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Management of Patients with Breast Biopsy under Anticoagulation or Antiplatelet Therapy: Results of a Survey of German Experts 对接受抗凝或抗血小板治疗的乳腺活检患者的管理:德国专家调查结果
IF 2.1 4区 医学
Breast Care Pub Date : 2024-01-10 DOI: 10.1159/000536079
F. Riedel, Markus Hahn, Werner Bader, B. Schäfgen, S. Fastner, A. Hennigs, C. Gomez, A. Stieber, Christian Fastner, Markus Wallwiener, M. Golatta, J. Heil, Eva Fallenberg
{"title":"Management of Patients with Breast Biopsy under Anticoagulation or Antiplatelet Therapy: Results of a Survey of German Experts","authors":"F. Riedel, Markus Hahn, Werner Bader, B. Schäfgen, S. Fastner, A. Hennigs, C. Gomez, A. Stieber, Christian Fastner, Markus Wallwiener, M. Golatta, J. Heil, Eva Fallenberg","doi":"10.1159/000536079","DOIUrl":"https://doi.org/10.1159/000536079","url":null,"abstract":"Introduction\u0000Pre-therapeutic histologic diagnosis through image-guided core needle biopsy (CNB) or vacuum-assisted biopsy (VAB) for suspicious breast findings is a standard procedure. Despite the moderate risk of bleeding, a significant proportion of patients are on temporary or permanent anti-coagulation therapy (ACT) or anti-platelet therapy (APT). Currently, there are no established guidelines for managing biopsies in such patients, leading to varying approaches in clinical practice.\u0000\u0000Methods\u0000An online survey was conducted among all members of the breast ultrasound working group at the German Society for Ultrasound in Medicine (DEGUM) and the working group for breast diagnostics at the German Radiology Society (DRG). It included n=51 questions about individual risk perception of biopsy-related bleeding complications and the specific management of biopsies on ACT/APT.\u0000\u0000Results \u0000A total of 332 experts participated, with 51.8% reporting the absence of a standardized management plan for breast biopsies on ACT/APT. Concerning specific ACT/APT medications, the survey revealed discrepancies in risk perception and management: The majority preferred discontinuing medication with directly acting oral anti-coagulants (DOACs; CNB: 66.9%; VAB: 91.1%), phenprocoumon (CNB: 74.9%; VAB: 96.7%), or therapeutic heparin (CNB: 46.1%; VAB: 72.7%). However, there was a lower inclination to discontinue acetylsalicylic acid (ASA; CNB: 15.2%; VAB: 50.3%) or prophylactic heparin (CNB: 11.9%, VAB: 36.3%).\u0000\u0000Conclusion \u0000Breast biopsies for patients on ASA or prophylactic heparin are deemed safe and part of standard clinical practice. However, despite available feasibility studies, conducting breast biopsies on ACT medications such as DOACs or phenprocoumon appears feasible only for a minority of experts.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"81 19","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139440456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
TP53 gene polymorphism at codon 72 as a response predictor for neoadjuvant chemotherapy 作为新辅助化疗反应预测因子的 TP53 基因 72 号密码子多态性
IF 2.1 4区 医学
Breast Care Pub Date : 2024-01-08 DOI: 10.1159/000536115
Jussane Oliveira Vieira, J. Pesquero, A. Nazário
{"title":"TP53 gene polymorphism at codon 72 as a response predictor for neoadjuvant chemotherapy","authors":"Jussane Oliveira Vieira, J. Pesquero, A. Nazário","doi":"10.1159/000536115","DOIUrl":"https://doi.org/10.1159/000536115","url":null,"abstract":"Introduction: Breast cancer is one of the most prevalent cancers in women worldwide and neoadjuvant chemotherapy is a favored method for achieving pathologic complete response (pCR). The TP53 gene is involved in inducing the response to chemotherapy drugs.\u0000Objectives: The present study sought to correlate polymorphism variants at codon 72 with pathologic complete response to neoadjuvant chemotherapy.