Jin Ran, Mahtani Reshma L, Accortt Neil, Lawrence Tatiana, Sandschafer Darcie, Loaiza-Bonilla Arturo
Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.
Sylvester Cancer Center, University of Miami, Deerfield Beach, FL, USA.
Ther Adv Med Oncol. 2021 Sep 1;13:17588359211041961. doi: 10.1177/17588359211041961. eCollection 2021.
In July 2019, bevacizumab-awwb and trastuzumab-anns were marketed in the USA as the first therapeutic oncology biosimilars. We aimed to investigate the initial real-world use of bevacizumab-awwb and trastuzumab-anns for cancer management in US oncology practices.
A retrospective, observational analysis of data from US cancer patients (⩾18 years of age) was carried out to describe the use of bevacizumab-awwb and trastuzumab-anns during the first 12 months following their market entry, using structured data from the Flatiron Health electronic health record-derived database.
A total of 2952 and 2997 patients with recorded use of bevacizumab-awwb and trastuzumab-anns, respectively, were included in the analysis. The first use of bevacizumab-awwb and trastuzumab-anns was in a patient with metastatic colorectal cancer (mCRC) within 10 days of market availability and in a patient with early stage breast cancer (eBC) within 4 days, respectively. The use of these biosimilars was observed across all approved cancer indications; 68% of bevacizumab-awwb users were those diagnosed with mCRC and 72% of trastuzumab-anns users were those diagnosed with eBC. Approximately half the patients were previously exposed to reference product (RP) prior to initiation of bevacizumab-awwb or trastuzumab-anns. Among pre-exposed patients, the majority received the biosimilars [bevacizumab-awwb (63-85%) or trastuzumab-anns (75-81%)] within 28 days of the last infusion of the RP. For both biosimilars, no major differences were observed in patient characteristics between RP-naïve and pre-exposed patients.
Initial evidence from the first 12 months following market entry suggests rapid clinical adoption of bevacizumab-awwb and trastuzumab-anns across all approved tumor types. Usage of these two biosimilars was observed in both RP-naïve patients and patients who were previously treated with RP, with no distinctive differences in patient characteristics between the two groups.A video abstract is available for this article as part of the Kanjintionline supplemental material.
2019年7月，贝伐单抗 - awwb和曲妥珠单抗 - anns作为首批治疗性肿瘤生物类似药在美国上市。我们旨在调查贝伐单抗 - awwb和曲妥珠单抗 - anns在美国肿瘤治疗实践中用于癌症管理的初始真实世界使用情况。
对美国癌症患者（年龄≥18岁）的数据进行回顾性观察分析，使用来自Flatiron Health电子健康记录衍生数据库的结构化数据，描述贝伐单抗 - awwb和曲妥珠单抗 - anns在上市后的前12个月内的使用情况。
分析共纳入分别有贝伐单抗 - awwb和曲妥珠单抗 - anns使用记录的2952例和2997例患者。贝伐单抗 - awwb和曲妥珠单抗 - anns首次使用分别是在上市后10天内用于一名转移性结直肠癌（mCRC）患者和在4天内用于一名早期乳腺癌（eBC）患者。在所有获批的癌症适应症中均观察到了这些生物类似药的使用；68%的贝伐单抗 - awwb使用者被诊断为mCRC，72%的曲妥珠单抗 - anns使用者被诊断为eBC。大约一半的患者在开始使用贝伐单抗 - awwb或曲妥珠单抗 - anns之前曾接触过参照产品（RP）。在预先接触过的患者中，大多数在最后一次输注RP后28天内接受了生物类似药[贝伐单抗 - awwb（63 - 85%）或曲妥珠单抗 - anns（75 - 8l%）]。对于这两种生物类似药，未接触过RP的患者和预先接触过的患者在患者特征方面未观察到重大差异。
上市后前12个月的初步证据表明，贝伐单抗 - awwb和曲妥珠单抗 - anns在所有获批肿瘤类型中迅速得到临床应用。在未接触过RP的患者和先前接受过RP治疗的患者中均观察到了这两种生物类似药的使用，两组患者的特征无明显差异。本文有视频摘要，作为Kanjintionline补充材料的一部分。
