一项针对接受抗HER2治疗的早期乳腺癌患者的应变引导心脏保护试验（PROTECT HER2）。
A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2).
作者信息
Gong Fei Fei, Grunblatt Eli, Voss Woo Bin, Rangarajan Vibhav, Raissi Sasan, Chow Kimberly, Jafari Lua, Patel Nikita P, Vaitenas Inga, Marion Milica, Ramirez Haydee, Zhao Manyun, Andrei Adin-Christian, Baldridge Abigail S, Murtagh Gillian, Maganti Kameswari, Rigolin Vera H, Akhter Nausheen
机构信息
Division of Cardiovascular Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 600, Chicago, IL, 60611, USA.
Department of Medicine, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair, Suite 2330, Chicago, IL, 60611, USA.
出版信息
Cardiooncology. 2024 Nov 27;10(1):85. doi: 10.1186/s40959-024-00291-5.
BACKGROUND
Global longitudinal strain (GLS) has been used to identify patients at risk for cancer-therapy related cardiac dysfunction (CTRCD). However, there is limited data on the effectiveness of initiating cardioprotective therapy based on a strain-guided strategy in early stage HER2+ breast cancer patients. This randomized clinical trial assessed if treatment with carvedilol based on a strain-guided strategy can prevent development of CTRCD in HER2+ breast cancer patients on non-anthracycline based regimens.
METHODS
Study participants were prospectively assigned to one of four arms. Patients with normal LVEF and GLS remained in Arm A. Patients whose GLS decreased by > 15% from baseline or to < -15% during follow up were randomized 1:1 to prophylactic carvedilol (Arm B) or no therapy (Arm C). Patients who developed CTRCD were assigned to Arm D. The primary endpoint was GLS stability. The secondary endpoints were development of CTRCD and rate of anti-HER2 treatment interruption.
RESULTS
Among 110 patients who completed follow up, 84 were assigned to Arm A, 10 each were randomized to Arms B or C, and 6 were assigned to Arm D. At the end of the study period, there were no significant differences in GLS stability, development of CTRCD, or number of cancer therapy cycles completed between patients who did and did not receive cardioprotective therapy.
CONCLUSIONS
In this prospective randomized GLS-guided study of prophylactic carvedilol in early stage HER2+ breast cancer patients on non-anthracycline regimens, there were no significant difference between groups in GLS stability, CTRCD or trastuzumab cycles held. These findings may identify a low-risk group of patients who may be considered for less intensive cardiac surveillance.
TRIAL REGISTRATION
https://clinicaltrials.gov/study/NCT02993198 . Start date: 4/2015. This trial included patients who were retrospectively registered.
背景
整体纵向应变（GLS）已被用于识别有癌症治疗相关心脏功能障碍（CTRCD）风险的患者。然而，关于在早期HER2阳性乳腺癌患者中基于应变指导策略启动心脏保护治疗的有效性的数据有限。这项随机临床试验评估了基于应变指导策略使用卡维地洛治疗是否能预防接受非蒽环类方案治疗的HER2阳性乳腺癌患者发生CTRCD。
方法
研究参与者被前瞻性地分配到四个组之一。左心室射血分数（LVEF）和GLS正常的患者留在A组。随访期间GLS较基线下降>15%或降至<-15%的患者按1:1随机分配至预防性使用卡维地洛组（B组）或不进行治疗组（C组）。发生CTRCD的患者被分配到D组。主要终点是GLS稳定性。次要终点是CTRCD的发生情况和抗HER2治疗中断率。
结果
在110名完成随访的患者中，84名被分配到A组，10名分别随机分配到B组或C组，6名被分配到D组。在研究期结束时，接受和未接受心脏保护治疗的患者在GLS稳定性、CTRCD的发生情况或完成的癌症治疗周期数方面没有显著差异。
结论
在这项针对接受非蒽环类方案治疗的早期HER2阳性乳腺癌患者进行的前瞻性随机GLS指导的预防性卡维地洛研究中，各组在GLS稳定性、CTRCD或曲妥珠单抗治疗周期方面没有显著差异。这些发现可能确定了一组低风险患者，他们可能被认为无需进行强化心脏监测。
试验注册
https://clinicaltrials.gov/study/NCT02993198 。开始日期：2015年4月。该试验纳入了回顾性注册的患者。
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