\u0000Casuistry and Methods: The study was conducted in the state of Sergipe, in Northeastern Brazil. A total of 206 patients with a histopathological diagnosis of breast cancer who underwent neoadjuvant chemotherapy from 2019 to 2022 were included. DNA samples were collected for the evaluation of TP53 polymorphism at codon 72. A prospective evaluation of the cases was conducted to verify the surgical pathologic response after chemotherapy; the response evaluation criteria in solid tumors were used (RECIST). The study was approved by the University of São Paulo Ethics and Research Committee.\u0000Results: Of the 168 patients, 44.6% were Arg72Arg, 17.3% Pro72Pro, and 38.0% Arg72Pro; pCR was achieved in 21.4% of the patients; 10.1% had progressive disease, 13.7% stable disease, and 54.2% had a partial pathologic response. The only predictor of pCR in multivariate regression was immunohistochemistry (p < 0.001). In the multivariate analysis, Arg72Pro and Pro72Pro increased the odds of the patient evolve with stable disease.This study was innovative in demonstrating a predictor of stable disease in response to neoadjuvant chemotherapy\u0000Conclusion: TP53 polymorphism at codon 72 is not a predictor of pathologic complete response, but it can be a predictor of stable disease.\u0000","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"50 14","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139446409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Interview ABC 7, Bridging the Gap 采访 ABC 7,缩小差距
IF 2.1 4区 医学
Breast Care Pub Date : 2023-12-16 DOI: 10.1159/000535632
Rachel Würstlein, Maria-João Cardoso, Joana M. Ribeiro, Renate Haidinger, Volkmar Müller, Matteo Lambertini, E. Schumacher-Wulf
{"title":"Interview ABC 7, Bridging the Gap","authors":"Rachel Würstlein, Maria-João Cardoso, Joana M. Ribeiro, Renate Haidinger, Volkmar Müller, Matteo Lambertini, E. Schumacher-Wulf","doi":"10.1159/000535632","DOIUrl":"https://doi.org/10.1159/000535632","url":null,"abstract":"<jats:p>None</jats:p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"5 s11","pages":""},"PeriodicalIF":2.1,"publicationDate":"2023-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138968072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Budget Impact of the Oncotype DX Breast Recurrence Score® Test in Patients with Early Primary Hormone-Receptor-Positive, HER2-Negative, Node-Positive (pN1) Breast Cancer in Germany Oncotype DX 乳房复发评分® 检测对德国早期原发性激素受体阳性、HER2 阴性、结节阳性 (pN1) 乳腺癌患者的预算影响
IF 2.1 4区 医学
Breast Care Pub Date : 2023-12-05 DOI: 10.1159/000534096
Michael Patrick Lux, C. Minartz, Harald Müller-Huesmann, M. Sandor, S. Radeck-Knorre, Aljoscha Neubauer
{"title":"Budget Impact of the Oncotype DX Breast Recurrence Score® Test in Patients with Early Primary Hormone-Receptor-Positive, HER2-Negative, Node-Positive (pN1) Breast Cancer in Germany","authors":"Michael Patrick Lux, C. Minartz, Harald Müller-Huesmann, M. Sandor, S. Radeck-Knorre, Aljoscha Neubauer","doi":"10.1159/000534096","DOIUrl":"https://doi.org/10.1159/000534096","url":null,"abstract":"BACKGROUND: \u0000Gene expression tests can inform decisions on whether to recommend or omit chemotherapy for patients with early HR+, HER2- breast cancer. The benefit of these tests is well established and fully reimbursed by sickness funds for lymph node-negative (pN0) patients in Germany. A budget impact model was built to evaluate the effect of using the Oncotype DX Breast Recurrence Score® test also for node-positive (pN1: 1-3 positive lymph nodes) patients.\u0000METHODS: \u0000The prospective randomized clinical trial, RxPONDER, defined conditions (Recurrence Score result 0-25 for postmenopausal patients with 1-3 positive lymph nodes) under which omitting chemotherapy does not significantly impact invasive disease-free survival with results currently reported for 5 years follow-up. The present budget impact model calculates average total cost per node-positive patient versus no testing from a sickness funds perspective, taking into account not only the budgetary impact of avoiding chemotherapy and associated side effects, but also the costs of treating those patients who develop distant metastasis. The stability of the results was investigated by probabilistic multivariate sensitivity analysis.