接受蒽环类药物化疗并接受左侧乳房放射治疗的乳腺癌患者的亚临床心脏损伤监测：一项3期试验的亚组分析
Subclinical cardiac damage monitoring in breast cancer patients treated with an anthracycline-based chemotherapy receiving left-sided breast radiation therapy: subgroup analysis from a phase 3 trial.
作者信息
Marrazzo Livia, Meattini Icro, Becherini Carlotta, Salvestrini Viola, Visani Luca, Barletta Giuseppe, Saieva Calogero, Del Bene Maria Riccarda, Pilato Giuseppe, Desideri Isacco, Arilli Chiara, Paoletti Lisa, Russo Serenella, Scoccianti Silvia, Martella Francesca, Francolini Giulio, Simontacchi Gabriele, Nori Cucchiari Jacopo, Pellegrini Roberto, Livi Lorenzo, Pallotta Stefania
机构信息
Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Medical Physics Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
出版信息
Radiol Med. 2024 Dec;129(12):1926-1935. doi: 10.1007/s11547-024-01897-6. Epub 2024 Oct 22.
OBJECTIVE
This study, derived from the phase 3 SAFE trial (ClinicalTrials.gov identifier: NCT2236806), explores subclinical cardiac damage in breast cancer patients receiving anthracycline-based chemotherapy and left-sided breast radiation therapy (RT).
MATERIALS AND METHODS
Eligible patients were randomized to a cardioprotective pharmacological therapy (bisoprolol, ramipril, or both) or placebo, with cardiac surveillance at multiple time-point using standard and 3-dimensional echocardiography. Dosimetric parameters were analysed, including mean heart dose (MHD) and various metrics for heart substructures, employing advanced contouring techniques and auto-contouring software.
RESULTS
In the analysis of left-sided breast RT patients, the study encompassed 39 out of 46 irradiated individuals, focusing on GLS and 3D-LVEF outcomes with ≥ 10% worsening, defined as subclinical heart damage. Distinct RT schedules were used, with placebo exhibiting the highest ≥ 10% worsening (36.4%). In terms of treatment arms, bisoprolol exhibited 11.1% worsening, while ramipril 16.7% and bisoprolol + ramipril 25%. For patients with no subclinical damage, the mean MHD was 1.5 Gy; for patients with subclinical heart damage, the mean MHD was 1.6 Gy (p = 0.94). Dosimetric parameters related to heart and heart substructures (left anterior descending artery, right and left atrium, right and left ventricle) showed no statistically significant differences between patients with and without subclinical damage.
CONCLUSION
Our results emphasize the crucial role of cardioprotective measures in mitigating adverse effects, highlighting RT as having negligible influence on cardiac performance. An extended follow-up assessment of the whole series is warranted to determine whether a subclinical effect could significantly influence clinical outcomes and cardiac events.
目的
本研究源自3期SAFE试验（ClinicalTrials.gov标识符：NCT2236806），旨在探讨接受蒽环类化疗和左侧乳房放射治疗（RT）的乳腺癌患者的亚临床心脏损伤情况。
材料与方法
符合条件的患者被随机分为心脏保护药物治疗组（比索洛尔、雷米普利或两者联用）或安慰剂组，使用标准和三维超声心动图在多个时间点进行心脏监测。分析剂量学参数，包括平均心脏剂量（MHD）和心脏亚结构的各种指标，采用先进的轮廓勾画技术和自动轮廓勾画软件。
结果
在左侧乳房RT患者的分析中，该研究纳入了46名接受照射个体中的39名，重点关注GLS和3D-LVEF恶化≥10%的情况，将其定义为亚临床心脏损伤。采用了不同的RT方案，安慰剂组表现出最高的≥10%恶化率（36.4%）。在治疗组方面，比索洛尔的恶化率为11.1%，雷米普利为16.7%，比索洛尔+雷米普利为25%。对于没有亚临床损伤的患者，平均MHD为1.5 Gy；对于有亚临床心脏损伤的患者，平均MHD为1.6 Gy（p = 0.94）。与心脏和心脏亚结构（左前降支动脉、右心房和左心房、右心室和左心室）相关的剂量学参数在有和没有亚临床损伤的患者之间没有统计学上的显著差异。
结论
我们的结果强调了心脏保护措施在减轻不良反应方面的关键作用，突出了RT对心脏功能的影响可忽略不计。有必要对整个系列进行延长随访评估，以确定亚临床效应是否会显著影响临床结果和心脏事件。
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