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Non-irradiated area of intraoperative radiotherapy with electron technique: outcomes and pattern of failure in early-stage breast cancer from a single-center, registry study 采用电子技术进行术中放疗的非照射区:一项单中心登记研究得出的早期乳腺癌疗效和失败模式
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-10 DOI: 10.1007/s12282-024-01624-z
Tanun Jitwatcharakomol, Jiraporn Setakornnukul, Suebwong Chuthatisith, Adune Ratanawichitrasin, Janjira Petsuksiri, Naponwan Sirima, Kullathorn Thephamongkhol

Introduction

Intraoperative radiotherapy (IORT) with electrons has revealed to have higher rates of ipsilateral breast tumor recurrence (IBTR) than external beam radiotherapy in updated large-scale, randomized controlled trials in 2021. This study details the oncological outcomes of IORT with electron beams using our strict IORT policies. We have found new and important observations regarding the location of recurrence.

Methods and materials

This is a single institution registry of early-stage breast cancer patients who underwent lumpectomy and electron beam IORT with appropriate cone size. All patients met our pre-excision requirements. The primary endpoint was 5-year IBTR rate, with secondary endpoints being 5-year locoregional failure rate, 5-year distant metastasis rate, 5-year overall survival and, importantly, the failure patterns.

Results

Between January 2011 and December 2022, 124 patients were recruited. The median follow-up was 6.7 years. The 5-year IBTR rate was 1.87% (95% CI 0.47–7.29%), which is much lower than the ELIOT trial and comparable with other accelerated partial breast irradiation (APBI) techniques. The 5-year locoregional failure rate was 3.68% (95% CI 1.40–9.52%), and the 5-year distant metastasis rate was 0.88% (95% CI 0.13–6.12%), while the 5-year overall survival rate was 97.52% (95% CI 92.44–99.19%). Six patients experienced IBTR. All recurrences were in surgical area, occurring superficial to the tumor bed and within 1 cm of the skin dermis. This failure pattern is very unique and might be explained by our hypothesis of the non-irradiated area beneath the skin.

Conclusions

IORT with electron beams with strict patient selection criteria and strict large cone size is still an acceptable treatment for select patients with early-stage breast cancer. However, our new findings support extreme caution in the non-irradiated area beneath the skin around the tumor cavity. Given the constraints of our sample size, these findings should be interpreted cautiously and warrant further investigation in larger, more comprehensive studies.

导言在2021年更新的大规模随机对照试验中发现,使用电子束的术中放疗(IORT)的同侧乳腺肿瘤复发率(IBTR)高于外照射放疗。本研究详细介绍了使用电子束进行IORT的肿瘤学结果,并采用了我们严格的IORT政策。我们发现了关于复发位置的新的重要观察结果。方法和材料这是一项单机构登记,对象是接受肿块切除术和适当锥体大小的电子束 IORT 的早期乳腺癌患者。所有患者均符合切除术前要求。主要终点是 5 年 IBTR 率,次要终点是 5 年局部失败率、5 年远处转移率、5 年总生存率,以及重要的失败模式。中位随访时间为 6.7 年。5年IBTR率为1.87%(95% CI 0.47-7.29%),远低于ELIOT试验,与其他加速乳腺部分照射(APBI)技术相当。5年局部失败率为3.68%(95% CI 1.40-9.52%),5年远处转移率为0.88%(95% CI 0.13-6.12%),5年总生存率为97.52%(95% CI 92.44-99.19%)。6名患者出现了IBTR。所有复发均发生在手术区域,位于肿瘤床表层,距离皮肤真皮层不到 1 厘米。这种失败模式非常独特,也许可以用我们关于皮下非照射区的假设来解释。然而,我们的新研究结果表明,对肿瘤腔周围皮下非照射区的治疗要格外谨慎。鉴于我们的样本量有限,这些发现应谨慎解读,并值得在更大规模、更全面的研究中进一步探讨。
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引用次数: 0
Contrast-enhanced mammography in the management of breast architectural distortions and avoidance of unnecessary biopsies. 对比增强乳腺 X 射线照相术在处理乳房结构变形和避免不必要的活组织检查中的应用。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-29 DOI: 10.1007/s12282-024-01599-x
Chiara Bellini, Francesca Pugliese, Giulia Bicchierai, Francesco Amato, Diego De Benedetto, Federica Di Naro, Cecilia Boeri, Ermanno Vanzi, Giuliano Migliaro, Ludovica Incardona, Cinzia Tommasi, Lorenzo Orzalesi, Vittorio Miele, Jacopo Nori

Background: To assess contrast-enhanced mammography (CEM) in the management of BI-RADS3 breast architectural distortions (AD) in digital breast tomosynthesis (DBT).

Methods: We retrospectively reviewed 328 women with 332 ADs detected on DBT between 2017 and 2021 and selected those classified as BI-RADS3 receiving CEM as problem-solving. In CEM recombined images, we evaluated AD's contrast enhancement (CE) according to its presence/absence, type, and size. AD with enhancement underwent imaging-guided biopsy while AD without enhancement follow-up or biopsy if detected in high/intermediate-risk women.

Results: AD with enhancement were 174 (52.4%): 72 (41.4%) were malignant lesions, 102 (59.6%) false positive results: 28 (16%) B3 lesions, and 74 (42.5%) benign lesions. AD without enhancement were 158 (47.6%): 26 (16.5%) were subjected to biopsy (1 malignant and 25 benign) while the other 132 cases were sent to imaging follow-up, still negative after two years. CEM's sensitivity, specificity, positive (PPV) and negative predictive values (NPV), and accuracy were 98.63%, 60.62%, 41.38%, 99.37%, and 68.98%. The AUC determined by ROC was 0.796 (95% CI, 0.749-0.844).