\u0000RESULTS: \u0000After deducting testing cost, applying the Oncotype DX Breast Recurrence Score test yielded an average savings per node-positive patient of 4,272 €. Without the test costs, the greatest savings resulted from reductions in direct treatment costs and costs arising from the treatment of chemotherapy-related side effects, which together averaged 6,677 €. The targeted use of chemotherapy after testing also resulted in slightly lower costs for treatment of distant metastasis, if it did occur. The multivariate sensitivity analysis also almost exclusively resulted in cost savings.\u0000CONCLUSION: \u0000Analogous to the pN0 situation, this budget impact model demonstrates that the Oncotype DX Breast Recurrence Score test can also reduce healthcare costs in Germany in treatment of node-positive (pN1: 1-3 positive lymph nodes) patients by minimizing both unnecessary chemotherapy and undertreatment. Additional benefits to patients would include reduced morbidity and improved quality of life for those patients who can safely avoid chemotherapy or undertreatment.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"18 2","pages":""},"PeriodicalIF":2.1,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138601219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Contents Vol. 18, 2023 目录 第 18 卷,2023 年
IF 2.1 4区 医学
Breast Care Pub Date : 2023-12-01 DOI: 10.1159/000535581
MD – Rupert Bartsch, MD – Ute Berndt, MD – Massimo Calabrese, MD – Stefanie Corradini, MD Peter Dall, MD – BrustGesundheitZentrum Daniel Egle, Tirol, PhD – Martin Filipits, MD – Breast Oreste Davide Gentilini, Surgery, MD – Gynecological Volker Hanf, Kerstin Hermelink, PhD – Breast Center, MD – Jens Huober, MD – Thorsten Kühn, MD – Annette Lebeau, MD – Christian Marth, MD – Volker Möbus, MD – Volkmar Müller, MD – Markus Müller-Schimpfle, MD PhD – Mafalda Oliveira, MD – Georg Pfeiler, MD – Toralf Reimer, MD – Alexandra Resch, MD – Marcus Schmidt, MD – Walter Paul Weber, MD – Joachim Widder, MD – Isabell Witzel, MD – Rachel Würstlein, Munich Sylvia Heywang-Köbrunner, Raimund Jakesz, C. Suppan, M. Balic, Graz, Erratum, PharmaNews No, L. Kiesel, M. Sourouni, M. Khosla, R. Vidya, Wolverhampton Kothari, A. London, B. M. Gulluoglu
{"title":"Contents Vol. 18, 2023","authors":"MD – Rupert Bartsch, MD – Ute Berndt, MD – Massimo Calabrese, MD – Stefanie Corradini, MD Peter Dall, MD – BrustGesundheitZentrum Daniel Egle, Tirol, PhD – Martin Filipits, MD – Breast Oreste Davide Gentilini, Surgery, MD – Gynecological Volker Hanf, Kerstin Hermelink, PhD – Breast Center, MD – Jens Huober, MD – Thorsten Kühn, MD – Annette Lebeau, MD – Christian Marth, MD – Volker Möbus, MD – Volkmar Müller, MD – Markus Müller-Schimpfle, MD PhD – Mafalda Oliveira, MD – Georg Pfeiler, MD – Toralf Reimer, MD – Alexandra Resch, MD – Marcus Schmidt, MD – Walter Paul Weber, MD – Joachim Widder, MD – Isabell Witzel, MD – Rachel Würstlein, Munich Sylvia Heywang-Köbrunner, Raimund Jakesz, C. Suppan, M. Balic, Graz, Erratum, PharmaNews No, L. Kiesel, M. Sourouni, M. Khosla, R. Vidya, Wolverhampton Kothari, A. London, B. M. Gulluoglu","doi":"10.1159/000535581","DOIUrl":"https://doi.org/10.1159/000535581","url":null,"abstract":"","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"269 1","pages":"503 - 510"},"PeriodicalIF":2.1,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139015680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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 factors influencing shoulder mobility disorders in patients after radical breast cancer surgery 影响乳腺癌根治性手术后患者肩部活动障碍的因素
