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EACVI/HFA 乳腺癌患者心脏肿瘤毒性登记研究:基本原理、研究设计和方法(EACVI/HFA COT 登记研究)——欧洲心脏病学会的 EURObservational Research Program。

EACVI/HFA Cardiac Oncology Toxicity Registry in breast cancer patients: rationale, study design, and methodology (EACVI/HFA COT Registry)--EURObservational Research Program of the European Society of Cardiology.

机构信息

University of Liège Hospital, GIGA Cardiovascular Science, Heart Valve Clinic, Imaging Cardiology, Belgium and GVM Care and Research, E.S. Health Science Foundation, Lugo (RA), Italy

Department of Innovative Clinical Trials, University Medical Center Göttingen (UMG), Göttingen, Germany.

出版信息

Eur Heart J Cardiovasc Imaging. 2015 May;16(5):466-70. doi: 10.1093/ehjci/jev024. Epub 2015 Mar 4.

Abstract

The goal of adjuvant anti-cancer therapies is cure with limited or no side effects, in particular long-term side effects with negative impact on quality of life. In the palliative setting disease control, quality of life and overall survival are important end points. Partly due to improvements in treatment, the population of cancer survivors is large and growing. However, anti-cancer drug-related cardiotoxicity (ADRC) is the leading cause of treatment-associated mortality in cancer survivors. It is one of the most common post-treatment problems among 5- to 10-year survivors of adult cancer. This is particularly true for breast cancer, the most common cancer in women. The EACVI/HFA COT registry is designed for comprehensive data collection and evaluation of the current European practice in terms of diagnosis and management of ADRC in breast cancer patients. The COT registry will be carried out in two continuing phases, the pilot study phase involving 13 countries followed by the long-term registry in which all the 56 ESC countries will be invited to participate. With the COT registry, several critical information will be obtained: on predisposing factors for the development of ADRC, the rate of subclinical LV dysfunction and its transition to overt heart failure, the clinical impact and outcome of ADRC.

摘要

辅助抗癌疗法的目标是治愈疾病,同时限制或避免副作用,特别是对生活质量有负面影响的长期副作用。在姑息治疗环境中,疾病控制、生活质量和总生存是重要的终点。部分由于治疗的改进,癌症幸存者的人数众多且不断增加。然而,抗癌药物相关的心脏毒性(ADRC)是癌症幸存者治疗相关死亡的主要原因。它是成年癌症 5-10 年幸存者中最常见的治疗后问题之一。对于乳腺癌,女性中最常见的癌症,更是如此。EACVI/HFA COT 注册研究旨在全面收集数据,并评估目前欧洲在乳腺癌患者 ADRC 的诊断和管理方面的实践情况。COT 注册研究将分两个连续阶段进行,包括 13 个国家的试点研究阶段和随后的长期注册阶段,届时将邀请所有 56 个 ESC 国家参与。通过 COT 注册研究,将获得以下几个关键信息:ADRC 发展的易患因素、亚临床左心室功能障碍的发生率及其向明显心力衰竭的转变、ADRC 的临床影响和结局。

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