Pub Date : 2024-08-22DOI: 10.1016/j.clbc.2024.08.010
Neda Stjepanovic , Sudhir Kumar , Katarzyna J. Jerzak , Maureen Trudeau , Ellen Warner , Xingshan Cao , Andrea Eisen , William Tran , Rossanna C. Pezo
Purpose
This study aimed to examine the impact of the level of HER2 overexpression on pathologic and clinical outcomes in HER2-positive breast cancer (BC) patients treated with neoadjuvant therapy (NAT).
Methods
Women with Stage II or III HER2-positive BC who received anthracycline-taxane-trastuzumab NAT regimens followed by curative-intent surgery were included. Patients were classified according to tumor HER2 expression into HER2-high (immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) HER2/CEP17 ratio ≥5 or HER2 copy number ≥10) and HER2-intermediate (IHC 2+ with HER2/CEP17 ratio ≥2 to <5 or copy number ≥4 to <10). Univariate and multivariate logistic regression analyses were performed using HER2 expression as a categorical variable. The primary outcome was pathological complete response (pCR). Estimated 3-year disease-free survival (DFS) and Overall Survival (OS) were secondary outcomes.
Results
Among 161 patients with HER2-positive BC, 139 (86%) and 22 (14%) were classified as HER2-high and HER2-intermediate, respectively; 105 (65.2%) had hormone receptor (HR)-positive tumors; 72 (45%) achieved a pCR. In the overall population, pCR rates of 18% and 49% were achieved in HER2-intermediate and HER2-high cases, respectively (odds ratio [OR] = 0.23 95% CI 0.07-0.72; P = .007). No pCRs were observed among HR-positive, HER2-intermediate cases. Estimated 3-year DFS was 97.1% versus 89.3% for patients achieving a pCR versus those with residual disease, respectively (P = .0011).
Conclusion
We found that patients with HER2-high disease were more likely to achieve pCR after NAT compared to patients with HER2-intermediate BC, a subgroup of patients that may benefit from more personalized NAT strategies.
{"title":"Analysis of Factors Associated With Pathological Complete Response in Patients With HER2-Positive Breast Cancer Receiving Neoadjuvant Chemotherapy","authors":"Neda Stjepanovic , Sudhir Kumar , Katarzyna J. Jerzak , Maureen Trudeau , Ellen Warner , Xingshan Cao , Andrea Eisen , William Tran , Rossanna C. Pezo","doi":"10.1016/j.clbc.2024.08.010","DOIUrl":"10.1016/j.clbc.2024.08.010","url":null,"abstract":"<div><h3>Purpose</h3><div>This study aimed to examine the impact of the level of HER2 overexpression on pathologic and clinical outcomes in HER2-positive breast cancer (BC) patients treated with neoadjuvant therapy (NAT).</div></div><div><h3>Methods</h3><div>Women with Stage II or III HER2-positive BC who received anthracycline-taxane-trastuzumab NAT regimens followed by curative-intent surgery were included. Patients were classified according to tumor HER2 expression into HER2-high (immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) HER2/CEP17 ratio ≥5 or HER2 copy number ≥10) and HER2-intermediate (IHC 2+ with HER2/CEP17 ratio ≥2 to <5 or copy number ≥4 to <10). Univariate and multivariate logistic regression analyses were performed using HER2 expression as a categorical variable. The primary outcome was pathological complete response (pCR). Estimated 3-year disease-free survival (DFS) and Overall Survival (OS) were secondary outcomes.</div></div><div><h3>Results</h3><div>Among 161 patients with HER2-positive BC, 139 (86%) and 22 (14%) were classified as HER2-high and HER2-intermediate, respectively; 105 (65.2%) had hormone receptor (HR)-positive tumors; 72 (45%) achieved a pCR. In the overall population, pCR rates of 18% and 49% were achieved in HER2-intermediate and HER2-high cases, respectively (odds ratio [OR] = 0.23 95% CI 0.07-0.72; <em>P</em> = .007). No pCRs were observed among HR-positive, HER2-intermediate cases. Estimated 3-year DFS was 97.1% versus 89.3% for patients achieving a pCR versus those with residual disease, respectively (<em>P</em> = .0011).</div></div><div><h3>Conclusion</h3><div>We found that patients with HER2-high disease were more likely to achieve pCR after NAT compared to patients with HER2-intermediate BC, a subgroup of patients that may benefit from more personalized NAT strategies.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"24 8","pages":"Pages e723-e730"},"PeriodicalIF":2.9,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Breast cancer continues to pose a significant public health challenge, with its incidence and disproportionate impact on underserved populations in the United States. The relationship between obesity and clinicopathological characteristics at presentation remains a critical area of investigation. Safety-net hospitals caring for underserved communities provide a unique setting to explore these associations. This study seeks to explore a critical gap in knowledge on obesity and breast cancer characteristics in underserved populations in the United States.
