IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

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

Multidisciplinary meeting for breast cancer care: EUSOMA recommendations for optimization 乳腺癌护理多学科会议：EUSOMA优化建议。

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-27 DOI: 10.1016/j.breast.2025.104682

G. Curigliano , L. Marotti , C. Barrios , N.M.L. Battisti , K.L. Cheung , S. Chia , S.L. Graff , O.J. Hartmann , I. Rubio , D. Santini , F. Sardanelli , E. Senkus , P. van Dam , M. Walker , J. Wu , C. Aristei

Introduction

In breast cancer care multidisciplinary meetings (MDMs) are fundamental. Recently, the increasing number of patients, the complexity of cancer treatments, the shortages of specialists, and constrained hospital budgets have underscored the urgency of optimizing MDM processes to ensure that every patient benefits from thorough and timely multidisciplinary evaluation.

Material and methods

The European Society of Breast Cancer Specialists (EUSOMA) set up a multidisciplinary working group of international experts to develop consensus-based recommendations to optimize MDM management. To obtain insights into the current state of MDM organization and management within Europe and elsewhere, the experts designed and conducted an international survey.

Results

Briefly, the survey showed that most centres held a weekly MDM, either in person, online or combining the modalities, which lasted for 1−2 h. Discussion times for each case varied with its complexity. Some differences emerged between European and non- European breast cancer centres. The recommendations for improving MDM management focused on: i) timing, venue, logistics, administrative support; ii) technologies/equipment; iii) documentation; iv) planning and preparation; v) structure; vi) minutes/reporting; and viii) other issues.

Conclusion

Optimizing MDM ensures that each patient receives the most appropriate, guideline-aligned treatment, tailored to individual needs. With the present recommendations, EUSOMA wishes to support breast centres in improving and standardizing MDM management.

简介：在乳腺癌治疗中，多学科会议（MDMs）是基础。最近，随着患者数量的增加、癌症治疗的复杂性、专家的短缺以及医院预算的限制，迫切需要优化MDM流程，以确保每位患者都能从全面和及时的多学科评估中受益。材料和方法：欧洲乳腺癌专家协会（EUSOMA）建立了一个多学科的国际专家工作组，以制定基于共识的建议，以优化MDM管理。为了深入了解欧洲和其他地方的MDM组织和管理的现状，专家们设计并进行了一次国际调查。结果：简单地说，调查显示，大多数中心每周举行一次MDM，无论是亲自、在线还是结合各种方式，持续1-2小时。每个病例的讨论时间因其复杂程度而异。欧洲和非欧洲乳腺癌中心之间出现了一些差异。改善MDM管理的建议集中在：i)时间、场地、后勤、行政支持；(二)技术/设备;3)文档;Iv)策划和准备；v)结构;(六)分钟/报告;（八）其他问题。结论：优化MDM可确保每位患者接受最合适的、符合指南的治疗，并根据个人需求量身定制。根据目前的建议，欧洲乳腺组织希望支持乳腺中心改进和标准化MDM管理。

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引用次数: 0

Baseline systemic inflammatory indices predict late radiation-induced fibrosis and toxicity in patients with early breast cancer 基线全身性炎症指数预测早期乳腺癌患者晚期放射诱导的纤维化和毒性。

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-26 DOI: 10.1016/j.breast.2025.104685

Lorenzo Vinante , Jerry Polesel , Andrea Sacilotto , Anna Giroldi , Angela Caroli , Alberto Revelant , Cristina Cappelletto , Paola Chiovati , Alessia Chiofalo , Samuele Massarut , Barbara Belletti , Maurizio Mascarin , Agostino Steffan , Lorena Baboci

Radiation therapy (RT) is a standard component of treatment for early breast cancer and ductal carcinoma in situ. Although survival is excellent, RT-related side effects can impair long-term quality of life. We aimed to develop models to predict the risk of Grade ≥2 fibrosis and other late toxicities by combining clinical risk factors with baseline systemic inflammatory indices.

