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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 Pub Date : 2026-02-01 Epub 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
Neoadjuvant endocrine therapy with sequential palbociclib and chemotherapy based on Ki67 status in stage II-III breast cancer: An open-label, phase II study 基于Ki67状态的II- iii期乳腺癌新辅助内分泌治疗与序贯帕博西尼和化疗:一项开放标签的II期研究
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-10 DOI: 10.1016/j.breast.2025.104672
Christina Engebrethsen , Synnøve Yndestad , Mari E. Rasmussen , Emiel A.M. Janssen , Bjørnar Gilje , Egil S. Blix , Helge Espelid , Steinar Lundgren , Jürgen Geisler , Laura Minsaas , Reidun Lillestøl , Hildegunn S. Aase , Turid Aas , Per E. Lønning , Hans P. Eikesdal , Stian Knappskog

Background

While neoadjuvant endocrine therapy (NET), with or without a CDK4/6 inhibitor, is an established treatment option for estrogen receptor-positive breast cancers, optimal patient selection and second-line treatment for non-responders remain uncertain.

Methods

In the open-label, phase 2 PETREMAC trial (NCT02624973), pre- and postmenopausal patients with large T2 (>4 cm) or locally advanced ER/PGR>50 %, HER2-, and TP53 wild-type breast cancers received NET (tamoxifen + goserelin for premenopausal and letrozole for postmenopausal patients). Palbociclib was added if the Ki67 reduction was ≤50 % after 14 days. Neoadjuvant chemotherapy (NAC) was introduced if NET ± palbociclib failed to reduce Ki67 sufficiently or if there was no objective response on MRI after 24 weeks. Tumor biopsies underwent targeted sequencing of 360 cancer-related genes and subsequent gene expression profiling.

Results

Among 88 patients, the median tumor size was 48 mm (range 16–140 mm). NET alone reduced Ki67 > 50 % in 49/88 (56 %) of evaluable tumors. Adding palbociclib yielded a Ki67 reduction >50 % in 24/34 (71 %) of tumors where neoadjuvant endocrine therapy alone failed to suppress Ki67, providing a Ki67 reduction of >50 % in a total of 72/88 (82 %) of patients. NAC was administered to 34/88 (39 %) due to inadequate Ki67 response or lack of MRI response. Overall, 70 % achieved a pre-surgical objective response. Pathological complete response was seen in 3/84 patients. Postmenopausal status (p = 0.005) and invasive lobular carcinoma (p = 0.02) predicted Ki67-based response to NET.

Conclusion

Sequential NET with palbociclib, limiting NAC to non-responders, is a feasible strategy for ER/PGR>50 %, HER2-, TP53 wild-type breast cancers.
背景:虽然新辅助内分泌治疗(NET),有或没有CDK4/6抑制剂,是雌激素受体阳性乳腺癌的既定治疗选择,但最佳患者选择和无反应的二线治疗仍不确定。方法:在开放标签的2期PETREMAC试验(NCT02624973)中,绝经前和绝经后大T2 (>4 cm)或局部晚期ER/PGR> 50%, HER2-和TP53野生型乳腺癌患者接受NET(绝经前患者使用他莫昔芬+戈瑟林,绝经后患者使用来曲唑)。14天后,如果Ki67减少≤50%,则加入帕博西尼。如果NET±帕博西尼未能充分降低Ki67或24周后MRI无客观反应,则引入新辅助化疗(NAC)。对肿瘤活检进行360个癌症相关基因的靶向测序和随后的基因表达谱分析。结果:88例患者中位肿瘤大小为48 mm(范围16 ~ 140 mm)。在49/88(56%)可评估的肿瘤中,单纯NET可减少50%的ki67>。在单纯新辅助内分泌治疗无法抑制Ki67的24/34(71%)肿瘤中,加入palbociclib可使Ki67降低50%,在总共72/88(82%)患者中,Ki67降低50%。由于Ki67反应不足或缺乏MRI反应,34/88(39%)患者接受NAC治疗。总体而言,70%的患者达到了术前客观反应。病理完全缓解3/84例。绝经后状态(p = 0.005)和浸润性小叶癌(p = 0.02)预测基于ki67的NET反应。结论:帕博西尼的序贯NET,将NAC限制在无反应者,是治疗ER/PGR> 50%, HER2-, TP53野生型乳腺癌的可行策略。
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引用次数: 0
Nivolumab in combination with ipilimumab versus capecitabine as post-operative treatment for triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy: a multicentre, randomized, open-label phase II trial – BREASTIMMUNE-03 Nivolumab联合易普利姆单抗与卡培他滨作为新辅助化疗后残留疾病的三阴性乳腺癌患者的术后治疗:一项多中心、随机、开放标签的II期试验- breasttimmune -03
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-21 DOI: 10.1016/j.breast.2025.104648
Olivier Trédan , Delphine Loirat , Sylvie Chabaud , Philippe Toussaint , Thierry Petit , Frédéric Viret , Christelle Levy , Aurélien Robert , Julien Grenier , Laura Mansi , Jean-Philippe Spano , Anne Patsouris , Olfa Derbel , Christelle Jouannaud , Jean Marc Ferrero , Jean Sébastien Frenel , Yann Molin , Louis Doublet , Pierre-Etienne Heudel , Jean-Yves Pierga , Thomas Bachelot