Materials and Methods
In this retrospective study, 927 breast cancer patients were included. Analysis was conducted to assess the association between body mass index (BMI), age of diagnosis, tumor clinicopathologic characteristics, and molecular types stratified by menopausal status at diagnosis. Analysis was performed using the Statistical Package for Social Sciences version 29.
Results
A significant association was found between BMI and menopausal status (P < .05). Disease stage at presentation was significantly associated with BMI (P < .05). Further investigation into BMI categories and tumor characteristics revealed a significant correlation in postmenopausal women, with obesity linked to tumor size and lymph node status (P < .05). No significant associations were observed between HER-2 status, ER/PR status, and obesity in either premenopausal or postmenopausal groups.
Conclusion
This observational retrospective hypothesis-generating study revealed the association between obesity and disease stage and menopause status at diagnosis. In postmenopausal patients, obesity correlated with larger tumor size and advanced lymph node disease involvement. Additionally, ethnic variations were observed, with a higher prevalence of obesity among African American patients.
{"title":"Impact of Obesity on Breast Cancer Clinicopathological Characteristics in Underserved US Community Safety-Net Hospital: A Retrospective Single-Center Study","authors":"Ekaterina Proskuriakova , Barun Babu Aryal , Dhan Bahadur Shrestha , Stephanie Valencia , Iuliia Kovalenko , Megan Adams , Mubaraka Boxwala , Larissa Verda , Paramjeet Grewal Khosla","doi":"10.1016/j.clbc.2024.08.008","DOIUrl":"10.1016/j.clbc.2024.08.008","url":null,"abstract":"<div><h3>Background</h3><div>Breast cancer continues to pose a significant public health challenge, with its incidence and disproportionate impact on underserved populations in the United States. The relationship between obesity and clinicopathological characteristics at presentation remains a critical area of investigation. Safety-net hospitals caring for underserved communities provide a unique setting to explore these associations. This study seeks to explore a critical gap in knowledge on obesity and breast cancer characteristics in underserved populations in the United States.</div></div><div><h3>Materials and Methods</h3><div>In this retrospective study, 927 breast cancer patients were included. Analysis was conducted to assess the association between body mass index (BMI), age of diagnosis, tumor clinicopathologic characteristics, and molecular types stratified by menopausal status at diagnosis. Analysis was performed using the Statistical Package for Social Sciences version 29.</div></div><div><h3>Results</h3><div>A significant association was found between BMI and menopausal status (<em>P</em> < .05). Disease stage at presentation was significantly associated with BMI (<em>P</em> < .05). Further investigation into BMI categories and tumor characteristics revealed a significant correlation in postmenopausal women, with obesity linked to tumor size and lymph node status (<em>P</em> < .05). No significant associations were observed between HER-2 status, ER/PR status, and obesity in either premenopausal or postmenopausal groups.</div></div><div><h3>Conclusion</h3><div>This observational retrospective hypothesis-generating study revealed the association between obesity and disease stage and menopause status at diagnosis. In postmenopausal patients, obesity correlated with larger tumor size and advanced lymph node disease involvement. Additionally, ethnic variations were observed, with a higher prevalence of obesity among African American patients.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"24 8","pages":"Pages e714-e722"},"PeriodicalIF":2.9,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142139435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-08DOI: 10.1016/j.clbc.2024.08.002
Chiara M Ciniselli, Paolo Verderio, Paolo Baili, Milena Sant, Sara Pizzamiglio, Valeria Duroni, Filippo G de Braud, Secondo Folli, Gianfranco Scaperrotta, Maria C De Santis, Giovanni Apolone, Cinzia De Marco, Andrea Vingiani, Vera Cappelletti, Giancarlo Pruneri, Serena Di Cosimo
Background: Ductal carcinoma in situ (DCIS) is the most common form of preinvasive breast cancer, with 5-10% of cases progressing into invasive disease. Herein, we investigated the association between HER2-low and clinico-pathological characteristics in DCIS and subsequent ipsilateral loco-regional relapse (LRR).
Materials and methods: We accessed our prospectively maintained institutional database. HER2 status was determined by immunohistochemistry and classified as null (score 0), over-expressed (3+), and low (1+ or 2+); in situ hybridization was not considered since it is not used for routine DCIS diagnostics.
