Abemaciclib Persistence in Patients with HR+, HER2-, Node-Positive Early Breast Cancer: a Real-World Analysis.

IF 3.2 Q2 ONCOLOGY

Oncology and Therapy Pub Date : 2025-10-02 DOI:10.1007/s40487-025-00385-9

Kathryn Hudson, Wambui Gathirua-Mwangi, Lindsay A Williams, Zhanglin Lin Cui, Madeline Richey, Brenda Grimes, Jingru Wang, Astra M Liepa, Erich Brechtelsbauer, Raisa Volodarsky, Katheryn Moreira, Hatem Soliman

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引用次数: 0

Abstract

Introduction: Patients with node-positive, high-risk, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC) can be treated with 2 years of abemaciclib plus endocrine therapy (ET) to improve invasive disease-free survival (IDFS; hazard ratio 0.68; absolute 7.6% 5-year IDFS benefit) over ET alone as observed in the monarchE trial. Most adverse events (AEs) from abemaciclib occurred early in treatment and could be managed with dose reductions while maintaining efficacy. Describing adjuvant abemaciclib dosing patterns and early treatment persistence in patients in a real-world node-positive EBC cohort provides new evidence on abemaciclib administration in clinical practice and may inform AE management.

Methods: Using the Flatiron Health Research Database de-identified data from October 2021 to February 2023, this retrospective study included patients aged ≥ 18 years with node-positive, HR+, HER2- EBC without prior CDK4/6 inhibitor exposure who initiated adjuvant abemaciclib at 150 mg twice daily (BID) and had ≥ 3 months follow-up. Dose modifications were identified. The persistence rate (%) and reasons for treatment discontinuation were described.

Results: Among 354 patients (99.7% female), 88.1% of patients continued abemaciclib beyond 3 months. Dose reductions were observed in 50.8% of patients. Median time to first dose reduction was 59 days (IQR 35, 99). Of the patients with a dose reduction, 93.3% continued abemaciclib beyond 3 months. Among patients who discontinued abemaciclib because of AEs within 3 months of initiation without evidence of reinitiation (n = 40), 70.0% had no evidence of a dose reduction.

Conclusion: Eighty-eight percent of patients continued adjuvant abemaciclib beyond 3 months, demonstrating high early persistence and tolerance of abemaciclib in patients with node-positive EBC in a real-world clinical practice cohort. Persistence was 93.3% among patients who had a dose reduction, suggesting that timely dose adjustments, when needed, can promote early persistence on abemaciclib, particularly when patient-felt AEs are most frequent and can be effectively managed.

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Abemaciclib在HR+， HER2-，淋巴结阳性早期乳腺癌患者中的持续性：一项现实世界分析

在monarchE试验中观察到，淋巴结阳性、高风险、激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）早期乳腺癌（EBC）患者可以接受2年的阿贝马昔利布联合内分泌治疗（ET），以提高侵袭性无病生存（IDFS；风险比0.68；5年IDFS绝对获益7.6%）。abemaciclib的大多数不良事件（ae）发生在治疗早期，可以通过减少剂量来控制，同时保持疗效。描述abemaciclib辅助给药模式和真实世界淋巴结阳性EBC队列患者的早期治疗持续性，为临床实践中的abemaciclib给药提供了新的证据，并可能为AE管理提供信息。方法：使用Flatiron健康研究数据库（Flatiron Health Research Database）从2021年10月至2023年2月的去识别数据，这项回顾性研究纳入了年龄≥18岁、淋巴结阳性、HR+、HER2- EBC、之前没有CDK4/6抑制剂暴露的患者，这些患者开始了阿贝马昔利（abemaciclib）的辅助治疗，剂量为150 mg，每日两次（BID），随访时间≥3个月。确定了剂量调整。描述了持续率（%）和停止治疗的原因。结果：在354例患者中（99.7%为女性），88.1%的患者持续使用阿贝马昔单抗超过3个月。50.8%的患者出现剂量减少。至首次减量的中位时间为59天（IQR 35,99）。在剂量减少的患者中，93.3%的患者在3个月后继续服用阿贝马昔利。在开始治疗3个月内因不良事件而停止使用阿贝马昔利布且无重新开始治疗证据的患者中（n = 40）， 70.0%的患者没有剂量减少的证据。结论：在现实世界的临床实践队列中，88%的患者继续使用abemaciclib辅助治疗超过3个月，在淋巴结阳性EBC患者中显示出较高的早期持久性和abemaciclib耐受性。减少剂量的患者中有93.3%的患者坚持服用，这表明在需要时及时调整剂量可以促进早期对abemaciclib的坚持，特别是当患者感觉ae最频繁且可以有效管理时。

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来源期刊

Oncology and Therapy ONCOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of clinical therapies. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. Digital features and plain language summaries Oncology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors'' or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Please see here for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case by case basis and should be sent to the journal editor. Copyright Oncology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. 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