{"title":"Breast-Conserving Surgery with Immediate Partial Breast Reconstruction by Using Pedicled Thoracodorsal Artery Perforator Flap: A 7-Year Follow-Up of 50 Women.","authors":"Xing Wang, Ling Huo, Yingjian He, Jinfeng Li, Tianfeng Wang, Zhaoqing Fan, Tao Ouyang","doi":"10.1159/000541340","DOIUrl":"10.1159/000541340","url":null,"abstract":"<p><strong>Introduction: </strong>Thoracodorsal artery perforator (TDAP) flap has been used for more than 10 years in the immediate partial breast reconstruction (IPBR) of breast cancer, allowing many patients to maximize reserved autologous breast tissue who do not have indications for breast-conserving surgery (BCS). No large sample size survival data for this operation have been reported worldwide.</p><p><strong>Methods: </strong>There are 212 primary breast cancer patients who were prepared to receive BCS with IPBR of pedicled TDAP flaps in our institution from June 2013 to December 2017. Finally, the operations were completed successfully in 50 cases. All patients were female with a median age of 40 years.</p><p><strong>Results: </strong>The average diameter of TDAPs measured by Doppler ultrasound before the operation was 1.8 ± 0.6 mm (ranging from 0.6 to 3.3 mm). The average size of the flaps was 15 × 6 cm. The average time of operations was 282 ± 71 min (ranging from 120 to 425 min). The drainage tube was removed 4.8 ± 1.9 days after the operation (ranging from 3 to 12 days). All TDAP flaps survived, and the wound complication rate was 4% (2/50). The median follow-up time was 88 (67, 94) months (M [IQR]), with a 5-year ipsilateral breast tumor recurrence rate of 4% (95% CI: 0.1-9.5%), a 5-year breast cancer-free interval of 88.0% (95% CI: 79.0-97.0%), and a 5-year overall survival rate of 96.0% (95% CI: 90.5-99.9%).</p><p><strong>Conclusion: </strong>IPBR using pedicled TDAP flaps is a good choice for repairing local breast defects in BCS. The advantages of this surgery are no influence on latissimus dorsi function, few complications in the donor area, and good long-term prognosis.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 6","pages":"297-306"},"PeriodicalIF":2.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11649294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2024-12-01Epub Date: 2024-10-04DOI: 10.1159/000541707
Buşra Burcu, Işık Çetinoğlu, Nadir Adnan Hacim, Esma Çerekçi, Aziz Şener, Ramazan Uçak, Ceylan Yanar, Cemal Kaya
{"title":"Comparing the Efficacy of Intralesional Injection versus Systemic Steroids in Treating Idiopathic Granulomatous Mastitis: Insights from a Single-Center Experience.","authors":"Buşra Burcu, Işık Çetinoğlu, Nadir Adnan Hacim, Esma Çerekçi, Aziz Şener, Ramazan Uçak, Ceylan Yanar, Cemal Kaya","doi":"10.1159/000541707","DOIUrl":"10.1159/000541707","url":null,"abstract":"<p><strong>Objective: </strong>Idiopathic granulomatous mastitis (IGM) is a benign inflammatory condition predominantly affecting women of reproductive age, particularly those with a history of breastfeeding. Although the precise etiology remains unknown, treatment strategies continue to be a subject of debate. This study aimed to compare the efficacy of intralesional steroid (ILS) injections with oral steroid (OS) therapy in managing IGM.</p><p><strong>Materials and methods: </strong>A total of 72 patients, clinically and histopathologically diagnosed with IGM, were treated with either ILSs (group ILS, <i>n</i> = 47) or OSs (group OS, <i>n</i> = 25) at a tertiary referral hospital between January 2022 and January 2024. The data were retrospectively analyzed.</p><p><strong>Results: </strong>The mean age of the patients was 33.5 years (range: 22-56). No statistically significant differences were observed between the two groups in terms of demographic characteristics, presenting symptoms, clinical findings, or laboratory results. The mean treatment duration was 6 months. There were no significant differences in treatment response or recurrence rates between the two groups. However, there was a statistically significant difference in the incidence of side effects, with 6.3% in the ILS group compared to 36% in the OS group (<i>p</i> = 0.001).</p><p><strong>Conclusion: </strong>Given its ease of application, lower incidence of side effects, and comparable efficacy, ILS injections may be considered a first-line treatment option in the management of IGM.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 6","pages":"307-315"},"PeriodicalIF":2.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11649297/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2024-12-01Epub Date: 2024-10-02DOI: 10.1159/000541421