Background

Triple negative breast cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy (NAC) face high risk of recurrence. BREASTIMMUNE-03 trial evaluates the efficacy of nivolumab and ipilimumab combination compared to capecitabine as adjuvant treatment.

Methods

This multicentre, randomized open-label phase II trial included TNBC patients with Residual Cancer Burden (RCB) of class II-III after NAC and surgery, and allocated them to randomization (1:1) to receive nivolumab plus ipilimumab or capecitabine for 24 weeks. Randomization was stratified by center, ECOG performance status (PS) 0 or 1, and RCB Class. Primary endpoint was disease free survival (DFS), assessed in the intent-to-treat population. Safety analysis according to NCI-CTCAE V5.0 included all patients who received at least one dose of study drug.

Results

From July 2019 to October 2021, 95 patients were randomized to the nivolumab plus ipilimumab arm (NIVO + IPI n = 45), or to the capecitabine arm (CT n = 50). With a median follow-up of 34.3 (IQR 33–36) months, 39 events (relapse or death) were reported: 17 (38 %) for NIVO + IPI; 22 (44 %) for CT (HR 0.84, 95 %CI 0.45–1.59; log-rank test p-value 0.5938). 17 (38 %) patients in the NIVO + IPI arm prematurely discontinued treatment due to treatment-related adverse events (AEs), versus 7 (14 %) in the CT arm.

Conclusion

A 6-month post-operative nivolumab plus ipilimumab treatment did not significantly improve DFS compared to capecitabine in TNBC patients with RCB II-III and resulted in increased immune-mediated AEs. Despite premature trial termination, our results do not support nivolumab plus ipilimumab adjuvant treatment in this setting.

Trial registration

NCT03818685.
背景三阴性乳腺癌(TNBC)患者在新辅助化疗(NAC)后存在残留病变,面临着较高的复发风险。BREASTIMMUNE-03试验评估了纳武单抗和伊匹单抗联合使用与卡培他滨辅助治疗的疗效。方法这项多中心、随机、开放标签的II期临床试验纳入了NAC和手术后伴有II- iii级残留癌负担(RCB)的TNBC患者,并将其随机分配(1:1),接受纳鲁单抗联合伊匹单抗或卡培他滨治疗24周。随机分组按中心、ECOG表现状态(PS) 0或1和RCB分级进行分层。主要终点是在意向治疗人群中评估的无病生存期(DFS)。根据NCI-CTCAE V5.0进行的安全性分析包括所有接受至少一剂研究药物的患者。从2019年7月到2021年10月,95名患者被随机分配到尼武单抗+伊匹单抗组(NIVO + IPI n = 45)或卡培他滨组(CT n = 50)。中位随访34.3 (IQR 33-36)个月,报告了39例事件(复发或死亡):NIVO + IPI 17例(38%);CT 22例(44%)(HR 0.84, 95% CI 0.45-1.59; log-rank检验p值0.5938)。NIVO + IPI组中有17例(38%)患者因治疗相关不良事件(ae)过早停止治疗,而CT组中有7例(14%)患者过早停止治疗。结论与卡培他滨相比,术后6个月纳鲁单抗联合伊匹单抗治疗未显著改善RCB II-III型TNBC患者的DFS,并导致免疫介导的ae增加。尽管试验过早终止,我们的结果不支持在这种情况下纳武单抗加伊匹单抗辅助治疗。registrationNCT03818685审判。
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引用次数: 0
Real-world outcomes with palbociclib, ribociclib, and abemaciclib plus endocrine therapy in HR+/HER2− advanced breast cancer: A multicenter retrospective study palbociclib、ribociclib和abemaciclib联合内分泌治疗HR+/HER2−晚期乳腺癌的实际结果:一项多中心回顾性研究
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-24 DOI: 10.1016/j.breast.2025.104665
Renata Duchnowska , Katarzyna Soter , Katarzyna Pogoda , Jolanta Smok-Kalwat , Aleksandra Grela-Wojewoda , Karolina Winsko-Szczęsnowicz , Agnieszka Kowalewska-Felczak , Marek Szwiec , Iwona Danielewicz , Joanna Streb , Tomasz Lewandowski , Bartosz Szymanowski , Joanna Kiszka , Barbara Radecka , Ewa Kalinka , Bartosz K. Sobocki , Maria Litwiniuk , Aleksandra Łacko , Anna Bałata , Justyna Żubrowska , Jacek Jassem

Background

Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) are the standard first- and second-line treatments for hormone receptor-positive (HR+), HER2-negative (HER2−) advanced breast cancer (ABC). Real-world data (RWD) may inform the optimal use of these agents in routine practice.

