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Baseline organ dysfunction precluding standard cisplatin-based chemoradiation or pembroli...

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IDRF-HNSCC-ORGAN-DYSFUNCTION
TipoSeñal de alerta
Situaciónreviewed 2026-04-27 | pending_clinical_signoff
EnfermedadesDIS-HNSCC
FuentesSRC-ESMO-HNSCC-2020 SRC-NCCN-HNSCC-2025

Origen de la bandera roja

DefiniciónBaseline organ dysfunction precluding standard cisplatin-based chemoradiation or pembrolizumab + 5-FU + cisplatin / cetuximab in head and neck squamous cell carcinoma: CrCl <60 mL/min (cisplatin contraindicated at full dose, switch to carboplatin or cetuximab), hearing loss / ototoxicity baseline (cisplatin contraindicated), LVEF <50% (5-FU cardiac risk), bilirubin >3× ULN (taxane / 5-FU metabolism), or severe peripheral neuropathy (cisplatin + taxane contraindicated).
Dirección clínicadecreciente
Categoríadisfunción de los órganos

Lógica de activación

{
  "any_of": [
    {
      "comparator": "<",
      "finding": "creatinine_clearance_ml_min",
      "threshold": 60
    },
    {
      "finding": "baseline_ototoxicity",
      "value": true
    },
    {
      "comparator": "<",
      "finding": "lvef_percent",
      "threshold": 50
    },
    {
      "comparator": ">=",
      "finding": "bilirubin_ratio_to_uln",
      "threshold": 3
    },
    {
      "comparator": ">",
      "finding": "peripheral_neuropathy_grade",
      "threshold": 2
    }
  ],
  "type": "lab_value"
}

Notas

Cisplatin-based CRT is the curative-intent standard (Intergroup 0099, TAX 324, EORTC 24891) but ~30% of HNSCC patients are cisplatin- ineligible at presentation due to age + organ dysfunction. CrCl <60: switch to carboplatin (RTOG 81-17 lower local control but acceptable) or cetuximab + RT (Bonner trial — less effective than cisplatin per RTOG 1016 / De-ESCALaTE post hoc but tolerated in cisplatin-ineligible). Baseline hearing loss is gating for cisplatin — high cumulative ototoxicity rate (40% Gr2+) compounds. LVEF <50: 5-FU + cisplatin triplet risky — pembrolizumab monotherapy (KEYNOTE-048 if PD-L1 CPS ≥1) is alternative for R/M setting.

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Señal de alerta