Patrick M Schnell, Mahmoud Kassem, Abdul Miah, Bhuvaneswari Ramaswamy, Nicole Williams, Mathew Cherian, Daniel G Stover, Margaret E Gatti-Mays, Ashley Pariser, Robert Wesolowski, Sagar Sardesai, Preeti K Sudheendra, Kate Ormiston, Jessica N Mezzanotte, Tonya S Orchard, Maryam Lustberg
{"title":"Changes in Glucose level During Chemotherapy Treatment in Patients With Stage I-IV Breast Cancer.","authors":"Patrick M Schnell, Mahmoud Kassem, Abdul Miah, Bhuvaneswari Ramaswamy, Nicole Williams, Mathew Cherian, Daniel G Stover, Margaret E Gatti-Mays, Ashley Pariser, Robert Wesolowski, Sagar Sardesai, Preeti K Sudheendra, Kate Ormiston, Jessica N Mezzanotte, Tonya S Orchard, Maryam Lustberg","doi":"10.1016/j.clbc.2025.05.021","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.021","url":null,"abstract":"<p><strong>Purpose: </strong>Glucose dysregulation may occur during chemotherapy treatment of patients with breast cancer. Absent appropriate management, patients may experience worsened morbidity and mortality. Mechanisms regarding glucose dysregulation are well-studied, but the role of chemotherapy is not. Previous studies of glucose dysregulation among patients undergoing chemotherapy have yielded inconsistent results.</p><p><strong>Methods: </strong>We evaluate changes in blood glucose in women with breast cancer undergoing chemotherapy and explore effects of covariates. Records of 981 patients with stage I-IV breast cancer were evaluated, including blood glucose levels and other clinical and histopathological data. Patients were treated at The Ohio State University, an NCI-designated Comprehensive Cancer Center, from 2016 to 2018. Subgroups reflecting populations studied by previous reports were analyzed.</p><p><strong>Results: </strong>Overall, blood glucose decreased slightly after chemotherapy versus baseline (131.3 mg/dL vs. 134.8 mg/dL, P = .048). Among patients with baseline random glucose levels lower than 125 mg/dL, levels increased versus baseline (113 vs 99 mg/dL, P < .001). Among patients younger than 70 and without diabetes mellitus, there was no statistically significant change (120 vs 122 mg/dL, P = .47). Adjusting for baseline variables including glucose levels, estimated change from baseline is higher among patients exposed to docetaxel/cyclophosphamide versus other regimens assessed (P < .001).</p><p><strong>Conclusions: </strong>Random blood glucose decreased slightly during chemotherapy. Differences in results in previous reports are attributable to differing study populations. Baseline glucose levels, age, and chemotherapy regimen are predictors of change in glucose level.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144336374","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}
Marcus Vetter, Lisa Holer, Karin Rothgiesser, Wolfgang Schönfeld, Salome Riniker, Roger von Moos, Andreas Trojan, Elena Kralidis, Manuela Rabaglio, Mathias K Fehr, Andreas Müller, Markus Borner, Lorenzo Rossi, Christian Kurzeder, Beat Thürlimann
{"title":"Final Overall Survival Analysis of the Phase II SAKK 21/12 Trial of Transdermal CR1447 in Patients With Metastatic Breast Cancer.","authors":"Marcus Vetter, Lisa Holer, Karin Rothgiesser, Wolfgang Schönfeld, Salome Riniker, Roger von Moos, Andreas Trojan, Elena Kralidis, Manuela Rabaglio, Mathias K Fehr, Andreas Müller, Markus Borner, Lorenzo Rossi, Christian Kurzeder, Beat Thürlimann","doi":"10.1016/j.clbc.2025.05.015","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.015","url":null,"abstract":"<p><strong>Objective: </strong>CR1447 is a transdermal formulation of 4-hydroxytestosterone with aromatase-inhibiting and androgen receptor (AR)-modulating activity. This multicenter, phase II study assessed the efficacy and safety of CR1447 in patients with metastatic breast cancer. The primary endpoint, the disease control rate at week 24, was published in 2019. Here, we report the final overall survival (OS) data of this study.