In this prospective study, 324 women underwent breast-conserving surgery followed by whole-breast RT and were followed for 24 months. Pre-surgical blood counts were used to calculate inflammatory indices, including NLR, dNLR, PLR, MLR, NLPR, SII, SIRI and AISI. Optimal cut-offs for each index was determined using ROC curves. Predictive models integrated clinical factors (surgical complications, post-menopausal status, chemotherapy, smoking, RT dose) with individual inflammatory indices to predict Grade ≥2 fibrosis and overall late side effects (fibrosis, skin side effects, chronic pain, lymphoedema).

At 24 months, 13.0 % of patients had developed Grade ≥2 fibrosis and 17.9 % had at least one Grade ≥2 late side effect. Patients who developed fibrosis had higher baseline NLR, dNLR, MLR, NLPR and SIRI. Models incorporating MLR or NLPR achieved area under the curve values > 0.70 and negative predictive values ≥ 93 %, outperforming models based on clinical risk factors alone. These findings suggest that routinely measured systemic inflammatory indices can identify patients at low risk of late RT side effects. If validated in external cohorts, these models may help tailor RT regimens to minimize long-term complications while maintaining therapeutic benefit.

放射治疗（RT）是早期乳腺癌和导管原位癌治疗的标准组成部分。虽然生存率很好，但rt相关的副作用会损害长期生活质量。我们的目标是建立模型，通过结合临床危险因素和基线全身性炎症指数来预测≥2级纤维化和其他晚期毒性的风险。在这项前瞻性研究中，324名妇女接受了保乳手术，随后进行了全乳RT，随访24个月。术前血球计数计算炎症指标，包括NLR、dNLR、PLR、MLR、NLPR、SII、SIRI、AISI。采用ROC曲线确定各指标的最佳截止点。预测模型将临床因素（手术并发症、绝经后状态、化疗、吸烟、RT剂量）与个体炎症指数结合，预测≥2级纤维化和总体晚期副作用（纤维化、皮肤副作用、慢性疼痛、淋巴水肿）。在24个月时，13.0%的患者发生≥2级纤维化，17.9%的患者至少有一个≥2级的晚期副作用。发生纤维化的患者有更高的基线NLR、dNLR、MLR、NLPR和SIRI。纳入MLR或NLPR的模型的曲线下面积值为> 0.70，阴性预测值≥93%，优于仅基于临床危险因素的模型。这些发现表明，常规测量全身炎症指数可以识别晚期RT副作用风险低的患者。如果在外部队列中得到验证，这些模型可能有助于定制放疗方案，以最大限度地减少长期并发症，同时保持治疗效果。

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引用次数: 0

Standardized patient coaching improves therapy persistence in patients with hormone receptor–positive, HER2–negative advanced/metastatic breast cancer treated with abemaciclib 标准化的患者指导提高了接受abemaciclib治疗的激素受体阳性、her2阴性的晚期/转移性乳腺癌患者的治疗持久性

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-23 DOI: 10.1016/j.breast.2025.104684

Manfred Welslau , Peter A. Fasching , Nicole Semmler-Lins , Lothar Mueller , Erik Belleville , Lorenz Rieger , Sabrina Uhrig , Mark-Oliver Zahn , Benno Lex , Christoph Uleer , Natalija Deuerling , Tobias Hesse , Dagmar Langanke , Lothar Häberle , Hans Tesch

Introduction

Therapy adherence is critical, particularly for patients with breast cancer undergoing oral endocrine therapies. The use of combination regimes, such as CDK4/6 inhibitors, has introduced additional side effects, which can affect adherence. A structured patient coaching and communication tool may positively affect therapy adherence.

Methods

The IMPACT study (NCT04030728) was a randomized trial including patients with advanced breast cancer (aBC) receiving abemaciclib as part of routine clinical care. The study examined the influence of structured coaching on patient adherence. Participants were randomized to receive therapy management incorporating the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool (MOATT©) or local standard of care practice (LSOC). The primary endpoint was the persistence rate at week 24 (PR24). Secondary endpoints included time to therapy discontinuation (TTD) and quality of life.

