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Effect of HER2-Low Expression on the Efficacy of CDK4/6 Inhibitors in Breast Cancer: A Meta-Analysis. her2低表达对CDK4/6抑制剂治疗乳腺癌疗效的影响:一项荟萃分析
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-30 DOI: 10.1016/j.clbc.2025.10.018
Lingling Ye, Yan Dai, Liushan Chen, Yuqi Liang, Jiafa He, Shenying Chen, Xue Song, Rui Xu, Qianjun Chen

CDK4/6 inhibitors combined with endocrine therapy have become the standard first-line and second-line therapy for advanced HR+/HER2- breast cancer. This study aimed to evaluate the impact of HER2 low expression on the efficacy of breast cancer patients treated with CDK4/6 inhibitors. We systematically searched 4 major databases and important conference proceedings up to May 2025, and screened out studies that reported the progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in HR+/HER2-low breast cancer patients and HR+/HER2-zero breast cancer patients treated with CDK4/6 inhibitors. We calculated the pooled hazard ratio (HR) and its 95% confidence interval (CI). A total of 18 studies involving 8461 patients were finally included. Among them, HER2-low breast cancer patients accounted for 41.25% of the sample, and HER2-zero breast cancer patients accounted for 57.98% of the sample. The results showed that the progression-free survival (PFS) of HR+/HER2-low breast cancer patients treated with the combination of CDK4/6 inhibitors and endocrine therapy was significantly lower than that of HR+/HER2-zero breast cancer patients (HR = 1.19, 95% CI, 1.10-1.28, P < .0001). Further subgroup analysis indicated that among HER2-low patients, whether they received first-line treatment, subsequent treatment, or were treated with Ribociclib, their prognosis was worse. Analysis of OS showed no statistically significant difference between groups (HR = 1.00, 95% CI, 0.93-1.07, P = .93). Similarly, no significant differences were observed in ORR. In addition, no significant differences in the PFS were observed in HR+/HER2-low breast cancer patients, regardless of whether the HER2 status changed due to treatment, the presence of visceral metastases. In conclusion, among patients receiving CDK4/6 inhibitor combined with endocrine therapy, HER2-low status was associated with significantly shorter PFS but not with significant differences in OS or ORR. However, it is worth noting that most of these studies are retrospective and real-world studies, with limited adjustments for confounding factors, and the statistical power of testing may be insufficient.

