Pub Date : 2025-02-18DOI: 10.1016/j.breast.2025.104425
Eva L. Claassens , Roxanne A.W. Ploumen , Loes F.S. Kooreman , Maartje A.C.E. van Kats , Sabine Siesling , Thiemo J.A. van Nijnatten , Marjolein L. Smidt
Purpose
Recent studies show that ductal carcinoma in situ (DCIS) accompanying HER2+ breast cancer can be completely eradicated following neoadjuvant systemic therapy in up to 52 %. We aimed to determine the complete response rate of DCIS in triple-negative breast cancer (TNBC) patients in a nationwide cohort and to assess clinicopathological variables associated with response. Furthermore, the impact on surgical treatment after neoadjuvant chemotherapy (NACT) was investigated.
Methods
Women diagnosed with TNBC, treated with NACT followed by surgery, between 2010 and 2020, were selected from the Netherlands Cancer Registry (NCR). Pre-NACT and postoperative pathology reports were obtained from Palga, the Dutch nationwide pathology databank, to determine presence of DCIS. Clinicopathological factors associated with DCIS response were investigated using uni- and multivariable logistic regression analysis.
Results
In total, 4494 patients were included. A DCIS component was present in the pre-NACT biopsy of 442 (9.8 %) patients. Pathologic complete response of the DCIS component was achieved in 53.6 % of these patients. The presence of calcifications in the pre-NACT biopsy was associated with a lower chance of DCIS response in univariable logistic regression analysis (OR 0.52, CI 95 % 0.27–0.98, p = 0.04). In multivariable analysis, no statistically significant associations were found between DCIS response and clinicopathological variables. Mastectomy rates were higher in case of IBC + DCIS compared to IBC (53.4 % vs 40.1 %, p < 0.001).
Conclusion
Pathologic complete response of DCIS to NACT occurred in 53.6 % of TNBC patients. Future studies are required to be able to predict DCIS response based on clinicopathological variables and imaging.
{"title":"The effect of neoadjuvant chemotherapy on ductal carcinoma in situ in triple-negative breast cancer patients: A nationwide analysis","authors":"Eva L. Claassens , Roxanne A.W. Ploumen , Loes F.S. Kooreman , Maartje A.C.E. van Kats , Sabine Siesling , Thiemo J.A. van Nijnatten , Marjolein L. Smidt","doi":"10.1016/j.breast.2025.104425","DOIUrl":"10.1016/j.breast.2025.104425","url":null,"abstract":"<div><h3>Purpose</h3><div>Recent studies show that ductal carcinoma in situ (DCIS) accompanying HER2+ breast cancer can be completely eradicated following neoadjuvant systemic therapy in up to 52 %. We aimed to determine the complete response rate of DCIS in triple-negative breast cancer (TNBC) patients in a nationwide cohort and to assess clinicopathological variables associated with response. Furthermore, the impact on surgical treatment after neoadjuvant chemotherapy (NACT) was investigated.</div></div><div><h3>Methods</h3><div>Women diagnosed with TNBC, treated with NACT followed by surgery, between 2010 and 2020, were selected from the Netherlands Cancer Registry (NCR). Pre-NACT and postoperative pathology reports were obtained from Palga, the Dutch nationwide pathology databank, to determine presence of DCIS. Clinicopathological factors associated with DCIS response were investigated using uni- and multivariable logistic regression analysis.</div></div><div><h3>Results</h3><div>In total, 4494 patients were included. A DCIS component was present in the pre-NACT biopsy of 442 (9.8 %) patients. Pathologic complete response of the DCIS component was achieved in 53.6 % of these patients. The presence of calcifications in the pre-NACT biopsy was associated with a lower chance of DCIS response in univariable logistic regression analysis (OR 0.52, CI 95 % 0.27–0.98, p = 0.04). In multivariable analysis, no statistically significant associations were found between DCIS response and clinicopathological variables. Mastectomy rates were higher in case of IBC + DCIS compared to IBC (53.4 % vs 40.1 %, p < 0.001).</div></div><div><h3>Conclusion</h3><div>Pathologic complete response of DCIS to NACT occurred in 53.6 % of TNBC patients. Future studies are required to be able to predict DCIS response based on clinicopathological variables and imaging.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104425"},"PeriodicalIF":5.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143445510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-16DOI: 10.1016/j.breast.2025.104424
Nina Lykkegaard Gehr , Signe Timm , Kristine Bennedsgaard , Kasper Grosen , Erik Jakobsen , Anders Bonde Jensen , Jeanette Dupont Rønlev , Ann Søegaard Knoop , Nanna B. Finnerup , Lise Ventzel
Chemotherapy-induced peripheral neuropathy (CIPN) is a concerning late effect of taxane treatment. This study aimed to explore and compare long-term symptoms and consequences of CIPN after docetaxel and paclitaxel treatment.
