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Guiding treatment decisions in early breast cancer: A model-based comparison of the OncotypeDX and MammaPrint tests 指导早期乳腺癌的治疗决策:OncotypeDX和MammaPrint测试的基于模型的比较
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2026-01-12 DOI: 10.1016/j.breast.2026.104698
Frank Doornkamp , Liesbeth C. de Wreede , Elfi Verheul , Agnes Jager , Ewout W. Steyerberg

Introduction

Genomic tests may improve chemotherapy allocation in early-stage breast cancer beyond traditional clinical factors. We compared the clinical usefulness of two multi-genomic tests, MammaPrint and OncotypeDX, in guiding adjuvant chemotherapy decisions.

Methods

The MINDACT and TAILORx trials provided prospective validation for the MammaPrint and OncotypeDX tests, respectively. We generated two synthetic cohorts to evaluate both tests in both trial contexts. Chemotherapy was assumed to be indicated if it was expected to reduce the risk of an event by at least 5 %, defining events as 10-year distant metastases or breast cancer–related death. We compared treatment decision making informed by clinical risk information alone versus clinical information plus either the MammaPrint (dichotomous score: high/low risk) or OncotypeDX test (dichotomous and continuous scores). These strategies were evaluated using Net Benefit: a weighted difference of preventing events through treatment and the number of treatments given.

Results

Treatment decision-making informed by clinical information alone would result in a positive balance between preventing events and treatments given in both synthetic cohorts (4.8 net benefit in MINDACT, 3.0 in TAILORx per 1000 patients). Incorporating OncotypeDX into risk assessment improved treatment allocation more than MammaPrint (+2.6 vs + 1.6 in MINDACT, +1.3 vs + 1.0 in TAILORx contexts), with substantial uncertainty. Using the dichotomized OncotypeDX score limited its clinical usefulness compared to using its underlying continuous score.

Discussion

Both MammaPrint and OncotypeDX tests improve identifying candidates for chemotherapy among women with early breast cancer, with broadly equivalent clinical usefulness. The tests should be implemented into existing risk algorithms to maximize their clinical usefulness.
除了传统的临床因素外,基因组检测可能改善早期乳腺癌的化疗分配。我们比较了两种多基因组检测(MammaPrint和OncotypeDX)在指导辅助化疗决策方面的临床实用性。方法MINDACT和TAILORx试验分别为MammaPrint和OncotypeDX试验提供了前瞻性验证。我们生成了两个合成队列来评估两个试验背景下的两个测试。如果预期化疗可以将事件的风险降低至少5%,则认为化疗是指10年远处转移或乳腺癌相关死亡。我们比较了单独的临床风险信息与临床信息加mamaprint(二分评分:高/低风险)或OncotypeDX测试(二分和连续评分)的治疗决策。这些策略使用净效益进行评估:通过治疗预防事件的加权差异和给予的治疗次数。结果:仅根据临床信息做出治疗决策将导致两个合成队列中预防事件和给予治疗之间的积极平衡(每1000名患者中,MINDACT组净获益4.8,TAILORx组净获益3.0)。将OncotypeDX纳入风险评估比mamaprint更能改善治疗分配(在MINDACT中为+2.6 vs + 1.6,在TAILORx中为+1.3 vs + 1.0),但存在很大的不确定性。与使用其基础连续评分相比,使用二分类OncotypeDX评分限制了其临床实用性。mamaprint和OncotypeDX检测提高了早期乳腺癌女性化疗候选患者的识别,具有大致相同的临床用途。应将这些测试应用于现有的风险算法中,以最大限度地发挥其临床效用。
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引用次数: 0
A UK study of the experiences, information needs and attitudes to clinical research among patients living with secondary breast cancer in the UK: A prospective co-developed study 一项关于英国继发性乳腺癌患者的经历、信息需求和临床研究态度的英国研究:一项前瞻性共同开发的研究
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-12 DOI: 10.1016/j.breast.2025.104644
Lesley Stephen , Janet Dunn , Claire Balmer , Nada Elbeltagi , Sophie Gasson , Ellen Copson , Carlo Palmieri

Background

Clinical research is key to improving the outcomes of patients with metastatic breast cancer (MBC). However, participation is low, with little data on patients’ attitudes and experiences of clinical research. This study aimed to explore the experience and attitude of patients in accessing and participating in clinical research in the UK.

Methods

An online survey, available between May and November 2021, was open to people living with MBC in the UK; this was complemented with by qualitative interviews.