CDK4/6抑制剂联合内分泌治疗已成为晚期HR+/HER2-乳腺癌的标准一线和二线治疗。本研究旨在评估HER2低表达对CDK4/6抑制剂治疗乳腺癌患者疗效的影响。我们系统地检索了截至2025年5月的4个主要数据库和重要会议记录,筛选出了报告HR+/ her2低乳腺癌患者和HR+/ her2零乳腺癌患者接受CDK4/6抑制剂治疗的无进展生存期(PFS)、总生存期(OS)和客观缓解率(ORR)的研究。我们计算了合并风险比(HR)及其95%置信区间(CI)。最终纳入18项研究,涉及8461例患者。其中her2 -低乳腺癌患者占41.25%,her2 -零乳腺癌患者占57.98%。结果显示,CDK4/6抑制剂联合内分泌治疗的HR+/ her2低乳腺癌患者的无进展生存期(PFS)显著低于HR+/ her2零乳腺癌患者(HR = 1.19, 95% CI, 1.10 ~ 1.28, P < 0.0001)。进一步的亚组分析表明,her2 -低患者无论是接受一线治疗、后续治疗还是接受Ribociclib治疗,其预后都较差。OS分析显示,两组间差异无统计学意义(HR = 1.00, 95% CI: 0.93 ~ 1.07, P = 0.93)。同样,ORR也无显著差异。此外,在HR+/HER2低的乳腺癌患者中,无论HER2状态是否因治疗、是否存在内脏转移而改变,PFS均未观察到显著差异。总之,在接受CDK4/6抑制剂联合内分泌治疗的患者中,her2低状态与PFS显著缩短相关,但与OS或ORR无显著差异。然而,值得注意的是,这些研究大多是回顾性和现实世界的研究,对混杂因素的调整有限,检验的统计能力可能不足。
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引用次数: 0
Comment on “The USP8/CEP55/CHMP6 Axis Orchestrates Triple-Negative Breast Cancer Progression by Regulating Ferroptosis and Macrophage M2 Polarization” 评论“USP8/CEP55/CHMP6轴通过调节铁凋亡和巨噬细胞M2极化来协调三阴性乳腺癌的进展”。
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-28 DOI: 10.1016/j.clbc.2025.10.015
Wenyan Zhang, Zhongzhu Tang
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引用次数: 0
Cryotherapy in Taxane-Induced Peripheral Neuropathy: The Need for Objective Validation 冷冻治疗紫杉烷诱导的周围神经病变:需要客观验证。
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-28 DOI: 10.1016/j.clbc.2025.10.016
Kadri Altundag
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引用次数: 0
Letter to the editor regarding the article “Overweight and Risk of Recurrence Following Neoadjuvant Chemotherapy in Breast Cancer” 关于《乳腺癌新辅助化疗后超重与复发风险》一文的致编辑信
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-27 DOI: 10.1016/j.clbc.2025.10.014
Arin Natania S
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引用次数: 0
Diagnostic Heterogeneity and Healthcare Access Disparities: Latent Systemic Bias in Global Estimates of Male Breast Cancer Burden 诊断异质性和医疗可及性差异:全球男性乳腺癌负担估计的潜在系统性偏差
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-24 DOI: 10.1016/j.clbc.2025.10.013
Jiongjiong Zhang
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引用次数: 0
Adherence to Multidisciplinary Tumor Board (MTB) Recommendations in Patients With Breast Cancer: The Results From Two Cancer Centers in Germany 乳腺癌患者对多学科肿瘤委员会(MTB)建议的依从性:来自德国两个癌症中心的结果
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-23 DOI: 10.1016/j.clbc.2025.10.010
Esin Aysel Kandemir , Rebekka Adam , Julia Roeper , Lena Ansmann , Petra Hülper , Eduard Malik , Claus-Henning Köhne , Frank Griesinger

Background

Multidisciplinary care is essential for the management of breast cancer. Multidisciplinary tumor boards (MTBs) can improve the health outcomes in breast cancer; however, the association of adherence to MTB recommendations with survival time has not been studied.

Methods

This is a retrospective observational study of patients with breast cancer diagnosed between 2014 and 2018 and discussed in the MTB meetings at 2 breast cancer centers certified by the German Cancer Society. Primary endpoints were adherence rate to MTB recommendations and disease-free survival (DFS). The secondary endpoint was overall survival (OS). Kaplan–Meier survival analysis and Cox proportional hazard modelling were used. Ethics approval was obtained from the Ethical Commission of Carl von Ossietzky University of Oldenburg (2018-100).

Results

In total, 1563 patients with breast cancer were included in the study. The adherence rate to MTB recommendations was 89.6%. The most common reason for nonadherence was patient preference (122 out of 162 nonadherent patients, 75.3%). There was a statistically significant difference in DFS and OS between adherent and nonadherent patients (log-rank test, P < .05). In the multivariate analysis, adherence was a significant predictor of DFS but not OS.