Results

A total of 201 patients were randomized and initiated abemaciclib therapy. By week 24, 22 (10.9 %) patients had permanently discontinued abemaciclib for reasons other than progression or death: 14 (14.1 %) in the LSOC arm and 8 (7.8 %) in the MOATT© arm. PR24 was 68.9 % (95 % CI: 58.3–78.2) in the LSOC arm and 81.6 % (95 % CI: 72.5–88.7) in the MOATT© arm, yielding an odds ratio of 2.01 (95 % CI: 1.02–3.96; P = 0.04). TTD showed a hazard ratio of 0.59 (95 % CI: 0.32–1.07), favoring the MOATT© arm. No significant differences in quality of life between study arms were observed.

Conclusion

Individual patient coaching based on MOATT© demonstrated improved PR24 for patients undergoing abemaciclib treatment for aBC.

治疗依从性至关重要，特别是对接受口服内分泌治疗的乳腺癌患者。使用联合方案，如CDK4/6抑制剂，已经引入了额外的副作用，这可能会影响依从性。结构化的患者指导和沟通工具可能对治疗依从性产生积极影响。IMPACT研究（NCT04030728）是一项随机试验，纳入了接受abemaciclib作为常规临床护理一部分的晚期乳腺癌（aBC）患者。该研究考察了结构化指导对患者依从性的影响。参与者被随机分配接受治疗管理，包括多国癌症支持治疗协会（MASCC）口服药物教学工具（MOATT©）或当地护理实践标准（LSOC）。主要终点是第24周的持续率（PR24）。次要终点包括治疗停止时间（TTD）和生活质量。结果201例患者随机接受阿贝马昔单抗治疗。到第24周，22例（10.9%）患者因进展或死亡以外的原因永久停药：LSOC组14例（14.1%），MOATT©组8例（7.8%）。LSOC组PR24为68.9% (95% CI: 58.3-78.2)， MOATT©组PR24为81.6% (95% CI: 72.5-88.7)，优势比为2.01 （95% CI: 1.02-3.96; P = 0.04）。TTD的风险比为0.59 (95% CI: 0.32-1.07)，有利于MOATT©组。研究组之间的生活质量没有显著差异。结论基于MOATT©的个体患者指导显示，接受阿贝马昔利布治疗的aBC患者PR24得到改善。

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引用次数: 0

How should we manage abemaciclib in the peri-operative period during secondary breast reconstruction: balancing oncologic benefit and surgical safety 我们应该如何管理abemaciclib在围手术期的二次乳房重建：平衡肿瘤效益和手术安全。

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-22 DOI: 10.1016/j.breast.2025.104683

Michel Gabriel Cazenave , Leslie Elahi , Katia Mahiou , Claire Bonneau , Ornella Ammendola , Louise Benoit

Abemaciclib, a CDK4/6 inhibitor, has emerged as a pivotal therapy in hormone receptor–positive, HER2-negative breast cancer, including in the adjuvant setting for high-risk early disease. Its integration into long-term oncologic strategies poses new challenges for peri-operative management, particularly in the context of secondary breast reconstruction. Preclinical studies suggest impaired wound healing potential, while clinical data highlight an increased risk of venous thromboembolism. No study to date has specifically addressed surgical outcomes under abemaciclib therapy. We call for the need of a clinical trial in abemaciclib perioperative management and propose pragmatic peri-operative strategies to optimize patient safety without compromising oncologic benefit.

Abemaciclib是一种CDK4/6抑制剂，已成为激素受体阳性、her2阴性乳腺癌的关键治疗药物，包括高危早期疾病的辅助治疗。它与长期肿瘤学策略的结合对围手术期管理提出了新的挑战，特别是在二次乳房重建的背景下。临床前研究表明伤口愈合潜力受损，而临床数据强调静脉血栓栓塞的风险增加。到目前为止，还没有研究专门针对abemaciclib治疗下的手术结果。我们呼吁对abemaciclib围手术期管理进行临床试验，并提出实用的围手术期策略，以优化患者的安全性，同时不损害肿瘤效益。

引用次数: 0

HER2/CEP17 ratio is associated with pCR after HER2-directed neoadjuvant treatment in the phase III NeoALTTO trial 在III期NeoALTTO试验中，HER2/CEP17比率与HER2定向新辅助治疗后的pCR相关。

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-22 DOI: 10.1016/j.breast.2025.104679