Patients with breast cancer who had followed Danish recommended adjuvant docetaxel or paclitaxel treatment regimens completed an online questionnaire 2–3 years after treatment. The questionnaire comprised the Michigan Neuropathy Screen Instrument, the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, EORTC QLQ C30, and CIPN-specific symptoms. Painful CIPN was assessed using the Douleur Neuropathique 4 Questions.
Questionnaires from 411 patients (docetaxel: 192, paclitaxel: 219) were analyzed. No significant difference in the prevalence of possible CIPN between the two groups was observed (docetaxel: 48.4 % [93/192] vs. paclitaxel: 45.2 % [99/219]; 95 % CI: 6.4 - 12.9, p = 0.51). However, the EORTC-QLQ-CIPN20 sum score was higher in the docetaxel group (difference: 3.0; 95 % CI: 0.0–6.1, p = 0.05).
Among patients with reported CIPN symptoms, significantly more in the docetaxel group reported painful CIPN (docetaxel: 53.8 % [50/93] than in the paclitaxel group: 34.3 % [34/99]; p = 0.01). Quality of life scores from the EORCT-QLQ-C30 questionnaire were significantly lower in those with possible CIPN than in those without and lower in patients with painful possible CIPN than in those with painless CIPN.
Docetaxel caused more severe and painful CIPN symptoms than paclitaxel. These findings are highly relevant, as docetaxel remains a crucial component of cancer treatments.
{"title":"Chronic chemotherapy-induced peripheral neuropathy and pain following paclitaxel versus docetaxel in breast cancer survivors: A cross-sectional study","authors":"Nina Lykkegaard Gehr , Signe Timm , Kristine Bennedsgaard , Kasper Grosen , Erik Jakobsen , Anders Bonde Jensen , Jeanette Dupont Rønlev , Ann Søegaard Knoop , Nanna B. Finnerup , Lise Ventzel","doi":"10.1016/j.breast.2025.104424","DOIUrl":"10.1016/j.breast.2025.104424","url":null,"abstract":"<div><div>Chemotherapy-induced peripheral neuropathy (CIPN) is a concerning late effect of taxane treatment. This study aimed to explore and compare long-term symptoms and consequences of CIPN after docetaxel and paclitaxel treatment.</div><div>Patients with breast cancer who had followed Danish recommended adjuvant docetaxel or paclitaxel treatment regimens completed an online questionnaire 2–3 years after treatment. The questionnaire comprised the Michigan Neuropathy Screen Instrument, the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, EORTC QLQ C30, and CIPN-specific symptoms. Painful CIPN was assessed using the Douleur Neuropathique 4 Questions.</div><div>Questionnaires from 411 patients (docetaxel: 192, paclitaxel: 219) were analyzed. No significant difference in the prevalence of possible CIPN between the two groups was observed (docetaxel: 48.4 % [93/192] vs. paclitaxel: 45.2 % [99/219]; 95 % CI: 6.4 - 12.9, p = 0.51). However, the EORTC-QLQ-CIPN20 sum score was higher in the docetaxel group (difference: 3.0; 95 % CI: 0.0–6.1, p = 0.05).</div><div>Among patients with reported CIPN symptoms, significantly more in the docetaxel group reported painful CIPN (docetaxel: 53.8 % [50/93] than in the paclitaxel group: 34.3 % [34/99]; p = 0.01). Quality of life scores from the EORCT-QLQ-C30 questionnaire were significantly lower in those with possible CIPN than in those without and lower in patients with painful possible CIPN than in those with painless CIPN.</div><div>Docetaxel caused more severe and painful CIPN symptoms than paclitaxel. These findings are highly relevant, as docetaxel remains a crucial component of cancer treatments.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104424"},"PeriodicalIF":5.7,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143436569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Corrigendum to ‘Impact of adjuvant trastuzumab therapy and its discontinuation on cardiac function and mortality in patients with early-stage breast cancer: An analysis based on the Japanese Receipt Claim Database’ [The Breast 79 (2025) 103871]","authors":"Keiko Miyazato , Hiroshi Ohtsu , Akihiko Shimomura , Naohiro Yonemoto , Chikako Shimizu , Kazuhiro Sase , Shinichiro Ueda","doi":"10.1016/j.breast.2025.103894","DOIUrl":"10.1016/j.breast.2025.103894","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 103894"},"PeriodicalIF":5.7,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143394900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-11DOI: 10.1016/j.breast.2025.104416
L.M. Rademaker , R. Gal , A.M. May , M.C.T. Batenburg , F. van der Leij , R.M. Bijlsma , H.M. Verkooijen , A. Doeksen , M.F. Ernst , D.J. Evers , C.C. van der Pol , E.M. Monninkhof
Many women with breast cancer prematurely discontinue adjuvant endocrine therapy, leading to increased mortality. We performed a cross-sectional survey (n = 456) within the Dutch UMBRELLA-cohort to gain insight into the prevalence of side-effects and its association with premature discontinuation. Almost all current endocrine therapy users experienced side-effects (92.7 %), most frequent were vasomotor- and musculoskeletal symptoms. The most reported reason for premature discontinuation was side-effects (88.1 %). Former treatment with chemotherapy was associated with more reported side-effects (97.2 % vs 82.5 %, ORadj 6.31), but less premature discontinuation of endocrine therapy (18.6 % vs 28.6 %, p-value 0.016).
