Implementation of CDK4/6 Inhibitors and its Influence on the Treatment Landscape of Advanced Breast Cancer Patients - Data from the Real-World Registry PRAEGNANT

  • Tobias Engler
  • Peter A Fasching
  • Diana Lüftner
  • Andreas D Hartkopf
  • Volkmar Müller
  • Hans-Christian Kolberg
  • Peyman Hadji
  • Hans Tesch
  • Lothar Häberle
  • Johannes Ettl
  • Markus Wallwiener
  • Matthias W Beckmann
  • Alexander Hein
  • Erik Belleville
  • Sabrina Uhrig
  • Pauline Wimberger
  • Carsten Hielscher
  • Christian M Kurbacher
  • Rachel Wuerstlein
  • Michael Untch
  • Florin-Andrei Taran
  • Hans-Martin Enzinger
  • Petra Krabisch
  • Manfred Welslau
  • Michael Maasberg
  • Dirk Hempel
  • Michael P Lux
  • Laura L Michel
  • Wolfgang Janni
  • Diethelm Wallwiener
  • Sara Y Brucker
  • Tanja N Fehm
  • Andreas Schneeweiss

Related Research units

Abstract

Background Comprehensive data from prospective clinical trials have led to a high level of evidence establishing CDK4/6 inhibitors in combination with endocrine treatment (CDK4/6i + ET) as a standard for the treatment of HER2-negative, hormone receptor-positive (HER2- HR+) breast cancer patients in the first-line advanced therapy setting. Data on patient populations that have been treated in the real-world setting may provide an insight into changes of patient characteristics and prognosis over time. Methods The data were extracted from the prospective real-world registry PRAEGNANT (NCT02338167). Patients had to have HER2- HR+ advanced breast cancer in the first-line metastatic setting. The chosen therapies were described as well as progression-free survival (PFS) and overall survival (OS) in relation to the given therapies and time periods during which they were indicated. Results CDK4/6 inhibitors have been rapidly implemented since their introduction in November 2016. In recent years (2018 - 2022), about 70 - 80% of the patient population have been treated with CDK4/6 inhibitors, while endocrine monotherapy was given to about 10% and chemotherapy to about 15% of all patients. The prognosis was worst in patients treated with chemotherapy. Recently, mainly patients with a good prognosis are being treated with endocrine monotherapy, and patients who are treated with chemotherapy have an unfavorable prognosis. The PFS and OS of patients treated with CDK4/6i + ET have remained similar over time despite changes in patient characteristics. Conclusion A treatment with CDK4/6i + ET has rapidly become the therapy standard for patients in the first-line advanced breast cancer setting. After the implementation of CDK4/6i + ET, endocrine monotherapy is only given to patients with a very favorable prognosis, while chemotherapy is provided to patients with a rather unfavorable prognosis. These changes in patient characteristics did not seem to influence the prognosis of patients treated with CDK4/6i + ET.

Bibliographical data

Original languageEnglish
ISSN0016-5751
DOIs
Publication statusPublished - 10.2022

Comment Deanary

The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ).

PubMed 36186151