Nachresektions-Adrenokortikalkarzinom mit hohen Rezidiv-Risiko-Features — ENSAT-Stadium...
Deterministische Ansicht der Quelle YAML Entität. Klinische Autorität bleibt mit den zitierten Quell-IDs und Rezensenten Sign-off Zustand.
| ID | RF-ACC-HIGH-RECURRENCE-RISK-BIOLOGY |
|---|---|
| Art | Warnhinweis |
| Status | reviewed 2026-07-11 | pending_clinical_signoff |
| Erkrankungen | DIS-ADRENOCORTICAL-CARCINOMA |
| Quellen | SRC-ADIUVO-TERZOLO-2023 SRC-ENSAT-ACC-2018 SRC-ESMO-ACC-2020 |
Ursprung der Roten Flagge
| Begriffsbestimmung | Nachresektions-Adrenokortikalkarzinom mit hohen Rezidiv-Risiko-Features — ENSAT-Stufe III, Ki-67-Proliferationsindex >10% oder unvollständig/unsicher (R1/RX)-Resektionsmarge — definiert die Population, für die adjuvantes Mitotan empfohlen wird. In der randomisierten ADIUVO-Studie wurde kein signifikanter rezidivfreier Überlebensvorteil aus Adjuvantem Mitotane in der eingeschriebenen Gruppe mit geringem/mittlerem Risiko (ENSA-Stufe I-III, R0-Resektion, Ki 67 <=10%). |
|---|---|
| Klinische Richtung | Intensivierung |
| Kategorie | high-risk-biology |
| Schaltet Algorithmus | ALGO-ACC-1L |
Logik auslösen
{
"any_of": [
{
"finding": "acc_ensat_stage",
"value": "III"
},
{
"comparator": ">",
"finding": "ki67_proliferation_index_pct",
"threshold": 10
},
{
"finding": "resection_margin_status",
"value": "R1"
},
{
"finding": "resection_margin_status",
"value": "RX"
}
],
"type": "composite_clinical"
}
Anmerkungen
ADIUVO (Terzolo 2023, Lancet Diabetes Endocrinol) defined its low/intermediate-risk enrollment population as ENSAT stage I-III, R0 resection, Ki-67 <=10%, and found no significant recurrence-free- survival benefit from adjuvant mitotane in that population (5-yr RFS 79% mitotane vs 75% surveillance, HR 0.74, not significant). By extension, this RedFlag fires on the features that place a resected patient OUTSIDE the ADIUVO low/intermediate-risk definition: stage III, Ki-67 >10%, or incomplete/uncertain resection margin (R1/RX). This is this KB's first-pass operationalization of "high recurrence risk" for adjuvant mitotane and is STUB / pending clinical co-lead confirmation against the primary ENSAT/ESMO guideline text — those guidelines may specify additional or more granular risk criteria (e.g. tumor rupture, vascular invasion, mitotic count / Weiss-Helsinki score components) not yet encoded here. The finding keys used (acc_ensat_stage, ki67_proliferation_index_pct, resection_margin_status) are newly introduced in this authoring pass and not yet wired to any intake questionnaire — a mechanical/data-availability gap, not a clinical-content gap.
Verwendet von
Algorithmen
ALGO-ACC-1L- ALGO-ACC-1L
Arzneimittel
DRUG-MITOTANE- Mitotane
Anwendungsgebiet
IND-ACC-1L-RESECTION-MITOTANE- IND-ACC-1L-RESECTION-MITOTANE
Therapieschema
REG-MITOTANE-ADJUVANT-ACC- Mitotane adjuvante Monotherapie (ACC)
Quellen
SRC-ADIUVO-TERZOLO-2023- Adjuvant mitotane Versus Überwachung bei niedriggradigen, lokalisierten adrenokortikalen Karzinomen (A...