CC BY-NC-ND 4.0 · Geburtshilfe Frauenheilkd 2020; 80(09): 924-931
DOI: 10.1055/a-1226-6666
GebFra Science
Original Article/Originalarbeit

Trastuzumab Biosimilars in the Therapy of Breast Cancer – “Real World” Experiences from four Bavarian University Breast Centres

Article in several languages: English | deutsch
Anna Hester
1   Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum und CCC München, Klinikum der Universität München, LMU München, München
,
Paul Gaß
2   Frauenklinik des Universitätsklinikums Erlangen, Erlangen
,
Peter A. Fasching
2   Frauenklinik des Universitätsklinikums Erlangen, Erlangen
,
Anne Katrin Krämer
3   Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe der Technischen Universität München und CCC München, München
,
Johannes Ettl
3   Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe der Technischen Universität München und CCC München, München
,
Joachim Diessner
4   Frauenklinik und Poliklinik des Universitätsklinikums Würzburg, Würzburg
,
Achim Wöckel
4   Frauenklinik und Poliklinik des Universitätsklinikums Würzburg, Würzburg
,
Tobias Egger
5   Apotheke des Universitätsklinikums Würzburg, Würzburg
,
Katja Stock
6   Apotheke des Universitätsklinikums Erlangen, Erlangen
,
Jutta Redlin
7   Krankenhausapotheke des Klinikums Rechts der Isar der Technischen Universität, München
,
Monika Andraschko
8   Apotheke des LMU Klinikums, München
,
Nadia Harbeck
1   Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum und CCC München, Klinikum der Universität München, LMU München, München
,
Rachel Würstlein
1   Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum und CCC München, Klinikum der Universität München, LMU München, München
› Author Affiliations

Abstract

Introduction With the introduction of the first trastuzumab biosimilar in the summer of 2018, biosimilar antibodies for breast cancer have found their way into the area of gynaecological oncology. The switch of anti-human epidermal growth factor receptor 2 (HER2) therapy from the reference drug Herceptin® to a biosimilar has presented challenges to the clinics. In addition to structural and organisational measures, training of employees as well as patient briefing and acceptance were major challenges. The study presented here records – within the context of quality assurance – how the switch to a trastuzumab biosimilar was implemented at four Bavarian university clinics in the Purchasing Association of Bavarian University Pharmacies.

Materials/Methods Questionnaires on treatment figures and the switching process were sent to breast centres and pharmacies of four Bavarian university clinics between July and December 2019. The neoadjuvant, adjuvant and metastasised anti-HER2 therapy with trastuzumab with or without pertuzumab was recorded, evaluated and summarised.

Results In the anti-HER2-therapy, trastuzumab was used intravenously (i. v.) and subcutaneously. Between July and December 2018, all four clinics in the Purchasing Association switched the i. v. trastuzumab therapy from the reference drug (Herceptin) to a biosimilar (for 2018: Kanjinti®). Over 200 patients were treated with trastuzumab i. v. in each of the two half-years of 2018 (before and after the switch). The spectrum of side effects and pCR rates under therapy with the biosimilar were comparable to the experiences made with the reference drug. Three out of four clinics provided training to employees and informed patients by means of a defined information leaflet. Patient acceptance was high.

Summary The anti-HER2 therapy could be switched successfully and safely to trastuzumab biosimilars at the Bavarian university hospitals. This may serve as guideline for the further implementation of biosimilars. The structures necessary for this initial switching process have been prepared with trastuzumab as an example.

Supporting Information

Ergänzendes Material



Publication History

Received: 29 June 2020

Accepted after revision: 22 July 2020

Article published online:
02 September 2020

© 2020. 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/)

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