Results: Among 375 patients with DCIS, median age was 54 (27-88) years, with a primary tumor size < 2.5 cm in 63%, grade III in 33%, and positive hormone receptor status (HR) in 81% of cases; 71% underwent breast-conserving surgery, 34% received adjuvant endocrine and 39% radiotherapy. A total of 197 (52%) had tumors with low HER2 expression, which resulted significantly associated with grade I/II (P < .001), Ki67< 20% (P < .001), and HR-positive status (P < .001). HER2-low distribution varied from 19.61% and 50% in ER negative and ER-low (<10%) to 60% and 69% in ER high (50%-95%) and very high tumors (> 95%) (P < .001). After a median 39-month follow-up (IQR 16-65), cumulative incidences of LRR was 0.054. Among 17 patients with paired primary tumor and LRR, 5 had discordant HER2 status, with an even distribution of increased and decreased HER2 expression.
Conclusions: Low HER2 expression in DCIS is associated with features of reduced aggressiveness. Importantly, changes in HER2 expression may occur prompting retesting in recurrent cases, in line with observations in invasive breast cancer.
{"title":"Clinical and Biological Significance of HER2-Low in Ductal Carcinoma In Situ of the Breast.","authors":"Chiara M Ciniselli, Paolo Verderio, Paolo Baili, Milena Sant, Sara Pizzamiglio, Valeria Duroni, Filippo G de Braud, Secondo Folli, Gianfranco Scaperrotta, Maria C De Santis, Giovanni Apolone, Cinzia De Marco, Andrea Vingiani, Vera Cappelletti, Giancarlo Pruneri, Serena Di Cosimo","doi":"10.1016/j.clbc.2024.08.002","DOIUrl":"https://doi.org/10.1016/j.clbc.2024.08.002","url":null,"abstract":"<p><strong>Background: </strong>Ductal carcinoma in situ (DCIS) is the most common form of preinvasive breast cancer, with 5-10% of cases progressing into invasive disease. Herein, we investigated the association between HER2-low and clinico-pathological characteristics in DCIS and subsequent ipsilateral loco-regional relapse (LRR).</p><p><strong>Materials and methods: </strong>We accessed our prospectively maintained institutional database. HER2 status was determined by immunohistochemistry and classified as null (score 0), over-expressed (3+), and low (1+ or 2+); in situ hybridization was not considered since it is not used for routine DCIS diagnostics.</p><p><strong>Results: </strong>Among 375 patients with DCIS, median age was 54 (27-88) years, with a primary tumor size < 2.5 cm in 63%, grade III in 33%, and positive hormone receptor status (HR) in 81% of cases; 71% underwent breast-conserving surgery, 34% received adjuvant endocrine and 39% radiotherapy. A total of 197 (52%) had tumors with low HER2 expression, which resulted significantly associated with grade I/II (P < .001), Ki67< 20% (P < .001), and HR-positive status (P < .001). HER2-low distribution varied from 19.61% and 50% in ER negative and ER-low (<10%) to 60% and 69% in ER high (50%-95%) and very high tumors (> 95%) (P < .001). After a median 39-month follow-up (IQR 16-65), cumulative incidences of LRR was 0.054. Among 17 patients with paired primary tumor and LRR, 5 had discordant HER2 status, with an even distribution of increased and decreased HER2 expression.</p><p><strong>Conclusions: </strong>Low HER2 expression in DCIS is associated with features of reduced aggressiveness. Importantly, changes in HER2 expression may occur prompting retesting in recurrent cases, in line with observations in invasive breast cancer.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-08DOI: 10.1016/j.clbc.2024.08.001
Danielle M. File , Yara Abdou , Jeremy Force , Dominic T. Moore , Carey K. Anders , Katherine Reeder-Hayes , Lisa A. Carey , Hyman B. Muss , Charles M. Perou , P. Kelly Marcom , E. Claire Dees
Background
Alpelisib is an oral α-specific class I PI3K inhibitor approved in combination with fulvestrant for the treatment of PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer. The tolerability of this drug with the oral chemotherapy capecitabine is unknown.
Patients and Methods
This phase I trial evaluated the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of alpelisib (250 mg or 300 mg daily for 3-weeks) with capecitabine (1000 mg/m2 twice daily for 2-weeks followed by a 1-week rest period) in patients with metastatic HER2-negative breast cancer, regardless of PIK3CA mutation status.