YanYan Dai, Jiarong Lan, Shasha Li, Guangxing Xu
{"title":"Exploring the Impact of Sarcopenia on Mortality in Breast Cancer Patients: A Comprehensive Systematic Review and Meta-Analysis.","authors":"YanYan Dai, Jiarong Lan, Shasha Li, Guangxing Xu","doi":"10.1159/000541421","DOIUrl":"10.1159/000541421","url":null,"abstract":"<p><strong>Background: </strong>This study assesses the frequency of sarcopenia in patients with breast cancer (BC) and its association with mortality rates.</p><p><strong>Methods: </strong>An all-encompassing search across (PubMed, Scopus, Web of Science, and CINAHL) was done, to identify studies, published until August 2023, that report data on sarcopenia and mortality in BC patients. A meta-analysis was then done using a random-effects model.</p><p><strong>Results: </strong>Out of 989 initially identified potential studies, 19 met inclusion criteria. Analysis of 15 studies showed a rate of sarcopenia of 38% (95% CI: 29-48%), with moderate heterogeneity (<i>I</i> <sup>2</sup> = 25.8%). Sarcopenia was linked to increased mortality risk in BC patients across 16 studies (HR: 1.77, CI: 1.35-2.32, <i>p</i> = <0.001) with both shorter and longer follow-up periods. Similarly, mortality risks were significantly higher in metastatic (HR: 1.52, CI: 1.14-2.03, <i>p</i> = 0.004) and non-metastatic (HR: 2.55, CI: 1.66-3.93, <i>p</i> < 0.001) BC patients with sarcopenia.</p><p><strong>Conclusion: </strong>Our analysis demonstrates a substantial prevalence of sarcopenia in BC patients. Importantly, sarcopenia was significantly linked to an elevated risk of mortality in this population. Subgroup analyses, stratified by follow-up periods and disease stage, consistently reveal increased mortality risks associated with sarcopenia, underscoring its clinical relevance in both short- and long-term patient outcomes. Our findings further strengthen the need to recognize and address sarcopenia as a critical factor in BC management and prognosis.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 6","pages":"316-328"},"PeriodicalIF":2.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11649298/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2024-10-01Epub Date: 2024-08-27DOI: 10.1159/000541015
Maximilian Pruss, Melissa Neubacher, Frederic Dietzel, Natalia Krawczyk, Jan-Philipp Cieslik, Svjetlana Mohrmann, Eugen Ruckhäberle, Elisabeth C Sturm-Inwald, Tanja N Fehm, Bianca Behrens
{"title":"Retrospective Impact of COVID-19 Pandemic on Primary Breast Cancer Care.","authors":"Maximilian Pruss, Melissa Neubacher, Frederic Dietzel, Natalia Krawczyk, Jan-Philipp Cieslik, Svjetlana Mohrmann, Eugen Ruckhäberle, Elisabeth C Sturm-Inwald, Tanja N Fehm, Bianca Behrens","doi":"10.1159/000541015","DOIUrl":"https://doi.org/10.1159/000541015","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic has transformed breast cancer care for patients and healthcare providers. Circumstances varied greatly by region and hospital, depending on COVID-19 prevalence, case mix, hospital type, and available resources. These challenges have disrupted screening programs and have been particularly distressing for both women with a breast cancer diagnosis and their providers.</p><p><strong>Summary: </strong>This review explores the retrospective impact of the COVID-19 pandemic on primary breast cancer care. It analyzes changes in screening participation, diagnosis rates, treatment modalities, and the delivery of psycho-oncological support during the pandemic. The study found a significant reduction in breast cancer screenings and a subsequent stage shift in diagnoses, with fewer early-stage and more advanced-stage cancers being detected. Additionally, the review discusses the psychosocial challenges faced by patients and the adaptations made in care delivery, such as the increased use of telemedicine. Despite these challenges, the healthcare systems showed resilience, with core treatment services largely maintained and rapid adaptations to new care models.</p><p><strong>Key messages: </strong>There was a marked decrease in breast cancer screenings and early diagnoses during the pandemic, with a shift toward more advanced-stage detections. While there was an increased use of neoadjuvant therapies and telemedicine, essential breast cancer treatments were mostly sustained, reflecting the resilience of healthcare systems. The pandemic significantly impacted the mental health of breast cancer patients, exacerbating anxiety and depression and highlighting the need for improved psycho-oncological support. The full impact of these disruptions on long-term breast cancer outcomes remains uncertain, necessitating ongoing monitoring and adaptation of care strategies to mitigate adverse effects.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 5","pages":"270-281"},"PeriodicalIF":2.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11493392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2024-10-01Epub Date: 2024-09-18DOI: 10.1159/000541482
