Piezzo Michela, D'Aniello Roberta, Avallone Ilaria, Barba Bruno, Cianniello Daniela, Cocco Stefania, D'Avino Antonio, Di Gioia Germira, Di Lauro Vincenzo, Fusco Giuseppina, Piscitelli Raffaele, von Arx Claudia, De Laurentiis Michelino, Maiolino Piera
Department of Breast and Thoracic Oncology, Division of Breast Medical Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", 80131 Naples, Italy.
Pharmacy, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", 80131 Naples, Italy.
Pharmaceutics. 2021 May 10;13(5):684. doi: 10.3390/pharmaceutics13050684.
The introduction of trastuzumab biosimilars in clinical practice plays an important role in promoting the sustainability of healthcare systems. By contrast, the switching process can be challenging to the clinics. This survey describes the switching process at a National Cancer Institute over a period of 2 years.
Data regarding all trastuzumab-based regimens for breast cancer (BC) from 1 January 2019 and 31 December 2020 were extracted from both adverse drug reactions (ADRs) reporting systems and electronic systems involved in inventory management, prescribing, dispensing, and administration. Both patients under monotherapy and combination treatment regimens were included. There were no exclusion criteria.
Overall 354 patients received at least one trastuzumab-based regimen for a total of 493 lines of treatment and 5769 administrations. Biosimilar were used in 34.3% of trastuzumab-based treatments. No differences between biosimilars and reference drug have been observed in terms of ADRs. The effective cost-saving of the first 2 years is greater than EUR 800,000 and it is estimated to increase over time.
曲妥珠单抗生物类似药引入临床实践对促进医疗保健系统的可持续性具有重要作用。相比之下，转换过程对临床机构而言可能具有挑战性。本调查描述了一家国家癌症研究所在两年时间内的转换过程。
从不良药物反应（ADR）报告系统以及涉及库存管理、处方开具、配药和给药的电子系统中提取了2019年1月1日至2020年12月31日期间所有基于曲妥珠单抗的乳腺癌（BC）治疗方案的数据。接受单药治疗和联合治疗方案的患者均被纳入。没有排除标准。
总体而言，354例患者接受了至少一种基于曲妥珠单抗的治疗方案，共计493个疗程和5769次给药。34.3%的基于曲妥珠单抗的治疗使用了生物类似药。在不良反应方面，未观察到生物类似药与参比药物之间存在差异。头两年有效节省成本超过80万欧元，且预计随着时间推移还会增加。