Conclusion: CEM has high sensitivity and NPV in evaluating BI-RADS3 AD and can be a complementary tool in assessing AD, avoiding unnecessary biopsies without compromising cancer detection.

背景:评估对比增强乳腺X线摄影(CEM)在数字乳腺断层合成术(DBT)中处理BI-RADS3乳腺结构变形(AD)的效果:目的:评估造影剂增强乳腺摄影(CEM)在数字乳腺断层合成术(DBT)中处理BI-RADS3乳腺结构变形(AD)的情况:我们回顾性地查看了2017年至2021年间328名女性在DBT中检测到的332个AD,并选择被归类为BI-RADS3的女性接受CEM作为问题解决方案。在CEM重组图像中,我们根据AD的有/无、类型和大小评估其对比度增强(CE)。如果在高危/中危妇女中发现有增强的 AD,则在成像引导下进行活检;如果发现无增强的 AD,则进行随访或活检:结果:有增强的 AD 为 174 例(52.4%):72例(41.4%)为恶性病变,102例(59.6%)为假阳性结果:28例(16%)为B3病变,74例(42.5%)为良性病变。无强化的 AD 为 158 例(47.6%):26 例(16.5%)进行了活检(1 例为恶性,25 例为良性),其他 132 例进行了影像学随访,两年后仍为阴性。CEM的敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)以及准确性分别为98.63%、60.62%、41.38%、99.37%和68.98%。ROC得出的AUC为0.796(95% CI,0.749-0.844):CEM在评估BI-RADS3 AD方面具有较高的灵敏度和NPV,可作为评估AD的辅助工具,在不影响癌症检测的情况下避免不必要的活检。
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引用次数: 0
Mesenchymal-like immune-altered is the fourth robust triple-negative breast cancer molecular subtype. 间质样免疫改变是第四个强大的三阴性乳腺癌分子亚型。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-22 DOI: 10.1007/s12282-024-01597-z
Pascal Jézéquel, Hamza Lasla, Wilfried Gouraud, Agnès Basseville, Bertrand Michel, Jean-Sébastien Frenel, Philippe P Juin, Fadoua Ben Azzouz, Mario Campone

Background: Robust molecular subtyping of triple-negative breast cancer (TNBC) is a prerequisite for the success of precision medicine. Today, there is a clear consensus on three TNBC molecular subtypes: luminal androgen receptor (LAR), basal-like immune-activated (BLIA), and basal-like immune-suppressed (BLIS). However, the debate about the robustness of other subtypes is still open.

Methods: An unprecedented number (n = 1942) of TNBC patient data was collected. Microarray- and RNAseq-based cohorts were independently investigated. Unsupervised analyses were conducted using k-means consensus clustering. Clusters of patients were then functionally annotated using different approaches. Prediction of response to chemotherapy and targeted therapies, immune checkpoint blockade, and radiotherapy were also screened for each TNBC subtype.

Results: Four TNBC subtypes were identified in the cohort: LAR (19.36%); mesenchymal stem-like (MSL/MES) (17.35%); BLIA (31.06%); and BLIS (32.23%). Regarding the MSL/MES subtype, we suggest renaming it to mesenchymal-like immune-altered (MLIA) to emphasize its specific histological background and nature of immune response. Treatment response prediction results show, among other things, that despite immune activation, immune checkpoint blockade is probably less or completely ineffective in MLIA, possibly caused by mesenchymal background and/or an enrichment in dysfunctional cytotoxic T lymphocytes. TNBC subtyping results were included in the bc-GenExMiner v5.0 webtool ( http://bcgenex.ico.unicancer.fr ).

Conclusion: The mesenchymal TNBC subtype is characterized by an exhausted and altered immune response, and resistance to immune checkpoint inhibitors. Consensus for molecular classification of TNBC subtyping and prediction of cancer treatment responses helps usher in the era of precision medicine for TNBC patients.

背景:对三阴性乳腺癌(TNBC)进行可靠的分子亚型鉴定是精准医疗取得成功的先决条件。如今,人们已就三种 TNBC 分子亚型达成明确共识:腔内雄激素受体 (LAR)、基底样免疫激活 (BLIA) 和基底样免疫抑制 (BLIS)。然而,关于其他亚型的稳健性仍有争议:方法:收集了数量空前(n = 1942)的 TNBC 患者数据。对基于芯片和 RNAseq 的队列进行了独立调查。使用 k-means 共识聚类法进行了无监督分析。然后使用不同的方法对患者群进行功能注释。还对每种 TNBC 亚型的化疗和靶向治疗、免疫检查点阻断和放疗反应进行了预测:结果:队列中发现了四种TNBC亚型:LAR(19.36%)、间充质干样(MSL/MES)(17.35%)、BLIA(31.06%)和BLIS(32.23%)。关于 MSL/MES 亚型,我们建议将其更名为间充质样免疫改变(MLIA),以强调其特殊的组织学背景和免疫反应性质。治疗反应预测结果显示,尽管存在免疫激活,但免疫检查点阻断在MLIA中可能效果较差或完全无效,这可能是间质背景和/或功能失调的细胞毒性T淋巴细胞富集所致。TNBC亚型结果已纳入bc-GenExMiner v5.0网络工具(http://bcgenex.ico.unicancer.fr ):间质 TNBC 亚型的特点是免疫反应衰竭和改变,以及对免疫检查点抑制剂的耐药性。TNBC 亚型分子分类和癌症治疗反应预测的共识有助于 TNBC 患者进入精准医疗时代。
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引用次数: 0
Comparison of water- vs. land-based exercise for improving functional capacity and quality of life in patients living with and beyond breast cancer (the AQUA-FiT study): a randomized controlled trial. 比较水上运动和陆上运动对提高乳腺癌患者和乳腺癌晚期患者的功能和生活质量的作用(AQUA-FiT 研究):随机对照试验。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-30 DOI: 10.1007/s12282-024-01596-0
E Mur-Gimeno, M Coll, A Yuguero-Ortiz, M Navarro, M Vernet-Tomás, A Noguera-Llauradó, R Sebio-García