{"title":"Side-effects in women treated with adjuvant endocrine therapy for breast cancer","authors":"L.M. Rademaker , R. Gal , A.M. May , M.C.T. Batenburg , F. van der Leij , R.M. Bijlsma , H.M. Verkooijen , A. Doeksen , M.F. Ernst , D.J. Evers , C.C. van der Pol , E.M. Monninkhof","doi":"10.1016/j.breast.2025.104416","DOIUrl":"10.1016/j.breast.2025.104416","url":null,"abstract":"<div><div>Many women with breast cancer prematurely discontinue adjuvant endocrine therapy, leading to increased mortality. We performed a cross-sectional survey (n = 456) within the Dutch UMBRELLA-cohort to gain insight into the prevalence of side-effects and its association with premature discontinuation. Almost all current endocrine therapy users experienced side-effects (92.7 %), most frequent were vasomotor- and musculoskeletal symptoms. The most reported reason for premature discontinuation was side-effects (88.1 %). Former treatment with chemotherapy was associated with more reported side-effects (97.2 % vs 82.5 %, ORadj 6.31), but less premature discontinuation of endocrine therapy (18.6 % vs 28.6 %, p-value 0.016).</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104416"},"PeriodicalIF":5.7,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143436570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-06DOI: 10.1016/j.breast.2025.104414
Antonio Di Meglio , Giuseppe Catanuto , Marzia Zambon , Alexandre Chan , Angelos P. Kassianos , Constantina Cloconi , Silvia Rohr , Rebecca Steele , Monique Coersmeyer , Sonia Ujupan , Fedro Peccatori
Background
Treatment-related side effects are common among women treated for early breast cancer and their effective management is essential to maintain quality of life, ensure treatment adherence, and optimise survival outcomes. This study aimed to investigate patient-reported experiences and preferences about information regarding side effects received during breast cancer care.
Methods
An international multi-stakeholder expert group conducted an online patient survey assessing comprehensiveness, timing, and delivery modality of information regarding treatment-related side effects among patients undergoing primary therapy (surgery, radiation, and [neo]adjuvant chemotherapy) and endocrine therapy for early breast cancer. Descriptive analyses were performed.
Results
From June–August 2023, 608 respondents from Brazil, France, Germany, Italy, Japan, and Spain completed the survey: 57.5 % were <50 years old, and all were or had been on endocrine therapy. Fatigue was the most reported side effect (47.0 % for primary and 42.3 % for endocrine therapy). A variable proportion of patients (14.4%–46.8 % across side effects) reported receiving information only after having experienced the side effect. Up to 43.6 % of respondents reported receiving insufficient or no information on side effects from their healthcare providers. Most patients reported preference for proactive communication from healthcare providers about side effects and prevention strategies. Respondents valued direct interactions with physicians and nurses and capitalised on a relevant role for peer-support, however utility of smartphone and web-based platforms to record and manage symptoms was acknowledged.
Conclusion
The survey underscores critical needs and offers insight informing the provision of comprehensive and timely information on treatment-related side effects across the cancer survivorship continuum.