Patients and methods

The multicenter, population-based POLiCDK study compared progression-free survival (PFS), second PFS, and overall survival (OS) in ABC patients with HR+/HER2− ABC treated with palbociclib (PAL), ribociclib (RIB), or abemaciclib (ABE) in first- or second-line ET settings at 16 Polish centers between September 2017 and January 2025. Analyses were stratified by endocrine sensitivity/resistance, and stabilized inverse probability of treatment weighting was used to balance baseline characteristics.

Results

Among 2063 patients (701 PAL, 968 RIB, 394 ABE), 1583 (76.7 %) received CDK4/6i in the first-line and 480 (23.3 %) in the second-line setting. Overall, 927 (44.9 %) had de novo ABC; 819 (39.7 %) were endocrine-naïve, 158 (8.9 %) primary resistant, and 808 (39.2 %) secondary resistant. Median follow-up was 35.9, 24.1, and 21.4 months for PAL, RIB, and ABE, respectively. In endocrine-naïve patients, PFS did not differ significantly between CDK4/6i combined with aromatase inhibitors (AIs). In secondary endocrine-resistant disease, RIB and ABE outperformed PAL with AI combinations, whereas outcomes with fulvestrant were similar. In second-line therapy, all three CDK4/6i showed comparable results. Adjusted hazard ratios confirmed these trends without consistent superiority of any single agent.