Results
Eighteen patients were treated with alpelisib-capecitabine. Half of the patients had HR+ breast cancer, and 16 had prior systemic therapy for metastatic disease. The MTD of alpelisib was 250 mg daily in combination with capecitabine 1000 mg/m2 twice daily. DLTs included hyperglycemia, QTc prolongation, fatigue, and chest pain. The most common grade 3 adverse event (AE) was hyperglycemia (28%). No grade 4 AEs were observed. Three patients discontinued therapy due to an AE. One-third of patients required dose reduction of both alpelisib and capecitabine. Four patients experienced a partial response and 8 patients experienced stable disease. The median progression-free survival was 9.7 months (95% CI 2.8-13.5 months) and median overall survival was 18.2 months (95% CI 7.2-35.2 months). Twelve patients had PIK3CA mutation testing completed, of these 2 had known or likely deleterious PIK3CA mutation.
Conclusion
This study provides safety data for an oral combination therapy of alpelisib-capecitabine and defines tolerable doses for further study.
{"title":"A Phase I Trial of Alpelisib Combined With Capecitabine in Patients With HER2-Negative Metastatic Breast Cancer","authors":"Danielle M. File , Yara Abdou , Jeremy Force , Dominic T. Moore , Carey K. Anders , Katherine Reeder-Hayes , Lisa A. Carey , Hyman B. Muss , Charles M. Perou , P. Kelly Marcom , E. Claire Dees","doi":"10.1016/j.clbc.2024.08.001","DOIUrl":"10.1016/j.clbc.2024.08.001","url":null,"abstract":"<div><h3>Background</h3><div>Alpelisib is an oral α-specific class I PI3K inhibitor approved in combination with fulvestrant for the treatment of <em>PIK3CA</em>-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer. The tolerability of this drug with the oral chemotherapy capecitabine is unknown.</div></div><div><h3>Patients and Methods</h3><div>This phase I trial evaluated the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of alpelisib (250 mg or 300 mg daily for 3-weeks) with capecitabine (1000 mg/m<sup>2</sup> twice daily for 2-weeks followed by a 1-week rest period) in patients with metastatic HER2-negative breast cancer, regardless of <em>PIK3CA</em> mutation status.</div></div><div><h3>Results</h3><div>Eighteen patients were treated with alpelisib-capecitabine. Half of the patients had HR+ breast cancer, and 16 had prior systemic therapy for metastatic disease. The MTD of alpelisib was 250 mg daily in combination with capecitabine 1000 mg/m<sup>2</sup> twice daily. DLTs included hyperglycemia, QTc prolongation, fatigue, and chest pain. The most common grade 3 adverse event (AE) was hyperglycemia (28%). No grade 4 AEs were observed. Three patients discontinued therapy due to an AE. One-third of patients required dose reduction of both alpelisib and capecitabine. Four patients experienced a partial response and 8 patients experienced stable disease. The median progression-free survival was 9.7 months (95% CI 2.8-13.5 months) and median overall survival was 18.2 months (95% CI 7.2-35.2 months). Twelve patients had <em>PIK3CA</em> mutation testing completed, of these 2 had known or likely deleterious <em>PIK3CA</em> mutation.</div></div><div><h3>Conclusion</h3><div>This study provides safety data for an oral combination therapy of alpelisib-capecitabine and defines tolerable doses for further study.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"24 8","pages":"Pages 683-690"},"PeriodicalIF":2.9,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-08DOI: 10.1016/j.clbc.2024.08.007
Hong Hou , Kun Fang , Ya-Lin Zhang , Qiang Mu , Jing Xia , Zhen-Feng Li
Objective
This study aimed to investigate the effect of a combination of functional exercise and psychological interventions on postoperative rehabilitation and intervention compliance in patients with breast cancer (BC).
Methods
This study involved 100 patients with BC who underwent a radical mastectomy in our hospital between April 2020 and April 2021. We assigned patients to a control group (with a functional exercise intervention for patients) and an observation group (where patients received psychological interventions based on functional exercise) using a random number table. We observed and recorded the general data, intervention compliance, range of motion (ROM) of the shoulder joint pre and postintervention, pre and postintervention quality of life scores, and anxiety and depression scores before and after the interventions.
Results
There were no significant differences in general data between the 2 groups (P > .05). Repeated measures analysis showed no preintervention differences in compliance, shoulder ROM, quality of life, or anxiety and depression scores (P > .05). Postintervention, compliance and shoulder ROM improved in both groups, with the observation group significantly outperforming the control group (P < .05). Quality of life scores improved significantly in both groups, with higher scores in the observation group at 1 and 3 months (P < .05). Anxiety and depression scores decreased in both groups, with the observation group showing lower scores than the control group (P < .05).
Conclusion
Combining functional exercise with psychological interventions improves treatment compliance, psychological status, postoperative shoulder ROM, and quality of life in breast cancer patients.