{"title":"Experiences and preferences about information on treatment-related side effects among patients with early breast cancer","authors":"Antonio Di Meglio , Giuseppe Catanuto , Marzia Zambon , Alexandre Chan , Angelos P. Kassianos , Constantina Cloconi , Silvia Rohr , Rebecca Steele , Monique Coersmeyer , Sonia Ujupan , Fedro Peccatori","doi":"10.1016/j.breast.2025.104414","DOIUrl":"10.1016/j.breast.2025.104414","url":null,"abstract":"<div><h3>Background</h3><div>Treatment-related side effects are common among women treated for early breast cancer and their effective management is essential to maintain quality of life, ensure treatment adherence, and optimise survival outcomes. This study aimed to investigate patient-reported experiences and preferences about information regarding side effects received during breast cancer care.</div></div><div><h3>Methods</h3><div>An international multi-stakeholder expert group conducted an online patient survey assessing comprehensiveness, timing, and delivery modality of information regarding treatment-related side effects among patients undergoing primary therapy (surgery, radiation, and [neo]adjuvant chemotherapy) and endocrine therapy for early breast cancer. Descriptive analyses were performed.</div></div><div><h3>Results</h3><div>From June–August 2023, 608 respondents from Brazil, France, Germany, Italy, Japan, and Spain completed the survey: 57.5 % were <50 years old, and all were or had been on endocrine therapy. Fatigue was the most reported side effect (47.0 % for primary and 42.3 % for endocrine therapy). A variable proportion of patients (14.4%–46.8 % across side effects) reported receiving information only after having experienced the side effect. Up to 43.6 % of respondents reported receiving insufficient or no information on side effects from their healthcare providers. Most patients reported preference for proactive communication from healthcare providers about side effects and prevention strategies. Respondents valued direct interactions with physicians and nurses and capitalised on a relevant role for peer-support, however utility of smartphone and web-based platforms to record and manage symptoms was acknowledged.</div></div><div><h3>Conclusion</h3><div>The survey underscores critical needs and offers insight informing the provision of comprehensive and timely information on treatment-related side effects across the cancer survivorship continuum.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104414"},"PeriodicalIF":5.7,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143394899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-05DOI: 10.1016/j.breast.2025.104412
Christina B. Walter , Andreas D. Hartkopf , Alexander Hein , Peter A. Fasching , Hans-Christian Kolberg , Peyman Hadji , Hans Tesch , Lothar Häberle , Johannes Ettl , Diana Lüftner , Markus Wallwiener , Volkmar Müller , Matthias W. Beckmann , Laura L. Michel , Erik Belleville , Hanna Huebner , Sabrina Uhrig , Chloë Goossens , Pauline Wimberger , Carsten Hielscher , Carlo Fremd
Background
Patients with first-line metastatic breast cancer (MBC) comprise patients with de novo metastases (dnMBC) or recurrent disease after primary breast cancer (rMBC). This analysis aimed to explore the prognostic value of dnMBC versus rMBC overall and particularly in subgroups according to age and metastasis site, in addition to other prognostic clinicopathological parameters in a first-line, hormone receptor (HR)-positive, HER2-negative (HRpos/HER2neg) population.
Methods
Within the prospective PRAEGNANT MBC registry (NCT02338167), 508 HRpos/HER2neg patients, receiving first-line treatment for advanced disease, were identified. Clinicopathological parameters (age, body mass index, performance status, tumor grading, metastasis site and therapy) were assessed according to metastatic status (dnMBC, rMBC within 5 years of primary diagnosis (rMBC <5 years), rMBC after more than 5 years (rMBC ≥5 years)). Cox regression analyses were performed to investigate whether metastatic status influences progression-free survival (PFS) and overall survival (OS).
Results
De novo metastatic disease was present in 180 patients (35.4 %), whereas 132 patients (26.0 %) had rMBC <5 years and 196 patients (38.6 %) had rMBC ≥5 years. Patients with dnMBC had the most favorable prognosis. Relative to dnMBC, hazard ratios for PFS were 1.75 (95%CI: 1.31–2.34) in rMBC<5 years and 1.25 (95%CI: 0.94–1.65) for rMBC ≥5 years. Subgroup-specific differences were not observed.
Conclusion
HRpos/HER2neg first-line MBC patients have a more favorable prognosis if the disease was previously not treated. This difference was similar across all examined clinicopathological parameters. It may therefore be beneficial to incorporate MBC categories as a stratification factor in clinical trials.
{"title":"Characteristics and prognosis of patients with primary metastatic disease vs. recurrent HER2-negative, hormone receptor-positive advanced breast cancer","authors":"Christina B. Walter , Andreas D. Hartkopf , Alexander Hein , Peter A. Fasching , Hans-Christian Kolberg , Peyman Hadji , Hans Tesch , Lothar Häberle , Johannes Ettl , Diana Lüftner , Markus Wallwiener , Volkmar Müller , Matthias W. Beckmann , Laura L. Michel , Erik Belleville , Hanna Huebner , Sabrina Uhrig , Chloë Goossens , Pauline Wimberger , Carsten Hielscher , Carlo Fremd","doi":"10.1016/j.breast.2025.104412","DOIUrl":"10.1016/j.breast.2025.104412","url":null,"abstract":"<div><h3>Background</h3><div>Patients with first-line metastatic breast cancer (MBC) comprise patients with de novo metastases (dnMBC) or recurrent disease after primary breast cancer (rMBC). This analysis aimed to explore the prognostic value of dnMBC versus rMBC overall and particularly in subgroups according to age and metastasis site, in addition to other prognostic clinicopathological parameters in a first-line, hormone receptor (HR)-positive, HER2-negative (HRpos/HER2neg) population.</div></div><div><h3>Methods</h3><div>Within the prospective PRAEGNANT MBC registry (NCT02338167), 508 HRpos/HER2neg patients, receiving first-line treatment for advanced disease, were identified. Clinicopathological parameters (age, body mass index, performance status, tumor grading, metastasis site and therapy) were assessed according to metastatic status (dnMBC, rMBC within 5 years of primary diagnosis (rMBC <5 years), rMBC after more than 5 years (rMBC ≥5 years)). Cox regression analyses were performed to investigate whether metastatic status influences progression-free survival (PFS) and overall survival (OS).