Alan Celik, Tobias Berg, Maj-Britt Jensen, Erik Jakobsen, Hanne Melgaard Nielsen, Iben Kümler, Vesna Glavicic, Jeanette Dupont Jensen, Ann Knoop
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To validate the optimal treatment for patients with mTNBC, real-world evidence in combination with data from clinical trials must be evaluated as complementary.</p><p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>This is a retrospective, non-interventional, multi-site, population-based observational study conducted across all oncology departments in Denmark.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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). 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引用次数: 0
摘要
背景：转移性三阴性癌症（mTNBC）是癌症的一种侵袭性亚型，生存率低。目前，文献缺乏关于局部复发和mTNBC患者的全面现实证据。为了验证mTNBC患者的最佳治疗方法，必须将现实世界的证据与临床试验的数据相结合，作为补充进行评估。目的：本研究的目的是利用丹麦所有肿瘤学站点患者的真实世界数据，检查晚期癌症三阴性患者的结果和治疗模式，在丹麦所有肿瘤科进行的基于人群的观察性研究。方法：我们纳入了2017年1月1日至2019年12月31日期间被诊断为转移性或局部复发性TNBC的所有女性，使用国家癌症乳腺癌组数据库。主要终点是第一至第三条治疗线的总生存期（OS）和无进展生存期（PFS）。结果：该研究包括243名被诊断为转移性或复发性TNBC的女性。中位OS（mOS）为第一线治疗后11.6个月、第二线治疗后6.5个月和第三线治疗后6.5月。新发mTNBC与较短的OS相关（mOS:8.3 vs 14.2个月），初次诊断后18个月内复发的患者的OS比18个月后复发的患者短（mOS:10.0 vs 18.2），而卡培他滨是复发性TNBC患者的首选。结论：这项现实世界的全国性研究表明，转移性或复发性TNBC患者的OS较差，mOS为11.6个月（95%CI，9.9-17.3）。初次诊断后18个月内出现新发mTNBC或乳腺癌症复发的患者OS较短。注册：该研究由丹麦首都地区研究综述（P-2021-605）注册并批准。
Real-World Survival and Treatment Regimens Across First- to Third-Line Treatment for Advanced Triple-Negative Breast Cancer.
Background: 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.
Objectives: 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.
Design: This is a retrospective, non-interventional, multi-site, population-based observational study conducted across all oncology departments in Denmark.
Methods: 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.
Results: 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.
Conclusions: 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.
Registration: The study was registered and approved by the Danish Capital Regions research overview (P-2021-605).
期刊介绍：
Breast Cancer: Basic and Clinical Research is an international, open access, peer-reviewed, journal which considers manuscripts on all areas of breast cancer research and treatment. We welcome original research, short notes, case studies and review articles related to breast cancer-related research. Specific areas of interest include, but are not limited to, breast cancer sub types, pathobiology, metastasis, genetics and epigenetics, mammary gland biology, breast cancer models, prevention, detection, therapy and clinical interventions, and epidemiology and population genetics.
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