Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US.
Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US.
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美国首个治疗性肿瘤生物仿制药贝伐单抗-awwb 和曲妥珠单抗-anns 治疗患者的临床和治疗特征。
DOI：
10.1177/17588359211041961
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发表时间：
2021
影响因子：
4.9
通讯作者：
Loaiza-Bonilla A
中科院分区：
文献类型：
--
作者：
Jin R;Mahtani RL;Accortt N;Lawrence T;Sandschafer D;Loaiza-Bonilla A
2019年7月，贝伐单抗-awwb和曲妥珠单抗-anns作为首个治疗性肿瘤生物仿制药在美国上市。我们的目的是调查贝伐珠单抗-awwb 和曲妥珠单抗-anns 在美国肿瘤实践中用于癌症管理的最初实际应用。使用来自 Flatiron Health 电子健康记录数据库的结构化数据，对美国癌症患者（18 岁以上）的数据进行回顾性观察分析，以描述贝伐单抗-awwb 和曲妥珠单抗-anns 在进入市场后前 12 个月内的使用情况。分析中分别纳入了 2952 名和 2997 名记录使用贝伐单抗-awwb 和曲妥珠单抗-anns 的患者。贝伐单抗-awwb 和曲妥珠单抗-anns 的首次使用分别是在上市 10 天内的转移性结直肠癌 (mCRC) 患者和 4 天内的早期乳腺癌 (eBC) 患者。观察到这些生物仿制药在所有已批准的癌症适应症中的使用情况； 68% 的贝伐珠单抗 awwb 用户被诊断患有 mCRC，72% 的曲妥珠单抗 anns 用户被诊断患有 eBC。大约一半的患者在开始贝伐单抗-awwb 或曲妥珠单抗-anns 之前曾接触过参考产品 (RP)。在预先暴露的患者中，大多数在最后一次输注 RP 后 28 天内接受了生物仿制药 [bevacizumab-awwb (63-85%) 或 trastuzumab-anns (75-81%)]。对于这两种生物仿制药，未接受过 RP 治疗的患者和已暴露于 RP 治疗前的患者之间没有观察到患者特征存在重大差异。进入市场后前 12 个月的初步证据表明，贝伐单抗-awwb 和曲妥珠单抗-anns 在所有已批准的肿瘤类型中得到了快速的临床采用。在未接受过 RP 治疗的患者和既往接受过 RP 治疗的患者中观察到这两种生物仿制药的使用情况，两组之间的患者特征没有显着差异。本文的视频摘要作为 Kanjintionline 补充材料的一部分提供。
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.
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DOI：
10.5639/gabij.2014.0303.028
发表时间：
2014-01-01
影响因子：
--
作者：
Felix, Abigail E.;Gupta, Anumeha;Riggs, Kim
通讯作者：
Riggs, Kim
影响因子：
3.3
作者：
Katkade, Vaibhav B.;Sanders, Kafi N.;Zou, Kelly H.
通讯作者：
Zou, Kelly H.
影响因子：
11.5
作者：
Casak, Sandra J.;Lemery, Steven J.;Pazdur, Richard
通讯作者：
Pazdur, Richard
影响因子：
3.8
作者：
Cohen, Hillel;Beydoun, Donna;Uy, Jonathan
通讯作者：
Uy, Jonathan
影响因子：
2
作者：
Giuliani, Jacopo;Bonetti, Andrea
通讯作者：
Bonetti, Andrea