Conclusions

Endocrine sensitivity/resistance and ET partner were major determinants of outcome with CDK4/6i plus ET in HR+/HER2− ABC, informing individualized treatment selection and sequencing.
细胞周期蛋白依赖性激酶4/6抑制剂(CDK4/6i)联合内分泌治疗(ET)是激素受体阳性(HR+)、HER2阴性(HER2−)晚期乳腺癌(ABC)的标准一线和二线治疗方法。现实世界的数据(RWD)可以告知这些药物在日常实践中的最佳使用。患者和方法多中心、基于人群的POLiCDK研究比较了2017年9月至2025年1月在16个波兰中心的一线或二线ET设置中接受帕博西尼(PAL)、核糖西尼(RIB)或阿贝美西尼(ABE)治疗的HR+/HER2 - ABC ABC患者的无进展生存期(PFS)、二次PFS和总生存期(OS)。根据内分泌敏感性/耐药性对分析进行分层,并使用稳定的治疗加权逆概率来平衡基线特征。结果在2063例患者中(701例PAL, 968例RIB, 394例ABE), 1583例(76.7%)在一线接受CDK4/6i治疗,480例(23.3%)在二线接受CDK4/6i治疗。总体而言,927例(44.9%)有新发ABC;819例(39.7%)为endocrine-naïve, 158例(8.9%)为原发性耐药,808例(39.2%)为继发性耐药。PAL、RIB和ABE的中位随访时间分别为35.9、24.1和21.4个月。在endocrine-naïve患者中,CDK4/6i联合芳香酶抑制剂(AIs)之间的PFS没有显着差异。在继发性内分泌抵抗疾病中,RIB和ABE联合AI优于PAL,而氟维司汀的结果相似。在二线治疗中,所有三种CDK4/6i都显示出类似的结果。调整后的风险比证实了这些趋势,但没有任何单一药物的一贯优势。结论CDK4/6i + ET在HR+/HER2−ABC中预后的主要决定因素是药物敏感性/耐药和ET伴侣,为个体化治疗选择和测序提供信息。
{"title":"Real-world outcomes with palbociclib, ribociclib, and abemaciclib plus endocrine therapy in HR+/HER2− advanced breast cancer: A multicenter retrospective study","authors":"Renata Duchnowska ,&nbsp;Katarzyna Soter ,&nbsp;Katarzyna Pogoda ,&nbsp;Jolanta Smok-Kalwat ,&nbsp;Aleksandra Grela-Wojewoda ,&nbsp;Karolina Winsko-Szczęsnowicz ,&nbsp;Agnieszka Kowalewska-Felczak ,&nbsp;Marek Szwiec ,&nbsp;Iwona Danielewicz ,&nbsp;Joanna Streb ,&nbsp;Tomasz Lewandowski ,&nbsp;Bartosz Szymanowski ,&nbsp;Joanna Kiszka ,&nbsp;Barbara Radecka ,&nbsp;Ewa Kalinka ,&nbsp;Bartosz K. Sobocki ,&nbsp;Maria Litwiniuk ,&nbsp;Aleksandra Łacko ,&nbsp;Anna Bałata ,&nbsp;Justyna Żubrowska ,&nbsp;Jacek Jassem","doi":"10.1016/j.breast.2025.104665","DOIUrl":"10.1016/j.breast.2025.104665","url":null,"abstract":"<div><h3>Background</h3><div>Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) are the standard first- and second-line treatments for hormone receptor-positive (HR+), HER2-negative (HER2−) advanced breast cancer (ABC). Real-world data (RWD) may inform the optimal use of these agents in routine practice.</div></div><div><h3>Patients and methods</h3><div>The multicenter, population-based POLiCDK study compared progression-free survival (PFS), second PFS, and overall survival (OS) in ABC patients with HR+/HER2− ABC treated with palbociclib (PAL), ribociclib (RIB), or abemaciclib (ABE) in first- or second-line ET settings at 16 Polish centers between September 2017 and January 2025. Analyses were stratified by endocrine sensitivity/resistance, and stabilized inverse probability of treatment weighting was used to balance baseline characteristics.</div></div><div><h3>Results</h3><div>Among 2063 patients (701 PAL, 968 RIB, 394 ABE), 1583 (76.7 %) received CDK4/6i in the first-line and 480 (23.3 %) in the second-line setting. Overall, 927 (44.9 %) had <em>de novo</em> ABC; 819 (39.7 %) were endocrine-naïve, 158 (8.9 %) primary resistant, and 808 (39.2 %) secondary resistant. Median follow-up was 35.9, 24.1, and 21.4 months for PAL, RIB, and ABE, respectively. In endocrine-naïve patients, PFS did not differ significantly between CDK4/6i combined with aromatase inhibitors (AIs). In secondary endocrine-resistant disease, RIB and ABE outperformed PAL with AI combinations, whereas outcomes with fulvestrant were similar. In second-line therapy, all three CDK4/6i showed comparable results. Adjusted hazard ratios confirmed these trends without consistent superiority of any single agent.</div></div><div><h3>Conclusions</h3><div>Endocrine sensitivity/resistance and ET partner were major determinants of outcome with CDK4/6i plus ET in HR+/HER2− ABC, informing individualized treatment selection and sequencing.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104665"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615859","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
Outcomes for ER-positive CHEK2 c.1100delC breast cancer patients compared with breast cancer patients without the variant er阳性CHEK2 c.1100delC乳腺癌患者与无该变异的乳腺癌患者的结果比较
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-24 DOI: 10.1016/j.breast.2025.104666
Maartje A.C. Schreurs , Muriel A. Adank , Bernadette A.M. Heemskerk-Gerritsen , Antoinette Hollestelle , Nyrée Smallenbroek , Christi J. van Asperen , Margreet G.E.M. Ausems , Irma van de Beek , Geertruida H. de Bock , Ingrid Boere , Liselotte P. van Hest , Kim J.A.F. van Kaam , Linda de Munck , Janet R. Vos , Agnes Jager , Marjanka K. Schmidt , Maartje J. Hooning , Hebon

Purpose

Germline CHEK2 c.1100delC-associated breast cancer (BC) patients have been reported with worse prognosis than patients without the variant. However, results are based on older cohorts and treatment regimens. As part of the Hebon-CHEK2 study, we aim to study prognosis in a Dutch cohort of genetically tested ER-positive BC patients diagnosed from 2006 onwards.

Methods

All patients underwent genetic testing based on personal and family history risk, and data on BC outcomes were collected. Hazard ratios (HRs) and 95 % confidence intervals (CI) for the association of CHEK2-status with prognosis were estimated via delayed entry Cox regression models, adjusted for age and year of diagnosis, tumor size, nodal status, and primary treatment regimens. Furthermore, we meta-analyzed our results with previous studies.

Results

We included 480 CHEK2 BC patients and 944 BC patients without the variant. Median follow-up was 6.0 years. Heterozygotes were more often diagnosed with small tumors, and lymph node positive disease. No significant difference was found for recurrent disease and distant disease-free survival, neither before 5 years (HR = 0.73; 95 %CI = 0.35–1.53 and HR = 0.99; 95 %CI = 0.44–2.21, respectively), nor after 5 years follow-up (HR = 0.29; 95 %CI = 0.06–1.28 and HR = 0.39; 95 %CI = 0.10–1.39, respectively). Also no significant difference in BC-specific survival (HR = 0.77; 95 %CI = 0.42–1.39) or overall survival (HR = 0.69; 95 %CI = 0.43–1.08) was found. Meta-analysis of our results with previous studies showed a worse BC-specific survival for heterozygotes.

