Maria Eleni Hatzipanagiotou, Verena Tannert, Michael Gerken, Miriam Pigerl, Sophie Räpple, Jonas Roth, Monika Klinkhammer-Schalke, Olaf Ortmann, Stephan Seitz
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引用次数: 0
Abstract
Background and Aims
Real-world evidence on the treatment of early triple-negative breast cancer (TNBC) remains limited. This study provides an overview of neoadjuvant chemotherapy (NACT) regimens used in the 2010s of the 21st century, analyzing patient outcomes and treatment patterns based on real-world data from a large population-based cancer registry.
Methods
In this retrospective, noninterventional, single-center study, we analyzed data from TNBC patients diagnosed between January 1, 2010, and December 31, 2018, registered in the Tumor Centre Regensburg. Data included demographics, pathology, treatment regimen, recurrence, and survival, with follow-up extending to December 2023. Outcomes included pathologic complete response (pCR), overall survival (OS), and recurrence-free survival (RFS).
Results
A total of 319 patients were included. Among them, 132 patients (41.4%) received NACT with epirubicin/cyclophosphamide (EC) and paclitaxel (EC-T), 74 patients (23.2%) received NACT with EC-T and platinum (EC-P/T), and 22 patients (6.9%) received NACT with EC-P/nab-paclitaxel (EC-P/nabP). Other NACT protocols were administered in 91 (28.5%) patients. A pCR occurred in 49.8% of NACT patients, with a 37.1% rate in the subgroup without platinum. Addition of platinum significantly increased the pCR rate to 54.1% compared to EC-T (odds ratio [OR] 3.476, 95% confidence interval [CI] 1.655–7.300, p = 0.001). EC-P/nabP led to a significant increase in pCR rate to 77.3% (OR 8.767, 95% CI 2.421–31.744, p < 0.001).
Conclusion
The evidence from clinical trials was quickly incorporated into clinical practice, leading to higher pCR rates and benefits for patients. In the next step, the implementation of immune checkpoint inhibitors in real-world practice will be analyzed.
背景和目的:关于早期三阴性乳腺癌(TNBC)治疗的真实证据仍然有限。本研究概述了21世纪2010年代使用的新辅助化疗(NACT)方案,分析了基于大型人群癌症登记处的真实数据的患者结果和治疗模式。方法:在这项回顾性、非介入性、单中心研究中,我们分析了2010年1月1日至2018年12月31日期间在雷根斯堡肿瘤中心登记的TNBC患者的数据。数据包括人口统计学、病理、治疗方案、复发和生存,随访时间延长至2023年12月。结果包括病理完全缓解(pCR)、总生存期(OS)和无复发生存期(RFS)。结果:共纳入319例患者。其中,表柔比星/环磷酰胺(EC)联合紫杉醇(EC-T)的NACT患者132例(41.4%),联合EC-T和铂(EC- p /T)的NACT患者74例(23.2%),联合EC- p /nab-紫杉醇(EC- p /nabP)的NACT患者22例(6.9%)。91例(28.5%)患者采用其他NACT方案。49.8%的NACT患者出现pCR,而未使用铂的亚组出现pCR的比例为37.1%。与EC-T相比,铂的加入显著提高了pCR率至54.1%(优势比[OR] 3.476, 95%可信区间[CI] 1.655-7.300, p = 0.001)。EC-P/nabP使pCR率显著增加至77.3% (OR 8.767, 95% CI 2.421-31.744, p < 0.001)。结论:临床试验的证据被迅速纳入临床实践,导致更高的pCR率和患者的利益。下一步,将分析免疫检查点抑制剂在现实世界中的应用。
期刊介绍:
The Breast Journal is the first comprehensive, multidisciplinary source devoted exclusively to all facets of research, diagnosis, and treatment of breast disease. The Breast Journal encompasses the latest news and technologies from the many medical specialties concerned with breast disease care in order to address the disease within the context of an integrated breast health care. This editorial philosophy recognizes the special social, sexual, and psychological considerations that distinguish cancer, and breast cancer in particular, from other serious diseases. Topics specifically within the scope of The Breast Journal include:
Risk Factors
Prevention
Early Detection
Diagnosis and Therapy
Psychological Issues
Quality of Life
Biology of Breast Cancer.