Fitness for FOLFIRINOX in metastatic PDAC per PRODIGE-4 / ACCORD-11 inclusion criteria (C...

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

ID	`RF-PDAC-FIT-FOR-FOLFIRINOX`
Type	Red flag
Status	reviewed 2026-04-29 \| pending_clinical_signoff
Diseases	`DIS-PDAC`
Sources	`SRC-ESMO-PANCREATIC-2024` `SRC-NCCN-PANCREATIC-2025`

Red Flag Origin

Definition	Fitness for FOLFIRINOX in metastatic PDAC per PRODIGE-4 / ACCORD-11 inclusion criteria (Conroy NEJM 2011): ECOG 0-1, age ≤75 (≤76 by protocol; convention <=70-75 in real-world), bilirubin ≤1.5× ULN (resolved post-biliary stenting if needed), no significant cardiac comorbidity, adequate hepatic / renal / bone-marrow function. Selects IND-PDAC-METASTATIC-1L-FOLFIRINOX over IND-PDAC-METASTATIC-1L-GEM-NAB-PAC (mOS 11.1 vs 6.8 mo in PRODIGE-4; toxicity tradeoff acceptable in fit patients). Frail / ECOG ≥2 / bilirubin elevated → de-escalate to gem-nab-paclitaxel (MPACT, Von Hoff NEJM 2013).
Clinical direction	intensify
Category	fitness-eligibility
Shifts algorithm	ALGO-PDAC-METASTATIC-1L

Trigger Logic

{
  "all_of": [
    {
      "comparator": "<=",
      "finding": "bilirubin_uln_x",
      "threshold": 1.5
    },
    {
      "comparator": "<=",
      "finding": "ecog",
      "threshold": 1
    },
    {
      "comparator": "<=",
      "finding": "age",
      "threshold": 75
    }
  ],
  "type": "composite_score"
}

Notes

Trigger uses `bilirubin_uln_x` (alias `bilirubin_ratio_to_uln`, `total_bilirubin_ulnratio` per FINDING_ALIASES). Bilirubin threshold ≤1.5× ULN matches PRODIGE-4 inclusion; clinical practice tolerates resolved-post-stenting cases with biliary obstruction history. ECOG ≤1 and age ≤75 are the canonical fitness gates. Note that RF-PDAC-FRAILTY-AGE already encodes the de-escalation direction (gem-nab-pac) and fires earlier in ALGO-PDAC-METASTATIC-1L step 2; this RF intensifies into FOLFIRINOX at step 3 only AFTER step 2 rejects frailty. NALIRIFOX (NAPOLI-3) emerging as 1L alternative — separate Indication when added; trigger may need to widen with liposomal-irinotecan-eligible criterion if route forks.

Used By

Algorithms

ALGO-PDAC-LAPC - ALGO-PDAC-LAPC
ALGO-PDAC-METASTATIC-1L - ALGO-PDAC-METASTATIC-1L
ALGO-PDAC-RESECTABLE-PERIOP - ALGO-PDAC-RESECTABLE-PERIOP