预防乳腺癌和淋巴癌患者的心脏损伤

IF 12 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
David Austin MBChB, MD , Rebecca H. Maier MSc , Nasima Akhter PhD , Mohammad Sayari MSc , Emmanuel Ogundimu PhD , Jamie M. Maddox MBChB , Sharareh Vahabi MBChB, MD , Alison C. Humphreys MBBcH, MD , Janine Graham MBChB , Helen Oxenham MBChB, MD , Sophie Haney MBBS , Nicola Cresti MD, PhD , Mark Verrill MB, BChir , Wendy Osborne MBBS , Kathryn L. Wright MBChB , Rebecca Goranova MBBS , James R. Bailey MBBS, PhD , Nagesh Kalakonda MBBS, PhD , Mac Macheta MBChB , Mari F. Kilner MBChB , Chris Plummer BM, BCh, PhD
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引用次数: 0

摘要

背景心脏毒性是接受蒽环类化疗的癌症幸存者所担心的问题。依那普利被认为具有减轻癌症患者心脏毒性的潜力。目的 PROACT(预防乳腺癌和淋巴瘤患者心脏损伤)临床试验评估了依那普利在预防乳腺癌或非霍奇金淋巴瘤高剂量蒽环类化疗患者心脏毒性(表现为心肌损伤和心功能损害)方面的效果。方法这项前瞻性、多中心、开放标签、随机对照试验采用了观察者盲法终点的优效设计。共有 111 名参与者计划接受 6 个周期的化疗,计划剂量≥300 毫克/平方米多柔比星当量,他们被随机分配接受依那普利(滴定至每天 20 毫克)或不含依那普利的标准治疗。结果 在化疗期间和化疗后1个月,依那普利组54名患者中有42名(77.8%)观察到心肌损伤,而标准治疗组54名患者中有45名(83.3%)观察到心肌损伤(OR:0.65;95% CI:0.23-1.78)。在服用依那普利的 53 名患者中,有 25 人(47.2%)通过心肌肌钙蛋白 I(26.2 ng/L)检测到损伤,而在服用标准疗法的 53 名患者中,有 24 人(45.3%)通过心肌肌钙蛋白 I 检测到损伤(OR:1.10;95% CI:0.50-2.38)。在使用依那普利的 47 名患者中,有 10 人(21.3%)的左室整体纵向应变较基线相对下降超过 15%,而在使用标准护理的 41 名患者中,有 9 人(21.9%)的左室整体纵向应变较基线相对下降超过 15%(OR:0.95;95% CI:0.33-2.74)。服用依那普利的 49 例患者中,有 2 例(4.1%)患者的左心室射血分数绝对值下降了 10%至 50%,而接受标准护理的患者中没有出现这种情况。结论在化疗期间的标准护理中加入依那普利并不能预防接受高剂量蒽环类化疗患者的心脏毒性。(PROACT:我们能预防乳腺癌和淋巴瘤患者化疗相关的心脏损伤吗?)
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Preventing Cardiac Damage in Patients Treated for Breast Cancer and Lymphoma

Background

Cardiotoxicity is a concern for cancer survivors undergoing anthracycline chemotherapy. Enalapril has been explored for its potential to mitigate cardiotoxicity in cancer patients. The dose-dependent cardiotoxicity effects of anthracyclines can be detected early through the biomarker cardiac troponin.

Objectives

The PROACT (Preventing Cardiac Damage in Patients Treated for Breast Cancer and Lymphoma) clinical trial assessed the effectiveness of enalapril in preventing cardiotoxicity, manifesting as myocardial injury and cardiac function impairment, in patients undergoing high-dose anthracycline-based chemotherapy for breast cancer or non-Hodgkin lymphoma.

Methods

This prospective, multicenter, open-label, randomized controlled trial employed a superiority design with observer-blinded endpoints. A total of 111 participants, scheduled for 6 cycles of chemotherapy with a planned dose of ≥300 mg/m2 doxorubicin equivalents, were randomized to receive either enalapril (titrated up to 20 mg daily) or standard care without enalapril.

Results

Myocardial injury, indicated by cardiac troponin T (≥14 ng/L), during and 1 month after chemotherapy, was observed in 42 (77.8%) of 54 patients in the enalapril group vs 45 (83.3%) of 54 patients in the standard care group (OR: 0.65; 95% CI: 0.23-1.78). Injury detected by cardiac troponin I (>26.2 ng/L) occurred in 25 (47.2%) of 53 patients on enalapril compared with 24 (45.3%) of 53 in standard care (OR: 1.10; 95% CI: 0.50-2.38). A relative decline of more than 15% from baseline in left ventricular global longitudinal strain was observed in 10 (21.3%) of 47 patients on enalapril and 9 (21.9%) of 41 in standard care (OR: 0.95; 95% CI: 0.33-2.74). An absolute decline of >10% to <50% in left ventricular ejection fraction was seen in 2 (4.1%) of 49 patients on enalapril vs none in patients in standard care.

Conclusions

Adding enalapril to standard care during chemotherapy did not prevent cardiotoxicity in patients receiving high-dose anthracycline-based chemotherapy. (PROACT: Can we prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?; NCT03265574)
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来源期刊
CiteScore
12.50
自引率
6.30%
发文量
106
期刊介绍: JACC: CardioOncology is a specialized journal that belongs to the esteemed Journal of the American College of Cardiology (JACC) family. Its purpose is to enhance cardiovascular care for cancer patients by publishing high-quality, innovative scientific research and sharing evidence-based knowledge. The journal aims to revolutionize the field of cardio-oncology and actively involve and educate professionals in both cardiovascular and oncology fields. It covers a wide range of topics including pre-clinical, translational, and clinical research, as well as best practices in cardio-oncology. Key areas of focus include understanding disease mechanisms, utilizing in vitro and in vivo models, exploring novel and traditional therapeutics (across Phase I-IV trials), studying epidemiology, employing precision medicine, and investigating primary and secondary prevention. Amyloidosis, cardiovascular risk factors, heart failure, and vascular disease are some examples of the disease states that are of particular interest to the journal. However, it welcomes research on other relevant conditions as well.
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