Eingeschränktes Axilla-Staging bei klinisch und sonografisch nodal-negativen Patientinnen mit frühem invasiven Mammakarzinom (c/iT1–2) im Rahmen der brusterhaltenden Therapie: erste Erkenntnisse nach Start der Intergroup-Sentinel-Mamma-(INSEMA-)Studie

Zusammenfassung

Der axilläre Nodalstatus wird beim frühen Mammakarzinom immer noch als wichtiger Prognosefaktor und Indikator für eine (neo-)adjuvante System- und postoperative Strahlentherapie der Lymphabflusswege (LAW) gesehen. Die im September 2015 gestartete INSEMA-Studie untersucht, ob beim frühen Mammakarzinom (c/iT1–2 c/iN0) auf die operative Bestimmung des Nodalstatus im Rahmen der brusterhaltenden Therapie (BET) verzichtet werden kann, ohne dass die onkologische Sicherheit beeinträchtigt wird. Nach Einschluss von 1001 Patientinnen war die Akzeptanz des komplexen Studiendesigns bei Patientinnen und Prüfärzten gegeben, sodass die Rekrutierung für die erste Randomisierung (axilläre Sentinel-Lymphknoten-Biopsie [SLNB]: ja oder nein) im Rahmen der Fallzahlprognose liegt. Die 2. Randomisierung (SLNB allein versus Komplettierung der Axilladissektion bei 1 oder 2 Makrometastasen in der SLNB) rekrutiert dagegen aus 3 Gründen weniger als erwartet: a) Der Nachweis von 1 bis 2 Makrometastasen nach der SLNB im INSEMA-Kollektiv ist mit 13 % geringer als erwartet; b) etwa 20 % der Patientinnen lehnten die 2. Randomisierung ab; c) der Einstieg der österreichischen Prüfzentren, die ausschließlich für die 2. Randomisierung rekrutieren, erfolgt zeitlich verzögert. Die Unkenntnis des Nodalstatus bei Verzicht auf die SLNB bringt eine neue Herausforderung für die postoperative Tumorkonferenz. Insbesondere die Indikation zur Chemotherapie bei Luminal-like-Tumoren und zur Bestrahlung der LAW (ohne Axilla) muss nun an den tumorbiologischen Parametern ausgerichtet werden. Einige wichtige Fragen können durch die INSEMA-Studie nicht beantwortet werden. Unklar bleibt beispielsweise, ob Patientinnen ohne SLNB eine alleinige Teilbrustbestrahlung in Low-Risk-Situationen angeboten werden kann bzw. ob auch bei Patientinnen mit einer Mastektomieindikation auf die SLNB im Stadium T1–2 verzichtet werden kann.

Schlüsselwörter

Mammakarzinom - INSEMA - Nodalstatus - Sentinel-Lymphknoten- Biopsie - Strahlentherapie

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