</div></div><div><h3>Results</h3><div><em>De novo</em> metastatic disease was present in 180 patients (35.4 %), whereas 132 patients (26.0 %) had rMBC <5 years and 196 patients (38.6 %) had rMBC ≥5 years. Patients with dnMBC had the most favorable prognosis. Relative to dnMBC, hazard ratios for PFS were 1.75 (95%CI: 1.31–2.34) in rMBC<5 years and 1.25 (95%CI: 0.94–1.65) for rMBC ≥5 years. Subgroup-specific differences were not observed.</div></div><div><h3>Conclusion</h3><div>HRpos/HER2neg first-line MBC patients have a more favorable prognosis if the disease was previously not treated. This difference was similar across all examined clinicopathological parameters. It may therefore be beneficial to incorporate MBC categories as a stratification factor in clinical trials.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104412"},"PeriodicalIF":5.7,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143394901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-04DOI: 10.1016/j.breast.2025.104411
Annemiek K.E. van Hemert , Ariane A. van Loevezijn , Marie-Sophie P.D. Baas , Marcel P.M. Stokkel , Emma J. Groen , Vincent van der Noort , Claudette E. Loo , Gabe S. Sonke , Nicola Russell , Frederieke H. van Duijnhoven , Marie-Jeanne T.F.D. Vrancken Peeters
Purpose
Axillary lymph node staging techniques after primary systemic therapy (PST) show low false negative rates, stimulating the omission of axillary lymph node dissection (ALND). Breast cancer patients with extensive nodal disease are underreported in studies on response-guided axillary treatment. In this study, we present the oncologic outcome of breast cancer patients with ≥4 involved axillary lymph nodes treated according to the MARI-protocol.
Methods
This prospective single arm registration study included breast cancer patients with extensive nodal disease defined as ≥4 involved axillary lymph nodes on FDG-PET/CT pre-PST between July 2014 and December 2021. After PST, the marked (MARI) lymph node was excised. Patients with a pathologic complete response (pCR) of the MARI node (ypN0) received locoregional radiation treatment (RT). In patients with residual disease of the MARI node (ypN+), ALND was performed followed by RT. Primary endpoint was axillary recurrence rate. Secondary endpoints were invasive disease-free survival (DFS) and overall survival (OS).
Results
In total, 218 patients were registered of which 39 % of patients also had extra-axillary nodal disease. Median (IQR) age was 50 (42–57) years. After PST 47 % of patients (103/218) had ypN0, whereas 53 % of patients (115/218) had ypN+. After a median follow up of 44 (26–62) months, axillary recurrence rate was 2.9 % (n = 3) in the ypN0 group and 3.5 % (n = 4) in the ypN + group. Five-year invasive DFS and OS were respectively 89 % (95 % CI 83 %–96 %) and 95 % (95 % CI 91 %–99 %) in ypN0 patients.
Conclusion
Omission of ALND after PST in breast cancer patients with extensive nodal involvement who achieve pCR of the MARI node is associated with excellent five-year oncologic outcome.
{"title":"Omitting axillary lymph node dissection in breast cancer patients with extensive nodal disease and excellent response to primary systemic therapy using the MARI protocol","authors":"Annemiek K.E. van Hemert , Ariane A. van Loevezijn , Marie-Sophie P.D. Baas , Marcel P.M. Stokkel , Emma J. Groen , Vincent van der Noort , Claudette E. Loo , Gabe S. Sonke , Nicola Russell , Frederieke H. van Duijnhoven , Marie-Jeanne T.F.D. Vrancken Peeters","doi":"10.1016/j.breast.2025.104411","DOIUrl":"10.1016/j.breast.2025.104411","url":null,"abstract":"<div><h3>Purpose</h3><div>Axillary lymph node staging techniques after primary systemic therapy (PST) show low false negative rates, stimulating the omission of axillary lymph node dissection (ALND). Breast cancer patients with extensive nodal disease are underreported in studies on response-guided axillary treatment. In this study, we present the oncologic outcome of breast cancer patients with ≥4 involved axillary lymph nodes treated according to the MARI-protocol.</div></div><div><h3>Methods</h3><div>This prospective single arm registration study included breast cancer patients with extensive nodal disease defined as ≥4 involved axillary lymph nodes on FDG-PET/CT pre-PST between July 2014 and December 2021. After PST, the marked (MARI) lymph node was excised. Patients with a pathologic complete response (pCR) of the MARI node (ypN0) received locoregional radiation treatment (RT). In patients with residual disease of the MARI node (ypN+), ALND was performed followed by RT. Primary endpoint was axillary recurrence rate. Secondary endpoints were invasive disease-free survival (DFS) and overall survival (OS).</div></div><div><h3>Results</h3><div>In total, 218 patients were registered of which 39 % of patients also had extra-axillary nodal disease. Median (IQR) age was 50 (42–57) years. After PST 47 % of patients (103/218) had ypN0, whereas 53 % of patients (115/218) had ypN+. After a median follow up of 44 (26–62) months, axillary recurrence rate was 2.9 % (<em>n</em> = 3) in the ypN0 group and 3.5 % (<em>n</em> = 4) in the ypN + group. Five-year invasive DFS and OS were respectively 89 % (95 % CI 83 %–96 %) and 95 % (95 % CI 91 %–99 %) in ypN0 patients.</div></div><div><h3>Conclusion</h3><div>Omission of ALND after PST in breast cancer patients with extensive nodal involvement who achieve pCR of the MARI node is associated with excellent five-year oncologic outcome.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104411"},"PeriodicalIF":5.7,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143420145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-04DOI: 10.1016/j.breast.2025.104413
Binghe Xu , Qingyuan Zhang , Tao Sun , Wei Li , Yue'e Teng , Xichun Hu , Igor Bondarenko , Hryhoriy Adamchuk , Liangming Zhang , Dmytro Trukhin , Shusen Wang , Hong Zheng , Zhongsheng Tong , Yaroslav Shparyk , Futang Yang , Haoyu Yu , Jing Li , Qingyu Wang , Jun Zhu , HLX02-BC01 Investigators
Aim
Equivalence between HLX02 and trastuzumab sourced from the European Union (EU-trastuzumab), in combination with docetaxel, was demonstrated in a phase III study. This study aimed to evaluate the long-term efficacy and safety data after 3 years of follow-up.