Mustafa Emiroglu, Alper Akcan, Mehmet Velidedeoglu, Sadullah Girgin, Ozgur Aytac, N Zafer Canturk, Kerim Bora Yilmaz, Hande Koksal, Neslihan Cabioglu, Kenan Cetin, Bahadır Gulluoglu
{"title":"Diagnosis, Approach, and Clinical Classification of Idiopathic Granulomatous Mastitis: Consensus Report.","authors":"Mustafa Emiroglu, Alper Akcan, Mehmet Velidedeoglu, Sadullah Girgin, Ozgur Aytac, N Zafer Canturk, Kerim Bora Yilmaz, Hande Koksal, Neslihan Cabioglu, Kenan Cetin, Bahadır Gulluoglu","doi":"10.1159/000541482","DOIUrl":"https://doi.org/10.1159/000541482","url":null,"abstract":"<p><strong>Objective: </strong>The aim of the idiopathic granulomatous mastitis (IGM) consensus study was to evaluate the etiology, diagnostic steps, and differential diagnosis and propose a widely accepted clinical classification of this mysterious breast disease.</p><p><strong>Method: </strong>The organization of a national IGM consensus was decided by the joint evaluation of the Turkish Federation of Breast Diseases Societies, SENATURK, and the Society of Breast Surgery. First, a working group of 11 members was formed, and a survey and workshop were organized to reach a common consensus. The modified Delphi method was used in the consensus methodology. Voting rates of 80% and above were considered as acceptance.</p><p><strong>Results: </strong>The consensus was 45/50 (92%) that core needle biopsies are necessary for the diagnosis of IGM and 39/40 (97%) that a new clinical classification is needed. The proposed Turkish clinical classification of IGM was accepted by 94% in three rounds of voting.</p><p><strong>Conclusion: </strong>This disease should be considered etiologically idiopathic. Tissue diagnosis and pathological evaluation are recommended for treatment. The proposed IGM Turkey classification was strongly accepted.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 5","pages":"243-251"},"PeriodicalIF":2.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11493389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Association of Aromatase Inhibitor-Induced Musculoskeletal Symptoms with Central Sensitization-Related Symptoms: A Cross-Sectional Study.","authors":"Akira Mibu, Masahiro Manfuku, Tomohiko Nishigami, Hirofumi Yamashita, Ryota Imai, Hiroe Kanamori, Kazuhiro Sumiyoshi","doi":"10.1159/000539867","DOIUrl":"10.1159/000539867","url":null,"abstract":"<p><strong>Introduction: </strong>Aromatase inhibitor (AI)-induced musculoskeletal symptoms (AIMSS) can decrease health-related quality of life and lead to discontinuation of AI therapy for postmenopausal women with breast cancer (BC). Although central sensitization (CS) may contribute to AIMSS, the relevance of CS-related symptoms to AIMSS has not been fully clarified. This study aimed to investigate the relationship between AIMSS and CS-related symptoms in women with BC who received AI therapy.</p><p><strong>Methods: </strong>This cross-sectional study recruited women who underwent BC surgery before at least 1 year and were taking AI for at least 6 months. Participants were assessed for joint pain and CS-related symptoms using the central sensitization inventory (CSI). The severity of CS-related symptoms was classified into three groups, and the prevalence of AIMSS was calculated. Multiple logistic regression analysis was used to assess the relationship between AIMSS and factors of possible relevance to AIMSS, including CSI severity.</p><p><strong>Results: </strong>Of the 73 women who were included in this study, 31 (42.4%) were categorized into the AIMSS group and 42 (57.6%) into the non-AIMSS group. Participants with a history of chemotherapy and higher CSI score were significantly more likely to have AIMSS. Multiple logistic regression analysis showed that a history of chemotherapy (odds ratio = 4.21) and higher CSI severity (odds ratio = 13.43) had significantly associated with AIMSS.</p><p><strong>Conclusion: </strong>CS-related symptoms assessed using CSI may be strongly associated with AIMSS. Further longitudinal studies to investigate the causal relationship and effectiveness of CS-targeted interventions are needed to prevent and treat AIMSS effectively.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 4","pages":"207-214"},"PeriodicalIF":2.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341075/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055021","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2024-08-01Epub Date: 2024-06-20DOI: 10.1159/000539869