</p><p><strong>Patients and methods: </strong>This study enrolled patients with estrogen receptor (ER)-positive, HER2-negative breast cancer pretreated with a maximum of 1 line of prior endocrine therapy (ET) without progression for at least 6 months (cohort A) (n = 29) and patients with AR-positive triple-negative metastatic breast cancer treated with a maximum of 2 prior lines of chemotherapy (cohort B) (n = 8). The intention-to-treat (ITT) population included eligible patients who received at least 1 dose of the study drug. The non-ITT population in cohort A comprised patients with more than 1 line of prior ET. Accrual was stopped in 2018 due to futility in cohort A and slow accrual in cohort B.</p><p><strong>Results: </strong>At the data cut-off, 92% of patients had died. The median OS in cohort A was 35.4 months (95% CI: 24.6-49.1) in the ITT population (n = 21) and 19.4 months (95% CI: 2.3-36.8) in the non-ITT population (n = 8). In cohort B, the median OS was 10.8 months (95% CI: 3.3-28.6). Most adverse events were grade 1 - 2 and most frequently included hypertriglyceridemia, increased levels of aspartate aminotransferase and dry skin.</p><p><strong>Conclusions: </strong>In this final OS analysis, CR1447 was associated with an OS in line with other ET agents in patients with metastatic ER-positive, HER2-negative breast cancer who had received no more than 1 prior line of ET. Therapy was well tolerated with no treatment-related grade 3 to 5 toxicities.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332506","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}
María Herrán, Emily C Zabor, Saad Sabbagh, Nadeem Bilani, Ali Hijazi, Mohamed Mohanna, Mira Itani, Zeina Nahleh
{"title":"Disparities in Access to Multigene Testing in Early-Stage, HR-positive, HER2-negative, Lymph Node-negative Breast Cancer.","authors":"María Herrán, Emily C Zabor, Saad Sabbagh, Nadeem Bilani, Ali Hijazi, Mohamed Mohanna, Mira Itani, Zeina Nahleh","doi":"10.1016/j.clbc.2025.05.018","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.018","url":null,"abstract":"<p><strong>Background: </strong>Multigene testing (MGT) has refined breast cancer treatment. We examined real-world access to MGT for early-stage (I-II), HR-positive, HER2-negative, node-negative breast cancer and identified factors related to disparities.</p><p><strong>Materials and methods: </strong>This retrospective analysis used the National Cancer Database (2007-2017). Socio-demographic and clinical-pathologic factors of interest were included in a multivariable logistic regression to examine associations with MGT use. Multiple imputation was used to find missing data.</p><p><strong>Results: </strong>A total of N = 107,642 patients were eligible, of which 65,066 (60%) underwent MGT. The odds of undergoing MGT were lower among Black patients compared to White (OR 0.83, 95% CI, 0.79-0.87, P < .001), Hispanic compared to non-Hispanic (OR 0.91, 95% CI, 0.86-0.97, P = .004), uninsured compared to privately insured (OR 0.73,95% CI, 0.64-0.83, P < .001), and those in the West South-Central compared to New England region (OR 0.76, 95% CI, 0.70-0.82, P < .001). Increased odds were observed among those treated at an Integrated Network Cancer Program (OR 1.12, 95% CI, 1.05-1.19, P < .001), higher education level (OR 1.12, 95% CI, 1.06-1.18, P < .001), and a household income between $50,354 to $63,332 (OR 1.08, 95% CI, 1.02-1.14, P = .006). Those with access to MGT had higher odds of receiving adjuvant chemotherapy (OR 1.89,95% CI, 1.80-1.99, P < .001) and hormonal therapy (OR 3.17, 95% CI, 3.02-3.32, P < .001) compared to those without access to MGT after adjusting for other factors of interest.</p><p><strong>Conclusions: </strong>This study highlights gaps in access to MGT in breast cancer. Ensuring equitable access to diagnostic and prognostic precision tools could positively impact the odds of receiving appropriate adjuvant therapy and improve patient outcomes.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144336375","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}
Dan Gao, Zeng Yongjia, Yingying Gao, Liujin Zeng, Meichan Yang, Zhouyang Lian, Chunling Liu