Background: Patients living with and beyond breast cancer frequently exhibit several side effects that can impact quality of life and physical functioning way beyond diagnosis and cancer therapies. Traditional on-land exercise has shown to be effective in reducing several symptoms of BC but little is known about the role of water-based exercise in improving physical and psychological well-being.

Objectives: To compare land- vs. water-based exercise training for BC survivors to improve Health-Related Quality of Life (HRQoL), cancer-related fatigue (CRF), physical functioning, body composition and physical activity in patients with BC.

Methods: A randomised, parallel group (1:1) controlled trial was conducted between 2020 and 2022. Patients were randomly allocated to complete a similar exercise training twice weekly during 12 weeks either on land (LG) using traditional gym equipment or in a swimming pool (WG) using body-weight exercises and water-suitable accessories. Both groups were supervised and monitored by an experienced physiotherapist. Main outcome was HRQoL (EORTC QLQ C30 and B23 module) and CRF measured with the Piper Scale. Secondary variables included functional capacity with the 6 Minutes Walking Test (6MWT), upper and lower body strength (handgrip strength and 30″ Sit-to-Stand (STS) test), body composition and objectively measured physical activity.

Results: 28 patients were assessed and randomised during the study period. One patient did not receive the allocated intervention due to skin issues and one patient was dropped out during the intervention. A significant effect of time was found for both symptom severity (F(2,52) = 6.46, p = 0.003) and overall functioning (F1.67,43.45 = 5.215, p =0 .013) but no interaction was found between group and time. No effects were reported for CRF. Similar findings were reported for functional capacity (time effect F1.231,32.019 = 16.818, p < 0.001) and lower body strength (time effect F2,52 = 15.120, p < 0.001) as well as fat mass (time effect F2,52 = 4.38, p = 0.017). Notably, a significant time per group interaction was reported for physical activity (F2,52 = 6.349, p =0.003) with patients in the WG significantly improving PA levels over time while patients in the LG exhibited a marked decreased.

Conclusions: Exercise training either in water or on land can decrease symptom severity and improve functionality and body composition. Water-based training seems more effecting than land-based exercise to improve physical activity patterns over time.

