Celik Alan, Berg Tobias, Jensen Maj-Britt, Jakobsen Erik, Nielsen Hanne Melgaard, Kümler Iben, Glavicic Vesna, Jensen Jeanette Dupont, Knoop Ann
Danish Breast Cancer Group (DBCG), Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Breast Cancer (Auckl). 2023 Oct 4;17:11782234231203292. doi: 10.1177/11782234231203292. eCollection 2023.
Metastatic triple-negative breast cancer (mTNBC) is an aggressive subtype of breast cancer with poor survival. Currently, the literature lacks comprehensive real-world evidence on locally recurrent and mTNBC patients. To validate the optimal treatment for patients with mTNBC, real-world evidence in combination with data from clinical trials must be evaluated as complementary.
The objective of the study is to examine outcomes and treatment patterns of patients with advanced triple-negative breast cancer (TNBC) utilizing real-world data of patients from all oncology sites across Denmark.
This is a retrospective, non-interventional, multi-site, population-based observational study conducted across all oncology departments in Denmark.
We included all women diagnosed with metastatic or locally recurrent TNBC from January 1, 2017, to December 31, 2019, using the national Danish Breast Cancer Group database. The primary endpoints were overall survival (OS) and progression-free survival (PFS) in the first to third treatment line.
The study included 243 women diagnosed with metastatic or recurrent TNBC. The median OS (mOS) was 11.6 months after the first line of treatment, 6.5 months after the second line, and 6.5 months after the third line. De novo mTNBC was associated with shorter OS (mOS: 8.3 vs 14.2 months), and those with a relapse within 18 months of primary diagnosis had shorter OS than those with a relapse after 18 months (mOS: 10.0 vs 18.2). In the first line, taxane was the preferred choice of treatment for patients with de novo mTNBC, whereas capecitabine was preferred for patients with recurrent TNBC.
This real-world, nationwide study demonstrated poor OS among patients with metastatic or recurrent TNBC, with a mOS of 11.6 months (95% CI, 9.9-17.3). Patients who presented with de novo mTNBC or who had a relapse of their breast cancer within 18 months of primary diagnosis had shorter OS.
The study was registered and approved by the Danish Capital Regions research overview (P-2021-605).
转移性三阴性乳腺癌（mTNBC）是一种侵袭性乳腺癌亚型，生存率低。目前，文献中缺乏关于局部复发和mTNBC患者的全面真实世界证据。为验证mTNBC患者的最佳治疗方法，必须将真实世界证据与临床试验数据结合起来进行评估，二者相辅相成。
本研究的目的是利用丹麦所有肿瘤治疗点患者的真实世界数据，研究晚期三阴性乳腺癌（TNBC）患者的治疗结果和治疗模式。
这是一项在丹麦所有肿瘤科室开展的回顾性、非干预性、多中心、基于人群的观察性研究。
我们使用丹麦国家乳腺癌组数据库，纳入了2017年1月1日至2019年12月31日期间所有诊断为转移性或局部复发性TNBC的女性患者。主要终点是一线至三线治疗中的总生存期（OS）和无进展生存期（PFS）。
该研究纳入了243例诊断为转移性或复发性TNBC的女性患者。一线治疗后的中位总生存期（mOS）为11.6个月，二线治疗后为6.5个月，三线治疗后为6.5个月。初发性mTNBC与较短的总生存期相关（mOS：8.3个月对14.2个月），且在初次诊断后18个月内复发的患者的总生存期短于18个月后复发的患者（mOS：10.0个月对18.2个月）。在一线治疗中，紫杉烷是初发性mTNBC患者的首选治疗药物，而卡培他滨是复发性TNBC患者的首选药物。
这项全国性的真实世界研究表明，转移性或复发性TNBC患者的总生存期较差，mOS为11.6个月（95%CI，9.9 - 17.3）。初发性mTNBC患者或在初次诊断后18个月内乳腺癌复发的患者的总生存期较短。
该研究已在丹麦首都地区研究综述中注册并获得批准（P - 2021 - 605）。