Conclusion

In our study, with more recent years of diagnosis and treatment, we found no difference in prognosis, as opposed to previous studies. Further research is needed to validate our findings.
目的:据报道,种系CHEK2 c. 1100delc相关乳腺癌(BC)患者的预后比没有该变异的患者差。然而,结果是基于年龄较大的队列和治疗方案。作为Hebon-CHEK2研究的一部分,我们的目标是研究2006年以后诊断的基因检测er阳性BC患者的预后。方法对所有患者进行基于个人和家族史风险的基因检测,收集BC预后数据。通过延迟进入Cox回归模型估计chek2状态与预后相关的风险比(hr)和95%置信区间(CI),并根据年龄和诊断年份、肿瘤大小、淋巴结状态和主要治疗方案进行调整。此外,我们将我们的结果与之前的研究进行了meta分析。结果我们纳入了480例CHEK2 BC患者和944例无该变异的BC患者。中位随访时间为6.0年。杂合子更常被诊断为小肿瘤和淋巴结阳性疾病。5年前(HR = 0.73, 95% CI = 0.35-1.53, HR = 0.99, 95% CI = 0.44-2.21)和5年后(HR = 0.29, 95% CI = 0.06-1.28, HR = 0.39, 95% CI = 0.10-1.39),复发性疾病和远处无病生存率均无显著差异。bc特异性生存率(HR = 0.77; 95% CI = 0.42-1.39)或总生存率(HR = 0.69; 95% CI = 0.43-1.08)也无显著差异。我们的结果与先前研究的荟萃分析显示,杂合子的bc特异性生存率较差。结论在我们的研究中,随着近年来的诊断和治疗,我们发现预后没有差异,这与以往的研究相反。需要进一步的研究来验证我们的发现。
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引用次数: 0
The Breast International Group (BIG) Patient Partnership: Embedding meaningful patient involvement in the design and conduct of breast cancer clinical research 乳腺国际组织(BIG)患者合作:将有意义的患者参与到乳腺癌临床研究的设计和实施中。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-10 DOI: 10.1016/j.breast.2025.104642
Carmela Caballero , Virginie Adam , Orsolya Birta , Lydie Meheus , Judy Needham , Christine Hodgdon , Leslie Gilhams , Concepcion Biurrun , Mairead MacKenzie , Tanja Spanic , Hilary Stobart , Lynda Belhadi , Julia Maués , Ana Casas , Eva Schumacher-Wulf , Carolyn Straehle , Seamus O'Reilly , David Cameron , Martine Piccart , Judith Bliss , Boon Chua
Involving those with a lived experience of the relevant condition in the design of clinical research ensures that studies address real-world needs and priorities, enabling more relevant, ethical, and impactful outcomes. In 2019, the Breast International Group (BIG) established the BIG Patient Partnership to facilitate the meaningful involvement of people affected by breast cancer in the design and conduct of its studies. The members provide a strong international patient voice in academic breast cancer research. The partnership is based on 4 pillars: foundational and ongoing training, meaningful and systematic involvement, patients as a strategic driving force in BIG's research, and promoting the value of the patients' voice in research. In this paper, we describe a model to enable performing transnational clinical research for and with patient partners. We hope to inspire organizations and people who are burdened by cancer from different cultural backgrounds to develop an interactive, engaging, and empowering process for researchers and patient partners to work together.
在临床研究的设计中,让那些有相关疾病生活经验的人参与进来,可以确保研究满足现实世界的需求和优先事项,从而实现更相关、更符合伦理、更有影响力的结果。2019年,乳腺国际集团(BIG)建立了BIG患者合作伙伴关系,以促进乳腺癌患者有意义地参与其研究的设计和实施。其成员为乳腺癌学术研究提供了强有力的国际患者声音。该合作伙伴关系基于四大支柱:基础和持续培训,有意义和系统的参与,患者作为BIG研究的战略推动力,以及促进患者在研究中的价值。在本文中,我们描述了一个模型,使执行跨国临床研究与患者的合作伙伴。我们希望激励来自不同文化背景的组织和受癌症困扰的人们,为研究人员和患者合作伙伴开发一个互动、吸引人、赋权的过程。
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引用次数: 0
Corrigendum to “Climate change impacts and sustainability integration among breast international group members” [The Breast Volume 81 June 2025 104469] “气候变化影响和乳房国际小组成员的可持续性整合”的勘误表[The breast Volume 81 June 2025 104469]。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-18 DOI: 10.1016/j.breast.2025.104653
Seamus O'Reilly , Jessica Griffiths , Lisa Fox , Catherine S. Weadick , Nay My Oo , Lucy Murphy , Robert O'Leary , Theodora Goulioti , Virginie Adam , Evangelia D. Razis , Barbro Lindholm , Gustavo Werutsky , David Cameron , Judith Bliss
{"title":"Corrigendum to “Climate change impacts and sustainability integration among breast international group members” [The Breast Volume 81 June 2025 104469]","authors":"Seamus O'Reilly ,&nbsp;Jessica Griffiths ,&nbsp;Lisa Fox ,&nbsp;Catherine S. Weadick ,&nbsp;Nay My Oo ,&nbsp;Lucy Murphy ,&nbsp;Robert O'Leary ,&nbsp;Theodora Goulioti ,&nbsp;Virginie Adam ,&nbsp;Evangelia D. Razis ,&nbsp;Barbro Lindholm ,&nbsp;Gustavo Werutsky ,&nbsp;David Cameron ,&nbsp;Judith Bliss","doi":"10.1016/j.breast.2025.104653","DOIUrl":"10.1016/j.breast.2025.104653","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104653"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145547880","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
Early Ki67 change predicts prognosis and supports response-adapted therapy in breast cancer treated with neoadjuvant chemotherapy 早期Ki67变化预测预后并支持新辅助化疗治疗乳腺癌的反应适应治疗。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-13 DOI: 10.1016/j.breast.2025.104649
Ying Zhang , Siyu Wu , Liang Xue , Yifan Xie , Juping Shen , Zhimin Shao , Guangyu Liu