4区 医学
Breast Care Pub Date : 2023-11-09 DOI: 10.1159/000535063
Xin Zhang, Chao Wang, Jiali Fan, Shinichiro Murakami, Hualong Xie, Ming Huo
{"title":"The factors influencing shoulder mobility disorders in patients after radical breast cancer surgery","authors":"Xin Zhang, Chao Wang, Jiali Fan, Shinichiro Murakami, Hualong Xie, Ming Huo","doi":"10.1159/000535063","DOIUrl":"https://doi.org/10.1159/000535063","url":null,"abstract":"Abstract Introduction: To investigate the factors influencing shoulder mobility in terms of pain, grip strength, and supraspinatus muscle thickness in patients with impaired shoulder mobility during radiotherapy after radical breast cancer surgery. Methods: This study included 165 female patients with unilateral breast cancer who had shoulder joint mobility disorders during chemotherapy within 3 months after surgery. The clinical examination included the maximum active range of motion of the shoulder (flexion, extension, abduction, adduction, external rotation, and internal rotation), pain score (visual analog scale [VAS]), grip strength, and supraspinatus muscle thickness. Results: During shoulder abduction, supraspinatus muscle thickness was greatest at 90°, lowest at 0°, and higher at 60° than at 30° (p<0.01). The factors influencing the active movement of shoulder flexion were the VAS score, body weight, grip strength, and supraspinatus contraction rate (R2=0.295), while the factors influencing active shoulder abduction were the VAS score, body weight, grip strength, supraspinatus muscle thickness (drooping position), and supraspinatus contraction rate (R2=0.295). Moreover, the factors influencing the active movement of shoulder external rotation were age, VAS score, body weight, grip strength, and supraspinatus muscle thickness (drooping position) (R2=0.258). There were no intentional results from multiple linear regressions for shoulder extension, adduction, or internal rotation. Conclusion: Pain, weight, grip strength, supraspinatus muscle thickness, and supraspinatus distensibility are the main factors affecting shoulder flexion, abduction, and external rotation. In addition, supraspinatus muscle thickness and contraction rate may be a new index for assessing shoulder dysfunction.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":" 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135192742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
HER2+ early breast cancer: from escalation via targeted and postneoadjuvant treatment to de-escalation HER2+早期乳腺癌:通过靶向和新辅助治疗从升级到降级
4区 医学
Breast Care Pub Date : 2023-10-25 DOI: 10.1159/000534670
Monika Graeser, Oleg Gluz
{"title":"HER2+ early breast cancer: from escalation via targeted and postneoadjuvant treatment to de-escalation","authors":"Monika Graeser, Oleg Gluz","doi":"10.1159/000534670","DOIUrl":"https://doi.org/10.1159/000534670","url":null,"abstract":"Background: Human epidermal growth factor receptor 2 positive (HER2+, also referred to as ERBB2+) breast cancer is a subtype historically associated with a particularly poor prognosis. Research into biological and molecular pathomechanisms of breast cancer has resulted in the development and adoption of several therapies targeting HER2. In parallel, various escalation/de-escalation strategies have been examined to further optimize patient outcomes and care. Summary: In this review, we highlighted the landmark trials in the evolution of treatment and management of HER2+ early breast cancer. Key Messages: Continuous research over the last two decades has gradually prolonged survival in patients with early HER2+ early breast cancer. Incorporation of post-neoadjuvant setting into clinical practice improved long-term outcomes in high-risk patients with residual disease after neoadjuvant therapy. In parallel, use of modern anti-HER2 agents may potentially allow omission of chemotherapy without compromising the survival in a significant number of selected patients. Current research focused on exploring the molecular heterogeneity of HER2+ breast cancer resulted in identification of new prognostic and predictive biomarkers which could pave the way towards the development of truly personalized therapy.