{"title":"Efficacy of a Combination of Functional Exercise and Psychological Interventions in Improving Postoperative Rehabilitation and Intervention Compliance in Patients With Breast Cancer","authors":"Hong Hou , Kun Fang , Ya-Lin Zhang , Qiang Mu , Jing Xia , Zhen-Feng Li","doi":"10.1016/j.clbc.2024.08.007","DOIUrl":"10.1016/j.clbc.2024.08.007","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to investigate the effect of a combination of functional exercise and psychological interventions on postoperative rehabilitation and intervention compliance in patients with breast cancer (BC).</div></div><div><h3>Methods</h3><div>This study involved 100 patients with BC who underwent a radical mastectomy in our hospital between April 2020 and April 2021. We assigned patients to a control group (with a functional exercise intervention for patients) and an observation group (where patients received psychological interventions based on functional exercise) using a random number table. We observed and recorded the general data, intervention compliance, range of motion (ROM) of the shoulder joint pre and postintervention, pre and postintervention quality of life scores, and anxiety and depression scores before and after the interventions.</div></div><div><h3>Results</h3><div>There were no significant differences in general data between the 2 groups (<em>P</em> > .05). Repeated measures analysis showed no preintervention differences in compliance, shoulder ROM, quality of life, or anxiety and depression scores (<em>P</em> > .05). Postintervention, compliance and shoulder ROM improved in both groups, with the observation group significantly outperforming the control group (<em>P</em> < .05). Quality of life scores improved significantly in both groups, with higher scores in the observation group at 1 and 3 months (<em>P</em> < .05). Anxiety and depression scores decreased in both groups, with the observation group showing lower scores than the control group (<em>P</em> < .05).</div></div><div><h3>Conclusion</h3><div>Combining functional exercise with psychological interventions improves treatment compliance, psychological status, postoperative shoulder ROM, and quality of life in breast cancer patients.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"24 8","pages":"Pages 699-704"},"PeriodicalIF":2.9,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142124924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-08DOI: 10.1016/j.clbc.2024.07.012
Gordon R. Daly , Gavin P. Dowling , Mohammad Said , Yazan Qasem , Sandra Hembrecht , Gavin G. Calpin , Ma'en M. AlRawashdeh , Arnold D.K. Hill
In 2016 the Choosing Wisely guidelines advised against routine performance of a sentinel lymph node biopsy (SLNB) in women ≥ 70 years of age with clinically node negative (cN0), early-stage, oestrogen receptor positive/ human epidermal growth factor receptor 2 negative (ER+/HER2−), invasive breast cancer. The argument in favour of its continued performance is that it may serve as a useful guide for subsequent management. This systematic review was performed in accordance with the PRISMA guidelines. Studies reporting on rate of adjuvant chemotherapy, adjuvant radiotherapy and performance of completion axillary lymph node dissection (cALND) post SLNB in women aged ≥ 65 years with cN0, early-stage, ER+/HER2−, invasive breast cancer were included. A random effects meta-analysis was performed with summary estimates made using the Mantel–Haenszel method. Dichotomous outcomes were reported as odds ratios (ORs) with 95% confidence intervals (CIs). Ten retrospective studies across 4 countries. Of 105,514 patients, 15,509 had a positive SLNB and 90,005 had a negative SLNB. On meta-analysis, a positive SLNB was significantly associated with receipt of adjuvant chemotherapy (OR 4.64 (95% CI 3.18, 6.77), P < .00001), adjuvant radiotherapy (1.71 (95% CI 1.18, 2.47), P = .005) and undergoing completion axillary lymph node dissection (OR 68.97 (95% CI, 7.47, 636.88), P = .0002). Adjuvant treatment decisions continue to be influenced by SLNB positivity in the era of the Choosing Wisely guidelines. The effects of a positive SLNB and subsequent treatments on outcomes remain inconclusive. However, it is likely clinicians are continuing to over-investigate and over-treat this cohort.