背景:乳腺癌患者经常会出现一些副作用,这些副作用对生活质量和身体机能的影响远远超出了诊断和癌症治疗的范围。传统的陆上运动可有效减轻乳腺癌的一些症状,但人们对水中运动在改善身心健康方面的作用知之甚少:目的:比较陆上运动训练与水上运动训练对于改善 BC 患者健康相关生活质量 (HRQoL)、癌症相关疲劳 (CRF)、身体机能、身体成分和体育锻炼的作用:在 2020 年至 2022 年期间进行了一项随机平行组(1:1)对照试验。患者被随机分配在12周内每周两次完成类似的运动训练,训练方式可以是在陆地上(LG)使用传统健身器材,也可以是在游泳池里(WG)使用体重练习和适合水的附件。两组均由一名经验丰富的理疗师进行指导和监测。主要结果是 HRQoL(EORTC QLQ C30 和 B23 模块)和 CRF(使用派博量表测量)。次要变量包括 6 分钟步行测试(6MWT)的功能能力、上半身和下半身力量(手握力量和 30″ 坐立(STS)测试)、身体成分和客观测量的体力活动。一名患者因皮肤问题未接受分配的干预,一名患者在干预期间退出。研究发现,时间对症状严重程度(F(2,52) = 6.46,p = 0.003)和整体功能(F1.67,43.45 = 5.215,p = 0.013)有明显影响,但组别与时间之间没有交互作用。在 CRF 方面没有发现任何影响。功能能力方面也有类似的结果(时间效应 F1.231,32.019 = 16.818, p 2,52 = 15.120, p 2,52 = 4.38, p = 0.017)。值得注意的是,在体力活动方面,各组之间存在明显的时间交互作用(F2,52 = 6.349,p =0.003),随着时间的推移,WG 组患者的体力活动水平明显提高,而 LG 组患者的体力活动水平则明显下降:结论:在水中或陆地上进行运动训练可减轻症状的严重程度,改善机能和身体成分。随着时间的推移,水上训练似乎比陆上运动更能改善身体活动模式。
{"title":"Comparison of water- vs. land-based exercise for improving functional capacity and quality of life in patients living with and beyond breast cancer (the AQUA-FiT study): a randomized controlled trial.","authors":"E Mur-Gimeno, M Coll, A Yuguero-Ortiz, M Navarro, M Vernet-Tomás, A Noguera-Llauradó, R Sebio-García","doi":"10.1007/s12282-024-01596-0","DOIUrl":"10.1007/s12282-024-01596-0","url":null,"abstract":"<p><strong>Background: </strong>Patients living with and beyond breast cancer frequently exhibit several side effects that can impact quality of life and physical functioning way beyond diagnosis and cancer therapies. Traditional on-land exercise has shown to be effective in reducing several symptoms of BC but little is known about the role of water-based exercise in improving physical and psychological well-being.</p><p><strong>Objectives: </strong>To compare land- vs. water-based exercise training for BC survivors to improve Health-Related Quality of Life (HRQoL), cancer-related fatigue (CRF), physical functioning, body composition and physical activity in patients with BC.</p><p><strong>Methods: </strong>A randomised, parallel group (1:1) controlled trial was conducted between 2020 and 2022. Patients were randomly allocated to complete a similar exercise training twice weekly during 12 weeks either on land (LG) using traditional gym equipment or in a swimming pool (WG) using body-weight exercises and water-suitable accessories. Both groups were supervised and monitored by an experienced physiotherapist. Main outcome was HRQoL (EORTC QLQ C30 and B23 module) and CRF measured with the Piper Scale. Secondary variables included functional capacity with the 6 Minutes Walking Test (6MWT), upper and lower body strength (handgrip strength and 30″ Sit-to-Stand (STS) test), body composition and objectively measured physical activity.</p><p><strong>Results: </strong>28 patients were assessed and randomised during the study period. One patient did not receive the allocated intervention due to skin issues and one patient was dropped out during the intervention. A significant effect of time was found for both symptom severity (F(<sub>2</sub>,<sub>52</sub>) = 6.46, p = 0.003) and overall functioning (F<sub>1.67,43.45</sub> = 5.215, p =0 .013) but no interaction was found between group and time. No effects were reported for CRF. Similar findings were reported for functional capacity (time effect F<sub>1.231,32.019</sub> = 16.818, p < 0.001) and lower body strength (time effect F<sub>2,52</sub> = 15.120, p < 0.001) as well as fat mass (time effect F<sub>2,52</sub> = 4.38, p = 0.017). Notably, a significant time per group interaction was reported for physical activity (F<sub>2,52</sub> = 6.349, p =0.003) with patients in the WG significantly improving PA levels over time while patients in the LG exhibited a marked decreased.</p><p><strong>Conclusions: </strong>Exercise training either in water or on land can decrease symptom severity and improve functionality and body composition. Water-based training seems more effecting than land-based exercise to improve physical activity patterns over time.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141176874","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
Cost-effectiveness of adjuvant endocrine treatment with tamoxifen for male breast cancer. 使用他莫昔芬辅助内分泌治疗男性乳腺癌的成本效益。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-06-15 DOI: 10.1007/s12282-024-01605-2
Yaping Huang, Chengjie Ke, Jiaqin Cai, Xiaoxia Wei, Maohua Chen, Hong Sun

Background: Tamoxifen (TAM) is recommended as the first-line strategy for men with estrogen receptor (ER)-positive early breast cancer who are candidates for adjuvant endocrine therapy in ASCO guideline. Our study aims to analyze the cost-effectiveness of receiving adjuvant endocrine therapy with TAM compared to no TAM, and to assess the cost-effectiveness of using TAM with high adherence over low adherence for ER-positive early male breast cancer in the USA.

Methods: Two Markov models comprising three mutually exclusive health states were constructed: (1) the first Markov model compared the cost-effectiveness of adding TAM with not using TAM (TAM versus Not-TAM); (2) the second model compared the cost-effectiveness of receiving TAM with high adherence and low adherence (High-adherence-TAM versus Low-adherence-TAM). The simulation time horizon for both models was the lifetime of patients. The efficacy and safety data of two models were elicited from the real-world studies. Model inputs were derived from the US website and published literature. The main outcomes of two models both included the total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).

Results: In the first model, TAM yielded an ICER of $5707.29 per QALY compared to Not-TAM, which was substantially below the WTP threshold of $50,000.00 per QALY in the USA. Probabilistic sensitivity analysis results demonstrated a 100.00% probability of cost-effectiveness for this strategy. In the second model, High-adherence-TAM was dominated absolutely compared to Low-adherence-TAM. The High-adherence-TAM was cost-effective with a 99.70% probability over Low-adherence-TAM when WTP was set as $50,000.00/QALY. All of these parameters within their plausible ranges did not reversely change the results of our models.

Conclusions: Our study will offer valuable guidance for physicians or patients when making treatment decisions and provide an effective reference for decision-making to consider the appropriate allocation of funds to this special group.