Christian F. Singer , Franz Koenig , Stephanie Kacerovsky-Strobl , Sabine Danzinger , Christine Brunner , Christoph Suppan , Christine Deutschmann , Marija Balic , Richard Greil , Daniel Egle , Evandro de Azambuja , Serena Di Cosimo , Anup Choudhury , Michael Gnant

Purpose

In early breast cancer, HER2-directed therapies are approved for the treatment of patients with HER2-positive invasive breast cancer as defined by HER2 protein overexpression, or HER2 gene amplification with HER2/CEP17 ratios ≥2.2. Beyond this cut-off, however, it is unknown whether the efficacy of HER2-directed therapy improves with increasing HER2/CEP17 ratios. We evaluated whether quantitative assessment of the HER2/CEP17 ratio predicts pathological complete response (pCR) and event-free survival (EFS) in patients treated with neoadjuvant HER2-based regimen in the prospective phase III NeoALTTO trial.

Patients and methods

455 women with HER2-positive early breast cancer, who had received neoadjuvant trastuzumab and/or lapatinib, together with 12 cycles of weekly paclitaxel, were included in this analysis. The HER2/CEP17 ratio in the primary tumor samples was correlated with pCR and survival outcome.

Results

The median HER2/CEP17 ratio was 5.1 (range: 1.1–100.0), and ratios were not associated with age, hormone receptor (HR) status, or any other clinicopathological variable analyzed. The log HER2/CEP17 ratio significantly predicted pCR in both univariate (OR: 1.83; 95 % CI: 1.11–3.01, p = 0.0176) and multivariate analysis (OR: 1.79; 95 % CI: 1.07–2.99, p = 0.0257). Higher HER2/CEP17 ratios were, however, not associated with improved EFS (adjusted HR = 0.795; p = 0.3537). A pCR prediction model including HER2/CEP17 ratio, treatment arm, and HR status improved the predictive strength of treatment arm alone from a ROC AUC value of 0.60–0.69.

Conclusion

In patients treated with HER2-based neoadjuvant therapy, quantitative analysis of the readily available pretreatment HER2/CEP17 ratio by FISH is predictive of pCR.

目的：在早期乳腺癌中，HER2定向疗法被批准用于治疗HER2蛋白过表达或HER2基因扩增且HER2/CEP17比值≥2.2的HER2阳性浸润性乳腺癌患者。然而，在这个临界值之外，目前尚不清楚HER2/CEP17比值的增加是否会提高HER2定向治疗的疗效。在前瞻性III期NeoALTTO试验中，我们评估了HER2/CEP17比率的定量评估是否能预测基于HER2的新辅助方案治疗的患者的病理完全缓解（pCR）和无事件生存期（EFS）。患者和方法：455名her2阳性早期乳腺癌患者接受了新辅助曲妥珠单抗和/或拉帕替尼，以及每周12个周期的紫杉醇治疗，纳入本分析。原发肿瘤样本中HER2/CEP17比值与pCR和生存结局相关。结果：中位HER2/CEP17比值为5.1（范围：1.1-100.0），该比值与年龄、激素受体（HR）状态或任何其他临床病理变量分析无关。log HER2/CEP17比值在单因素分析（OR: 1.83; 95% CI: 1.11-3.01, p = 0.0176）和多因素分析（OR: 1.79; 95% CI: 1.07-2.99, p = 0.0257）中均显著预测pCR。然而，较高的HER2/CEP17比率与改善的EFS无关（调整后的HR = 0.795; p = 0.3537）。包含HER2/CEP17比值、治疗组和HR状态的pCR预测模型从0.60-0.69的ROC AUC值提高了单独治疗组的预测强度。结论：在接受基于HER2的新辅助治疗的患者中，通过FISH定量分析现成的预处理HER2/CEP17比值可预测pCR。

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引用次数: 0

Korean nationwide analysis of male breast Cancer: Incidence trends, treatment disparities, and survival compared with female patients 韩国男性乳腺癌的全国分析：发病率趋势、治疗差异和女性患者的生存率。

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-18 DOI: 10.1016/j.breast.2025.104680

Jiyeong Kim , Shin Jeong Pak , Min Sung Chung , Chihwan David Cha

Background

s: Male breast cancer (MBC) accounts for less than 1 % of all breast cancer cases and is considered a rare disease. However, its incidence is steadily increasing. Despite this trend, comprehensive analyses comparing the clinicopathological characteristics and outcomes between male and female breast cancer (FBC) patients remain limited.