{"title":"MRI Response Pattern of Breast Invasive Micropapillary Carcinoma After Neoadjuvant Chemotherapy: A Matched Cohort Study With Invasive Breast Cancer of no Special Type.","authors":"Dan Gao, Zeng Yongjia, Yingying Gao, Liujin Zeng, Meichan Yang, Zhouyang Lian, Chunling Liu","doi":"10.1016/j.clbc.2025.05.014","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.014","url":null,"abstract":"<p><strong>Introduction: </strong>Neoadjuvant chemotherapy (NAC) is more widely used to treat localized invasive breast cancer. Invasive micropapillary carcinoma (IMPC) is considered more aggressive than invasive breast cancer of no special type (IBC- NST), as an independent histological type of invasive breast cancer (IBC). However, it is rarely reported about the response of IMPC to NAC. Therefore, we compared the NAC response of IMPC and IBCNST groups to provide an evidence-based foundation for precise clinical management of breast IMPC about NAC.</p><p><strong>Methods: </strong>The retrospective study included 127 patients with pathologically confirmed IMPC or IBCNST patients from December 2016 to April 2021, and divided them into 3 group. The MRI feature and Clinicopathologic data of all the patients were assessed before and after NAC. One-way ANOVA test and Krukal-Wallis test were used for statistical analysis.</p><p><strong>Results: </strong>After NAC, IMPC patients showed less changes in lesion size, EER, shrinking rate and ADC values compared to the IBC patients (P < .05). In IPMC patients, 7.7% of lesions achieved a pathologic complete response (pCR), 61.5% with partial response (PR), 2.6% with progressive disease (PD) and 28.2% with stable disease (SD). Moreover, the lesions response to NAC was not significantly different between IMPC group and IBC2 group.</p><p><strong>Conclusions: </strong>Most patients with IMPC can obtain the same PR rates after NAC as IBCNST. Breast-conserving treatment (BCT) can be applied in More patients with IMPC. Therefore, we hold the opinion that NAC can be strongly suggested to be used for IMPC patients.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293416","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}
Stephen Kinsey-Trotman, Alain Nguyen, Suzanne Edwards, Adam Swalling, Pallave Dasari, David Walsh, Wendy V Ingman
{"title":"Tumor ki67 Impact on Survival in Male Breast Cancer Patients: A Systematic Review and Meta-Analysis.","authors":"Stephen Kinsey-Trotman, Alain Nguyen, Suzanne Edwards, Adam Swalling, Pallave Dasari, David Walsh, Wendy V Ingman","doi":"10.1016/j.clbc.2025.05.013","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.013","url":null,"abstract":"<p><strong>Purpose: </strong>Histological features with prognostic utility for survival in male breast cancer remain elusive. Tumor ki67 expression may provide an early prognostic marker in this disease. This systematic review investigated ki67 prognostication for overall survival in male breast cancer patients.</p><p><strong>Methods: </strong>Following prospective registration MEDLINE, PUBMED Central and EMBASE databases were searched to identify suitable studies. Studies were considered for meta-analysis when both comparable research methodologies were utilized and survival outcomes were reported for the same threshold value for ki67.</p><p><strong>Results: </strong>A total of fifteen observational type studies were included in the review with 9 meeting inclusion criteria for data extraction. Six studies contributed to a meta-analysis. Two studies demonstrated a statistically-significant difference in survival outcome at a ki67 threshold of 20%, however meta-analysis for ki67 set at 2 thresholds (14% and 20%) did not demonstrate any significant association with overall survival.</p><p><strong>Conclusions: </strong>This review did not confirm an association between ki67 and overall survival in male breast cancer patients. Further research including the use of artificial intelligence methods and consideration of a higher threshold value are needed to better define Tumor ki67 in this patient group.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332507","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}
Jesus D Anampa, Alvaro Alvarez Soto, Shuwen Lin, Ana M Bernal, Xiaonan Xue, Maja H Oktay