Methods
Patients with previously untreated, HER2-positive metastatic breast cancer received intravenous HLX02 or EU-trastuzumab (initial dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for up to 12 months) in combination with docetaxel. Primary endpoint was the overall response rate up to week 24 (ORR24). Secondary endpoints including updated overall survival (OS), progression-free survival (PFS), safety and immunogenicity are reported in this long-term follow-up analysis.
Results
After a median follow-up duration of 35.0 months, 270 out of the 649 enrolled patients had died; 128 (39.5 %) in the HLX02 and 142 (43.7 %) in the EU-trastuzumab group. Median OS was 37.3 (95 % CI 36.2, not evaluable [NE]) months and not reached (95 % CI 34.2, NE) (stratified HR 0.86 [95 % CI 0.68, 1.10]; p = 0.229), with a 3-year OS rate of 57.5 % and 54.0 %, respectively. Median PFS at this long-term follow-up assessment was 11.7 (95 % CI 11.5, 12.1) months for the HLX02 group and 10.6 (95 % CI 9.5, 11.7) months for the EU-trastuzumab group (stratified HR 0.86 [95 % CI 0.69, 1.06]; p = 0.158). No new safety concerns were reported until the end of the survival follow-up.
Conclusion
Long-term efficacy and safety were consistent with the previous findings. No clinically meaningful differences between HLX02 and reference trastuzumab were demonstrated.
{"title":"Updated efficacy and safety of HLX02 versus reference trastuzumab in metastatic HER2-positive breast cancer: A randomized phase III equivalence trial","authors":"Binghe Xu , Qingyuan Zhang , Tao Sun , Wei Li , Yue'e Teng , Xichun Hu , Igor Bondarenko , Hryhoriy Adamchuk , Liangming Zhang , Dmytro Trukhin , Shusen Wang , Hong Zheng , Zhongsheng Tong , Yaroslav Shparyk , Futang Yang , Haoyu Yu , Jing Li , Qingyu Wang , Jun Zhu , HLX02-BC01 Investigators","doi":"10.1016/j.breast.2025.104413","DOIUrl":"10.1016/j.breast.2025.104413","url":null,"abstract":"<div><h3>Aim</h3><div>Equivalence between HLX02 and trastuzumab sourced from the European Union (EU-trastuzumab), in combination with docetaxel, was demonstrated in a phase III study. This study aimed to evaluate the long-term efficacy and safety data after 3 years of follow-up.</div></div><div><h3>Methods</h3><div>Patients with previously untreated, HER2-positive metastatic breast cancer received intravenous HLX02 or EU-trastuzumab (initial dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for up to 12 months) in combination with docetaxel. Primary endpoint was the overall response rate up to week 24 (ORR<sub>24</sub>). Secondary endpoints including updated overall survival (OS), progression-free survival (PFS), safety and immunogenicity are reported in this long-term follow-up analysis.</div></div><div><h3>Results</h3><div>After a median follow-up duration of 35.0 months, 270 out of the 649 enrolled patients had died; 128 (39.5 %) in the HLX02 and 142 (43.7 %) in the EU-trastuzumab group. Median OS was 37.3 (95 % CI 36.2, not evaluable [NE]) months and not reached (95 % CI 34.2, NE) (stratified HR 0.86 [95 % CI 0.68, 1.10]; <em>p</em> = 0.229), with a 3-year OS rate of 57.5 % and 54.0 %, respectively. Median PFS at this long-term follow-up assessment was 11.7 (95 % CI 11.5, 12.1) months for the HLX02 group and 10.6 (95 % CI 9.5, 11.7) months for the EU-trastuzumab group (stratified HR 0.86 [95 % CI 0.69, 1.06]; <em>p</em> = 0.158). No new safety concerns were reported until the end of the survival follow-up.</div></div><div><h3>Conclusion</h3><div>Long-term efficacy and safety were consistent with the previous findings. No clinically meaningful differences between HLX02 and reference trastuzumab were demonstrated.</div></div><div><h3>Clinical trial registration</h3><div>Chinadrugtrials.org CTR20160526 (September 12, 2016), <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> NCT03084237 (March 20, 2017), EudraCT 2016-000206-10 (April 27, 2017).</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104413"},"PeriodicalIF":5.7,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143402631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.breast.2024.103866
Bryan F. Vaca-Cartagena , Ana S. Ferrigno Guajardo , Hatem A. Azim Jr , Federico Rotolo , Antonio Olivas-Martinez , Alejandra Platas , Alan Fonseca , Fernanda Mesa-Chavez , Marlid Cruz-Ramos , Ana Rodriguez , Alejandro Mohar , Cynthia Villarreal-Garza
Introduction
Cancer treatments have a detrimental impact on the quality of life (QoL) of young women with breast cancer (YWBC). Research exploring QoL trajectories has been mostly centered on postmenopausal women. Here we report longitudinal changes across all QoL domains and associated factors in YWBC.
Methods