背景:ASCO指南推荐他莫昔芬(TAM)作为雌激素受体(ER)阳性早期乳腺癌男性患者辅助内分泌治疗的一线策略。我们的研究旨在分析与不使用 TAM 相比,使用 TAM 接受辅助内分泌治疗的成本效益,并评估美国 ER 阳性早期男性乳腺癌患者使用高依从性 TAM 而非低依从性 TAM 的成本效益:方法:构建了两个马尔可夫模型,包括三种相互排斥的健康状态:(1)第一个马尔可夫模型比较了添加 TAM 与不使用 TAM 的成本效益(TAM 与 Not-TAM);(2)第二个模型比较了接受高依从性 TAM 与低依从性 TAM 的成本效益(High-adherence-TAM 与 Low-adherence-TAM)。两个模型的模拟时间范围均为患者的终生。两个模型的疗效和安全性数据均来自真实世界的研究。模型输入数据来自美国网站和公开发表的文献。两个模型的主要结果均包括总成本、质量调整生命年(QALYs)和增量成本效益比(ICERs):在第一个模型中,TAM 与非 TAM 相比,每 QALY 的 ICER 为 5707.29 美元,大大低于美国每 QALY 50,000.00 美元的 WTP 临界值。概率敏感性分析结果表明,该策略的成本效益概率为 100.00%。在第二个模型中,与低依从性-TAM 相比,高依从性-TAM 占绝对优势。当 WTP 设为 50,000.00 美元/QALY 时,高依从性-TAM 的成本效益概率为 99.70%,而低依从性-TAM 的成本效益概率为 99.70%。所有这些参数在其合理范围内都不会反向改变我们的模型结果:我们的研究将为医生或患者做出治疗决定提供有价值的指导,并为考虑向这一特殊群体适当分配资金提供有效的决策参考。
{"title":"Cost-effectiveness of adjuvant endocrine treatment with tamoxifen for male breast cancer.","authors":"Yaping Huang, Chengjie Ke, Jiaqin Cai, Xiaoxia Wei, Maohua Chen, Hong Sun","doi":"10.1007/s12282-024-01605-2","DOIUrl":"10.1007/s12282-024-01605-2","url":null,"abstract":"<p><strong>Background: </strong>Tamoxifen (TAM) is recommended as the first-line strategy for men with estrogen receptor (ER)-positive early breast cancer who are candidates for adjuvant endocrine therapy in ASCO guideline. Our study aims to analyze the cost-effectiveness of receiving adjuvant endocrine therapy with TAM compared to no TAM, and to assess the cost-effectiveness of using TAM with high adherence over low adherence for ER-positive early male breast cancer in the USA.</p><p><strong>Methods: </strong>Two Markov models comprising three mutually exclusive health states were constructed: (1) the first Markov model compared the cost-effectiveness of adding TAM with not using TAM (TAM versus Not-TAM); (2) the second model compared the cost-effectiveness of receiving TAM with high adherence and low adherence (High-adherence-TAM versus Low-adherence-TAM). The simulation time horizon for both models was the lifetime of patients. The efficacy and safety data of two models were elicited from the real-world studies. Model inputs were derived from the US website and published literature. The main outcomes of two models both included the total cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).</p><p><strong>Results: </strong>In the first model, TAM yielded an ICER of $5707.29 per QALY compared to Not-TAM, which was substantially below the WTP threshold of $50,000.00 per QALY in the USA. Probabilistic sensitivity analysis results demonstrated a 100.00% probability of cost-effectiveness for this strategy. In the second model, High-adherence-TAM was dominated absolutely compared to Low-adherence-TAM. The High-adherence-TAM was cost-effective with a 99.70% probability over Low-adherence-TAM when WTP was set as $50,000.00/QALY. All of these parameters within their plausible ranges did not reversely change the results of our models.</p><p><strong>Conclusions: </strong>Our study will offer valuable guidance for physicians or patients when making treatment decisions and provide an effective reference for decision-making to consider the appropriate allocation of funds to this special group.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141328190","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
The effect of exercise and educational programs for breast cancer patients on the development of breast cancer-related lymphoedema: secondary endpoint from a randomized controlled trial in the Setouchi Breast Project-10. 乳腺癌患者运动和教育计划对乳腺癌相关淋巴水肿发展的影响:濑户内乳腺项目-10随机对照试验的次要终点。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-09 DOI: 10.1007/s12282-024-01610-5
Shogo Nakamoto, Takayuki Iwamoto, Naruto Taira, Yukiko Kajiwara, Kengo Kawada, Daisuke Takabatake, Yuichiro Miyoshi, Shinichiro Kubo, Yoko Suzuki, Mari Yamamoto, Yutaka Ogasawara, Minami Hatono, Seiji Yoshitomi, Kyoko Hara, Asako Sasahara, Shozo Ohsumi, Masahiko Ikeda, Hiroyoshi Doihara, Yuri Mizota, Seiichiro Yamamoto, Tadahiko Shien, Shinichi Toyooka

Background: Although the association between higher physical activity and preventive effect on breast-cancer-related lymphoedema (BCRL) has been reported, it is unclear what intervention is optimal. We aimed to investigate the effect of exercise and educational programs on BCRL development.

Methods: This study was a secondary endpoint analysis from a prospective randomized controlled trial. We enrolled patients with stage 0-III breast cancer from March 2016 to March 2020 and randomly assigned them to the control (n = 111), education (n = 115), or exercise (n = 104) group. As secondary endpoint, we assessed the incidence of and preventive effect on BCRL at 12 months post-intervention.

Results: There were no significant differences in the incidence of BCRL at 12 months post-intervention between the exercise and control groups (9.8% and 10.8%, P = 0.83) and the education and control groups (11.6% and 10.8%, P = 1.00). There were no significant differences in time to BCRL onset from the day of surgery between the exercise and control groups (event rate at 12 months: 20.7% and 17.2%, log-rank, P = 0.54) and the education and control groups (18.8% and 17.2%, log-rank, P = 0.57). The multivariable analyses indicated that axillary dissection and obesity significantly increased the risk of BCRL [hazard ratio (HR): 2.36, 95% confidence interval (CI) 1.52-3.67 and HR: 1.68, 95% CI 1.07-2.63, respectively].

Conclusions: The intervention did not decrease the risk of BCRL, and axillary dissection and obesity were the risk factors of BCRL.

Trial registration number: UMIN000020595 at UMIN Clinical Trial Registry.

