MSI-H (misto-instabilité élevée) CRC est le biomarqueur primaire pour les pembr...
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
| ID | BMA-MSI-STATUS-CRC |
|---|---|
| Type | Pertinence thérapeutique |
| État | reviewed 2026-05-07 | actionability review required |
| Maladies | DIS-CRC |
| Sources | SRC-ESMO-CRC-2024 SRC-KEYNOTE-177-ANDRE-2020 SRC-NCCN-COLON-2025 |
Faits relatifs à l ' action en justice
| Biomarqueur | BIO-MSI-STATUS |
|---|---|
| Variante | MSI-H |
| Maladie | DIS-CRC |
| Niveau ESCAT | IA |
| Combinaisons recommandées | pembrolizumab monotherapy (MSI-H 1L mCRC per SRC-KEYNOTE-177-ANDRE-2020, SRC-NCCN-COLON-2025), pembrolizumab monotherapy (tumor-agnostic MSI-H per SRC-ESMO-CRC-2024) |
| Résumé des faits | MSI-H (microsatellite instability-high) CRC is the primary biomarker for first-line pembrolizumab monotherapy (KEYNOTE-177; mPFS 16.5 vs 8.2 mo, HR 0.60; FDA-approved 2020 for 1L mCRC MSI-H). Pembrolizumab is also FDA-approved tumor-agnostically for MSI-H/dMMR solid tumors (KEYNOTE-158, 2017). MSS/pMMR CRC does not benefit from ICI monotherapy. MSI-H (~5% of metastatic CRC) is typically detected by PCR-based fragment analysis or NGS; result correlates closely with IHC-based dMMR testing (MLH1/MSH2/MSH6/PMS2 loss). Threshold selection (MSI-H positive/negative) enforced by algorithm layer; this BMA entry surfaces ESCAT tier context only. For Lynch syndrome germline implications see BMA entries for BIO-MLH1 / BIO-MSH2 / BIO-MSH6 / BIO-PMS2. |
Notes
Variant_qualifier: "MSI-H" — only matches positive MSI-H values; MSS/pMMR falls through to a different pathway. Gene-stem matching ("MSI") does not intersect with BIO-DMMR-IHC BMA entries (stem "DMMR") — these are complementary, not overlapping. KEYNOTE-158 source stub not yet ingested separately; ESMO CRC 2024 covers the tumor-agnostic context.
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