Real-world Outcomes of Dual HER2 Blockade Therapy in Metastatic HER2-Positive Breast Cancer: from Induction to Maintenance.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY Drugs - Real World Outcomes Pub Date : 2024-09-01 Epub Date: 2024-06-16 DOI:10.1007/s40801-024-00438-x
Marija Križić, Marina Popović, Tajana Silovski, Dorotea Grbin, Natalija Dedić Plavetić
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Abstract

Background and objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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转移性 HER2 阳性乳腺癌 HER2 双阻断疗法的实际效果:从诱导到维持。
背景和目的:由于 CLEOPATRA 研究取得了令人瞩目的成果,曲妥珠单抗和百妥珠单抗联合他坦类药物化疗(Cht)的双重人类表皮生长因子受体 2(HER2)阻断疗法多年来一直是 HER2 阳性转移性乳腺癌(mBC)的标准一线治疗方法。真实世界(RW)研究已成为评估现实生活中治疗有效性和安全性的关键。本研究旨在分析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)患者使用维持性内分泌治疗(ET)的情况:这项回顾性分析纳入了2015年10月至2020年12月期间在萨格勒布大学医院中心接受曲妥珠单抗和百妥珠单抗联合紫杉类药物治疗的106例HER2阳性mBC患者:中位随访时间为 30 个月,全部患者的中位无进展生存期 (PFS) 为 25 个月(95% 置信区间 [CI] 16 - 未分析)。与复发患者相比,新发 mBC 患者的中位无进展生存期更长(未达 18 个月 vs. 18 个月;危险比 1.99;95% CI 0.69-3.64,p):这项回顾性研究提供了更多有关RW HER2阳性乳腺癌患者的特征、治疗和预后的数据,这些患者接受了百妥珠单抗和曲妥珠单抗作为一线疗法。在我院,诱导 Cht 后的维持 ET 已成为标准临床实践。
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来源期刊
Drugs - Real World Outcomes
Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-
CiteScore
3.60
自引率
5.00%
发文量
49
审稿时长
8 weeks
期刊介绍: Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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