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"33 8","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135217933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Use of the gene expression test Prosigna® in premenopausal patients with HR+, HER2- early breast cancer: Correlation of the results with the proliferation marker Ki-67 基因表达检测Prosigna®在绝经前HR+、HER2-早期乳腺癌患者中的应用:结果与增殖标志物Ki-67的相关性
4区 医学
Breast Care Pub Date : 2023-10-17 DOI: 10.1159/000534634
Cordula Ziegler, Karl Sotlar, Daniel Maria Hofmann, Thomas Kolben, Nadia Harbeck, Rachel Würstlein
{"title":"Use of the gene expression test Prosigna® in premenopausal patients with HR+, HER2- early breast cancer: Correlation of the results with the proliferation marker Ki-67","authors":"Cordula Ziegler, Karl Sotlar, Daniel Maria Hofmann, Thomas Kolben, Nadia Harbeck, Rachel Würstlein","doi":"10.1159/000534634","DOIUrl":"https://doi.org/10.1159/000534634","url":null,"abstract":"<b><i>Introduction:</i></b> In hormone receptor-positive (ER+/PR+) and human epidermal growth factor receptor 2-negative (HER2−) early-stage breast cancer (EBC), gene expression tests such as the Prosigna are increasingly used since classic clinicopathological parameters and the proliferation factor Ki-67 often do not allow a definite therapy decision regarding an adjuvant chemotherapy. While the Prosigna test has been validated for postmenopausal patients, few data are available regarding its use in premenopausal patients. The present study compared the Prosigna test with the Ki-67 index in premenopausal patients. <b><i>Materials and Methods:</i></b> Premenopausal patients with HR+ HER2−, pN0-1, G1-2 EBC were retrospectively enrolled (<i>n</i> = 55). The Prosigna assay was performed in formalin-fixed paraffin-embedded tumor samples of surgical resection specimens. Ki-67 was reassessed in original diagnostic core needle biopsy specimens and defined as low, intermediate, or high with the threshold of &amp;lt;10%, 10–24%, ≥25%. <b><i>Results:</i></b> According to Ki-67, patients were in the low (LR)-, intermediate (IR)-, and high-risk (HR) groups in 40%, 36%, and 24% of the cases. The Prosigna gene signature assay assessed the risk of recurrence as LR for 45% of the patients, IR for 35%, and HR for 20%. The most frequent intrinsic subtypes were luminal A in 73% and luminal B in 24% of the patients. A moderate correlation was found between Prosigna and Ki-67 scores with a Pearson correlation coefficient of 0.51. In the overall cohort, 47% of the Ki-67-based therapy decision would correspond to those based on the Prosigna score. After exclusion of IR patients, matching of low/low or high/high results was observed in 57% of the cases. <b><i>Conclusion:</i></b> According to the present study, there is only limited concordance regarding the risk group stratification between Ki-67 and Prosigna-based risk assessment. The relevance and frequency of premenopausal breast cancer emphasizes the need for further evaluation of gene expression analyses in this setting and the correlation with classic clinicopathological parameters regarding therapy decision-making.","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"141 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135993916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Breast Cancer Outome – What have we achieved 乳腺癌预后-我们取得了什么成就
4区 医学
Breast Care Pub Date : 2023-10-16 DOI: 10.1159/000534589
Volker Möbus, Marcus Schmidt
