一项2期、开放标签、多中心、单臂试验，评估Abemaciclib +芳香酶抑制剂（AIs）作为一线富维司汀后二线治疗激素受体阳性（HR+）、人表皮生长因子受体阴性（HER2-）转移性乳腺癌（MBC）患者的活性和安全性。heromone -7试验的最终结果。

IF 2.5 3区医学 Q2 ONCOLOGY

Clinical breast cancer Pub Date : 2025-05-13 DOI:10.1016/j.clbc.2025.05.003

Cazzaniga Marina Elena , Pepe Francesca Fulvia , Rossi Emanuela , Coltelli Luigi , Beano Alessandra , Valerio Maria Rosaria , Ferro Antonella , Zustovich Fable , Moretti Gabriella , Toniolo Davide , Cordani Nicoletta , Galimberti Stefania , Capici Serena

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引用次数: 0

摘要

背景和目的：cdk4 /6抑制剂联合ET被推荐为HR+/HER2- MBC患者的一线治疗选择，但单独ET可能仍然是其中一些患者的选择。herone -7是一项多中心，单臂，II期研究，旨在评估Abemaciclib 150mg BID + AIs，在一线富维司汀进展的患者中。材料和方法：主要目标是Abemaciclib + AIs在临床获益率（CBR）方面的有效性，次要目标是进展时间（TTP）、总缓解率（ORR）、缓解持续时间（DOR）和安全性。结果：从2020年4月到2022年1月，我们入组了31例患者。中位年龄为72岁（47-86岁），55%有< 2合并症，以高血压为主（12.38.7%）。临床获益率为69% (95%CI, 49-85)， ORR为21% （95%CI, 8-40）。1年TTP和OS率分别为53.8% （95% CI, 38.6-74.9%）和69.5% （95% CI, 54.8%-88.5%）。主要不良事件为腹泻（80.6%）、疲劳（54.8%）和恶心（35.5%），非药物相关死亡事件3例（10.7%）。结论：herone -7研究表明，Abemaciclib + AIs的二线治疗对于一线使用富维司汀治疗进展的MBC患者是一种可行的选择，特别是在一些国家，从优化成本效益比的角度来看，这可能是一种替代方案。

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A Phase 2, Open Label, Multicenter, Single Arm Trial Evaluating the Activity and Safety of Abemaciclib + Aromatase Inhibitors (AIs) as Second-Line Treatment After First-Line Fulvestrant in Hormone-Receptor-Positive (HR+), Human-Epidermal-Growth-Factor-Receptor-Negative (HER2-) Metastatic Breast Cancer (MBC) Patients. Final Results of HERMIONE-7 Trial

Background and Purpose

CDK 4/6 inhibitors with ET are the recommended choice as 1st-line therapy in HR+/HER2- MBC patients, however ET alone could remain an option for some of them. HERMIONE-7 is a multicenter, single-arm, Phase II study, aimed to evaluate Abemaciclib 150 mg BID + AIs, in patients who progressed on 1st line Fulvestrant.

Materials and Methods

Primary aim was the efficacy of Abemaciclib + AIs in terms of Clinical Benefit Rate (CBR), secondary aims were Time to Progression (TTP), Overall Response Rate (ORR), duration of response (DOR), and safety.

Results

From April 2020 to January 2022, we enrolled 31 patients. Median age was 72 years (range 47-86), 55% had < 2 comorbidities, mainly hypertension (12, 38.7%). Clinical Benefit Rate was 69% (95% CI, 49-85) and ORR was 21% (95%CI, 8-40). 1-year TTP and OS rates were 53.8% (95% CI, 38.6-74.9%) and 69.5% (95% CI, 54.8%-88.5%), respectively. Main adverse events remain diarrhea (80.6%), fatigue (54.8%) and nausea (35.5%), 3 patients (10.7%) had non drug-related fatal events.

Conclusions

HERMIONE-7 study showed that 2nd-line treatment with Abemaciclib + AIs is a feasible option in MBC patients who progressed on Fulvestrant in 1st-line setting and could be an alternative especially in terms of optimizing the cost-benefit ratio in some Countries.

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来源期刊

Clinical breast cancer 医学-肿瘤学

CiteScore

5.40

自引率

3.20%

发文量

174

审稿时长

48 days

期刊介绍： Clinical Breast Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of breast cancer. Clinical Breast Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of breast cancer. The main emphasis is on recent scientific developments in all areas related to breast cancer. Specific areas of interest include clinical research reports from various therapeutic modalities, cancer genetics, drug sensitivity and resistance, novel imaging, tumor genomics, biomarkers, and chemoprevention strategies.