Long-term cardiac tolerability of trastuzumab in metastatic breast cancer: The M.D. Anderson Cancer Center experience

Long-term cardiac tolerability of trastuzumab in metastatic breast cancer: The M.D. Anderson Cancer Center experience
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DOI:
10.1200/jco.2005.04.9551
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发表时间:
2006-09-01
影响因子:
45.3
通讯作者:
Esteva, Francisco J.
Esteva, Francisco J.
中科院分区:
医学1区
文献类型:
--
作者:
Guarneri, Valentina;Lenihan, Daniel J.;Esteva, Francisco J.

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目的评价长期曲妥珠单抗治疗在德克萨斯大学医学院接受治疗的人表皮生长受体2(HER 2)过表达转移性乳腺癌(MBC)患者的心脏安全性。安德森癌症中心(Houston,TX).患者和方法在用基于曲妥珠单抗的疗法治疗至少1年的218名MBC患者中,173名患者可评估心脏毒性。心脏事件(CE)的定义如下:无症状的左心室射血分数(LVEF)低于50%的下降,降低20个百分点的LVEF与基线相比,或充血性心力衰竭(CHF)的体征或症状。中位随访时间为32.6个月(范围:11.8 - 79.0个月)。49例患者(28%)发生CE:3例患者(1.7%)LVEF无症状性降低20个百分点,27例患者(15.6%)发生2级心脏毒性,19例患者(10.9%)发生3级心脏毒性。除3例患者外,所有患者在曲妥珠单抗停药和适当治疗后LVEF或CHF症状均改善。有1例心脏相关死亡(0.5%)。基线LVEF与CE显著相关(风险比,0.94; P = .001)。服用伴随紫杉烷类的患者之间的CE的风险是较高的早期在随访期间,但在follow-up.ConclusionThe长期曲妥珠单抗为基础的治疗心脏毒性的风险下降在这个人群中是可以接受的,这种毒性是可逆的,在大多数患者。在发生CE的患者中,在心脏功能恢复后可以考虑使用曲妥珠单抗进行额外治疗。
PurposeTo evaluate the cardiac safety of long-term trastuzumab therapy in patients with human epidermal growth receptor 2 (HER2) -overexpressing metastatic breast cancer (MBC) treated at The University of Texas M.D. Anderson Cancer Center (Houston, TX).Patients and MethodsAmong 218 MBC patients treated with trastuzumab-based therapy for at least 1 year, 173 patients were assessable for cardiac toxicity. Cardiac events (CEs) were defined as follows: asymptomatic decrease of left ventricular ejection fraction (LVEF) below 50%; decrease of 20 percentage points in LVEF compared with the baseline; or signs or symptoms of congestive heart failure (CHF).ResultsThe median cumulative time for trastuzumab administration was 21.3 months. The median follow-up was 32.6 months (range, 11.8 to 79.0 months). Forty-nine patients (28%) experienced a CE: three patients (1.7%) had an asymptomatic decrease in the LVEF of 20 percentage points, 27 patients (15.6%) experienced grade 2 cardiac toxicity, and 19 patients (10.9%) experienced grade 3 cardiac toxicity. All but three patients had improved LVEF or symptoms of CHF with trastuzumab discontinuation and appropriate therapy. There was one cardiac-related death (0.5%). Baseline LVEF was significantly associated with CE (hazard ratio, 0.94; P = .001). The hazard of a CE among patients taking concomitant taxanes was higher early in the follow-up period but declined during the course of follow-up.ConclusionThe risk of cardiac toxicity of long-term trastuzumab-based therapy is acceptable in this population, and this toxicity is reversible in the majority of the patients. In patients who have experienced a CE, additional treatment with trastuzumab can be considered after recovery of cardiac function.