Methods

Using Korean National Health Insurance data (2007–2023), we analyzed 368,577 patients (1437 men; 367,140 women). Age-standardized incidence rates (ASR), clinicopathological features (age at diagnosis, Charlson Comorbidity Index), treatment modalities, recurrence rates, and mortality outcomes were compared between MBC and FBC. Multivariate Cox proportional hazards regression was performed to assess the association of sex with recurrence and survival.

Results

ASR of MBC doubled (0.59–1.19), while female breast cancer (FBC) increased from 67.6 to 157.3. Male patients were older at diagnosis (64 vs. 51 years, p < 0.001), had higher comorbidity (p < 0.001), and showed worse outcomes. Recurrence was more frequent in men (14.3 % vs. 12.5 %, p = 0.038) as was mortality (31.3 % vs. 11.1 %, p < 0.001). Multivariate analysis confirmed male sex as a significant risk factor for recurrence (p = 0.010).

Conclusion

Despite its rarity, MBC incidence is increasing, with distinct clinicopathological features and poorer prognosis compared to FBC. These findings emphasize the need for sex-specific strategies and inclusion of male patients in breast cancer research.

背景：男性乳腺癌（MBC）占所有乳腺癌病例的不到1%，被认为是一种罕见的疾病。然而，其发病率正在稳步上升。尽管有这种趋势，但比较男性和女性乳腺癌（FBC）患者的临床病理特征和结局的综合分析仍然有限。方法：使用韩国国民健康保险数据（2007-2023），我们分析了368,577例患者（男性1437例；女性367,140例）。比较MBC和FBC的年龄标准化发病率（ASR）、临床病理特征（诊断年龄、Charlson合并症指数）、治疗方式、复发率和死亡率。采用多因素Cox比例风险回归来评估性别与复发和生存率的关系。结果：MBC的ASR翻倍（0.59-1.19），女性乳腺癌（FBC）由67.6上升至157.3。结论：与FBC相比，MBC虽然罕见，但发病率呈上升趋势，具有明显的临床病理特征，预后较差。这些发现强调了在乳腺癌研究中需要有针对性别的策略和纳入男性患者。

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引用次数: 0

Comparative validation of PREDICT versions 3.1 and 2.2 for overall survival in the Dutch breast cancer population 预测3.1和2.2版本在荷兰乳腺癌人群中总生存期的比较验证

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-16 DOI: 10.1016/j.breast.2025.104681

Lara W.A. Vreven , Elfi M. Verheul , Marissa C. van Maaren , Frank Doornkamp , Robert-Jan Schipper , Sabine Siesling , Paul D.P. Pharoah , Vivianne C.G. Tjan-Heijnen , Adri C. Voogd

Background

PREDICT Breast is a clinical decision-support tool estimating prognosis and the absolute benefit of adjuvant systemic therapies in early breast cancer. PREDICT v2.2 is recommended in Dutch guidelines. Both v2.2 and the recently updated v3.1 have not been validated in the Dutch population. This study compares the predictive performance of PREDICT v3.1 and v2.2 for 10-year OS in Dutch breast cancer patients.

Methods

Women diagnosed between 2005 and 2013 with primary invasive breast cancer were selected from the Netherlands Cancer Registry. Ten-year OS predictions from v2.2 and v3.1 were compared with observed OS for the overall cohort and 36 subgroups defined by oestrogen receptor (ER) status, HER2-status, age, and tumour stage. Discrimination (ability to distinguish patients with different outcomes) and calibration (agreement between predicted and observed outcomes) of both models were assessed.

Results

Among 101,282 patients, both versions showed moderate discrimination (AUC v2.2 = 0.768; v3.1 = 0.775) and calibration (v2.2 intercept: 0.07; slope: 1.09; v3.1 intercept: 0.12, slope: 1.00). V3.1 slightly overestimated (1.9%), whereas v2.2 slightly underestimated (1.6%) 10-year OS. Across subgroups, v3.1 generally outperformed v2.2 except in patients aged >75 years, where v2.2 provided more accurate estimates. In ER-/HER- patients aged 50–75 years, v3.1 overestimated (1.5–2.8%) and v2.2 underestimated (2.8–5.3%) 10-year OS.

