Prevalence and prognosis of patients with breast cancer eligible for adjuvant abemaciclib or ribociclib: a nationwide population-based study

IF 13 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2025-09-29 DOI:10.1016/j.lanepe.2025.101471

Xingrong Liu , Behnaz Binicy , Balazs Acs , Louise Eriksson Bergman , Sibylle Loibl , Michael Gnant , Michael Untch , Antonios Valachis , Jonas Bergh , Johan Hartman , Theodoros Foukakis , Alexios Matikas

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引用次数: 0

Abstract

Background

Nationwide studies on the prevalence, characteristics and long-term prognosis of patients with early breast cancer and a potential indication for adjuvant CDK4/6 inhibitors are lacking.

Methods

We leveraged a prospectively collected nationwide cohort of all patients treated for breast cancer in Sweden in 2007–2023 and identified patients fulfilling the monarchE and/or the NATALEE eligibility criteria, to estimate the proportion of eligible patients for adjuvant CDK4/6 inhibitors and their outcomes. Overall survival (OS) was the primary endpoint of interest. In addition, we compared distant relapse-free survival and OS of a patient subset treated in the Stockholm–Gotland region in 2012–2020 to patients enrolled in the phase 3 PANTHER trial (NCT00798070) in 2007–2011, before and after alignment of key inclusion criteria.

Findings

Of 52,602 patients with ER-positive, HER2-negative breast cancer, 9553 (18.2%) fulfilled both the monarchE and the NATALEE criteria, 9800 (18.6%) fulfilled the NATALEE criteria only and 745 patients (1.4%) fulfilled the monarchE criteria only. Median follow-up was 6.87 years. Ten-year OS rates were 65.7% (95% CI 65.3%–67.0%) for monarchE-eligible and 70.2% (95% CI 69.3%–71.1%) for NATALEE-eligible patients, and 84.0% (95% CI 83.4%–84.6%) for non-eligible, 75.5% (74.4$–76.7%) for NATALEE-only eligible and 64.3% (95% CI 62.9%–65.7%) for concordant eligible patients for both studies (p < 0.0001). Before alignment of inclusion criteria, patients treated within the PANTHER trial had improved outcomes compared to those treated in clinical routine. However, the differences in outcomes disappeared after alignment.

Interpretation

These results inform on the prevalence and prognosis of candidates for adjuvant CDK4/6 inhibitors at a nationwide level.

Funding

Cancerfonden, Bröstcancerförbundet, Radiumhemmets Forskningsfonder, Amgen, Roche, Sanofi-Aventis.

查看原文本刊更多论文

乳腺癌患者接受阿贝马昔单抗或核糖西尼辅助治疗的患病率和预后：一项基于全国人群的研究

关于早期乳腺癌患者的患病率、特征和长期预后以及辅助CDK4/6抑制剂的潜在适应症的全国性研究尚缺乏。方法：我们前瞻性地收集了2007-2023年瑞典所有乳腺癌患者的全国队列，并确定了符合monarchE和/或NATALEE资格标准的患者，以估计符合辅助CDK4/6抑制剂的患者比例及其结局。总生存期（OS）是主要研究终点。此外，我们比较了2012-2020年在斯德哥尔摩-哥特兰地区接受治疗的患者亚群与2007-2011年参加3期PANTHER试验（NCT00798070）的患者，在调整关键纳入标准之前和之后的远期无复发生存期和OS。结果：在52,602例er阳性her2阴性乳腺癌患者中，9553例（18.2%）同时满足monarchE和NATALEE标准，9800例（18.6%）仅满足NATALEE标准，745例（1.4%）仅满足monarchE标准。中位随访时间为6.87年。君主组10年OS率为65.7% (95% CI 65.3%-67.0%)， natalee组10年OS率为70.2% (95% CI 69.3%-71.1%)，非合格组10年OS率为84.0% (95% CI 83.4%-84.6%)，两项研究中仅natalee组10年OS率为75.5%(74.4美元-76.7%)，协和组10年OS率为64.3% (95% CI 62.9%-65.7%) （p < 0.0001）。在纳入标准调整之前，与临床常规治疗相比，在PANTHER试验中治疗的患者预后改善。然而，校正后结果的差异消失。这些结果说明了在全国范围内CDK4/6佐剂抑制剂候选患者的患病率和预后。FundingCancerfonden, Bröstcancerförbundet, radiumhemmet forskingsfonder，安进，罗氏，赛诺菲安万特。

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.