背景:尽管有报道称增加体育锻炼与预防乳腺癌相关淋巴水肿(BCRL)之间存在关联,但目前尚不清楚哪种干预措施是最佳的。我们旨在研究运动和教育项目对乳腺癌相关淋巴水肿发展的影响:本研究是一项前瞻性随机对照试验的次要终点分析。我们在2016年3月至2020年3月期间招募了0-III期乳腺癌患者,并将他们随机分配到对照组(n = 111)、教育组(n = 115)或运动组(n = 104)。作为次要终点,我们评估了干预后 12 个月 BCRL 的发生率和预防效果:结果:干预后 12 个月,运动组和对照组(9.8% 和 10.8%,P = 0.83)以及教育组和对照组(11.6% 和 10.8%,P = 1.00)的 BCRL 发生率无明显差异。运动组和对照组(12 个月时的事件发生率分别为 20.7% 和 17.2%,对数秩和,P = 0.54)以及教育组和对照组(18.8% 和 17.2%,对数秩和,P = 0.57)在从手术当天到 BCRL 发病的时间上没有明显差异。多变量分析表明,腋窝解剖和肥胖会显著增加 BCRL 的风险[危险比(HR):2.36,95% 置信区间(CI)分别为 1.52-3.67 和 HR:1.68,95% CI 1.07-2.63]:干预并没有降低 BCRL 的风险,腋窝解剖和肥胖是 BCRL 的风险因素:UMIN000020595 at UMIN Clinical Trial Registry.
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引用次数: 0
Resilience's impact on quality of life and post-traumatic growth in breast cancer patients during treatment. 复原力对乳腺癌患者在治疗期间的生活质量和创伤后成长的影响。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-05-17 DOI: 10.1007/s12282-024-01594-2
Songül Duran, Umut Varol, Özlem Tekir, Ahmet Hakan Soytürk

Background: This article aims to examine how psychological resilience influences the interplay between quality of life and post-traumatic growth among breast cancer patients receiving follow-up care and treatment in Türkiye.

Methods: The study involved 119 female individuals diagnosed with breast cancer who visited the Oncology outpatient clinic at a state hospital in Türkiye from January to September 2023. Data were gathered through the administration of a survey form and the utilization of several assessment tools, including the Adult Life Quality Scale in Cancer Survivors (QLACS), the Brief Resilience Scale (BRS), and the Post-traumatic Growth Inventory (PTGI). Data analysis was carried out using SPSS 25 software.

Results: The participants demonstrated an inverse correlation between Post-Traumatic Growth (PTG) and two QLACS sub-dimensions, namely recurrence and family concern. Conversely, a positive association was identified between PTG and the advantages of dealing with cancer. Furthermore, a statistically significant positive association was established between BRS and all QLACS sub-dimensions, except for family concern and appearance. However, it was determined that psychological resilience did not act as a moderator in the relationship between PTG and QLACS.

Conclusion: It is important to enhance psychological resilience in women who have survived cancer at all stages of the cancer journey, including the years after treatment, to have a positive impact on post-traumatic growth and quality of life.

研究背景本文旨在研究在土耳其接受后续护理和治疗的乳腺癌患者中,心理复原力如何影响生活质量和创伤后成长之间的相互作用:本研究涉及 119 名确诊为乳腺癌的女性患者,她们于 2023 年 1 月至 9 月期间在土耳其一家国立医院的肿瘤科门诊就诊。通过发放调查表和使用多种评估工具收集数据,包括癌症幸存者成人生活质量量表(QLACS)、简易复原力量表(BRS)和创伤后成长量表(PTGI)。数据分析采用 SPSS 25 软件进行:结果:受试者的创伤后成长(PTG)与 QLACS 的两个子维度(即复发和家庭关注)呈反向相关。相反,创伤后成长与应对癌症的优势之间存在正相关。此外,除家庭关注和外表外,BRS 与所有 QLACS 子维度之间均存在统计学意义上的显著正相关。然而,研究结果表明,在 PTG 与 QLACS 的关系中,心理复原力并没有起到调节作用:结论:在癌症治疗过程的各个阶段,包括治疗后的数年,增强癌症女性患者的心理复原力对创伤后成长和生活质量具有积极影响,这一点非常重要。
{"title":"Resilience's impact on quality of life and post-traumatic growth in breast cancer patients during treatment.","authors":"Songül Duran, Umut Varol, Özlem Tekir, Ahmet Hakan Soytürk","doi":"10.1007/s12282-024-01594-2","DOIUrl":"10.1007/s12282-024-01594-2","url":null,"abstract":"<p><strong>Background: </strong>This article aims to examine how psychological resilience influences the interplay between quality of life and post-traumatic growth among breast cancer patients receiving follow-up care and treatment in Türkiye.</p><p><strong>Methods: </strong>The study involved 119 female individuals diagnosed with breast cancer who visited the Oncology outpatient clinic at a state hospital in Türkiye from January to September 2023. Data were gathered through the administration of a survey form and the utilization of several assessment tools, including the Adult Life Quality Scale in Cancer Survivors (QLACS), the Brief Resilience Scale (BRS), and the Post-traumatic Growth Inventory (PTGI). Data analysis was carried out using SPSS 25 software.</p><p><strong>Results: </strong>The participants demonstrated an inverse correlation between Post-Traumatic Growth (PTG) and two QLACS sub-dimensions, namely recurrence and family concern. Conversely, a positive association was identified between PTG and the advantages of dealing with cancer. Furthermore, a statistically significant positive association was established between BRS and all QLACS sub-dimensions, except for family concern and appearance. However, it was determined that psychological resilience did not act as a moderator in the relationship between PTG and QLACS.</p><p><strong>Conclusion: </strong>It is important to enhance psychological resilience in women who have survived cancer at all stages of the cancer journey, including the years after treatment, to have a positive impact on post-traumatic growth and quality of life.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341573/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140961090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Breast cancer epigenetics: current and evolving treatment. 乳腺癌表观遗传学:当前和不断发展的治疗方法。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-06-11 DOI: 10.1007/s12282-024-01601-6
Sujata Purja, Dung Thuy Nguyen, Eunyoung Kim

Background: Breast cancer (BC) presents persistent challenges due to subtype-specific limited efficacy and potential resistance to standard therapy, influenced by the dynamic reversible nature of epigenetic plasticity. This study aims to comprehensively explore the evolving BC epigenetic landscape, analyzing trends and evaluating the therapeutic potential of epigenetic drugs (epi-drugs) for BC treatment.

