NALIRIFOX
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-LIPOSOMAL-IRINOTECAN DRUG-OXALIPLATIN DRUG-LEUCOVORIN DRUG-5-FLUOROURACIL |
|---|
| ID | REG-NALIRIFOX |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-05-08 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-PANCREATIC-2024 SRC-NAPOLI-3-WAINBERG-2024 SRC-NCCN-PANCREATIC-2025 |
Notes
NAPOLI-3 (Wainberg, Lancet 2023; n=770, phase 3 RCT; NCT04083235): NALIRIFOX vs gem-nab-pac as 1L therapy in metastatic PDAC, ECOG 0-1. mOS 11.1 vs 9.2 mo (HR 0.83, 95% CI 0.70-0.99, p=0.04); mPFS 7.4 vs 5.6 mo (HR 0.69, 95% CI 0.58-0.83, p<0.0001); ORR 41.8% vs 36.2%. Grade ≥3 TEAEs comparable: diarrhea (20% vs 4.5%), nausea (12% vs 3%), hypokalemia (15% vs 4%), neutropenia (14% vs 25%), febrile neutropenia (3% vs 1%), peripheral neuropathy (3% vs 2%), thrombocytopenia (2% vs 9%). NCCN Category 1 (preferred) 1L option for mPDAC alongside FOLFIRINOX and gem-nab-pac. Eligibility: PS 0-1, bilirubin <1.5-2× ULN, no severe cardiac comorbidity. NALIRIFOX vs FOLFIRINOX: no head-to-head trial; cross-trial OS appears comparable; NALIRIFOX may have somewhat better tolerability profile (lower neutropenia, less alopecia) but more diarrhea and nausea. Choice between FOLFIRINOX and NALIRIFOX in Ukraine is dominated by ONIVYDE access (not registered) — FOLFIRINOX remains the accessible Category 1 option. between_visit_watchpoints authoring deferred to PATIENT_MODE Phase 3 backlog.
Used By
Indication
IND-PDAC-METASTATIC-1L-NALIRIFOX- IND-PDAC-METASTATIC-1L-NALIRIFOX