Background

Early prediction of response to neoadjuvant chemotherapy (NACT) in breast cancer is critical for optimizing treatment strategies and improving outcomes. This study assessed the prognostic value of early Ki67 change (ΔKi67 %) via on-treatment core needle biopsy (CNB) in stratifying event-free survival (EFS) and informing potential treatment escalation.

Methods

In this prospective cohort study, 1388 breast cancer patients treated from 2013 to 2021 were randomly divided into training and validation sets (7:3 ratio). ΔKi67 % was calculated as the percentage change from baseline to on-treatment CNB after a median of two NACT cycles. K-means clustering determined an optimal 40 % cutoff classifying patients as poor (≤40 %) or good responders (>40 %). EFS was analyzed using Kaplan-Meier estimates, multivariable Cox models, and restricted mean survival time (RMST).

Results

Good responders had significantly superior 5-year EFS compared to poor responders in both training (78.8 % versus 62.4 %, p < 0.001) and validation (78.6 % versus 60.9 %, p = 0.001) sets. ΔKi67 % showed stronger stratification than imaging-based metrics in RMST analysis and remained an independent predictor after adjustment. Subgroup analyses suggested poor responders in the ER-negative/HER2-negative subgroup derived a 32.0 % 3-year EFS benefit from chemotherapy intensification. The 3-year survival benefit was 14.1 % in poor responders in the HER2-positive subtype with dual HER2 blockade, though these findings require further validation.