Conclusion

Adherence to MTB recommendations demonstrated an improved DFS and OS in patients with breast cancer in the univariate analysis. In the multivariate analysis, adherence was a significant predictor of DFS but not OS. This suggests further research is needed to determine the factors underlying behind the survival time of patients with breast cancer.
背景:多学科治疗对乳腺癌的治疗至关重要。多学科肿瘤委员会(MTBs)可以改善乳腺癌的健康结果;然而,坚持MTB建议与生存时间的关系尚未得到研究。方法:本研究是一项回顾性观察性研究,研究对象是2014年至2018年间诊断出乳腺癌的患者,并在德国癌症协会认证的2个乳腺癌中心的MTB会议上进行了讨论。主要终点是MTB建议的依从率和无病生存期(DFS)。次要终点是总生存期(OS)。采用Kaplan-Meier生存分析和Cox比例风险模型。获得了奥尔登堡卡尔·冯·奥西茨基大学伦理委员会(2018-100)的伦理批准。结果共纳入1563例乳腺癌患者。对MTB建议的依从率为89.6%。最常见的不依从性原因是患者偏好(162例不依从性患者中有122例,占75.3%)。坚持治疗与未坚持治疗患者的DFS和OS差异有统计学意义(log-rank检验,P < 0.05)。在多变量分析中,依从性是DFS的重要预测因子,而不是OS。结论在单变量分析中,坚持MTB建议可以改善乳腺癌患者的DFS和OS。在多变量分析中,依从性是DFS的重要预测因子,而不是OS。这表明需要进一步的研究来确定乳腺癌患者生存时间背后的因素。
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引用次数: 0
Comment on “Sequential Therapy With HER2 Tyrosine Kinase Inhibitors in Patients With HER2-Positive Metastatic Breast Cancer” 《HER2酪氨酸激酶抑制剂序贯治疗HER2阳性转移性乳腺癌》评论
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-22 DOI: 10.1016/j.clbc.2025.10.012
S. Dhanya Dedeepya , Vaishali Goel , Nivedita Nikhil Desai
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引用次数: 0
Long-Term Health Issues of Adolescent and Young Adult Breast Cancer Survivors. 青少年和青年乳腺癌幸存者的长期健康问题。
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-22 DOI: 10.1016/j.clbc.2025.10.009
Noëlle J M C Vrancken Peeters, Marianne J Heins, Gioele Re, Marleen Kok, Iris M C van der Ploeg, Winette T A van der Graaf, Olga Husson

Background: The prognosis for adolescent and young adult (AYA) breast cancer patients has increased significantly. Research concerning long-term health problems is especially relevant given the long life expectancy of these young patients. This study aimed to compare the long-term health issues registered by general practitioners (GPs) of AYA breast cancer survivors to age-matched controls.

Methods: Data of all female AYAs diagnosed with invasive breast cancer between 1999 and 2020 were obtained from the Netherlands Cancer Registry (NCR) and linked with longitudinal data on health problems recorded by GPs organized in the Nivel Primary Care Database (Nivel-PCD). A female normative sample was obtained from the Nivel Primary Care Database (Nivel-PCD). Cox proportional hazard models were used to compare the hazard of a GP consult for a specific health condition after diagnosis between AYA breast cancer survivors and controls.

Results: A total of 793 AYA breast cancer survivors (mean age 35.3 years, mean follow-up 4.7 years) and 2379 controls were included. AYA breast cancer survivors had significantly increased hazards of consulting the GP for eye (HR = 1.25), musculoskeletal (HR = 1.12), psychological/psychiatric (HR = 1.18), skin (HR = 1.26), and urinary tract conditions (HR = 1.20) and decreased hazards for pregnancy-related conditions (HR = 0.47) and conditions of the female genital system (HR = 0.85) compared to controls.

Conclusion: AYA breast cancer survivors face a higher risk of various long-term health challenges compared to age-matched controls, including physical and psychological conditions. This emphasizes the need for the development of multidisciplinary follow-up programs tailored to the specific and ongoing health needs of this young population.

