Abstract PS10-50: Patterns of use of a trastuzumab biosimilar (ABP 980) in patients with HER2+ breast cancer treated in clinical practice in Europe: An interim analysis from an observational chart review study (GARDENIA)

Joanna Kufel-Grabowska, T. San, A. Bernardo, L. Cavanna, I. Pérez, G. Suchodolska, J. Hippenmeyer, P. Gokani, M. Lillie, C. Rodríguez
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Methods: This descriptive observational chart review study included consecutive patients aged ≥18 years with HER2+ breast cancer (any disease stage or treatment phase) who were receiving or had previously received ABP 980 and had medical charts available for data extraction. Patients were followed up from ABP 980 initiation to withdrawal of consent, death, loss to follow up, entry into an interventional trial, or study end (12 months after last patient enrolled). Follow-up data from ABP 980 initiation to enrolment were retrospectively collected; data after enrolment were prospectively collected. Data were extracted into electronic case report forms quarterly. The primary objective is to describe patient demographics and disease characteristics by treatment phase and prior trastuzumab exposure and communication with patients about biosimilar use is an exploratory objective. Other exploratory endpoints are ABP 980 safety (including cardiac dysfunction, infusion-related reactions and other adverse events of interest) and efficacy (both to be assessed in the final analysis). This planned interim analysis was performed approximately 6 months after the first patient enrolled and provides baseline data on patient characteristics. Results: At the time of analysis, 135 women were included from five countries (Poland n=42; Italy n=38; the Netherlands n=32; France n=21; Spain n=2). Patients were mostly recruited from hospital-based sites (61%), including a mixture of academic/non-academic and publicly/privately funded centers. A policy on biosimilar use was documented in 28% of sites and 36% of patients were informed they were starting a biosimilar, with the brand mentioned to 34% of patients. Mean (standard deviation [SD]) age at ABP 980 initiation was 58.3 (11.5) years and mean (SD) time from ABP 980 initiation to enrolment was 7.3 (4.8) months. At ABP 980 initiation, 22%, 27%, 13% and 28% of patients had Stage I, II, III or IV disease, respectively. Overall, 68% of patients had estrogen/progesterone receptor-positive tumors and all patients with known ECOG performance status (n=73) had a score of 0 or 1. ABP 980 usage was approximately equally distributed across neoadjuvant (39%), adjuvant (30%), and metastatic settings (30%). Of the patients receiving treatment for metastatic disease (n=41), most received ABP 980 as their 1st- (56%) or 2nd- (20%) line treatment. Overall, 40% of patients had switched to ABP 980 from another trastuzumab product. Of these 54 patients, 44% switched from the intravenous form of originator trastuzumab and 15% switched from the subcutaneous form. Most of those switching from subcutaneous originator trastuzumab to ABP 980 were being treated for metastatic disease (7/8 patients). Conclusions: These interim results report usage patterns of the trastuzumab biosimilar ABP 980 in Europe. There was uptake across a mixture of institution types and breast cancer treatment settings, including those with curative potential, and 40% of patients switched to ABP 980 from another trastuzumab product. Recruitment to this study is ongoing. Citation Format: Joanna Kufel-Grabowska, Tevy San, Antonio Bernardo, Luigi Cavanna, Isaura Fernandez Perez, Grazyna Suchodolska, Jane Hippenmeyer, Priya Gokani, Mark Lillie, Cesar A. Rodriguez. Patterns of use of a trastuzumab biosimilar (ABP 980) in patients with HER2+ breast cancer treated in clinical practice in Europe: An interim analysis from an observational chart review study (GARDENIA) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. 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引用次数: 0