Conclusion

Both PREDICT v2.2 and v3.1 accurately predict 10-year OS in Dutch breast cancer patients, with small differences between versions that vary by subgroup. No single model is optimal for all patients highlighting the need for subgroup-specific recalibration and careful interpretation when applying PREDICT.

predict Breast是一个临床决策支持工具，用于评估早期乳腺癌辅助全身治疗的预后和绝对获益。荷兰指南中推荐使用PREDICT v2.2。v2.2和最近更新的v3.1都没有在荷兰人口中得到验证。本研究比较了PREDICT v3.1和v2.2对荷兰乳腺癌患者10年OS的预测性能。方法从荷兰癌症登记处选择2005年至2013年诊断为原发性浸润性乳腺癌的妇女。将v2.2和v3.1的10年OS预测与整个队列和36个由雌激素受体（ER）状态、her2状态、年龄和肿瘤分期定义的亚组的观察OS进行比较。对两种模型的区分（区分不同结果患者的能力）和校准（预测和观察结果之间的一致性）进行评估。结果在101282例患者中，两种版本均具有中等的鉴别性（AUC v2.2 = 0.768; v3.1 = 0.775）和校准性（v2.2截距：0.07；斜率：1.09;v3.1截距：0.12，斜率：1.00）。V3.1略微高估了（1.9%），而v2.2略微低估了（1.6%）10年OS。在各个亚组中，v3.1的表现普遍优于v2.2，但在75岁的患者中，v2.2提供了更准确的估计。在50-75岁的ER-/HER-患者中，v3.1高估（1.5-2.8%），v2.2低估（2.8-5.3%）10年OS。结论PREDICT v2.2和v3.1均能准确预测荷兰乳腺癌患者的10年OS，不同亚组版本间差异较小。没有单一模型对所有患者都是最佳的，这突出了在应用PREDICT时需要针对亚组进行重新校准和仔细解释。

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引用次数: 0

Impact of the interruption of tamoxifen for pregnancy on the recurrence and survival outcomes among young women with breast cancer 妊娠期中断他莫昔芬治疗对年轻乳腺癌患者复发和生存结局的影响

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-12 DOI: 10.1016/j.breast.2025.104675

Chihwan David Cha , Somin Jeon , Jihyun Keum , Shin Jeong Pak , Boyoung Park , Min Sung Chung

Background

Young survivors of breast cancer often consider pregnancy after completing or interrupting endocrine therapy. However, concerns remain regarding the safety of tamoxifen interruption for pregnancy and its impact on survival outcomes. We aimed to evaluate the impact of interrupting and resuming tamoxifen for pregnancy on recurrence and mortality in patients with breast cancer, using real-world data.

Methods

We conducted a retrospective cohort study using data from the Korean National Health Insurance Service National Health Information Database. Among 32,378 women aged 18–45 years diagnosed with invasive breast cancer and who underwent surgery between 2009 and 2014, patients were categorized into groups based on tamoxifen interruption and pregnancy: Group 1 (interruption and resumption, n = 126), Group 2 (interruption without resumption, n = 261), Group 3 (initiation of tamoxifen after childbirth, n = 41), and Control (no interruption nor pregnancy, n =428). The control group was age-matched to the interruption groups in a 1:1 ratio. Clinical outcomes, including recurrence and mortality, were compared among groups.

Results

Over a median follow-up of 8.5 years, Groups 1 and 2 showed significantly lower risks of recurrence than the control group did (hazard ratio [HR] 0.41, 95 % confidence interval [CI]: 0.22–0.76, P = 0.005; HR 0.30, 95 % CI: 0.18–0.50, P < 0.001). In multivariate analysis, Group 2 also showed better survival outcomes (HR 0.18, 95% CI: 0.08–0.41, P < 0.001). Pregnancy outcomes differed across groups: Groups 1 and 2 had higher rates of full-term pregnancies, whereas Group 3 had a significantly higher abortion rate (23.8 %, 23.4 % vs. 56.1 %, respectively).

