Križić Marija, Popović Marina, Silovski Tajana, Grbin Dorotea, Dedić Plavetić Natalija
Department of Oncology, University Hospital Centre Zagreb, Kišpatićeva 12, 10000, Zagreb, Croatia.
School of Medicine, University of Zagreb, Zagreb, Croatia.
Drugs Real World Outcomes. 2024 Sep;11(3):413-423. doi: 10.1007/s40801-024-00438-x. Epub 2024 Jun 16.
Dual human epidermal growth factor receptor 2 (HER2) blockade with trastuzumab and pertuzumab combined with taxane-based chemotherapy (Cht) has been the standard first-line treatment for HER2-positive metastatic breast cancer (mBC) for years, due to the impressive results of the CLEOPATRA study. Real-world (RW) studies have become critical for assessing treatment effectiveness and safety in real-life circumstances. The aim of this study was to analyze the treatment outcomes of first-line therapy for HER2-positive mBC in RW clinical practice, specifically focusing on the use of maintenance endocrine therapy (ET) in hormone receptor positive (HR-positive) patients.
This retrospective analysis included 106 HER2-positive mBC patients treated with trastuzumab and pertuzumab combined with taxane-based Cht from October 2015 to December 2020 at the University Hospital Centre Zagreb.
At a median follow-up of 30 months, median progression-free survival (PFS) was 25 months for the total population (95% confidence interval [CI] 16 - not analyzed). Patients with de novo mBC had longer median PFS than patients with recurrent disease (not reached vs. 18 months; hazard ratio 1.99; 95% CI 0.69-3.64, p<0.022). Age, hormone receptor positivity, visceral involvement, number of Cht cycles and previous adjuvant trastuzumab did not impact PFS. Most HR-positive patients (N=55, 88.7%) received maintenance ET after induction Cht.
This retrospective study provides additional data on patient characteristics, treatment and outcomes of RW HER2-positive mBC patients treated with pertuzumab and trastuzumab as first-line therapy. In our institution, maintenance ET after induction Cht has become standard clinical practice.
由于CLEOPATRA研究取得了令人瞩目的结果，多年来，曲妥珠单抗和帕妥珠单抗双重阻断人表皮生长因子受体2（HER2）并联合紫杉类化疗（Cht）一直是HER2阳性转移性乳腺癌（mBC）的标准一线治疗方案。真实世界（RW）研究对于评估实际临床环境中的治疗效果和安全性至关重要。本研究的目的是分析RW临床实践中HER2阳性mBC一线治疗的疗效，特别关注激素受体阳性（HR阳性）患者维持内分泌治疗（ET）的使用情况。
本回顾性分析纳入了2015年10月至2020年12月在萨格勒布大学医院中心接受曲妥珠单抗和帕妥珠单抗联合紫杉类Cht治疗的106例HER2阳性mBC患者。
在中位随访30个月时，总体人群的中位无进展生存期（PFS）为25个月（95%置信区间[CI] 16 - 未分析）。初发mBC患者的中位PFS长于复发患者（未达到 vs. 18个月；风险比1.99；95% CI 0.69 - 3.64，p<0.022）。年龄、激素受体阳性状态、内脏受累情况、Cht周期数和既往辅助曲妥珠单抗治疗均不影响PFS。大多数HR阳性患者（N = 55，88.7%）在诱导Cht后接受了维持ET。
本回顾性研究提供了关于接受帕妥珠单抗和曲妥珠单抗作为一线治疗的RW HER2阳性mBC患者的患者特征、治疗及疗效的更多数据。在我们机构，诱导Cht后进行维持ET已成为标准临床实践。