In this prospective longitudinal cohort study, women aged ≤40 with stage I-III BC completed the European Organization for the Research and Treatment of Cancer Core QoL questionnaire at diagnosis and during 4 follow-up visits over 5 years, alongside demographic and clinical data collection. Group-based multivariate trajectory modeling was used to identify patient groups based on their functional and symptom scores, finding 3 groups (best, good, and poor). Factors associated with each trajectory pattern were identified with multinomial logistic models.
Results
A total of 477 women (median age: 36; IQR: 32–38) were clustered into the best (n = 259, 54 %), good (n = 79, 17 %), or poor trajectory groups (n = 139, 29 %). Throughout the disease, patients with a poor QoL experienced clinically significant impairment in emotional functioning, nausea and vomiting, and pain. They also had significant cognitive impairment, dyspnea, and diarrhea. Patients with a good QoL had clinically meaningful diarrhea for the first 7 months, while those with the best QoL had clinically important nausea and vomiting during the first 2 months since diagnosis. Noteworthy, all groups experienced significant financial difficulties throughout their follow-up. Regular alcohol consumption at diagnosis (aOR [adjusted odds ratio] 1.64; 95 % CI [confidence interval] 1.02–2.65) and HER2-positive BC (aOR 2.53; 95 % CI 1.35–4.73) were independent factors associated with classification to the poor and good groups, respectively.
Conclusion
This study underscores the variability in QoL among YWBC and the importance of ongoing monitoring. Strategies to improve access to economic resources, manage treatment-related adverse effects, and support patients in discontinuing modifiable risk factors are needed.
{"title":"Describing quality of life trajectories in young Hispanic women with breast cancer: 5-year results from a large prospective cohort","authors":"Bryan F. Vaca-Cartagena , Ana S. Ferrigno Guajardo , Hatem A. Azim Jr , Federico Rotolo , Antonio Olivas-Martinez , Alejandra Platas , Alan Fonseca , Fernanda Mesa-Chavez , Marlid Cruz-Ramos , Ana Rodriguez , Alejandro Mohar , Cynthia Villarreal-Garza","doi":"10.1016/j.breast.2024.103866","DOIUrl":"10.1016/j.breast.2024.103866","url":null,"abstract":"<div><h3>Introduction</h3><div>Cancer treatments have a detrimental impact on the quality of life (QoL) of young women with breast cancer (YWBC). Research exploring QoL trajectories has been mostly centered on postmenopausal women. Here we report longitudinal changes across all QoL domains and associated factors in YWBC.</div></div><div><h3>Methods</h3><div>In this prospective longitudinal cohort study, women aged ≤40 with stage I-III BC completed the European Organization for the Research and Treatment of Cancer Core QoL questionnaire at diagnosis and during 4 follow-up visits over 5 years, alongside demographic and clinical data collection. Group-based multivariate trajectory modeling was used to identify patient groups based on their functional and symptom scores, finding 3 groups (best, good, and poor). Factors associated with each trajectory pattern were identified with multinomial logistic models.</div></div><div><h3>Results</h3><div>A total of 477 women (median age: 36; IQR: 32–38) were clustered into the best (n = 259, 54 %), good (n = 79, 17 %), or poor trajectory groups (n = 139, 29 %). Throughout the disease, patients with a poor QoL experienced clinically significant impairment in emotional functioning, nausea and vomiting, and pain. They also had significant cognitive impairment, dyspnea, and diarrhea. Patients with a good QoL had clinically meaningful diarrhea for the first 7 months, while those with the best QoL had clinically important nausea and vomiting during the first 2 months since diagnosis. Noteworthy, all groups experienced significant financial difficulties throughout their follow-up. Regular alcohol consumption at diagnosis (aOR [adjusted odds ratio] 1.64; 95 % CI [confidence interval] 1.02–2.65) and HER2-positive BC (aOR 2.53; 95 % CI 1.35–4.73) were independent factors associated with classification to the poor and good groups, respectively.</div></div><div><h3>Conclusion</h3><div>This study underscores the variability in QoL among YWBC and the importance of ongoing monitoring. Strategies to improve access to economic resources, manage treatment-related adverse effects, and support patients in discontinuing modifiable risk factors are needed.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103866"},"PeriodicalIF":5.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11755074/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.breast.2025.103873
Ke Liu , Guan-Qiao Li , Si-Qi Li , Xue-Qin Chen , San-Gang Wu
Purpose
To investigate the clinical value of Clinical Treatment Score Post-5 Years (CTS5) to predict the survival benefits of postmastectomy radiotherapy (PMRT) of patients with T1-2N1 luminal breast cancer (BC).