Mattea Reinisch, Paolo Tarantino, Nina Ditsch, Angelika Wolfrum, Frederik Marmé
{"title":"ASCO 2024: Personal Insights and a Look into the Future from an International Expert Group.","authors":"Mattea Reinisch, Paolo Tarantino, Nina Ditsch, Angelika Wolfrum, Frederik Marmé","doi":"10.1159/000539869","DOIUrl":"https://doi.org/10.1159/000539869","url":null,"abstract":"","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 4","pages":"223-228"},"PeriodicalIF":2.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341073/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy in Breast Cancer Patients with Positive Nodes Using Low-Cost Dual Dye Technique: Identifying Factors Associated with Adequate False Negative Rate Threshold.","authors":"Sanjay Kumar Yadav, Jayesh Chavda, Arpan Mishra, Dhananjaya Sharma, Shyam Ji Rawat, Rajesh Jain","doi":"10.1159/000538654","DOIUrl":"10.1159/000538654","url":null,"abstract":"<p><strong>Background: </strong>In this study, we evaluated the feasibility of the sentinel lymph node (SLN) identification rate (SLN-IR) of fluorescein-guided sentinel lymph node biopsy (SLNB) in combination with methylene blue dye (MBD) and factors which can lead to a false negative rate (FNR) threshold of 10%.</p><p><strong>Methods: </strong>This was a prospective cross-sectional non-randomized validation study in patients with post-neoadjuvant chemotherapy (NACT) clinically node negative axilla who were node positive prior to start of NACT. Patients underwent validation of SLNB using fluorescein (and blue LED light) and MBD. Axillary dissection was performed irrespective of SLNB histology. SLIN-IR and FNR were assessed and compared with various molecular subtypes.</p><p><strong>Results: </strong>The SLNs were identified in 102 out of 120 (85%) post-NACT patients. The median number of sentinel lymph nodes identified was 2 (range 1-3). The SLN-IR using MBD was 85%, FD was 82.5%, and combined MBD FD was 85%. Two or more SLNs were removed in 72 patients and 11 patients had tumor in the rest of the axilla, resulting in an FNR of 17.4%. An FNR was 25% in case only one SLN was found, and it was 11.42% if two or more than two SLNs were excised.</p><p><strong>Conclusions: </strong>This cohort study found that use of low-cost dual dyes in patients with positive axillary disease, rendered cN0 with NACT, with 2 or more negative SLNs with SLNB alone, results in an FNR of 11.4%. Her 2 positive and TNBC with 2 or more negative SLNs are associated with an FNR of <10%. However, the number of such patients was small and further studies with larger sample size are warranted to confirm these findings.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 3","pages":"142-148"},"PeriodicalIF":2.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11182632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141417879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Translating Evidence into Practice: A Review of Clinical Practice and Outcomes following the Adoption of an Early Post-Mastectomy Discharge Protocol in a Nigerian Hospital.","authors":"Olalekan Olasehinde, Michael Oluwatobiloba Fagbayimu, Adewale Aderounmu, Tolulope Komolafe, Muftiat Ameen, Olusegun Alatise, Adewale Adisa","doi":"10.1159/000536080","DOIUrl":"10.1159/000536080","url":null,"abstract":"<p><strong>Introduction: </strong>In Nigeria, mastectomy is the most common surgical treatment for breast cancer. Patients are often kept on admission for days until wound drains are removed. An early discharge programme was piloted in a Nigerian hospital in 2017 with very satisfactory outcomes. The impact of this evidence on clinical practice and surgical outcomes was evaluated over 5 years.</p><p><strong>Methods: </strong>From a prospectively maintained institutional database, the details of patients who underwent mastectomy between 2018 and 2022 were obtained. The duration of post-operative stay was obtained and analysed per year to determine the trend. Post-operative surgical complications such as seroma, haematoma, flap necrosis, and surgical site infection were analysed.