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DOI: 10.1055/a-2239-1284
Endokrine Therapielandschaft bei Patient*innen mit HR+ HER2− frühem Mammakarzinom in Deutschland vor Einführung der CDK4/6-Inhibitor-Behandlung – eine Real-World-Analyse
The Endocrine Treatment Landscape for Patients with HR+ HER2− Early-stage Breast Cancer in Germany Before the Introduction of CDK4/6 Inhibitor Therapy – A Real-World Analysis| Novartis Pharma | http://dx.doi.org/10.13 039/100 008 792
Zusammenfassung
Einleitung Während prämenopausale Patientinnen mit einem HR+ HER2− frühen Mammakarzinom mit Tamoxifen +/− ovarielle Suppression mit einem GnRH-Analogon oder einem Aromataseinhibitor (AI) + GnRH behandelt werden, erhalten postmenopausale Frauen vorwiegend einen AI aufgrund der besseren Wirksamkeit verglichen mit Tamoxifen. Da es durch den Einzug der CDK4/6-Inhibitoren in die Behandlung des frühen Mammakarzinoms mit höherem Rückfallrisiko vermutlich zu einer Verschiebung der endokrinen Therapielandschaft kommt, ist von Interesse, wie in Deutschland potenzielle CDK4/6-Inhibitor-Kandidat*innen vor deren Markteinführung behandelt wurden.
Patienten und Methoden Im Rahmen einer retrospektiven, multizentrischen Analyse wurden anonymisierte Daten von Patient*innen mit einem HR+ HER2− frühen Mammakarzinom und einer im Zeitraum zwischen 10/2021–03/2022 begonnenen Antihormontherapie erhoben. Potenzielle CDK4/6-Inhibitor-Kandidat*innen wurden anhand der Einschlusskriterien der NATALEE- und monarchE-Studien in entsprechende Risikokollektive unterteilt.
Ergebnisse Insgesamt wurden Daten von 238 Patient*innen aus 29 Zentren analysiert. Während den monarchE-Kriterien 20,6 % der Patient*innen zugeordnet werden konnten, enthielt das NATALEE-ähnliche Kollektiv 46,2 % der Patient*innen. 53,8 % der Patient*innen erfüllten weder die Einschlusskriterien der NATALEE- noch die der monarchE-Studie. Über die Hälfte der Patient*innen erhielt keine Chemotherapie. Im Gesamtkollektiv waren 28,6 % der Patientinnen prämenopausal. 67,6 % der prämenopausalen Frauen wurden mit einer neo-/adjuvanten Chemotherapie behandelt. 61,8 % der prämenopausalen Patientinnen erhielten als adjuvante Antihormontherapie Tamoxifen, 19,1 % AI + GnRH und 10,3 % Tamoxifen + GnRH.
Schlussfolgerung Trotz des hohen Anteils prämenopausaler Patientinnen, die mit einer aggressiven Therapie im Sinne einer Chemotherapie behandelt wurden, wurde bei nur einem Drittel der prämenopausalen Patientinnen GnRH zur Antihormontherapie hinzugenommen. Untersuchungen zu einem späteren Zeitpunkt sowie Registerstudien sind nötig, um zu sehen, wie sich durch den Einzug der CDK4/6-Inhibitoren die endokrine Therapielandschaft in Deutschland verändert.
Abstract
Introduction While premenopausal patients with HR+ HER2− early breast cancer are treated with tamoxifen +/− ovarian suppression with a GnRH analog or an aromatase inhibitor (AI) + GnRH, the majority of postmenopausal women receive an AI due to its higher efficacy compared to tamoxifen. As the introduction of CDK4/6 inhibitors into the treatment of earlystage breast cancer with a higher risk of recurrence will probably result in a shift in the endocrine treatment landscape, the question is what treatment did potential candidates for CDK4/6 inhibitors in Germany receive before CDK4/6 inhibitors were available.
Patients and Methods As part of a retrospective multicenter analysis, anonymized data were collected of patients with HR+ HER2− early-stage breast cancer who received endocrine therapy in the period between 10/2021 and 03/2022. Potential candidates for CDK4/6 inhibitor treatment were classified into different risk cohorts using the inclusion criteria of the NATALEE and monarchE trials.
Results The data of 238 patients from 29 different centers were analyzed. While 20.6 % of patients met the monarchE criteria, the subgroup which met the NATALEE inclusion criteria consisted of 46.2 % of patients. 53.8 % of patients did not meet the inclusion criteria for either the NATALEE or the monarchE trial. More than half of the patients did not receive chemotherapy. 28.6 % of patients in the whole cohort were premenopausal. 67.6 % of premenopausal women received neo-/adjuvant chemotherapy. 61.8 % of premenopausal patients received tamoxifen as adjuvant endocrine therapy, 19.1 % received an AI + GnRH and 10.3 % were treated with tamoxifen + GnRH.
Conclusion Despite the high percentage of premenopausal patients who received aggressive treatment in the form of chemotherapy, only one third of premenopausal patients received GnRH in addition to their standard endocrine therapy. Studies carried out at a later point in time and registry studies will be necessary to see how the endocrine therapy landscape in Germany has changed following the introduction of CDK4/6 inhibitors.
Schlüsselwörter
Brustkrebs - Mammakarzinom - Antihormontherapie - GnRH - Tamoxifen - AromataseinhibitorPublication History
Received: 28 April 2023
Accepted after revision: 24 May 2023
Article published online:
22 March 2024
© 2023. This article was originally published by Thieme as Naiba Nabieva et al. The Endocrine Treatment Landscape for Patients with HR+ HER2− Early-stage Breast Cancer in Germany Before the Introduction of CDK4/6 Inhibitor Therapy – A Real-World Analysis. Geburtsh Frauenheilk 2023; 83: 83: 1127-1137 as an open access article 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 commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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