Conclusion

Early ΔKi67 % change using a 40 % cutoff via on-treatment CNB is a reliable prognostic predictor supporting response-adapted treatment tailoring, particularly in ER-negative/HER2-negative and HER2-positive populations.
背景:早期预测乳腺癌患者对新辅助化疗(NACT)的反应对于优化治疗策略和改善预后至关重要。本研究通过治疗中芯针活检(CNB)评估早期Ki67改变(ΔKi67 %)在分层无事件生存(EFS)和提示潜在的治疗升级中的预后价值。方法:本前瞻性队列研究将2013 - 2021年接受治疗的1388例乳腺癌患者随机分为训练组和验证组(7:3比例)。ΔKi67 %计算为中位数两个NACT周期后从基线到治疗时CNB的变化百分比。K-means聚类确定了将患者分类为不良(≤40%)或良好(> 40%)的最佳40%截断值。使用Kaplan-Meier估计、多变量Cox模型和限制平均生存时间(RMST)对EFS进行分析。结果:在两种训练中,良好反应者的5年EFS明显优于不良反应者(78.8%对62.4%,p)。结论:通过治疗中CNB使用40%的截止值,早期ΔKi67 %变化是一个可靠的预后预测指标,支持适应反应的治疗定制,特别是在er阴性/ her2阴性和her2阳性人群中。
{"title":"Early Ki67 change predicts prognosis and supports response-adapted therapy in breast cancer treated with neoadjuvant chemotherapy","authors":"Ying Zhang ,&nbsp;Siyu Wu ,&nbsp;Liang Xue ,&nbsp;Yifan Xie ,&nbsp;Juping Shen ,&nbsp;Zhimin Shao ,&nbsp;Guangyu Liu","doi":"10.1016/j.breast.2025.104649","DOIUrl":"10.1016/j.breast.2025.104649","url":null,"abstract":"<div><h3>Background</h3><div>Early prediction of response to neoadjuvant chemotherapy (NACT) in breast cancer is critical for optimizing treatment strategies and improving outcomes. This study assessed the prognostic value of early Ki67 change (ΔKi67 %) via on-treatment core needle biopsy (CNB) in stratifying event-free survival (EFS) and informing potential treatment escalation.</div></div><div><h3>Methods</h3><div>In this prospective cohort study, 1388 breast cancer patients treated from 2013 to 2021 were randomly divided into training and validation sets (7:3 ratio). ΔKi67 % was calculated as the percentage change from baseline to on-treatment CNB after a median of two NACT cycles. K-means clustering determined an optimal 40 % cutoff classifying patients as poor (≤40 %) or good responders (&gt;40 %). EFS was analyzed using Kaplan-Meier estimates, multivariable Cox models, and restricted mean survival time (RMST).</div></div><div><h3>Results</h3><div>Good responders had significantly superior 5-year EFS compared to poor responders in both training (78.8 % versus 62.4 %, p &lt; 0.001) and validation (78.6 % versus 60.9 %, p = 0.001) sets. ΔKi67 % showed stronger stratification than imaging-based metrics in RMST analysis and remained an independent predictor after adjustment. Subgroup analyses suggested poor responders in the ER-negative/HER2-negative subgroup derived a 32.0 % 3-year EFS benefit from chemotherapy intensification. The 3-year survival benefit was 14.1 % in poor responders in the HER2-positive subtype with dual HER2 blockade, though these findings require further validation.</div></div><div><h3>Conclusion</h3><div>Early ΔKi67 % change using a 40 % cutoff via on-treatment CNB is a reliable prognostic predictor supporting response-adapted treatment tailoring, particularly in ER-negative/HER2-negative and HER2-positive populations.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104649"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145556338","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 Pub Date : 2026-02-01 Epub 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。
{"title":"Divergence of DNA tumor mutations in cerebrospinal fluid in metastatic breast cancer patients with leptomeningeal metastases","authors":"Peter H. Wessels ,&nbsp;Sten Cornellisen ,&nbsp;Kim Monkhorst ,&nbsp;Gabe S. Sonke ,&nbsp;Annegien Broeks ,&nbsp;Dorothe Linders ,&nbsp;Daan van den Broek ,&nbsp;Mirjam C. Boelens ,&nbsp;Dieta Brandsma","doi":"10.1016/j.breast.2025.104674","DOIUrl":"10.1016/j.breast.2025.104674","url":null,"abstract":"<div><h3>Purpose</h3><div>To study differences in genetic alterations between primary breast cancer, systemic metastases, and cerebrospinal fluid (CSF) in patients with leptomeningeal metastases (LM).</div></div><div><h3>Material and methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104674"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910427","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
The trajectory of fatigue over time in breast cancer patients treated with chemotherapy: exploring the effect of anthracycline-based chemotherapy 接受化疗的乳腺癌患者疲劳随时间的变化轨迹:探索蒽环类化疗的效果。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2026-01-14 DOI: 10.1016/j.breast.2026.104700
Anneke Kastelein , Laura Kervezee , Dieuwke R. Mink van der Molen , Daniel J. Evers , Carmen C. van der Pol , Annemiek Doeksen , N.H. Chavannes , Hans Gelderblom , Jacques Neefjes , Helena M. Verkooijen , Anne M. May

Background

Cancer-related fatigue is a common and profound side effect of cancer treatment. The specific impacts of different classes of chemotherapy remains understudied. This study aimed to compare the trajectory of fatigue between breast cancer patients treated with anthracycline-based versus non-anthracycline-based regimens over a period of 4 years.

Methods

Data were obtained from the Dutch UMBRELLA cohort. Included were breast cancer patients treated with (neo)adjuvant chemotherapy, categorized as anthracycline-containing vs. non-anthracycline-containing. Fatigue was measured using the Multidimensional Fatigue Inventory-20 and the fatigue scale of the EORTC QLQ-C30. A total of 1155 patients were included: 971 received anthracycline-based chemotherapy, and 184 received non-anthracycline-based chemotherapy. Linear mixed-effects models were employed to analyse time-by-treatment interactions for different dimensions of fatigue.