背景:青少年和青壮年乳腺癌(AYA)患者的预后显著增加。考虑到这些年轻患者的预期寿命较长,有关长期健康问题的研究尤为重要。本研究旨在比较全科医生(全科医生)登记的AYA乳腺癌幸存者与年龄匹配的对照组的长期健康问题。方法:从荷兰癌症登记处(NCR)获得1999年至2020年期间诊断为浸润性乳腺癌的所有女性AYAs的数据,并与Nivel初级保健数据库(Nivel- pcd)中组织的全科医生记录的健康问题纵向数据相关联。从Nivel初级保健数据库(Nivel- pcd)中获得女性标准样本。Cox比例风险模型用于比较AYA乳腺癌幸存者和对照组在诊断后因特定健康状况咨询全科医生的风险。结果:共纳入793例AYA乳腺癌幸存者(平均年龄35.3岁,平均随访4.7年)和2379例对照。与对照组相比,AYA乳腺癌幸存者在眼科(HR = 1.25)、肌肉骨骼(HR = 1.12)、心理/精神(HR = 1.18)、皮肤(HR = 1.26)和泌尿系统(HR = 1.20)方面咨询全科医生的风险显著增加,妊娠相关疾病(HR = 0.47)和女性生殖系统疾病(HR = 0.85)方面的风险显著降低。结论:与年龄匹配的对照组相比,AYA乳腺癌幸存者面临各种长期健康挑战的风险更高,包括身体和心理状况。这强调了针对这一年轻人口的具体和持续的健康需求制定多学科后续方案的必要性。
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引用次数: 0
Comment on: Prognostic Ability of the Indication for Adjuvant Systemic Therapy Based on Preoperative Biopsy and the Surgical Excision Specimen in Cases of Small Breast Tumors (CONSCIENCE): A Retrospective Cohort Study. 评论:基于术前活检和手术切除标本的乳腺小肿瘤辅助全身治疗指征的预后能力(良心):一项回顾性队列研究。
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-19 DOI: 10.1016/j.clbc.2025.10.007
Xuezheng Zhu, Daquan Liao, Shiye Huang, Yubin Feng, Ziye Zhuang
{"title":"Comment on: Prognostic Ability of the Indication for Adjuvant Systemic Therapy Based on Preoperative Biopsy and the Surgical Excision Specimen in Cases of Small Breast Tumors (CONSCIENCE): A Retrospective Cohort Study.","authors":"Xuezheng Zhu, Daquan Liao, Shiye Huang, Yubin Feng, Ziye Zhuang","doi":"10.1016/j.clbc.2025.10.007","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.10.007","url":null,"abstract":"","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.5,"publicationDate":"2025-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145512314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Feet Cooling As a Preventive Strategy against Chemotherapy-Induced Peripheral Neuropathy in Advanced Breast Cancer Patients: A Randomized Clinical Trial 足部降温作为晚期乳腺癌患者化疗诱导周围神经病变的预防策略:一项随机临床试验
IF 2.5 3区 医学 Q2 ONCOLOGY Pub Date : 2025-10-19 DOI: 10.1016/j.clbc.2025.10.008
Fatemeh Asadi , Elaheh Emadi , Reza Chaman , Pejman Porouhan , Mahboobeh Nematshahi , Babak PeyroShabany , Mohammad Salari Zare , Seyed Alireza Javadinia

Background

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of taxane-based chemotherapy, often persisting long after treatment completion. This study evaluates the efficacy of continuous foot cooling with an adjustable temperature wrap during taxane infusion to prevent CIPN in breast cancer patients.

Methods

In this open-label randomized controlled trial, 120 patients with stage I to III breast cancer undergoing paclitaxel-based chemotherapy were randomly assigned to an intervention group receiving continuous feet cooling (13°C-16°C) initiated 30 minutes before and maintained until 15 minutes after chemotherapy infusion, alongside standard care, or to a control group receiving standard care alone. CIPN was assessed using the modified EORTC QLQ-CIPN20 questionnaire at 6 weeks (t1), 12 weeks (t2), and 3 months post-treatment (t3).

Results

Baseline characteristics were balanced between groups. The intervention group demonstrated significantly lower-limb CIPN scores compared to controls at all time points: week 6 (21.58 ± 5.89 vs. 26.28 ± 7.78; P < .001), week 12 (22.75 ± 7.15 vs. 28.56 ± 6.99; P < .001), and 3 months post-treatment (19.73 ± 5.90 vs. 26.65 ± 19.48; P < .001). The number needed to treat (NNT) was 7, indicating a moderate protective effect. Foot cooling was well tolerated, with no differences in chemotherapy dose modifications.

Conclusion

Continuous foot cooling during chemotherapy significantly reduces the incidence of CIPN and may improve treatment adherence. Larger multicenter trials are needed to validate these findings.