{"title":"Use and Benefit of Neoadjuvant Versus Adjuvant Chemotherapy in Node-Negative, T1 Triple Negative Breast Cancer.","authors":"Jesus D Anampa, Alvaro Alvarez Soto, Shuwen Lin, Ana M Bernal, Xiaonan Xue, Maja H Oktay","doi":"10.1016/j.clbc.2025.05.011","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.011","url":null,"abstract":"<p><strong>Purpose: </strong>There are scarce data about the use and benefit of neoadjuvant chemotherapy (NACT) in small size, node-negative triple-negative breast cancer (TNBC). We examined pathological response and survival outcomes of patients with T1N0 TNBC who received NACT.</p><p><strong>Methods: </strong>This is a retrospective cohort study using data from the Surveillance, Epidemiology, and End Results database of patients with T1N0 TNBC diagnosed between 2010 and 2020. Cox regression models were used to compare overall survival (OS) for adjuvant chemotherapy (ACT) and NACT cohorts. Cumulative incidence functions and breast cancer-specific hazard models were used to compare breast cancer specific survival (BCSS) between ACT and NACT cohorts.</p><p><strong>Results: </strong>We found 8146 patients treated with ACT and 1263 patients treated with NACT. Age < 50 years, mastectomy and radiation therapy were associated with higher odds of receiving NACT. There was no difference in BCSS or OS for patients with T1b/T1cN0 TNBC who received NACT or ACT. However, patients with T1aN0 TNBC had worse BCSS and OS when treated with NACT as compared to those who received ACT. Pathological complete response (pCR) in T1N0 tumors was associated with improved OS (HR, 0.28) and BCSS (HR, 0.21). Furthermore, T1aN0 tumors had lower pCR rate than T1cN0 tumors (18% vs. 47%).</p><p><strong>Conclusion: </strong>Patients with node-negative, T1b and T1c tumors benefit equally from the use of ACT and NACT. The results of worse outcome in patients with node-negative, T1a tumors treated with NACT compared to ACT are intriguing and need further investigation.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293442","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}
{"title":"Prognostic Value of Immune-Inflammation Indexes for Breast Cancer Patients Undergoing Endocrine Therapy: A Systematic Review and Meta-analysis.","authors":"Yue Yang, Bing Shao, Chao Wei, Xuewen Zhang","doi":"10.1016/j.clbc.2025.05.010","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.010","url":null,"abstract":"<p><strong>Purpose: </strong>Research suggests that systemic immune-inflammation index (SII), neutrophil lymphocyte (NLR), platelet lymphocyte (PLR) and lymphocyte monocyte (LMR) can act as potential prognostic indicators for breast cancer (BC). However, its prognostic value for BC patients undergoing endocrine therapy (ET) remains inconclusive.</p><p><strong>Methods: </strong>We systematically searched Embase, Cochrane Library, PubMed, and Web of Science for studies on the prognostic significance of immune-inflammation indexes for BC patients undergoing ET from inception to May 5, 2024. Overall survival (OS), progression-free survival (PFS), and disease-free survival (DFS) were the primary outcomes, and they were statistically analyzed by hazard ratios (HR) with 95% confidence intervals (CI). Sensitivity and subgroup analyses were performed to explore the source of heterogeneity. STATA 15.1 and Review Manager 5.4 were adopted for data analyses.</p><p><strong>Results: </strong>Fifteen studies with 27 cohorts of 3168 BC patients undergoing ET were included. The results showed that low NLR was associated with prolonged OS (HR = 2.19, 95% CI, 1.67-2.87; P < .00001) and PFS (HR = 1.64, 95% CI, 1.32-2.04; P < .00001) in overall BC patients receiving ET. High LMR was associated with longer OS (HR = 2.67, 95% CI, 1.64-4.33; P < .0001) in the overall BC patients undergoing ET. Low PLR was significantly associated with prolonged PFS (HR = 1.89, 95% CI, 1.40-2.55; P < .0001). Additionally, low PLR was associated with longer OS (HR = 2.16, 95% CI, 1.03-4.52, P = .04), but sensitivity analysis showed that its significance was not robust enough. All subgroup analyses revealed overall roboust results.</p><p><strong>Conclusion: </strong>Immune-inflammation indexes can potentially act as prognostic biomarkers for BC patients undergoing ET, contributing to wiser decision-making in BC treatment.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293417","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}
