Celecoxib (cancer chemoprevention context — APC duodenal polyposis)
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| ID | DRUG-CELECOXIB-CHEMOPREVENTION |
|---|---|
| Тип | Препарат |
| Синоніми | CelebrexCelecoxib (cancer chemoprevention)Целекоксиб (хіміопрофілактика раку — поліпоз APC) |
| Статус | переглянуто 2026-05-18 | очікує клінічного підпису |
| Хвороби | Не вказано |
| Джерела | SRC-NCCN-COLON-2025 SRC-USPSTF-CRC-2021 |
Дані про препарат
| Клас | COX-2 selective non-steroidal anti-inflammatory drug (coxib) |
|---|---|
| Механізм дії | Selective inhibitor of cyclooxygenase-2 (COX-2; ~10-20-fold selectivity over COX-1 at therapeutic concentrations), suppressing prostaglandin- driven inflammation, proliferation, and angiogenesis with relatively spared platelet COX-1 (no antiplatelet effect at standard doses) and reduced gastric mucosal COX-1 (less GI bleeding than non-selective NSAIDs). Cancer-prevention rationale: COX-2 is upregulated in adenomas and many tumors; inhibition reduces PGE2-driven proliferation and immune escape. In FAP, celecoxib reduced duodenal polyp burden (Steinbach NEJM 2000) — formerly FDA-approved for FAP-related polyposis (orphan designation), withdrawn 2011 by sponsor after post-marketing study did not confirm benefit. |
| Типове дозування | FAP duodenal polyposis chemoprevention (historical FDA indication pre-2011): 400 mg PO BID (= 800 mg/day). Adjunct to surveillance endoscopy and polypectomy — not a replacement. General CV-risk caveat: lowest effective dose for shortest duration. Take with food; avoid in CrCl <30 mL/min, severe hepatic impairment. CYP2C9 poor metabolizers — consider half dose. |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-05-18 |
Застереження
- Cardiovascular thrombotic events (MI, stroke) — increased risk with all NSAIDs including COX-2 selective; contraindicated in CABG perioperative period
- GI bleeding, ulceration, perforation — risk lower than non-selective NSAIDs but not absent; can occur without warning
Нотатки
STUB — v0.2 chemoprevention-workstream authoring; pending two-Clinical- Co-Lead signoff per CHARTER §6.1 dev-mode. ORPHAN / HISTORICAL FAP indication. Celecoxib was FDA-approved (1999) for reducing duodenal polyp number in FAP based on Steinbach NEJM 2000 (6-month, 28% polyp burden reduction at 400 mg BID); approval withdrawn at sponsor request in 2011 after PreSAP/APC trials showed CV-risk signal outweighed benefit in adenoma-prevention populations. NCCN Genetic Familial High-Risk Assessment guidelines retain celecoxib as adjunct option in selected FAP patients (post-colectomy surveillance, retained rectum, duodenal disease) under specialist hereditary-CRC team. Engine should NOT auto-recommend; reserved for specialist hereditary- cancer center management with explicit CV risk discussion. Strict ASA / sulfa allergy screen.
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