Clinical Trial Registration

Iranian Registry of Clinical Trials (IRCT) number IRCT20231108059991N1.
背景:化疗引起的周围神经病变(CIPN)是紫杉烷类化疗常见的、使人衰弱的不良反应,通常在治疗结束后持续很长时间。本研究评估了紫杉烷输注期间持续足部冷却和可调温度包裹对预防乳腺癌患者CIPN的效果。方法在这项开放标签随机对照试验中,120例接受紫杉醇化疗的I至III期乳腺癌患者被随机分配到化疗前30分钟开始并维持至化疗输注后15分钟的持续足部冷却(13°C-16°C)的干预组,以及单独接受标准治疗的对照组。在治疗后6周(t1)、12周(t2)和3个月(t3)使用改进的EORTC QLQ-CIPN20问卷评估CIPN。结果各组基线特征平衡。干预组在所有时间点下肢CIPN评分均显著高于对照组:第6周(21.58±5.89比26.28±7.78;P < 0.001),第12周(22.75±7.15比28.56±6.99;P < 0.001),治疗后3个月(19.73±5.90比26.65±19.48;P < 0.001)。需要治疗的数量(NNT)为7,表明有中等保护作用。足部冷却耐受良好,化疗剂量调整无差异。结论化疗期间持续足部降温可显著降低CIPN发生率,提高治疗依从性。需要更大规模的多中心试验来验证这些发现。临床试验注册伊朗临床试验注册中心(IRCT)编号IRCT20231108059991N1。
{"title":"Feet Cooling As a Preventive Strategy against Chemotherapy-Induced Peripheral Neuropathy in Advanced Breast Cancer Patients: A Randomized Clinical Trial","authors":"Fatemeh Asadi ,&nbsp;Elaheh Emadi ,&nbsp;Reza Chaman ,&nbsp;Pejman Porouhan ,&nbsp;Mahboobeh Nematshahi ,&nbsp;Babak PeyroShabany ,&nbsp;Mohammad Salari Zare ,&nbsp;Seyed Alireza Javadinia","doi":"10.1016/j.clbc.2025.10.008","DOIUrl":"10.1016/j.clbc.2025.10.008","url":null,"abstract":"<div><h3>Background</h3><div>Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of taxane-based chemotherapy, often persisting long after treatment completion. This study evaluates the efficacy of continuous foot cooling with an adjustable temperature wrap during taxane infusion to prevent CIPN in breast cancer patients.</div></div><div><h3>Methods</h3><div>In this open-label randomized controlled trial, 120 patients with stage I to III breast cancer undergoing paclitaxel-based chemotherapy were randomly assigned to an intervention group receiving continuous feet cooling (13°C-16°C) initiated 30 minutes before and maintained until 15 minutes after chemotherapy infusion, alongside standard care, or to a control group receiving standard care alone. CIPN was assessed using the modified EORTC QLQ-CIPN20 questionnaire at 6 weeks (t<sub>1</sub>), 12 weeks (t<sub>2</sub>), and 3 months post-treatment (t<sub>3</sub>).</div></div><div><h3>Results</h3><div>Baseline characteristics were balanced between groups. The intervention group demonstrated significantly lower-limb CIPN scores compared to controls at all time points: week 6 (21.58 ± 5.89 vs. 26.28 ± 7.78; <em>P</em> &lt; .001), week 12 (22.75 ± 7.15 vs. 28.56 ± 6.99; <em>P</em> &lt; .001), and 3 months post-treatment (19.73 ± 5.90 vs. 26.65 ± 19.48; <em>P</em> &lt; .001). The number needed to treat (NNT) was 7, indicating a moderate protective effect. Foot cooling was well tolerated, with no differences in chemotherapy dose modifications.</div></div><div><h3>Conclusion</h3><div>Continuous foot cooling during chemotherapy significantly reduces the incidence of CIPN and may improve treatment adherence. Larger multicenter trials are needed to validate these findings.</div></div><div><h3>Clinical Trial Registration</h3><div>Iranian Registry of Clinical Trials (IRCT) number IRCT20231108059991N1.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"26 1","pages":"Pages 5-12"},"PeriodicalIF":2.5,"publicationDate":"2025-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145537035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
期刊
Clinical breast cancer
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