Stefania Morganti, Xiangying Chu, Tarah J Ballinger, Nisha Unni, Sarah Sinclair, Robert Wesolowski, Alyssa M Pereslete, Paulina Lange, Nabihah Tayob, Nancy U Lin, Jose P Leone, Ian E Krop, Sara M Tolaney, Heather A Parsons
{"title":"A Randomized Phase 2 Study of Neratinib With or Without Fulvestrant for Patients With HER2-Positive, Estrogen Receptor-Positive Metastatic Breast Cancer.","authors":"Stefania Morganti, Xiangying Chu, Tarah J Ballinger, Nisha Unni, Sarah Sinclair, Robert Wesolowski, Alyssa M Pereslete, Paulina Lange, Nabihah Tayob, Nancy U Lin, Jose P Leone, Ian E Krop, Sara M Tolaney, Heather A Parsons","doi":"10.1016/j.clbc.2025.05.009","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.009","url":null,"abstract":"<p><strong>Background: </strong>Most HER2-positive breast cancers co-express estrogen receptor (ER). Given crosstalk between HER2 and ER signaling pathways, dual blockade may be beneficial.</p><p><strong>Methods: </strong>In this randomized, open-label, phase 2 clinical trial, patients with ER-positive (ER ≥ 10%), HER2-positive metastatic breast cancer were randomized (1:1) to neratinib (240 mg daily) or the same dose of neratinib with fulvestrant. Any number of prior therapies was allowed; prior trastuzumab, pertuzumab and trastuzumab emtansine were required. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), overall response rate, and duration of response. Exploratory objectives included the identification of predictive biomarkers via circulating tumor DNA (ctDNA).</p><p><strong>Results: </strong>Of 21 patients enrolled, 18 were evaluable for outcomes and safety (neratinib-fulvestrant arm, n = 8; neratinib-only arm, n = 10). The study was closed before completing enrollment due to slow accrual. Median PFS did not differ between treatment arms (2.79 months with neratinib-fulvestrant versus 5.55 months with neratinib only [HR 0.94; 95% CI, 0.24-3.64; P = .98]). Grade 3 adverse events occurred in 1 (12.5%) patient in the neratinib-fulvestrant arm and 6 (60%) patients in the neratinib-only arm, with diarrhea being the most frequent. Median OS did not differ between the 2 arms (P = .91). Clearance of ctDNA was associated with PFS and OS.</p><p><strong>Conclusions: </strong>The combination of neratinib and fulvestrant is safe and tolerable. Due to early study closure, this study was underpowered to detect the benefit of adding fulvestrant to neratinib. Chemotherapy-free regimens targeting ER and HER2 warrant further investigation, along with prospective studies investigating ctDNA dynamics may guide treatment switch.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246741","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}
Soraia Lobo-Martins, Veronique Debien, Elisa Agostinetto, Marianna Sirico, Giselle de Souza Carvalho, Flavia Jacobs, Chiara Molinelli, Renata Colombo Bonadio, Pedro Bergmann, Cristiano de Pádua Souza, Laura Testa, Marina Nishimuni, André João Rossi, Gabriel Kamei Guimarães, Michel Moreau, Ugo De Giorgi, José Bines, Armando Santoro, Donatienne Taylor, Francois P Duhoux, Giacomo Barchiesi, Matteo Lambertini, Martine Piccart, Evandro de Azambuja
{"title":"Real-World 5-Year Outcomes of Patients Treated With the Adjuvant Paclitaxel Trastuzumab (APT) Regimen for Stage I HER2-Positive Early Breast Cancer: A Retrospective International Study.","authors":"Soraia Lobo-Martins, Veronique Debien, Elisa Agostinetto, Marianna Sirico, Giselle de Souza Carvalho, Flavia Jacobs, Chiara Molinelli, Renata Colombo Bonadio, Pedro Bergmann, Cristiano de Pádua Souza, Laura Testa, Marina Nishimuni, André João Rossi, Gabriel Kamei Guimarães, Michel Moreau, Ugo De Giorgi, José Bines, Armando Santoro, Donatienne Taylor, Francois P Duhoux, Giacomo Barchiesi, Matteo Lambertini, Martine Piccart, Evandro de Azambuja","doi":"10.1016/j.clbc.2025.05.002","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.002","url":null,"abstract":"<p><strong>Background: </strong>An anthracycline-free regimen of adjuvant paclitaxel and trastuzumab is the standard-of-care for patients with HER2-positive (HER2+) early breast cancer (eBC) with tumors ≤20 mm, node-negative tumors, based on the results of a single-arm phase II trial. We investigated the outcomes of this regimen in a real-world (RW) setting.