{"title":"Breast Cancer Outome – What have we achieved","authors":"Volker Möbus, Marcus Schmidt","doi":"10.1159/000534589","DOIUrl":"https://doi.org/10.1159/000534589","url":null,"abstract":"","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"75 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136079971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Neratinib as extended adjuvant treatment of HER2-positive/HR-positive early breast cancer patients in Germany, Austria and Switzerland: interim results of the prospective, observational ELEANOR study 在德国、奥地利和瑞士,Neratinib作为her2阳性/ hr阳性早期乳腺癌患者的延长辅助治疗:前瞻性、观察性ELEANOR研究的中期结果
4区 医学
Breast Care Pub Date : 2023-10-05 DOI: 10.1159/000533657
Nadia Harbeck, Denise Wrobel, Matthias Zaiss, Jürgen Terhaag, Dagmar Guth, Andrea Distelrath, Mark-Oliver Zahn, Rachel Würstlein, Andreas Lorenz, Rupert Bartsch, Urs Breitenstein, Michael Schwitter, Marija Balic, Christian Jackisch, Volkmar Müller, Gabriel Rinnerthaler, Marcus Schmidt, Khalil Zaman, Timo Schinköthe, Anna Resch, Roberta Valenti, Diana Lueftner
{"title":"Neratinib as extended adjuvant treatment of HER2-positive/HR-positive early breast cancer patients in Germany, Austria and Switzerland: interim results of the prospective, observational ELEANOR study","authors":"Nadia Harbeck, Denise Wrobel, Matthias Zaiss, Jürgen Terhaag, Dagmar Guth, Andrea Distelrath, Mark-Oliver Zahn, Rachel Würstlein, Andreas Lorenz, Rupert Bartsch, Urs Breitenstein, Michael Schwitter, Marija Balic, Christian Jackisch, Volkmar Müller, Gabriel Rinnerthaler, Marcus Schmidt, Khalil Zaman, Timo Schinköthe, Anna Resch, Roberta Valenti, Diana Lueftner","doi":"10.1159/000533657","DOIUrl":"https://doi.org/10.1159/000533657","url":null,"abstract":"Introduction: Prognosis of patients diagnosed with HER2+ early breast cancer (eBC) has substantially improved, but distant recurrences impacting quality of life and survival still occur. One treatment option for extended adjuvant treatment in patients with HER2+/HR+ eBC is neratinib; available in Europe for patients who completed adjuvant trastuzumab-based therapy within 1 year. The ELEANOR study is investigating the real-world use of neratinib in Germany, Austria and Switzerland. Results from an interim analysis of the first 200 patients observed for ≥3 months are reported. Methods: The primary objective of this prospective, multicentre, observational study is to assess patient adherence to neratinib (defined as percentage of patients taking neratinib on ≥75% prescribed days). Secondary objectives are patient characteristics and treatment outcomes. Results: At cut-off (May 2, 2022), 202 patients had been observed for ≥3 months, with neratinib treatment documented for 187 patients (median age 53.0 years; 67.9% at increased risk of disease recurrence). In total 151 (80.7%) patients had received prior neoadjuvant treatment; of these 82 (54.3%) achieved a pathological complete response. Neratinib was initiated at a median 3.6 months after trastuzumab-based treatment, with 36.4% starting at a dose <240 mg/day. Treatment is ongoing for 46.0% of patients, with median treatment duration of 11.2 (interquartile range 0.9–12.0) months. Diarrhoea was the most common adverse event (78.6% any grade, 20.3% Grade ≥3); pharmacologic prophylaxis was used in 85.6% of patients. Conclusions: The pattern of anti-HER2 pretreatment observed reflected the current treatment for HER2+/HR+ eBC in Germany, Austria and Switzerland. These interim results suggest that neratinib as an extended adjuvant is a feasible option after various anti-HER2 pretreatments, and that its tolerability can be managed and improved with proactive diarrhoea management. ClinicalTrials.gov identifier: NCT04388384","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"96 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135546529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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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