Findings

768 responses were received (766 female, 2 male); median age was 51–60 years with 235 (31 %) having de novo disease. 660 (86 %) respondents were confident in their understanding of clinical research. Discussion of participation in research with an oncologist was reported by 173 (23 %) respondents. Accessing new treatments was the most common reason for study participants wanting to take part in research, 737 (96 %). Of the 107 (14 %) respondents who had taken part in clinical trials, 77 (72 %) reported a positive experience. 276 (36 %) would consider travelling to participate in research and 430 (56 %) would be more likely to travel if expenses were met. Themes emerging from the qualitative interviews include ‘lack of information’, ‘barriers to participation’ and ‘participants research priorities’.

Interpretation

This is the largest UK prospective study in regards to the views of MBC patients towards research. It demonstrates keenness to be involved in research, but participants face barriers as well as a lack of opportunity for participation. Key messages include importance of clinical staff in providing research information, need to develop patient accessible information, and to support travel costs. Improvements within the UK health care system are necessary to enable MBC patients to have equitable access to clinical research.
临床研究是改善转移性乳腺癌(MBC)患者预后的关键。然而,参与率很低,很少有关于患者对临床研究的态度和经验的数据。本研究旨在探讨英国患者获取和参与临床研究的经验和态度。方法在2021年5月至11月期间对英国MBC患者进行在线调查;此外,还进行了定性访谈。共收到768份回复(女性766份,男性2份);中位年龄为51-60岁,其中235例(31%)为新发疾病。660名(86%)受访者对自己对临床研究的理解充满信心。173名(23%)受访者报告了与肿瘤学家讨论参与研究的情况。获得新的治疗方法是研究参与者想要参加研究的最常见原因,737(96%)。在参与临床试验的107名(14%)受访者中,77名(72%)报告了积极的经历。276人(36%)会考虑出差参加研究,430人(56%)在费用得到满足的情况下更有可能出差。定性访谈的主题包括“缺乏信息”、“参与障碍”和“参与者的研究重点”。这是英国最大的关于MBC患者对研究看法的前瞻性研究。它显示了参与研究的热情,但参与者面临着障碍以及缺乏参与机会。关键信息包括临床工作人员在提供研究信息方面的重要性、开发患者可获取信息的必要性以及支持差旅费用。为了使MBC患者能够公平地获得临床研究,英国医疗保健系统的改进是必要的。
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引用次数: 0
Critical appraisal of a machine learning model for predicting internal mammary lymph node metastasis in breast cancer 预测乳腺癌内乳淋巴结转移的机器学习模型的关键评价。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-14 DOI: 10.1016/j.breast.2025.104652
Kun Fang , Suxiao Jiang , Ping Zhang
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引用次数: 0
Beyond survival: Confronting the unmet needs in oncofertility care for young women with breast cancer 超越生存:面对年轻乳腺癌妇女的未满足的肿瘤生育保健需求。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-11 DOI: 10.1016/j.breast.2025.104676
Sophie Richard , Megan Tesch , Nathalie LeVasseur
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引用次数: 0
Optimizing adjuvant endocrine therapy in premenopausal patients with HER2-positive, hormone receptor-positive breast cancer 优化绝经前her2阳性、激素受体阳性乳腺癌患者的辅助内分泌治疗。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2026-01-12 DOI: 10.1016/j.breast.2026.104696
Carmine Valenza MD, MPH , Ann H. Partridge MD, MPH , Meredith M. Regan ScD
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引用次数: 0
Effect of a mobile mammography unit on participation and equity in breast cancer screening: a cluster randomised trial in Normandy, France 移动乳房x线照相术对参与和公平乳腺癌筛查的影响:法国诺曼底的一项随机分组试验
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-27 DOI: 10.1016/j.breast.2025.104686
Gniré Koné , Séverine Beuriot , Ludivine Launay , Guy Launoy , Elodie Guillaume

Background

Participation in organised breast cancer screening (OBCS) in France has declined over the past decade. This study evaluated the contribution of mobile mammography units (MMUs) to increasing screening participation through a prospective cluster-randomised controlled trial conducted in France.

Methods

This interventional study was conducted among the general population in four departments of the Normandy region. Areas located >15 min from a radiology centre were grouped into clusters and randomly assigned (1:1) to either an intervention or control arm. In total, 320 areas inhabited by 87,449 women aged 50 to 74 years were included. In the intervention arm, women whose last mammogram was performed at least 22 months earlier received, besides to the usual invitation, an appointment at the MMU sent by the regional screening management structure. The primary outcome was the BCS participation rate. A cluster-adjusted proportion test was used to compare participation between arms.

Results

In the intervention arm, 22,964 women were screened out of the 38,382 invited, yielding a participation rate of 59.8% vs 51.1% in the control areas (25,099/49,067). The MMU intervention was associated with a statistically significant increase in participation of 8.7% (p<0.0001) compared with the control arm. In the intervention arm, women screened in the MMU tended to be younger and more deprived than those who opted for a radiology centre.