Methods
Patients who were diagnosed with T1-2N1 luminal BC between 2010 and 2015 were included in the Surveillance, Epidemiology, and End Results database. The chi-square test, binomial logistic regression, Kaplan-Meier analysis, and multivariable Cox proportional hazard model were used for statistical analyses.
Results
A total of 11190 patients were included with a median follow-up time of 76 months. Regarding the CTS5 classification, 1641 (14.7 %), 3915 (35.0 %), and 5633 (50.3 %) patients had low-risk, intermediate-risk, and high-risk diseases, respectively. Patients with younger age, T2 stage, higher tumor grade, a higher number of positive lymph nodes, infiltrating lobular carcinoma subtype, and receipt of chemotherapy were associated with the receipt of PMRT (all P < 0.05). The multivariate analysis showed that the receipt of PMRT was the independent prognostic factor associated with better BCSS (P = 0.005) and OS (P < 0.001). The sensitivity analysis showed that PMRT did not improve BCSS (low-risk, P = 0.932; intermediate-risk, P = 0.952) and OS (low-risk, P = 0.637; intermediate-risk, P = 0.825) compared to those without PMRT in the low-risk and intermediate-risk groups. However, PMRT improved BCSS (P = 0.003) and OS (P < 0.001) in those with high-risk groups compared to those without PMRT.
Conclusions
CTS5 is an innovative model that could predict the survival benefit of PMRT for T1-2N1 luminal BC patients.
{"title":"Clinical treatment score Post-5 Years (CTS5) predicts the benefit of postmastectomy radiotherapy in patients with T1-2N1 luminal breast cancer","authors":"Ke Liu , Guan-Qiao Li , Si-Qi Li , Xue-Qin Chen , San-Gang Wu","doi":"10.1016/j.breast.2025.103873","DOIUrl":"10.1016/j.breast.2025.103873","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate the clinical value of Clinical Treatment Score Post-5 Years (CTS5) to predict the survival benefits of postmastectomy radiotherapy (PMRT) of patients with T1-2N1 luminal breast cancer (BC).</div></div><div><h3>Methods</h3><div>Patients who were diagnosed with T1-2N1 luminal BC between 2010 and 2015 were included in the Surveillance, Epidemiology, and End Results database. The chi-square test, binomial logistic regression, Kaplan-Meier analysis, and multivariable Cox proportional hazard model were used for statistical analyses.</div></div><div><h3>Results</h3><div>A total of 11190 patients were included with a median follow-up time of 76 months. Regarding the CTS5 classification, 1641 (14.7 %), 3915 (35.0 %), and 5633 (50.3 %) patients had low-risk, intermediate-risk, and high-risk diseases, respectively. Patients with younger age, T2 stage, higher tumor grade, a higher number of positive lymph nodes, infiltrating lobular carcinoma subtype, and receipt of chemotherapy were associated with the receipt of PMRT (all P < 0.05). The multivariate analysis showed that the receipt of PMRT was the independent prognostic factor associated with better BCSS (P = 0.005) and OS (P < 0.001). The sensitivity analysis showed that PMRT did not improve BCSS (low-risk, P = 0.932; intermediate-risk, P = 0.952) and OS (low-risk, P = 0.637; intermediate-risk, P = 0.825) compared to those without PMRT in the low-risk and intermediate-risk groups. However, PMRT improved BCSS (P = 0.003) and OS (P < 0.001) in those with high-risk groups compared to those without PMRT.</div></div><div><h3>Conclusions</h3><div>CTS5 is an innovative model that could predict the survival benefit of PMRT for T1-2N1 luminal BC patients.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"79 ","pages":"Article 103873"},"PeriodicalIF":5.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11758395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}