</p><p><strong>Results: </strong>Overall, 147 patients (69%) had early discharge during the review period. Twenty-two patients (10.3%) were discharged within 24 h of surgery, 61 patients (28.6%) were discharged within 24-48 h, and 64 patients (30%) were discharged between 48 and 72 h. There was a steady increase in the adoption of the early discharge protocol over time with a 50% adoption rate in 2018 and 95% in 2022. The mean duration of hospital stay declined steadily from 3.9 days in 2018 to 2.2 days in 2022. Early discharge did not result in any compromise to post-operative outcomes.</p><p><strong>Conclusion: </strong>This study demonstrates the sustainability of early post-mastectomy discharge in a resource-limited setting with very satisfactory outcomes. It also provides a unique example of how locally generated evidence can guide local practice. We consider these findings generalisable in other Nigerian hospitals and low- and middle-income countries with similar contexts.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 3","pages":"135-141"},"PeriodicalIF":2.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11182634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141417880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast CarePub Date : 2024-02-01Epub Date: 2023-12-20DOI: 10.1159/000535135
Thomas Decker, Matthias Zaiss, Dunja Klein, Antje Hahn, Volker Hagen, Paul La Rosée, Rüdiger Liersch, Thomas Wolff, Beate Niemeier, Larissa E Hillebrand, Carolin Lennartz, Marco Chiabudini, Fee Bengsch, Martin Indorf, Norbert Marschner
{"title":"Final Results from RIBBIT: A Randomized Phase III Study to Evaluate Efficacy and Quality of Life in Patients with Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Receiving Ribociclib in Combination with Endocrine Therapy or Chemotherapy with or without Bevacizumab in the First-Line Setting.","authors":"Thomas Decker, Matthias Zaiss, Dunja Klein, Antje Hahn, Volker Hagen, Paul La Rosée, Rüdiger Liersch, Thomas Wolff, Beate Niemeier, Larissa E Hillebrand, Carolin Lennartz, Marco Chiabudini, Fee Bengsch, Martin Indorf, Norbert Marschner","doi":"10.1159/000535135","DOIUrl":"10.1159/000535135","url":null,"abstract":"<p><strong>Background: </strong>We investigated the efficacy and health-related quality of life (HRQoL) in patients receiving either ribociclib plus endocrine therapy (ET) or chemotherapy with/without bevacizumab as first-line treatment of metastatic hormone receptor (HR)-positive, HER2-negative breast cancer (BC).</p><p><strong>Patients and methods: </strong>In this randomized, phase III study (RIBBIT), 38 patients diagnosed with metastatic HR-positive, HER2-negative BC with presence of visceral metastases recruited between May 2018 and December 2020 were randomly assigned in a 1:1 ratio to either arm A (ribociclib + ET) or arm B (chemotherapy with/without bevacizumab) at 12 sites in Germany. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall response rate (ORR), overall survival (OS), patient-reported HRQoL, and frequency and type of adverse events. During study conduction, the recruitment rate was persistently and considerably lower than originally expected. Therefore, the recruitment was ended prematurely. The study was initially designed to enroll and randomize 158 patients.</p><p><strong>Results: </strong>Median [95% CI] PFS was 27.3 months [19.1 - NA, parameter not estimable] in arm A and 15.8 months [8.2 - NA] in arm B. Complete responses were achieved only in arm A (<i>n</i> = 2, 10.5%). The ORR [95% CI] between arm A (57.9% [33.5-79.7]) and arm B (52.6% [28.9-75.6]) was comparable. Median OS [95% CI] was not reached in arm A, while in arm B median OS was 28.4 months [25.0 - NA]. Patients in arm A reported less burden by side-effects. No new safety signals emerged.</p><p><strong>Conclusion: </strong>Treatment of patients with visceral metastatic HR-positive, HER2-negative BC with ribociclib in combination with ET showed a tendency toward a more favorable clinical outcome. Despite small numbers of patients and sites, this head-to-head comparison with chemotherapy supports the use of ribociclib with ET in patients with visceral metastasis at risk of fast disease progression.</p>","PeriodicalId":9310,"journal":{"name":"Breast Care","volume":"19 1","pages":"49-61"},"PeriodicalIF":2.1,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10878705/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}