{"title":"Impact of Sentinel Lymph Node Biopsy on Management of Older Women With Clinically Node-Negative, Early-Stage, ER+/HER2−, Invasive Breast Cancer: A Systematic Review and Meta-Analysis","authors":"Gordon R. Daly , Gavin P. Dowling , Mohammad Said , Yazan Qasem , Sandra Hembrecht , Gavin G. Calpin , Ma'en M. AlRawashdeh , Arnold D.K. Hill","doi":"10.1016/j.clbc.2024.07.012","DOIUrl":"10.1016/j.clbc.2024.07.012","url":null,"abstract":"<div><div>In 2016 the Choosing Wisely guidelines advised against routine performance of a sentinel lymph node biopsy (SLNB) in women ≥ 70 years of age with clinically node negative (cN0), early-stage, oestrogen receptor positive/ human epidermal growth factor receptor 2 negative (ER+/HER2−), invasive breast cancer. The argument in favour of its continued performance is that it may serve as a useful guide for subsequent management. This systematic review was performed in accordance with the PRISMA guidelines. Studies reporting on rate of adjuvant chemotherapy, adjuvant radiotherapy and performance of completion axillary lymph node dissection (cALND) post SLNB in women aged ≥ 65 years with cN0, early-stage, ER+/HER2−, invasive breast cancer were included. A random effects meta-analysis was performed with summary estimates made using the Mantel–Haenszel method. Dichotomous outcomes were reported as odds ratios (ORs) with 95% confidence intervals (CIs). Ten retrospective studies across 4 countries. Of 105,514 patients, 15,509 had a positive SLNB and 90,005 had a negative SLNB. On meta-analysis, a positive SLNB was significantly associated with receipt of adjuvant chemotherapy (OR 4.64 (95% CI 3.18, 6.77), <em>P</em> < .00001), adjuvant radiotherapy (1.71 (95% CI 1.18, 2.47), <em>P</em> = .005) and undergoing completion axillary lymph node dissection (OR 68.97 (95% CI, 7.47, 636.88), <em>P</em> = .0002). Adjuvant treatment decisions continue to be influenced by SLNB positivity in the era of the Choosing Wisely guidelines. The effects of a positive SLNB and subsequent treatments on outcomes remain inconclusive. However, it is likely clinicians are continuing to over-investigate and over-treat this cohort.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"24 8","pages":"Pages e681-e688.e1"},"PeriodicalIF":2.9,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-08DOI: 10.1016/j.clbc.2024.07.011
Jorge Henrique Cavalcanti Orestes Cardoso MS , Isabella Christina Amaral de Lara , Luis Eduardo Rodrigues Sobreira , Artur de Oliveira Macena Lôbo , Iasmin Isabelli Luiz Silvério , Maria Eduarda Cavalcanti Souza , Francisco Cezar Aquino de Moraes , Maria Cristina Figueroa Magalhães
Background
Breast cancer (BC) is a global problem, however, despite ALND is considered the standard treatment for early stage BC with node-positive, there is no sufficient data to determine which of these patients should undergo it. Thus, the aim of this systematic review was to clarify if there is any difference between NALND and ALND in terms of safety and prognosis of the patients.
Methods
A shearch was carried in PubMed, Embase and Cochrane databases for studies that compared NALND and ALND. The statistics was performed in R software, in which a restricted maximum likelihood estimator random-effect model were employed to compute risk ratios and hazard ratios with 95% CI. Heterogeneity was accessed with I2 statistics.
Results
There was 7 included studies, involving 7.338 patients, of whom 3.710 were randomized to omission of ALND. The follow-up period ranged from 5 to 10 years, with participant ages varying from 53 to 61 years. The analysis revealed significant increase in 10 years regional recurrence (RR 1.43; 95%CI 0.78 to 2.64; I²=0%) and a significant decrease in lymphedema (RR 0.35; 95% CI 0.23 to 0.53; I²=60%), however no significant result was found for last reported OS (HR 0.96; 95% CI 0.79 to 1.17; I2= 6%) or DFS (HR 1.002; 95% CI 0.960 to 1.045; I2=55%).
Conclusions
Our data suggest that while the NALND offers benefits in terms of preventing lymphedema, it was associated with a higher risk of 10 years regional recurrence. Thus, further studies are necessary to fully assess the role of these techniques in BC management.
