her2阳性转移性乳腺癌患者的完全缓解：一项真实世界的SONABRE研究

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2025-09-23 DOI:10.1016/j.breast.2025.104583

Nan Ding , Renee Visserman , Sandra M.E. Geurts , Jolien Tol , Birgit E.P.J. Vriens , Kirsten N.A. Aaldering , Eline Boon , Marcus W. Dercksen , Franchette van den Berkmortel , Manon J.A.E. Pepels , Natascha A.J.B. Peters , Joan B. Heijns , Linda van de Winkel , Aude J.O. de Fallois , Vivianne C.G. Tjan-Heijnen , Maaike de Boer

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引用次数: 0

摘要

背景：本研究旨在描述接受一线帕妥珠单抗、曲妥珠单抗和化疗治疗的HER2阳性（HER2+）转移性乳腺癌（MBC）患者的真实世界完全缓解（CR）率、CR的预测因素和生存结果。方法选择2013-2021年开始一线帕妥珠单抗、曲妥珠单抗和化疗的HER2+ MBC患者，来自SONABRE Registry (NCT-03577197)，涉及11家荷兰医院。CR被定义为在一线全身治疗（有或没有局部治疗（手术和/或放疗））期间没有影像学上的疾病证据。使用多变量logistic回归来确定CR的预测因子。使用Kaplan-Meier方法计算一线帕妥珠单抗、曲妥珠单抗和化疗开始时的无进展生存期（PFS）和总生存期（OS）。我们纳入了244例接受一线帕妥珠单抗、曲妥珠单抗和化疗的患者，中位随访时间为71个月（四分位数范围：60-82个月）。63例患者（26%）在一线全身治疗期间达到CR。年龄小于65岁的患者（优势比(OR) = 5.24, 95% CI: 1.49-18.44, p = 0.01）、新发MBC患者（OR = 2.48, 95% CI: 1.24-4.93, p = 0.01）或单一转移部位患者（OR = 3.81, 95% CI: 1.83-7.96, p < 0.001）比其他患者更容易达到CR。5年PFS和OS率分别63% (95% CI: 48% - -75%)和85% (95% CI: 72% - -92%)患者CR和10% (95% CI: 6% - -16%)和36% (95% CI: 28% - -44%)的患者没有CR.ConclusionsIn现实世界中,四分之一的患者一线pertuzumab,曲妥珠单抗,化疗,有或没有局部治疗,达到CR。两个三分之一的患者CR五年后仍无进展。

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Complete responders in patients with HER2-positive metastatic breast cancer: a real-world SONABRE study

Background

We aimed to describe real-world complete response (CR) rates, predictors of CR, and survival outcomes in patients treated with first-line pertuzumab, trastuzumab, and chemotherapy for HER2-positive (HER2+) metastatic breast cancer (MBC).

Methods

Patients with HER2+ MBC who started first-line pertuzumab, trastuzumab, and chemotherapy in 2013–2021 were selected from the SONABRE Registry (NCT-03577197), involving eleven Dutch hospitals. CR was defined as no evidence of disease on imaging during first-line systemic therapy with or without local therapy (surgery and/or radiotherapy). Multivariable logistic regression was used to identify predictors for CR. Progression-free survival (PFS) and overall survival (OS) from the start of first-line pertuzumab, trastuzumab, and chemotherapy were computed with the Kaplan-Meier method.

Results

We included 244 patients treated with first-line pertuzumab, trastuzumab, and chemotherapy, with a median follow-up duration of 71 months (interquartile range: 60–82 months). A CR during first-line systemic therapy was reached in 63 patients (26 %). Patients younger than 65 years (odds ratio (OR) = 5.24, 95 %CI:1.49–18.44, p = 0.01), those with de Novo MBC (OR = 2.48, 95 %CI:1.24–4.93, p = 0.01), or those with a single metastatic site (OR = 3.81, 95 %CI:1.83–7.96, p < 0.001) were more likely to reach CR than their counterparts. The 5-year PFS and OS rates were, respectively, 63 % (95 %CI:48 %–75 %) and 85 % (95 %CI:72 %–92 %) in patients with a CR and 10 % (95 %CI:6 %–16 %) and 36 % (95 %CI:28 %–44 %) in patients without a CR.

Conclusions

In the real world, one in four patients treated with first-line pertuzumab, trastuzumab, chemotherapy, with or without local therapy, reached CR. Two third of patients with a CR were still free of progression after five years.

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来源期刊

Breast 医学-妇产科学

CiteScore

8.70

自引率

2.60%

发文量

165

审稿时长

59 days

期刊介绍： The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.