Methods: We conducted a cross-sectional study of BC epigenetic trials using ClinicalTrials.gov until July 18, 2023. Additionally, results from randomized controlled trials were retrieved from the registry or PubMed using trial registration numbers.

Results: In total, 22 epi-drugs were investigated in 100 trials, with 11 currently being studied in 38 ongoing trials for BC. Over the years, epigenetic clinical trials for BC have notably increased, with histone deacetylase inhibitors constituting 45.45% of the candidate agents in the development pipeline. All ongoing trials are enrolling human epidermal growth factor receptor2 (HER2)-negative BC patients. Epi-drugs are commonly explored in combination with multiple anti-cancer therapies, such as aromatase or microtubule inhibitors, using an intermittent sequential administration approach. Emerging strategies include new-generation epi-drugs and combination involving immunotherapy or targeted therapy. Among candidate drugs, tucidinostat and entinostat, in combination with exemestane, demonstrated significant improvements in progression-free survival in phase III trials for hormone receptor-positive, HER2-negative BC patients.

Conclusion: This study highlights the growing interest in BC epigenetics, suggesting a potential shift from a one-size-fits-all approach to precision medicine, and emphasizes the necessity for robust evidence on their efficacy and safety to support continuous development and approval, addressing the unmet needs in BC treatment.

背景:受表观遗传可塑性动态可逆性质的影响,乳腺癌(BC)因亚型特异性疗效有限和对标准疗法的潜在耐药性而面临持续挑战。本研究旨在全面探索不断变化的乳腺癌表观遗传学状况,分析趋势并评估表观遗传学药物(epi-drugs)治疗乳腺癌的潜力:我们利用 ClinicalTrials.gov 对截至 2023 年 7 月 18 日的 BC 表观遗传学试验进行了横断面研究。此外,我们还使用试验注册号从注册表或PubMed上检索了随机对照试验的结果:共有 22 种表观药物在 100 项试验中接受了研究,其中 11 种目前正在 38 项进行中的 BC 试验中接受研究。多年来,治疗巴氏综合征的表观遗传学临床试验明显增加,组蛋白去乙酰化酶抑制剂占研发中候选药物的45.45%。所有正在进行的试验都在招募人类表皮生长因子受体2(HER2)阴性的巴塞尔公约患者。表皮药物通常与多种抗癌疗法(如芳香化酶或微管抑制剂)联合使用,采用间歇性序贯给药方法。新出现的策略包括新一代表观药物和涉及免疫疗法或靶向疗法的组合。在候选药物中,tucidinostat和entinostat与依西美坦联用,在激素受体阳性、HER2阴性BC患者的III期试验中,无进展生存期明显改善:这项研究凸显了人们对乳腺癌表观遗传学日益增长的兴趣,表明了从 "一刀切 "方法到精准医疗的潜在转变,并强调有必要提供有关其疗效和安全性的有力证据,以支持持续开发和审批,满足乳腺癌治疗中尚未满足的需求。
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引用次数: 0
Quality of life in women with breast cancer undergoing neoadjuvant chemotherapy: comparison between PICC and PICC-port. 接受新辅助化疗的乳腺癌妇女的生活质量:PICC 和 PICC 端口的比较。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-07-09 DOI: 10.1007/s12282-024-01608-z
Fulvio Pinelli, Francesco Barbani, Barbara Defilippo, Angela Fundarò, Alessandra Nella, Valentina Selmi, Stefano Romagnoli, Gianluca Villa

Background: Peripherally inserted central catheters (PICCs) and new type of arm-port, the PICC-port, are currently used for neoadjuvant chemotherapy treatment in patients with breast cancer. We aimed to compare Quality of Life (QoL) of patients receiving one of these two devices investigating overall satisfaction, psychological impact, as well as the impact on professional, social and sport activities, and local discomfort.

Methods: We did a prospective observational before-after study of PICCs versus PICC-ports. Adult (aged ≥ 18 years) females with breast cancer candidate to neoadjuvant chemotherapy were included. The primary outcome was QoL according to the Quality-of-Life Assessment Venous Device Catheters (QLAVD) questionnaire assessed 12 months after device implantation.

Results: Between May 2019 and November 2020, of 278 individuals screened for eligibility, 210 were enrolled. PICC-ports were preferred over PICCs with a QLAVD score of 29 [25; 32] vs 31 [26; 36.5] (p = 0.014). Specifically, most QLAVD constructs related to psychological impact, social aspects, and discomfort were in favor of PICC-ports vs PICC, especially in women under the age of 60. Overall, pain scores at insertion and during therapy administration were not significantly different between the two groups, as well as infection, secondary malpositioning, thrombosis, or obstruction of the device.