Results

The fatigue trajectories differed significantly between treatment groups for general and physical fatigue. Pairwise comparisons indicate that anthracycline-treated patients reported higher levels of general fatigue and physical fatigue as well as reduced activity in the first six months after start of treatment. Notably, patients treated with non-anthracycline-based regimens reported better recovery over time, with significantly lower fatigue levels at 42–48 months compared to anthracyclines-treated patients, as measured by both the MFI-20 and the fatigue scale of the EORTC QLQ-C30.

Conclusion

These observations suggest that (neo)adjuvant anthracycline-based chemotherapy in breast cancer patients is associated with higher levels of fatigue during treatment as well as a prolonged burden of fatigue. Treatment tailored fatigue management strategies may be particularly useful for patients undergoing anthracycline-based chemotherapy.
背景:癌症相关性疲劳是癌症治疗中一种常见而深刻的副作用。不同类型化疗的具体影响仍有待进一步研究。本研究旨在比较4年期间接受蒽环类药物与非蒽环类药物治疗的乳腺癌患者的疲劳轨迹。方法:数据来自荷兰UMBRELLA队列。纳入了接受(新)辅助化疗的乳腺癌患者,分为含蒽环类和不含蒽环类。疲劳测量采用多维疲劳量表-20和EORTC QLQ-C30的疲劳量表。共纳入1155例患者:971例接受蒽环类药物化疗,184例接受非蒽环类药物化疗。采用线性混合效应模型分析了不同疲劳维度的随处理时间相互作用。结果:疲劳轨迹在治疗组之间有显著性差异。两两比较表明,蒽环类药物治疗的患者在治疗开始后的前六个月报告了更高水平的全身疲劳和身体疲劳以及活动减少。值得注意的是,根据MFI-20和EORTC QLQ-C30的疲劳量表,与蒽环类药物治疗的患者相比,接受非蒽环类药物治疗的患者随着时间的推移报告了更好的恢复,42-48个月的疲劳水平显着降低。结论:这些观察结果表明,(新)辅助蒽环类化疗在乳腺癌患者治疗期间与较高水平的疲劳以及延长的疲劳负担有关。治疗量身定制的疲劳管理策略可能对接受蒽环类化疗的患者特别有用。
{"title":"The trajectory of fatigue over time in breast cancer patients treated with chemotherapy: exploring the effect of anthracycline-based chemotherapy","authors":"Anneke Kastelein ,&nbsp;Laura Kervezee ,&nbsp;Dieuwke R. Mink van der Molen ,&nbsp;Daniel J. Evers ,&nbsp;Carmen C. van der Pol ,&nbsp;Annemiek Doeksen ,&nbsp;N.H. Chavannes ,&nbsp;Hans Gelderblom ,&nbsp;Jacques Neefjes ,&nbsp;Helena M. Verkooijen ,&nbsp;Anne M. May","doi":"10.1016/j.breast.2026.104700","DOIUrl":"10.1016/j.breast.2026.104700","url":null,"abstract":"<div><h3>Background</h3><div>Cancer-related fatigue is a common and profound side effect of cancer treatment. The specific impacts of different classes of chemotherapy remains understudied. This study aimed to compare the trajectory of fatigue between breast cancer patients treated with anthracycline-based versus non-anthracycline-based regimens over a period of 4 years.</div></div><div><h3>Methods</h3><div>Data were obtained from the Dutch UMBRELLA cohort. Included were breast cancer patients treated with (neo)adjuvant chemotherapy, categorized as anthracycline-containing vs. non-anthracycline-containing. Fatigue was measured using the Multidimensional Fatigue Inventory-20 and the fatigue scale of the EORTC QLQ-C30. A total of 1155 patients were included: 971 received anthracycline-based chemotherapy, and 184 received non-anthracycline-based chemotherapy. Linear mixed-effects models were employed to analyse time-by-treatment interactions for different dimensions of fatigue.</div></div><div><h3>Results</h3><div>The fatigue trajectories differed significantly between treatment groups for general and physical fatigue. Pairwise comparisons indicate that anthracycline-treated patients reported higher levels of general fatigue and physical fatigue as well as reduced activity in the first six months after start of treatment. Notably, patients treated with non-anthracycline-based regimens reported better recovery over time, with significantly lower fatigue levels at 42–48 months compared to anthracyclines-treated patients, as measured by both the MFI-20 and the fatigue scale of the EORTC QLQ-C30.</div></div><div><h3>Conclusion</h3><div>These observations suggest that (neo)adjuvant anthracycline-based chemotherapy in breast cancer patients is associated with higher levels of fatigue during treatment as well as a prolonged burden of fatigue. Treatment tailored fatigue management strategies may be particularly useful for patients undergoing anthracycline-based chemotherapy.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104700"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008930","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
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