Abstract

Background: Over recent years, therapeutic biosimilars have started to be licensed as oncology treatments in both palliative and potentially curative settings, but little is known about their uptake and usage in routine clinical practice. ABP 980 is a trastuzumab biosimilar that is licensed in Europe and the USA for the treatment of HER2+ early or metastatic breast cancer and metastatic gastric cancer. This European real-world study aimed to describe patterns of ABP 980 usage in clinical practice in patients with breast cancer. Methods: This descriptive observational chart review study included consecutive patients aged ≥18 years with HER2+ breast cancer (any disease stage or treatment phase) who were receiving or had previously received ABP 980 and had medical charts available for data extraction. Patients were followed up from ABP 980 initiation to withdrawal of consent, death, loss to follow up, entry into an interventional trial, or study end (12 months after last patient enrolled). Follow-up data from ABP 980 initiation to enrolment were retrospectively collected; data after enrolment were prospectively collected. Data were extracted into electronic case report forms quarterly. The primary objective is to describe patient demographics and disease characteristics by treatment phase and prior trastuzumab exposure and communication with patients about biosimilar use is an exploratory objective. Other exploratory endpoints are ABP 980 safety (including cardiac dysfunction, infusion-related reactions and other adverse events of interest) and efficacy (both to be assessed in the final analysis). This planned interim analysis was performed approximately 6 months after the first patient enrolled and provides baseline data on patient characteristics. Results: At the time of analysis, 135 women were included from five countries (Poland n=42; Italy n=38; the Netherlands n=32; France n=21; Spain n=2). Patients were mostly recruited from hospital-based sites (61%), including a mixture of academic/non-academic and publicly/privately funded centers. A policy on biosimilar use was documented in 28% of sites and 36% of patients were informed they were starting a biosimilar, with the brand mentioned to 34% of patients. Mean (standard deviation [SD]) age at ABP 980 initiation was 58.3 (11.5) years and mean (SD) time from ABP 980 initiation to enrolment was 7.3 (4.8) months. At ABP 980 initiation, 22%, 27%, 13% and 28% of patients had Stage I, II, III or IV disease, respectively. Overall, 68% of patients had estrogen/progesterone receptor-positive tumors and all patients with known ECOG performance status (n=73) had a score of 0 or 1. ABP 980 usage was approximately equally distributed across neoadjuvant (39%), adjuvant (30%), and metastatic settings (30%). Of the patients receiving treatment for metastatic disease (n=41), most received ABP 980 as their 1st- (56%) or 2nd- (20%) line treatment. Overall, 40% of patients had switched to ABP 980 from another trastuzumab product. Of these 54 patients, 44% switched from the intravenous form of originator trastuzumab and 15% switched from the subcutaneous form. Most of those switching from subcutaneous originator trastuzumab to ABP 980 were being treated for metastatic disease (7/8 patients). Conclusions: These interim results report usage patterns of the trastuzumab biosimilar ABP 980 in Europe. There was uptake across a mixture of institution types and breast cancer treatment settings, including those with curative potential, and 40% of patients switched to ABP 980 from another trastuzumab product. Recruitment to this study is ongoing. Citation Format: Joanna Kufel-Grabowska, Tevy San, Antonio Bernardo, Luigi Cavanna, Isaura Fernandez Perez, Grazyna Suchodolska, Jane Hippenmeyer, Priya Gokani, Mark Lillie, Cesar A. Rodriguez. Patterns of use of a trastuzumab biosimilar (ABP 980) in patients with HER2+ breast cancer treated in clinical practice in Europe: An interim analysis from an observational chart review study (GARDENIA) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS10-50.
PS10-50:曲妥珠单抗生物类似药(ABP 980)在欧洲临床治疗HER2+乳腺癌患者中的使用模式:一项观察图回顾研究的中期分析(GARDENIA)
背景:近年来,治疗性生物仿制药已开始获准作为姑息治疗和潜在治疗的肿瘤治疗药物,但对其在常规临床实践中的吸收和使用知之甚少。ABP 980是一种曲妥珠单抗生物仿制药,已在欧洲和美国获得许可,用于治疗HER2+早期或转移性乳腺癌和转移性胃癌。这项欧洲真实世界的研究旨在描述ABP 980在乳腺癌患者临床实践中的使用模式。方法:这项描述性观察图回顾研究纳入了年龄≥18岁的HER2+乳腺癌患者(任何疾病阶段或治疗阶段),这些患者正在接受或曾经接受过ABP 980治疗,并有可用于数据提取的医学图表。患者从ABP 980开始随访到撤回同意、死亡、失去随访、进入介入性试验或研究结束(最后一名患者入组后12个月)。回顾性收集了从ABP 980开始到入组的随访数据;前瞻性地收集入组后的数据。数据每季度被提取到电子病例报告表格中。主要目标是通过治疗阶段和曲妥珠单抗暴露来描述患者的人口统计学和疾病特征,并与患者就生物仿制药的使用进行沟通是一个探索性目标。其他探索性终点是ABP 980的安全性(包括心功能障碍、输注相关反应和其他相关不良事件)和疗效(两者都将在最终分析中进行评估)。该计划的中期分析在第一个患者入组后大约6个月进行,并提供患者特征的基线数据。结果:在分析时,135名妇女来自5个国家(波兰n=42;意大利n = 38岁;荷兰n=32;法国n = 21;西班牙n = 2)。患者大多来自医院(61%),包括学术/非学术和公共/私人资助的中心。28%的网站记录了生物仿制药的使用政策,36%的患者被告知他们正在开始使用生物仿制药,34%的患者提到了该品牌。ABP 980起始时的平均(标准差[SD])年龄为58.3(11.5)岁,从ABP 980起始到入组的平均(SD)时间为7.3(4.8)个月。在ABP 980起始时,分别有22%、27%、13%和28%的患者为I、II、III或IV期疾病。总体而言,68%的患者患有雌激素/孕激素受体阳性肿瘤,所有已知ECOG表现状态的患者(n=73)得分为0或1。ABP 980的使用在新辅助治疗(39%)、辅助治疗(30%)和转移治疗(30%)中大致均匀分布。在接受转移性疾病治疗的患者中(n=41),大多数接受ABP 980作为一线(56%)或二线(20%)治疗。总体而言,40%的患者从另一种曲妥珠单抗产品转向ABP 980。在这54名患者中,44%的患者从静脉曲妥珠单抗转为静脉曲妥珠单抗,15%的患者从皮下曲妥珠单抗转为静脉曲妥珠单抗。大多数从皮下起始曲妥珠单抗转向ABP 980的患者正在接受转移性疾病的治疗(7/8)。结论:这些中期结果报告了曲妥珠单抗生物类似药ABP 980在欧洲的使用模式。在各种机构类型和乳腺癌治疗环境中,包括那些具有治愈潜力的治疗环境中,有40%的患者从另一种曲妥珠单抗产品转向ABP 980。本研究的招募工作正在进行中。引文格式:Joanna Kufel-Grabowska, Tevy San, Antonio Bernardo, Luigi Cavanna, Isaura Fernandez Perez, Grazyna Suchodolska, Jane Hippenmeyer, Priya Gokani, Mark Lillie, Cesar A. Rodriguez。曲妥珠单抗生物类似药(ABP 980)在欧洲HER2+乳腺癌患者临床治疗中的使用模式:一项观察图回顾研究(GARDENIA)的中期分析[摘要]。参见:2020年圣安东尼奥乳腺癌虚拟研讨会论文集;2020年12月8-11日;费城(PA): AACR;癌症杂志,2021;81(4增刊):摘要nr PS10-50。
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