Romidepsin inaccessible, contraindicated, or intolerant in AITL 2L+. Scenarios driving in...

Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.

ID	`RF-AITL-ROMIDEPSIN-INELIGIBLE`
Тип	Тривожна ознака
Статус	переглянуто 2026-05-08
Хвороби	`DIS-AITL`
Джерела	`SRC-ESMO-PTCL-2024` `SRC-NCCN-BCELL-2025`

Походження тривожної ознаки

Визначення	Romidepsin inaccessible, contraindicated, or intolerant in AITL 2L+. Scenarios driving ineligibility: (1) Access — romidepsin is not approved in Ukraine (as of 2026); available only via named-patient programme or clinical trial; many patients cannot access; (2) Cardiac contraindication — class I/II QTc-prolonging cardiac arrhythmia or baseline QTc ≥480 ms; romidepsin HDACi class causes dose-dependent QTc prolongation and is contraindicated in significant baseline arrhythmia; (3) Prior HDACi intolerance — prior romidepsin or belinostat-related grade ≥3 cardiac event, thrombocytopenia, or GI toxicity requiring discontinuation. In all cases belinostat (BELIEF, 2014; PTCL ORR 25.8%, AITL ORR ~46%) is the preferred alternative HDACi: less QTc prolongation than romidepsin, IV weekly schedule, and UA-accessible via named-patient. Azacitidine remains an orthogonal alternative (HMA, not HDACi) r...
Клінічний напрям	de-escalate
Категорія	fitness-eligibility
Змінює алгоритм	ALGO-AITL-2L

Логіка спрацьовування

{
  "any_of": [
    {
      "finding": "romidepsin_accessible",
      "value": false
    },
    {
      "finding": "romidepsin_access",
      "value": "not_available"
    },
    {
      "finding": "romidepsin_access",
      "value": "inaccessible"
    },
    {
      "finding": "romidepsin_intolerant",
      "value": true
    },
    {
      "finding": "prior_romidepsin_intolerance",
      "value": true
    },
    {
      "finding": "qtc_prolonged_baseline",
      "value": true
    },
    {
      "comparator": ">=",
      "finding": "qtc_ms",
      "threshold": 480
    },
    {
      "finding": "baseline_cardiac_arrhythmia",
      "value": true
    },
    {
      "finding": "hdaci_cardiac_contraindication",
      "value": true
    },
    {
      "finding": "hdaci_intolerant",
      "value": true
    }
  ],
  "type": "treatment_contraindication"
}

Нотатки

This RF fires at ALGO-AITL-2L step 3, which is only reached when step 1 (azacitidine default) evaluated if_false AND step 2 (romidepsin composite with HDAC-naive + accessible + no cardiac) evaluated if_false. Step 3 is the disambiguation gate: if romidepsin inaccessible/intolerant → belinostat; else → azacitidine fallback. The primary cardiac risk gate (HDAC-naive + accessible + no cardiac arrhythmia) lives in step 2 as an MDT-composite — this RF captures the inverse (ineligibility) at step 3. Belinostat QTc note: belinostat also prolongs QTc but less severely than romidepsin; MDT cardiac review still recommended before initiating any HDACi in patients with arrhythmia history. Draft pending two-reviewer clinical co-lead signoff (CHARTER §6.1).

Де використовується

Algorithms

ALGO-AITL-2L - ALGO-AITL-2L