{"title":"Omitting axillary lymph node dissection is associated with an increased risk of regional recurrence in early stage breast cancer: a systematic review and meta-analysis of randomized clinical trials","authors":"Jorge Henrique Cavalcanti Orestes Cardoso MS , Isabella Christina Amaral de Lara , Luis Eduardo Rodrigues Sobreira , Artur de Oliveira Macena Lôbo , Iasmin Isabelli Luiz Silvério , Maria Eduarda Cavalcanti Souza , Francisco Cezar Aquino de Moraes , Maria Cristina Figueroa Magalhães","doi":"10.1016/j.clbc.2024.07.011","DOIUrl":"10.1016/j.clbc.2024.07.011","url":null,"abstract":"<div><h3>Background</h3><div>Breast cancer (BC) is a global problem, however, despite ALND is considered the standard treatment for early stage BC with node-positive, there is no sufficient data to determine which of these patients should undergo it. Thus, the aim of this systematic review was to clarify if there is any difference between NALND and ALND in terms of safety and prognosis of the patients.</div></div><div><h3>Methods</h3><div>A shearch was carried in PubMed, Embase and Cochrane databases for studies that compared NALND and ALND. The statistics was performed in R software, in which a restricted maximum likelihood estimator random-effect model were employed to compute risk ratios and hazard ratios with 95% CI. Heterogeneity was accessed with I<sup>2</sup> statistics.</div></div><div><h3>Results</h3><div>There was 7 included studies, involving 7.338 patients, of whom 3.710 were randomized to omission of ALND. The follow-up period ranged from 5 to 10 years, with participant ages varying from 53 to 61 years. The analysis revealed significant increase in 10 years regional recurrence (RR 1.43; 95%CI 0.78 to 2.64; I²=0%) and a significant decrease in lymphedema (RR 0.35; 95% CI 0.23 to 0.53; I²=60%), however no significant result was found for last reported OS (HR 0.96; 95% CI 0.79 to 1.17; I<sup>2</sup>= 6%) or DFS (HR 1.002; 95% CI 0.960 to 1.045; I<sup>2</sup>=55%).</div></div><div><h3>Conclusions</h3><div>Our data suggest that while the NALND offers benefits in terms of preventing lymphedema, it was associated with a higher risk of 10 years regional recurrence<strong>.</strong> Thus, further studies are necessary to fully assess the role of these techniques in BC management.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"24 8","pages":"Pages e665-e680"},"PeriodicalIF":2.9,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-06DOI: 10.1016/j.clbc.2024.08.006
Alper Tuğral , Murat Akyol , Öykü Çolakoğlu , Yeşim Bakar
Background
Breast Cancer-Related Lymphedema (BCRL) is one of the most prominent long-term side effects of breast cancer (BC) treatment. Although an increased BMI is a well-recognized risk factor for BCRL, there is a lack of knowledge regarding the potential associations between body composition and the risk of BCRL. Therefore, this study aimed to analyze the BCRL risk profiles of surgically operated BC patients via body composition and the Tissue Dielectric Constant (TDC) method, respectively.
Methods
A total of 72 patients were included. Patients’ risk for BCRL was assessed with Moisture MeterD (Delfin, Finland) in 4 different probes each has unique penetration depths from 0.5 (10 mm) to 5.0 (55 mm) at both upper extremities. The body composition was analyzed with Tanita-BC-420 (TANITA, Japan). Comparing the dielectric values of extremities and proportioning to one another as TDC ratio (at-risk side/unaffected side) was used to profile BCRL risk.
Results
TDC values of the thorax reference point were significantly higher in all four probes on the at-risk side (P < .05). TDC ratios in the forearm and Thorax points were significantly correlated with fat mass (r = 0.256, P = .030; r = 0.269, P = .022) as well as with visceral fat rating (VFR) (r = 0.340, P = .003; r = 0.466, P < .001).
Conclusion
This study highlights the need for further care and investigation in the assessment and prediction of BCRL by considering body composition. Since the risk reduction of BCRL can be maximized by considering the individual features, we can conclude that patients with higher body fat irrespective of the BMI should be followed up regularly.