</p><p><strong>Methods: </strong>This retrospective, international RW study included patients with stage I HER2+ eBC treated with the APT regimen (tumors of 5-20 mm, node-negative (N0 or Nmi) and no previous history of BC). Data on demographics, tumor characteristics, treatments, and survival were extracted from medical records from 11 hospitals in Belgium, Italy, and Brazil. The primary endpoint was 5-year RW disease-free survival (rwDFS), and secondary was RW overall survival (rwOS).</p><p><strong>Results: </strong>From January 2014 to July 2018, 252 patients were identified. The median age was 57.9 years, and 69.8% were postmenopausal women at diagnosis. Most tumors (88.1%) had ductal histology and were estrogen receptor-positive (81.7%). The median tumor size was 12 mm (Interquartile [IQR] 9.0-15.0). Breast-conserving surgery was performed in 77.8%, and radiotherapy was administered in 76.1% of patients. Median follow-up was 5.8 years (IQR 5.0-6.8). In total, 13 events were observed: 4 locoregional, 2 distant (1 bone and 1 visceral) and 7 second nonbreast primary malignancies. The 5-year rwDFS rate was 95.3% (95% Confidence Interval (CI) 92.7-98.1), and rwOS was 97.9% (95% CI 96.2-99.7).</p><p><strong>Conclusion: </strong>Our RW data supports the effectiveness of the APT regimen, showing excellent 5-year survival outcomes in selected patients with low-risk HER2+ eBC.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246743","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}
Eva Heeling, Jeroen B van de Kamer, Annemarie Bruining, Jip M E Pluim, Marie-Jeanne T F D Vrancken Peeters, Christianne A R Lok, Iris M C van der Ploeg
{"title":"The Safe Use of <sup>125</sup>I-Seeds as a Surgical Localization Technique for Breast Cancer Patients During Breastfeeding and Close Contact With an Infant.","authors":"Eva Heeling, Jeroen B van de Kamer, Annemarie Bruining, Jip M E Pluim, Marie-Jeanne T F D Vrancken Peeters, Christianne A R Lok, Iris M C van der Ploeg","doi":"10.1016/j.clbc.2025.05.008","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.008","url":null,"abstract":"<p><strong>Purpose: </strong>Currently, Dutch hospitals advise limiting mother-infant contact to 1 hour per day if an <sup>125</sup>I-seed is implanted for breast cancer surgery, possibly affecting bonding and the child's cognitive and behavioral development. By quantifying radiation exposure from an <sup>125</sup>I-seed to the infant through breastfeeding and close contact, we aim to provide evidence-based recommendations for clinical practice.</p><p><strong>Methods: </strong>We modelled the radiation exposure to an infant due to contact with a mother or patient with an <sup>125</sup>I-seed in situ in the breast, assessing both the ipsilateral and contralateral breast at different time periods (14 days, 90 days, and 180 days). The radiation exposure to the infant was considered safe as long as it remained below the threshold of 1 mSv.</p><p><strong>Results: </strong>When an <sup>125</sup>I-seed is surgical removed within 14 days after insertion, daily contact on the contralateral contact is safe (up to 24 hours a day). When ipsilateral contact is included, the maximum duration adjusts to 19 hours per day contralateral combined with 5 hours per day ipsilateral. When the <sup>125</sup>I-seed remains in situ for a longer period, such as during primary systemic treatment (PST) (e.g., 90 or 180 days), contact is possible with certain limitations.</p><p><strong>Conclusion: </strong>Contralateral close contact (including breastfeeding) with an infant < 1 year of age is safe in case of breast cancer and an <sup>125</sup>I-seed in situ in the breast. Short moments of ipsilateral contact are safe, even for a longer period of 180 days.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144282711","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}