Celik Alan, Berg Tobias, Nielsen Lise Birk, Jensen Maj-Britt, Ejlertsen Bent, Knoop Ann, Andersson Michael
Danish Breast Cancer Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Breast Cancer (Auckl). 2022 Mar 24;16:11782234221086992. doi: 10.1177/11782234221086992. eCollection 2022.
Dual blockade with trastuzumab and pertuzumab in combination with chemotherapy is the recommended first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC). The purpose of this retrospective study is to examine the clinical outcomes of the trastuzumab biosimilar SB3 in first-line dual blockade treatment using real-world data of patients with HER-positive mBC.
In Denmark, all women with breast cancer are registered in the database of the Danish Breast Cancer Group (DBCG). From this prospective observational registry, we extracted information on primary diagnosis and treatment of all women with HER2-positive mBC who received first-line treatment with SB3 and pertuzumab from September 1, 2018, to February 29, 2020. Retrospectively collected data from the DBCG database included information concerning treatment start, end, and reason for discontinuation. The primary endpoints for the study were overall survival (OS) and progression-free survival (PFS).
The study included 117 women who received first-line treatment with SB3 and pertuzumab for their HER2-positive mBC. The study population had a mean age of 60 years. A total of 71 patients (61%) had recurrent disease and 46 patients (39%) presented with de novo mBC. The median follow-up was 11.1 and 15.4 months for PFS and OS, respectively. At 12 months, OS was 84% (95% confidence interval [CI], 78-91), whereas the median OS was not reached. The median PFS was 12.7 months (95% CI, 11.1-16.2). Median time on treatment was 8.7 months (95% CI, 7.6-11.4); 36 patients (31%) were still on treatment at end of study.
This retrospective real-world, nationwide study demonstrated comparable median PFS to the historical data of using reference trastuzumab and pertuzumab as first-line dual blockade.
曲妥珠单抗和帕妥珠单抗联合化疗的双重阻断是推荐用于人表皮生长因子受体2（HER2）阳性转移性乳腺癌（mBC）的一线治疗方案。这项回顾性研究的目的是利用HER2阳性mBC患者的真实世界数据，研究曲妥珠单抗生物类似药SB3在一线双重阻断治疗中的临床疗效。
在丹麦，所有乳腺癌女性患者均登记在丹麦乳腺癌组（DBCG）的数据库中。从这个前瞻性观察登记库中，我们提取了2018年9月1日至2020年2月29日期间所有接受SB3和帕妥珠单抗一线治疗的HER2阳性mBC女性患者的初次诊断和治疗信息。从DBCG数据库中回顾性收集的数据包括治疗开始、结束及停药原因的信息。该研究的主要终点是总生存期（OS）和无进展生存期（PFS）。
该研究纳入了117例接受SB3和帕妥珠单抗一线治疗的HER2阳性mBC女性患者。研究人群的平均年龄为60岁。共有71例患者（61%）为复发性疾病，46例患者（39%）为初发性mBC。PFS和OS的中位随访时间分别为11.1个月和15.4个月。12个月时，OS为84%（95%置信区间[CI]，78 - 91），而中位OS未达到。中位PFS为12.7个月（95% CI，11.1 - 16.2）。中位治疗时间为8.7个月（95% CI，7.6 - 11.4）；36例患者（31%）在研究结束时仍在接受治疗。
这项回顾性的全国性真实世界研究表明，中位PFS与使用参比曲妥珠单抗和帕妥珠单抗作为一线双重阻断的历史数据相当。
