Gemcitabine
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-GEMCITABINE |
|---|---|
| Тип | Препарат |
| Синоніми | 2',2'-difluorodeoxycytidineGemzarInfugemdFdCГемцитабін |
| Статус | переглянуто 2026-04-26 | очікує клінічного підпису |
| Хвороби | DIS-BREAST DIS-CHOLANGIOCARCINOMA DIS-NK-T-NASAL DIS-OVARIAN DIS-PDAC DIS-SOFT-TISSUE-SARCOMA DIS-UROTHELIAL |
| Джерела | SRC-ESMO-PANCREATIC-2024 SRC-NCCN-PANCREATIC-2025 |
Дані про препарат
| Клас | Antimetabolite (deoxycytidine analog) |
|---|---|
| Механізм дії | Pyrimidine nucleoside analog of deoxycytidine. Phosphorylated by deoxycytidine kinase (rate-limiting) to active metabolites gemcitabine diphosphate (dFdCDP) and triphosphate (dFdCTP). dFdCDP inhibits ribonucleotide reductase, depleting deoxynucleotide pools required for DNA synthesis (self-potentiation effect — increases cellular dFdCTP). dFdCTP is incorporated into DNA, after which one additional natural nucleotide is added before DNA polymerase stalls — "masked chain termination" — making the lesion resistant to exonucleolytic repair. Cell cycle phase-specific (S phase) with G1/S blockade. PDAC backbone (gem-nab-pac MPACT, gem mono in frail), biliary tract cancers, NSCLC, bladder, NK/T-nasal lymphoma (SMILE), Hodgkin / DLBCL salvage (GDP). |
| Типове дозування | PDAC gem-nab-pac (MPACT): 1000 mg/m² IV over 30 min days 1, 8, 15 of 28-day cycle. PDAC mono (frail): 1000 mg/m² IV over 30 min weekly × 7, then rest 1 week, then 3-of-4-weekly thereafter. Adjuvant PDAC mono: 1000 mg/m² IV weekly × 3 of every 4 weeks × 6 cycles. Adjuvant biliary tract (BILCAP): 1000 mg/m² IV weekly × 3 of 4 × 8 cycles, with capecitabine. NSCLC (with cisplatin): 1000-1250 mg/m² IV days 1, 8 q21d. Bladder (gem-cis): 1000 mg/m² IV days 1, 8, 15 q28d with cisplatin. Ovarian (with carboplatin): 1000 mg/m² IV days 1, 8 q21d. GDP (lymphoma salvage): 1000 mg/m² IV days 1, 8 q21d. SMILE (NK/T): 1000 mg/m² IV day 1, 8 of 28-day cycle (with steroids, MTX, ifosfamide, L-asparaginase, e... |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | True |
| Остання перевірка для України | 2026-04-27 |
Застереження
- Hemolytic-uremic syndrome / thrombotic microangiopathy (rare but catastrophic; may occur after weeks-to-months of therapy; permanent discontinuation if confirmed)
- Pulmonary toxicity (interstitial pneumonitis, pulmonary edema, ARDS — can be fatal)
- Capillary leak syndrome (rare)
Нотатки
Day-15 dose often held for ANC <1.5 or platelets <100. HUS / TMA rare but catastrophic — monitor renal function + hemolysis labs (LDH, haptoglobin, schistocytes) periodically; discontinue permanently if confirmed. Pulmonary toxicity (cough, dyspnea, new hypoxia) requires immediate workup including CT and discontinuation. Already used in NK/T SMILE — reuse this entity rather than duplicate. Radiation recall: severe mucocutaneous reactions in prior RT field — increase awareness when sequencing or combining with RT (esp. esophageal, lung, pelvic). For PDAC: gem-nab-pac modestly outperforms gem mono (MPACT mOS 8.5 vs 6.7); FOLFIRINOX preferred in fit ECOG 0; gem mono for frail.
Де використовується
Regimens
REG-CARBO-GEM-BEV-OVARIAN- Carboplatin + Gemcitabine + Bevacizumab (platinum-sensitive recurrent ovarian, OCEANS reg...REG-CISPLATIN-GEMCITABINE-UROTHELIAL- Cisplatin + gemcitabine (urothelial neoadj + metastatic)REG-DURVA-GEM-CIS-CHOLANGIO- Durvalumab + gemcitabine + cisplatin (TOPAZ-1) — 1L advanced biliary tract cancerREG-GEM-CARBO-UROTHELIAL- Gemcitabine + carboplatin (urothelial carcinoma, cisplatin-ineligible)REG-GEM-NAB-PAC- Gemcitabine + nab-paclitaxel (MPACT)REG-GEMCITABINE-CISPLATIN-CHOLANGIO- Gemcitabine + cisplatin (advanced biliary tract cancer, 1L — ABC-02)REG-GEMCITABINE-DOCETAXEL-STS- Gemcitabine + docetaxel (soft tissue sarcoma)REG-P-GEMOX-NK-T- P-GEMOX (pegaspargase + gemcitabine + oxaliplatin) for NK/T-cell nasal lymphomaREG-PEMBRO-CHEMO-TNBC-MET- Pembrolizumab + chemotherapy (TNBC, metastatic PD-L1+)REG-PEMBRO-GEM-CIS-CHOLANGIO- Pembrolizumab + gemcitabine + cisplatin (KEYNOTE-966) — 1L advanced biliary tract cancer