Conclusions

The addition of an MMU to the OBCS programme in France significantly increased participation among women living furthest from radiology centres and can reduce social and geographic inequities.
背景:在过去的十年中,法国参加有组织的乳腺癌筛查(OBCS)的人数有所下降。本研究通过在法国进行的前瞻性集群随机对照试验,评估了移动乳房x线照相术(MMUs)对提高筛查参与率的贡献。方法对诺曼底地区4个省的普通人群进行介入研究。距离放射中心15分钟路程的区域被分组,并随机(1:1)分配到干预组或对照组。总共包括有87,449名50至74岁妇女居住的320个地区。在干预组,最后一次乳房x光检查至少在22个月前进行的妇女,除了通常的邀请外,还收到了由地区筛查管理机构发送的MMU预约。主要结果是BCS参与率。采用聚类调整比例检验比较各组间的参与情况。结果干预组38382名受邀妇女中,有22964名被筛查,参与率为59.8%,对照组为51.1%(25,099/49,067)。与对照组相比,MMU干预与8.7% (p<0.0001)的参与率显著增加相关。在干预组中,在MMU接受筛查的女性往往比选择放射中心的女性更年轻,也更贫困。结论:在法国的OBCS项目中增加了MMU,大大增加了居住在离放射中心最远的妇女的参与,并可以减少社会和地理上的不平等。
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引用次数: 0
FDA and EMA approval of datopotamab-deruxtecan: A paradigm shift in breast cancer drug evaluation? FDA和EMA批准datopotamab-deruxtecan:乳腺癌药物评估的范式转变?
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-23 DOI: 10.1016/j.breast.2025.104589
Armando Orlandi
The January 2025 FDA and EMA approvals of datopotamab-deruxtecan for metastatic HR-positive, HER2-negative breast cancer represents an unprecedented regulatory decision. The TROPION-Breast01 trial demonstrated significant progression-free survival improvement (6.9 vs 4.9 months; HR 0.63) but failed to show overall survival benefit (18.6 vs 18.3 months; HR 1.01)[1,2]. This marks the first full approval of a breast cancer therapeutic that failed a co-primary overall survival endpoint. Subsequently, the European Medicines Agency also granted marketing authorization in January 2025, creating a concerning precedent across both major regulatory agencies. With both major regulatory agencies now having approved this agent, breast cancer specialists must grapple with fundamental questions: What constitutes meaningful clinical benefit in heavily pretreated patients? How should we interpret trials with divergent endpoint results? This commentary examines the implications for breast cancer practice and argues for urgent reassessment of evidence standards as the therapeutic landscape evolves.
2025年1月,FDA和EMA批准datopotamab-deruxtecan治疗转移性hr阳性、her2阴性乳腺癌,这是一项前所未有的监管决定。TROPION-Breast01试验显示无进展生存期显著改善(6.9个月vs 4.9个月;HR 0.63),但未能显示总生存期获益(18.6个月vs 18.3个月;HR 1.01)[1,2]。这标志着首次全面批准了一种未能达到共同主要总生存终点的乳腺癌治疗方法。随后,欧洲药品管理局也于2025年1月批准了上市许可,在两个主要监管机构中创造了一个令人担忧的先例。现在两大监管机构都批准了这种药物,乳腺癌专家必须努力解决一些基本问题:什么构成了大量预处理患者的有意义的临床益处?我们应该如何解释具有不同终点结果的试验?这篇评论探讨了对乳腺癌实践的影响,并主张随着治疗领域的发展,对证据标准进行紧急重新评估。
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引用次数: 0
Effectiveness of hybrid digital breast tomosynthesis/digital mammography in women presenting for routine screening at Maroondah BreastScreen, Australia: Interim analysis 在澳大利亚Maroondah乳房筛查中心进行常规筛查的妇女中,混合数字乳腺断层合成/数字乳房x光检查的有效性:中期分析
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-27 DOI: 10.1016/j.breast.2025.104640
M Luke Marinovich , Darren Lockie , Michelle Giles , Sally Doncovio , Georgina Marr , David Taylor , Tong Li , Brooke Nickel , Nehmat Houssami
Hybrid digital breast tomosynthesis (DBT)/digital mammography (DM) (mediolateral oblique from DBT with synthetic 2D, craniocaudal from DM) can potentially improve breast cancer detection and address longer DBT screen-reading time. This pre-specified interim analysis presents the first 5,000 (of target 20,000) hybrid DBT/DM screens in an ongoing prospective trial in BreastScreen Australia. Cancer detection rate for hybrid DBT/DM was 10.6/1,000 screens; recall rate was 4.2 %; median screen-reading time was 36 seconds; and mean glandular dose was 2.49 mGy. Cancer detection and recall rates for hybrid DBT/DM were consistent with DBT metrics in a previous pilot study; screen-reading time was approximately halved.