Conclusion

These findings suggest that temporary tamoxifen interruption for pregnancy may be a viable option for young survivors of breast cancer. Further studies are warranted to clarify the long-term impact of tamoxifen interruption on prognosis.

背景：年轻的乳腺癌幸存者在完成或中断内分泌治疗后经常考虑怀孕。然而，人们仍然关注他莫昔芬中断妊娠的安全性及其对生存结果的影响。我们的目的是评估妊娠期中断和恢复他莫昔芬对乳腺癌患者复发和死亡率的影响，使用真实世界的数据。方法采用韩国国民健康保险局国民健康信息数据库的数据进行回顾性队列研究。在2009年至2014年间接受手术的32378名18-45岁的浸润性乳腺癌患者中，根据他莫昔芬中断和妊娠情况将患者分为：1组（中断并恢复，n = 126）， 2组（中断但未恢复，n = 261）， 3组（分娩后开始使用他莫昔芬，n = 41）和对照组（未中断也未妊娠，n =428）。对照组与中断组按1:1的比例进行年龄匹配。临床结果，包括复发率和死亡率，在组间进行比较。结果中位随访8.5年，1、2组患者的复发风险明显低于对照组（风险比[HR] 0.41, 95%可信区间[CI]: 0.22-0.76, P = 0.005；风险比[HR] 0.30, 95% CI: 0.18-0.50, P < 0.001）。在多变量分析中，第2组也显示出更好的生存结果（HR 0.18, 95% CI: 0.08-0.41, P < 0.001）。妊娠结局在各组之间存在差异：1组和2组足月妊娠率较高，而3组的流产率明显较高（分别为23.8%、23.4%和56.1%）。结论：对于年轻的乳腺癌幸存者来说，妊娠期暂时停用他莫昔芬可能是一个可行的选择。需要进一步的研究来阐明他莫昔芬中断对预后的长期影响。

{"title":"Impact of the interruption of tamoxifen for pregnancy on the recurrence and survival outcomes among young women with breast cancer","authors":"Chihwan David Cha , Somin Jeon , Jihyun Keum , Shin Jeong Pak , Boyoung Park , Min Sung Chung","doi":"10.1016/j.breast.2025.104675","DOIUrl":"10.1016/j.breast.2025.104675","url":null,"abstract":"<div><h3>Background</h3><div>Young survivors of breast cancer often consider pregnancy after completing or interrupting endocrine therapy. However, concerns remain regarding the safety of tamoxifen interruption for pregnancy and its impact on survival outcomes. We aimed to evaluate the impact of interrupting and resuming tamoxifen for pregnancy on recurrence and mortality in patients with breast cancer, using real-world data.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study using data from the Korean National Health Insurance Service National Health Information Database. Among 32,378 women aged 18–45 years diagnosed with invasive breast cancer and who underwent surgery between 2009 and 2014, patients were categorized into groups based on tamoxifen interruption and pregnancy: Group 1 (interruption and resumption, n = 126), Group 2 (interruption without resumption, n = 261), Group 3 (initiation of tamoxifen after childbirth, n = 41), and Control (no interruption nor pregnancy, n =428). The control group was age-matched to the interruption groups in a 1:1 ratio. Clinical outcomes, including recurrence and mortality, were compared among groups.</div></div><div><h3>Results</h3><div>Over a median follow-up of 8.5 years, Groups 1 and 2 showed significantly lower risks of recurrence than the control group did (hazard ratio [HR] 0.41, 95 % confidence interval [CI]: 0.22–0.76, <em>P</em> = 0.005; HR 0.30, 95 % CI: 0.18–0.50, <em>P</em> < 0.001). In multivariate analysis, Group 2 also showed better survival outcomes (HR 0.18, 95% CI: 0.08–0.41, <em>P</em> < 0.001). Pregnancy outcomes differed across groups: Groups 1 and 2 had higher rates of full-term pregnancies, whereas Group 3 had a significantly higher abortion rate (23.8 %, 23.4 % vs. 56.1 %, respectively).</div></div><div><h3>Conclusion</h3><div>These findings suggest that temporary tamoxifen interruption for pregnancy may be a viable option for young survivors of breast cancer. Further studies are warranted to clarify the long-term impact of tamoxifen interruption on prognosis.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104675"},"PeriodicalIF":7.9,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145973297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Divergence of DNA tumor mutations in cerebrospinal fluid in metastatic breast cancer patients with leptomeningeal metastases 转移性乳腺癌伴轻脑膜转移患者脑脊液DNA肿瘤突变的差异

