Palbociclib: Randomized Studies and Real-world Evidence as the Basis for Therapeutic Planning in Metastatic Breast Cancer

Eugen Ruckhäberle; Marcus Schmidt; Anja Welt; Nadia Harbeck; Achim Wöckel; Oleg Gluz; Tjoung-Won Park-Simon; Michael Untch; Michael P. Lux

doi:10.1055/a-2344-5269

Geburtshilfe und Frauenheilkunde, Table of Contents

CC BY-NC-ND 4.0 · Geburtshilfe Frauenheilkd 2024; 84(09): 813-836
DOI: 10.1055/a-2344-5269

GebFra Science

Review

Palbociclib: randomisierte Studien und Real-World-Evidenz als Grundlage für die Therapieplanung beim metastasierten Mammakarzinom

Article in several languages: English | deutsch

Authors

Eugen Ruckhäberle

¹Universitätsfrauenklinik Düsseldorf, Heinrich-Heine-Universität, CIO ABCD, Düsseldorf, Germany
Marcus Schmidt

²Klinik und Poliklinik für Geburtshilfe und Frauengesundheit, Brustzentrum, Universitätsmedizin Mainz, Mainz, Germany
Anja Welt

³Innere Klinik (Tumorforschung), Universitätsklinikum Essen, Essen, Germany (Ringgold ID: RIN39081)
Nadia Harbeck

⁴Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum, LMU Klinikum, München, Germany
Achim Wöckel

⁵Frauenklinik und Poliklinik, Universitätsklinikum Würzburg, Würzburg, Germany
Oleg Gluz

⁶Ev. Krankenhaus Bethesda Mönchengladbach, Brustzentrum Niederrhein, Mönchengladbach, Germany
Tjoung-Won Park-Simon

⁷Klinik für Frauenheilkunde und Geburtshilfe, Medizinische Hochschule Hannover, Hannover, Germany
Michael Untch

⁸Fachabteilung Gynäkologie, Helios Klinikum Berlin-Buch, Berlin, Germany (Ringgold ID: RIN62473)
Michael P. Lux

⁹Klinik für Gynäkologie und Geburtshilfe, Frauenklinik St. Louise, Paderborn, Frauenklinik St. Josefs-Krankenhaus, Salzkotten, St. Vincenz Kliniken Salzkotten + Paderborn, Paderborn, Germany

Abstract

Zusammenfassung

Die endokrin basierte Kombinationstherapie mit einem Inhibitor der cyclinabhängigen Kinasen 4 und 6 (CDK4/6-Inhibitor) gilt heute als Erstlinientherapie der ersten Wahl für Patientinnen und Patienten mit hormonrezeptorpositivem (HR+) und humaner epidermaler Wachstumsfaktor-Rezeptor 2 (HER2)-negativem lokal fortgeschrittenem bzw. metastasiertem Mammakarzinom (mBC). Wirksamkeit und Sicherheit einer Behandlung mit Palbociclib, dem ersten in dieser Indikation zugelassenen CDK4/6-Inhibitor, wurden in großen randomisierten, kontrollierten klinischen Studien (RCTs) mit streng definierten Patientinnenkollektiven belegt. Seither wurden zahlreiche relevante Fragen zur CDK4/6-Inhibition mit Palbociclib beim mBC in RCTs und Real-World-Evidenz-Erhebungen untersucht. Auf dem Boden dieser Evidenz wird Palbociclib im klinischen Alltag aufgrund der Wirksamkeit und der guten Verträglichkeit seit vielen Jahren breit eingesetzt.

Ziel des vorliegenden Reviews ist es, Ergebnisse aus RCTs einerseits und RWE andererseits unter klinisch bedeutsamen Gesichtspunkten wie Sicherheit, Verträglichkeit, Lebensqualität und Wirksamkeit mit dem Blick auf spezifische Fragestellungen und Patientencharakteristika zusammenzufassen. Die kritische Diskussion und Übersicht zur Gesamtevidenz der endokrin basierten Therapie mit dem CDK4/6-Inhibitor Palbociclib soll dazu beitragen, Therapieentscheidungen im klinischen Alltag zu stützen.

Schlüsselwörter

metastasiertes Mammakarzinom - CDK4/6-Inhibition - Palbociclib - Real-World-Evidenz

Full Text

References

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