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SystHERs 研究中激素受体状态不同的 HER2 阳性转移性乳腺癌患者的基线特征、治疗模式和结局

Baseline Characteristics, Treatment Patterns, and Outcomes in Patients with HER2-Positive Metastatic Breast Cancer by Hormone Receptor Status from SystHERs.

机构信息

Rush University Cancer Center, Rush University Medical Center, Chicago, Illinois.

Breast Cancer Research Program, Sarah Cannon Research Institute and Tennessee Oncology, Nashville, Tennessee.

出版信息

Clin Cancer Res. 2020 Mar 1;26(5):1105-1113. doi: 10.1158/1078-0432.CCR-19-2350. Epub 2019 Nov 26.

DOI:10.1158/1078-0432.CCR-19-2350
PMID:31772121
Abstract

PURPOSE

We report treatments and outcomes in a contemporary patient population with HER2-positive metastatic breast cancer (MBC) by hormone receptor (HR) status from the Systemic Therapies for HER2-positive Metastatic Breast Cancer Study (SystHERs).

EXPERIMENTAL DESIGN

SystHERs (NCT01615068) was an observational, prospective registry study of U.S.-based patients with newly diagnosed HER2-positive MBC. Endpoints included treatment patterns and clinical outcomes.

RESULTS

Of 977 eligible patients (enrolled from 2012 to 2016), 70.1% ( = 685) had HR-positive and 29.9% ( = 292) had HR-negative disease. Overall, 59.1% (405/685) of patients with HR-positive disease received any first-line endocrine therapy (with or without HER2-targeted therapy or chemotherapy); 34.9% (239/685) received HER2-targeted therapy + chemotherapy + sequential endocrine therapy. Patients with HR-positive versus HR-negative disease had longer median overall survival (OS; 53.0 vs 43.4 months; hazard ratio, 0.70; 95% confidence interval, 0.56-0.87). Compared with patients with high HR-positive staining (10%-100%, = 550), those with low HR-positive staining (1%-9%, = 60) received endocrine therapy less commonly (64.2% vs 33.3%) and had shorter median OS (53.8 vs 40.1 months). Similar median OS (43.4 vs 40.1 months) was observed in patients with HR-negative versus low HR-positive tumors (1%-9%).

CONCLUSIONS

Despite evidence that first-line HER2-targeted therapy, chemotherapy, and sequential endocrine therapy improves survival in patients with HR-positive, HER2-positive disease, only 34.9% of patients in this real-world setting received such treatment. Patients with low tumor HR positivity (1%-9%) had lower endocrine therapy use and worse survival than those with high tumor HR positivity (10%-100%).

摘要

目的

我们报告了一项当代人 HER2 阳性转移性乳腺癌(MBC)患者人群中,按激素受体(HR)状态进行的治疗和结果,这些患者来自 HER2 阳性转移性乳腺癌的系统治疗研究(SystHERs)。

实验设计

SystHERs(NCT01615068)是一项观察性、前瞻性注册研究,纳入了美国新诊断为 HER2 阳性 MBC 的患者。终点包括治疗模式和临床结局。

结果

在 977 例合格患者中(2012 年至 2016 年入组),70.1%(=685)为 HR 阳性,29.9%(=292)为 HR 阴性。总体而言,685 例 HR 阳性疾病患者中,59.1%(405/685)接受了任何一线内分泌治疗(联合或不联合 HER2 靶向治疗或化疗);34.9%(239/685)接受了 HER2 靶向治疗+化疗+序贯内分泌治疗。HR 阳性与 HR 阴性疾病患者的中位总生存期(OS)更长(53.0 与 43.4 个月;风险比,0.70;95%置信区间,0.56-0.87)。与高 HR 阳性染色(10%-100%,=550)患者相比,低 HR 阳性染色(1%-9%,=60)患者较少接受内分泌治疗(64.2%与 33.3%),中位 OS 更短(53.8 与 40.1 个月)。HR 阴性与低 HR 阳性肿瘤(1%-9%)患者的中位 OS 相似(43.4 与 40.1 个月)。

结论

尽管有证据表明一线 HER2 靶向治疗、化疗和序贯内分泌治疗可改善 HR 阳性、HER2 阳性疾病患者的生存,但在这一真实世界环境中,只有 34.9%的患者接受了此类治疗。肿瘤 HR 阳性率较低(1%-9%)的患者接受内分泌治疗的比例较低,生存较差,而肿瘤 HR 阳性率较高(10%-100%)的患者则不然。

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