IF 7.9 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast

Pub Date : 2025-12-11 DOI: 10.1016/j.breast.2025.104674

Peter H. Wessels , Sten Cornellisen , Kim Monkhorst , Gabe S. Sonke , Annegien Broeks , Dorothe Linders , Daan van den Broek , Mirjam C. Boelens , Dieta Brandsma

Purpose

To study differences in genetic alterations between primary breast cancer, systemic metastases, and cerebrospinal fluid (CSF) in patients with leptomeningeal metastases (LM).

Material and methods

Breast cancer patients with confirmed or probable LM and available primary tumor tissue were selected from a CSF-biobank study of the Netherlands Cancer Institute. Genetic analysis of cell-free DNA (cfDNA) in CSF and tissue from the primary tumor and/or systemic metastases was performed using Next Generation Sequencing (NGS). In patients with HR+/HER2-breast cancer, CSF and tumor tissues were also tested for ESR1 mutations with Sanger sequencing.

Results

27 breast cancer patients with LM (n = 23 confirmed LM; n = 4 probable LM) were included in the study. Fourteen patients had triple negative (TN), 11 HR+/HER2-and 3 HER2+ breast cancer. CSF-only genetic alterations were observed in 5 (20 %) of 25 evaluable patients. The majority of these genetic alterations were found in the PTEN-PI3K-AKT pathway, which were present in 3 of 14 evaluable patients with a TN breast cancer subtype (21 %) and in one patient wit HER2+ breastcancer. In one HR+/HER2+ patient, an ESR1 mutation was present in both CSF and systemic metastases, while it was absent in the primary tumor. All genetic alterations that were observed in either the primary tumor or systemic metastases were also observed in the CSF.

Conclusion

In 20 % of breast cancer patients with LM, genetic alterations in the CSF were discordant from the primary tumor and/or systemic metastases. These genetic alterations involved in particular the PTEN-PI3K-AKT pathway in TN breast cancer. No ESR1 mutation limited to CSF only was found in HR+/HER2-breast cancer. Divergence of genetic alterations in LM from breast cancer must be considered for optimization of future target treatment strategy.

目的：研究轻脑膜转移（LM）患者原发性乳腺癌、全身转移和脑脊液（CSF）基因改变的差异。材料和方法：从荷兰癌症研究所的CSF-biobank研究中选择确诊或可能患有LM和可用原发肿瘤组织的乳腺癌患者。使用下一代测序（NGS）对原发肿瘤和/或全身转移灶的脑脊液和组织中的游离DNA （cfDNA）进行遗传分析。在HR+/ her2乳腺癌患者中，CSF和肿瘤组织也用Sanger测序检测ESR1突变。结果：共纳入27例乳腺癌LM患者（确诊LM 23例，可能LM 4例）。三阴性（TN） 14例，HR+/HER2 11例，HER2+ 3例。25例可评估的患者中有5例（20%）仅观察到csf基因改变。这些基因改变主要出现在PTEN-PI3K-AKT通路中，在14例可评估的TN乳腺癌亚型患者中有3例（21%）和1例HER2+乳腺癌患者中出现。在一名HR+/HER2+患者中，ESR1突变在脑脊液和全身转移中都存在，而在原发肿瘤中不存在。在原发肿瘤或全身转移中观察到的所有遗传改变也在脑脊液中观察到。结论：在20%的乳腺癌LM患者中，脑脊液的遗传改变与原发肿瘤和/或全身转移不一致。这些基因改变特别涉及TN乳腺癌的PTEN-PI3K-AKT通路。在HR+/ her2乳腺癌中未发现仅限于CSF的ESR1突变。乳腺癌LM基因改变的差异必须被考虑，以优化未来的靶向治疗策略。

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引用次数: 0