Hester Anna, Gaß Paul, Fasching Peter A, Krämer Anne Katrin, Ettl Johannes, Diessner Joachim, Wöckel Achim, Egger Tobias, Stock Katja, Redlin Jutta, Andraschko Monika, Harbeck Nadia, Würstlein Rachel
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Brustzentrum und CCC München, Klinikum der Universität München, LMU München, München.
Frauenklinik des Universitätsklinikums Erlangen, Erlangen.
Geburtshilfe Frauenheilkd. 2020 Sep;80(9):924-931. doi: 10.1055/a-1226-6666. Epub 2020 Sep 2.
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. 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. 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. 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.
随着2018年夏季首款曲妥珠单抗生物类似药的推出，用于乳腺癌的生物类似抗体已进入妇科肿瘤学领域。抗人表皮生长因子受体2（HER2）治疗从参比药物赫赛汀转换为生物类似药给临床带来了挑战。除了结构和组织措施外，员工培训以及患者告知和接受度也是主要挑战。本文介绍的研究在质量保证的背景下记录了巴伐利亚大学药房采购协会下属的四家巴伐利亚大学诊所如何实施向曲妥珠单抗生物类似药的转换。2019年7月至12月期间，向四家巴伐利亚大学诊所的乳腺中心和药房发送了关于治疗数据和转换过程的问卷。记录、评估并总结了使用曲妥珠单抗联合或不联合帕妥珠单抗进行的新辅助、辅助和转移性抗HER2治疗。在抗HER2治疗中，曲妥珠单抗采用静脉注射（i.v.）和皮下注射。2018年7月至12月期间，采购协会的所有四家诊所将静脉注射曲妥珠单抗治疗从参比药物（赫赛汀）转换为生物类似药（2018年：Kanjinti）。在2018年的两个半年（转换前后）中，每半年均有超过200名患者接受静脉注射曲妥珠单抗治疗。使用生物类似药治疗时的副作用谱和病理完全缓解率与使用参比药物的经验相当。四家诊所中有三家为员工提供了培训，并通过一份明确的信息手册告知患者。患者接受度很高。巴伐利亚大学医院的抗HER2治疗可以成功且安全地转换为曲妥珠单抗生物类似药。这可为生物类似药的进一步实施提供指导。已以曲妥珠单抗为例准备了这一初始转换过程所需的结构。
