Urothelial cancer patient cisplatin-ineligible by Galsky criteria: ECOG ≥2, OR CrCl <60 m...

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

ID	`RF-UROTHELIAL-FRAILTY-AGE`
Type	Red flag
Status	reviewed 2026-04-27 \| pending_clinical_signoff
Diseases	`DIS-UROTHELIAL`
Sources	`SRC-EAU-BLADDER-2024` `SRC-NCCN-BLADDER-2025`

Red Flag Origin

Definition	Urothelial cancer patient cisplatin-ineligible by Galsky criteria: ECOG ≥2, OR CrCl <60 mL/min, OR grade ≥2 hearing loss, OR grade ≥2 peripheral neuropathy, OR NYHA class III heart failure. Also frailty composites (age ≥75 + ≥2 comorbidities; age ≥70 + albumin <3.0 + Charlson ≥3). Cisplatin-ineligibility is the central routing decision in advanced UC — directs to enfortumab-vedotin + pembrolizumab (EV-302) or carboplatin-gemcitabine + maintenance avelumab (JAVELIN-100).
Clinical direction	de-escalate
Category	frailty-age

Trigger Logic

{
  "any_of": [
    {
      "comparator": ">=",
      "finding": "ecog",
      "threshold": 2
    },
    {
      "comparator": "<",
      "finding": "creatinine_clearance_ml_min",
      "threshold": 60
    },
    {
      "comparator": ">=",
      "finding": "hearing_loss_grade",
      "threshold": 2
    },
    {
      "comparator": ">=",
      "finding": "peripheral_neuropathy_grade",
      "threshold": 2
    },
    {
      "finding": "nyha_class",
      "value": "III"
    },
    {
      "finding": "fit_for_cisplatin",
      "value": false
    },
    {
      "all_of": [
        {
          "comparator": ">=",
          "finding": "age",
          "threshold": 75
        },
        {
          "comparator": ">=",
          "finding": "comorbidity_count",
          "threshold": 2
        }
      ]
    },
    {
      "all_of": [
        {
          "comparator": ">=",
          "finding": "age",
          "threshold": 70
        },
        {
          "comparator": "<",
          "finding": "albumin_g_dl",
          "threshold": 3.0
        },
        {
          "comparator": ">=",
          "finding": "charlson_score",
          "threshold": 3
        }
      ]
    }
  ],
  "type": "composite_score"
}

Notes

Galsky cisplatin-ineligibility criteria (Lancet Oncol 2011) define the major UC routing fork: cisplatin-eligible → ddMVAC or gem-cisplatin (curative neoadjuvant; metastatic 1L); cisplatin- ineligible → EV+pembro (EV-302: OS HR 0.47 vs platinum-gem in metastatic UC, now preferred 1L for cisplatin-ineligible AND eligible per NCCN 2025 update), OR carbo-gem + maintenance avelumab (JAVELIN-100). Median age at UC diagnosis ~73 — most patients meet at least one Galsky criterion. Frail patients beyond Galsky (ECOG ≥3, severe organ dysfunction) → ICI monotherapy (pembro KEYNOTE-052) or best supportive care.

Used By

Indications

IND-UROTHELIAL-2L-ERDAFITINIB - IND-UROTHELIAL-2L-ERDAFITINIB