areas.
Де використовується
Regimens
REG-CETUXIMAB-RECHALLENGE- Cetuximab rechallenge (mCRC RAS/BRAF-WT, post-1L EGFRi response, ctDNA-guided 3L+)REG-ENCORAFENIB-CETUXIMAB- Encorafenib + Cetuximab (BEACON CRC)REG-EXTREME-HNSCC- EXTREME (cetuximab + cisplatin/carboplatin + 5-FU; HNSCC R/M, 1L)REG-FOLFOX-CETUX- FOLFOX + CetuximabREG-SOTORASIB-CETUXIMAB-CRC- Sotorasib + Cetuximab (CodeBreaK 300, KRAS G12C+ mCRC)