Cáncer colorrectal metastásico amplificado con HER2 (~3-5% en la población de RAS/BRAF-WT): tucatinib...
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
| ID | BMA-HER2-AMP-CRC |
|---|---|
| Tipo | Relevancia terapéutica |
| Situación | reviewed 2026-04-27 | pending_clinical_signoff | actionability review required |
| Enfermedades | DIS-CRC |
| Fuentes | SRC-CIVIC SRC-ESMO-COLON-2024 SRC-NCCN-COLON-2025 |
Hechos relativos a la posibilidad de adoptar medidas
| Biomarcador | BIO-HER2-SOLID |
|---|---|
| Variante | amplificación/expresión excesiva — IHC 3+ o (IHC 2+ + ISH amplificado, HER2/CEP17 ≥2,0); ~3-5% de cáncer colorrectal metastásico (RAS/BRAF-WT) |
| Enfermedad | DIS-CRC |
| El nivel de ESCAT | IB |
| Combinaciones recomendadas | tucatinib + trastuzumab (2L+ HER2+ RAS-WT mCRC per SRC-NCCN-COLON-2025), trastuzumab deruxtecan (2L+ HER2+ mCRC per SRC-NCCN-COLON-2025), trastuzumab + lapatinib (alternative per HERACLES, listed in SRC-NCCN-COLON-2025) |
| Monoterapia contraindicada | HER2-direccionado en el mCRC mutado por RAS (la mutación RAS impulsa la resistencia descendente por SRC-NCCN-COLON-2025), trastuzumab en monoterapia |
| Resumen de las pruebas | HER2-amplified metastatic colorectal cancer (~3-5% in RAS/BRAF-WT population): tucatinib + trastuzumab is FDA-approved 2L+ for HER2- positive RAS-WT mCRC based on MOUNTAINEER (Strickler Lancet Oncol 2023 — ORR 38%, mDOR 12 mo) per SRC-NCCN-COLON-2025. Trastuzumab deruxtecan also has activity (DESTINY-CRC01 Siena Lancet Oncol 2021 — ORR 45% in HER2 IHC 3+ RAS-WT) and tumor-agnostic FDA approval (2024) for HER2-positive solid tumors that have progressed on prior therapy. Older trastuzumab + lapatinib (HERACLES) is referenced as alternative. RAS-mutant tumors should not receive HER2-directed therapy in 2L because RAS-driven resistance is well-documented per SRC-NCCN-COLON-2025. |
Notas
ESCAT IB / OncoKB Level 2 (initially Level 2A in CRC pre-MOUNTAINEER; Level 1 tumor-agnostic for T-DXd 2024). HER2 testing recommended for metastatic CRC with RAS/BRAF-WT genotype per SRC-NCCN-COLON-2025. RAS mutation = exclusion criterion for anti-HER2 therapy. Bibliographic record SRC-DESTINY-CRC01-SIENA-2021 is available; SRC-MOUNTAINEER-STRICKLER-2023 and SRC-HERACLES remain source gaps. Claim-level linkage requires clinical sign-off.
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