数字乳房断层合成(DBT)/数字乳房x线摄影(DM) (DBT的中外侧斜位与合成2D, DM的颅侧侧)可以潜在地改善乳腺癌的检测,并解决DBT屏幕阅读时间较长的问题。这项预先指定的中期分析在澳大利亚乳房筛查中心进行的前瞻性试验中展示了前5000个(目标20000个)DBT/DM混合筛查。混合DBT/DM的肿瘤检出率为10.6/ 1000;召回率为4.2%;屏幕阅读时间中位数为36秒;平均腺剂量为2.49 mGy。在之前的试点研究中,混合DBT/DM的癌症检出率和召回率与DBT指标一致;屏幕阅读时间大约减半。
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引用次数: 0
Brain imaging screening in metastatic breast cancer: Is it time to rethink clinical guidelines and practice? 转移性乳腺癌的脑成像筛查:是时候重新思考临床指南和实践了吗?
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-17 DOI: 10.1016/j.breast.2025.104616
Sarah Sammons , Nayan Lamba , Nancy U. Lin
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引用次数: 0
Development and validation of a next-generation sequencing-based method for calculating the breast cancer polygenic risk score PRS313 新一代基于测序的乳腺癌多基因风险评分方法PRS313的开发和验证
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-16 DOI: 10.1016/j.breast.2025.104580
Flora Ponelle-Chachuat , Mathis Lepage , Sandrine Viala , Mikaïl Kelleci , Edith Le Floch , Claire Dandine-Roulland , Delphine Bacq , Robert Olaso , Jean-François Deleuze , Nancy Uhrhammer , Mathilde Gay-Bellile , Yannick Bidet , Maud Privat
Polygenic risk scores (PRS) are genetic tools that quantify an individual's predisposition to certain diseases by combining the effects of many genetic variants. The PRS313 includes 313 genomic variants and has been incorporated into the BOADICEA prediction model and in the CanRisk software to refine breast cancer risk. However, its current implementation relies on SNP microarrays, limiting its use in sequencing-based clinical workflows.
In this study, we directly compared SNP microarray technology and targeted NGS sequencing to determine the PRS313. The two methods were tested for 154 patients. To replace PRS313 SNPs with low sequencing coverage and/or in regions of low complexity, 27 proxy SNPs in high linkage disequilibrium were integrated into the panel. After this optimization, the NGS-derived PRS313 demonstrated strong concordance with the microarray reference (R2 = 0.95), with sensitivity and specificity reaching 96 % and 97 %, respectively. Moreover, the clinical risk category, as defined by CanRisk, remained consistent in 97 % of cases across both methods.
These findings validate the use of targeted NGS for PRS313 calculation, demonstrating its feasibility, accuracy, and potential for easy integration into routine oncogenetic workflows. By enabling PRS calculation from the same sequencing data used for gene panel testing, this approach eliminates the need for separate genotyping platforms, offering a cost-effective and clinically practical solution to support the broader implementation of personalized breast cancer risk prediction.
多基因风险评分(PRS)是一种遗传工具,通过结合许多遗传变异的影响,量化个体对某些疾病的易感性。PRS313包括313个基因组变体,已被纳入BOADICEA预测模型和CanRisk软件,以改善乳腺癌风险。然而,其目前的实施依赖于SNP微阵列,限制了其在基于测序的临床工作流程中的使用。在本研究中,我们直接比较了SNP微阵列技术和靶向NGS测序来确定PRS313。这两种方法在154例患者中进行了测试。为了取代低测序覆盖率和/或低复杂性区域的PRS313 snp,将27个高连锁不平衡的代理snp整合到面板中。优化后,ngs衍生的PRS313与芯片参考基因具有较强的一致性(R2 = 0.95),灵敏度和特异性分别达到96%和97%。此外,CanRisk定义的临床风险类别在两种方法中97%的病例保持一致。这些发现验证了靶向NGS在PRS313计算中的应用,证明了其可行性、准确性,以及易于整合到常规肿瘤发生工作流程中的潜力。通过从用于基因面板测试的相同测序数据中计算PRS,该方法消除了对单独的基因分型平台的需求,为支持个性化乳腺癌风险预测的更广泛实施提供了一种具有成本效益和临床实用性的解决方案。
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引用次数: 0
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