Conclusions: In women with breast cancer undergoing neoadjuvant chemotherapy, PICC-ports were overall better accepted than PICCs in terms of QoL, especially in those who were younger. Device-related complications were similar.

背景:外周置入中心导管(PICC)和新型臂端导管(PICC-port)目前被用于乳腺癌患者的新辅助化疗。我们旨在比较接受这两种装置之一的患者的生活质量(QoL),调查总体满意度、心理影响、对职业、社交和体育活动的影响以及局部不适:我们对 PICC 与 PICC 端口进行了前后对比的前瞻性观察研究。研究对象包括接受新辅助化疗的成年(年龄≥ 18 岁)女性乳腺癌患者。主要结果是根据生活质量评估静脉装置导管(QLAVD)问卷对装置植入12个月后的生活质量进行评估:结果:2019 年 5 月至 2020 年 11 月间,在筛选出的 278 名符合条件者中,有 210 人被纳入。与 PICC 相比,PICC 端口更受欢迎,QLAVD 得分为 29 [25; 32] vs 31 [26; 36.5] (p = 0.014)。具体而言,与心理影响、社会方面和不适感有关的大多数 QLAVD 构建都倾向于 PICC 端口,而不是 PICC,尤其是在 60 岁以下的女性中。总体而言,两组患者在插入时和用药期间的疼痛评分以及感染、继发性定位不良、血栓形成或装置阻塞等方面均无显著差异:结论:在接受新辅助化疗的乳腺癌女性患者中,就生活质量而言,PICC导管口的接受度总体上优于PICC导管,尤其是在年轻患者中。与装置相关的并发症相似。
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引用次数: 0
Prognosis of isolated locoregional recurrence after early breast cancer with immediate breast reconstruction surgery: a retrospective multi‑institutional study. 早期乳腺癌即刻乳房重建手术后孤立局部复发的预后:一项多机构回顾性研究。
IF 4 3区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-09-01 Epub Date: 2024-06-19 DOI: 10.1007/s12282-024-01607-0
Hirohito Seki, Akiko Ogiya, Naomi Nagura, Ayaka Shimo, Kazutaka Narui, Shinsuke Sasada, Makoto Ishitobi, Hiroko Nogi, Naoto Kondo, Teruhisa Sakurai, Chikako Yamauchi, Hiroki Mori, Miho Saiga, Naoki Niikura, Tadahiko Shien

Background: The prognosis in patients with breast cancer with isolated locoregional recurrence (ILRR) without simultaneous distant metastases after immediate breast reconstruction (IBR) remains unknown. We aimed to investigate the prognosis in this patient population.

Methods: This multi-institutional retrospective observational study evaluated 3295 patients with primary breast cancer who underwent IBR at 12 Japanese medical facilities between January 1, 2008 and December 31, 2016. The outcome measures were the prognostic factors for ILRR after IBR, 5-year distant metastasis-free interval (DMFI), and 5-year overall survival (OS).

Results: Mastectomy or skin-sparing mastectomy was performed in 3295 patients. ILRR occurred in 70 patients, and the median observation period from ILRR diagnosis was 39.3 months. Of the 70 patients, 9 (12.9%) had axillary lymph node recurrence (ALNR) at the time of ILRR diagnosis. The 5-year DMFI and OS rates after ILRR were 92.4% and 91.2%, respectively. Pathological lymph node metastasis at primary surgery (P = 0.041) and ALNR (P = 0.022) at ILRR were significantly associated with DMFI in the univariate analysis. ALNR was the only independent prognostic factor in the multivariate analysis (P = 0.041). Post-mastectomy radiation therapy (PMRT; P = 0.022) and ALNR (P = 0.043) were significantly associated with OS in the univariate analysis, and both PMRT (P = 0.010) and ALNR (P = 0.028) were independent prognostic factors in the multivariate analysis for OS.

Conclusions: Although patients with breast cancer who had ILRR after IBR have favorable prognosis, ALNR may lead to poor prognosis. To the best of our knowledge, this study is the first to report the prognosis of these patients.

背景:乳腺癌患者在接受即刻乳房重建术(IBR)后出现孤立性局部复发(ILRR)且无远处转移的预后仍不清楚。我们旨在调查这一患者群体的预后情况:这项多机构回顾性观察研究对 2008 年 1 月 1 日至 2016 年 12 月 31 日期间在日本 12 家医疗机构接受 IBR 手术的 3295 名原发性乳腺癌患者进行了评估。研究结果为IBR术后ILRR的预后因素、5年无远处转移间隔(DMFI)和5年总生存率(OS):3295名患者接受了乳房切除术或保皮乳房切除术。70例患者发生了ILRR,自诊断ILRR起的中位观察期为39.3个月。70 例患者中,9 例(12.9%)在确诊 ILRR 时腋窝淋巴结复发(ALNR)。ILRR后的5年DMFI和OS率分别为92.4%和91.2%。在单变量分析中,初次手术时的病理淋巴结转移(P = 0.041)和ILRR时的ALNR(P = 0.022)与DMFI显著相关。在多变量分析中,ALNR是唯一的独立预后因素(P = 0.041)。在单变量分析中,乳房切除术后放疗(PMRT;P = 0.022)和ALNR(P = 0.043)与OS显著相关,在OS的多变量分析中,PMRT(P = 0.010)和ALNR(P = 0.028)都是独立的预后因素:结论:虽然在IBR术后接受ILRR的乳腺癌患者预后良好,但ALNR可能会导致预后不良。据我们所知,本研究是首次报道这些患者的预后情况。
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引用次数: 0
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Breast Cancer
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