{"title":"Risk Profiling of Breast Cancer-Related Lymphedema (BCRL) in Patients With Breast Cancer Via Using Body Composition and Tissue Dielectric Constant (TDC) Method: A Cross-Sectional Study","authors":"Alper Tuğral , Murat Akyol , Öykü Çolakoğlu , Yeşim Bakar","doi":"10.1016/j.clbc.2024.08.006","DOIUrl":"10.1016/j.clbc.2024.08.006","url":null,"abstract":"<div><h3>Background</h3><div>Breast Cancer-Related Lymphedema (BCRL) is one of the most prominent long-term side effects of breast cancer (BC) treatment. Although an increased BMI is a well-recognized risk factor for BCRL, there is a lack of knowledge regarding the potential associations between body composition and the risk of BCRL. Therefore, this study aimed to analyze the BCRL risk profiles of surgically operated BC patients via body composition and the Tissue Dielectric Constant (TDC) method, respectively.</div></div><div><h3>Methods</h3><div>A total of 72 patients were included. Patients’ risk for BCRL was assessed with Moisture MeterD (Delfin, Finland) in 4 different probes each has unique penetration depths from 0.5 (10 mm) to 5.0 (55 mm) at both upper extremities. The body composition was analyzed with Tanita-BC-420 (TANITA, Japan). Comparing the dielectric values of extremities and proportioning to one another as TDC ratio (at-risk side/unaffected side) was used to profile BCRL risk.</div></div><div><h3>Results</h3><div>TDC values of the thorax reference point were significantly higher in all four probes on the at-risk side (<em>P</em> < .05). TDC ratios in the forearm and Thorax points were significantly correlated with fat mass (r = 0.256, <em>P</em> = .030; r = 0.269, <em>P</em> = .022) as well as with visceral fat rating (VFR) (r = 0.340, <em>P</em> = .003; <em>r</em> = 0.466, <em>P</em> < .001).</div></div><div><h3>Conclusion</h3><div>This study highlights the need for further care and investigation in the assessment and prediction of BCRL by considering body composition. Since the risk reduction of BCRL can be maximized by considering the individual features, we can conclude that patients with higher body fat irrespective of the BMI should be followed up regularly.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"24 8","pages":"Pages 691-698"},"PeriodicalIF":2.9,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-06DOI: 10.1016/j.clbc.2024.08.004
Florian Schindler , Rachel Wuerstlein , Timo Schinkoethe , Anna M. Debes , Caroline Paysen , Nadia Harbeck , Tanja K. Eggersmann
Introduction
The potential benefits of eHealth support in enhancing patient care, satisfaction, and cancer outcomes are well-established; however, its integration into routine care has been gradual. The emergence of the COVID-19 pandemic in 2020 dramatically affected cancer patients, imposing multifaceted challenges that impede traditional doctor-patient interactions. Consequently, there has been a surge in the adoption of eHealth for supporting oncological therapies. This study investigates the fundamental prerequisites for transitioning to a more digitally oriented routine care, focusing on the availability of appropriate technical equipment and the cultivation of a positive mindset towards eHealth among breast cancer patients.
Patients and Methods
In 2013, 2016, and 2020, breast cancer patients participated in surveys utilizing a comprehensive paper questionnaire encompassing 29 inquiries about their health status, technical equipment, and attitudes toward digital therapy support.
Results
A total of 959 patients participated in the interviews. Comparative analyses between the 2013, 2016, and 2020 surveys revealed a widespread increase in internet access and device ownership across various age groups. By 2020, 3 quarters of patients were utilizing the internet for health-related topics. Notably, there has been a considerable improvement in patients' personal attitudes towards eHealth and their expectations for future digital therapy support.
Discussion
Over the seven years spanned by the surveys, there has been a substantial positive shift in the attitudes of breast cancer patients towards eHealth, accompanied by a marked improvement in their technical equipment. This study reveals that the essential prerequisites for digital therapy support now appear to be prevalent among breast cancer patients.
{"title":"Changes in Technical Equipment and Patient Perspectives Navigating Towards Enhanced Digitalization in Breast Cancer Across Pre-COVID-19 and Early COVID-19 Eras","authors":"Florian Schindler , Rachel Wuerstlein , Timo Schinkoethe , Anna M. Debes , Caroline Paysen , Nadia Harbeck , Tanja K. Eggersmann","doi":"10.1016/j.clbc.2024.08.004","DOIUrl":"10.1016/j.clbc.2024.08.004","url":null,"abstract":"<div><h3>Introduction</h3><div>The potential benefits of eHealth support in enhancing patient care, satisfaction, and cancer outcomes are well-established; however, its integration into routine care has been gradual. The emergence of the COVID-19 pandemic in 2020 dramatically affected cancer patients, imposing multifaceted challenges that impede traditional doctor-patient interactions. Consequently, there has been a surge in the adoption of eHealth for supporting oncological therapies. This study investigates the fundamental prerequisites for transitioning to a more digitally oriented routine care, focusing on the availability of appropriate technical equipment and the cultivation of a positive mindset towards eHealth among breast cancer patients.</div></div><div><h3>Patients and Methods</h3><div>In 2013, 2016, and 2020, breast cancer patients participated in surveys utilizing a comprehensive paper questionnaire encompassing 29 inquiries about their health status, technical equipment, and attitudes toward digital therapy support.</div></div><div><h3>Results</h3><div>A total of 959 patients participated in the interviews. Comparative analyses between the 2013, 2016, and 2020 surveys revealed a widespread increase in internet access and device ownership across various age groups. By 2020, 3 quarters of patients were utilizing the internet for health-related topics. Notably, there has been a considerable improvement in patients' personal attitudes towards eHealth and their expectations for future digital therapy support.</div></div><div><h3>Discussion</h3><div>Over the seven years spanned by the surveys, there has been a substantial positive shift in the attitudes of breast cancer patients towards eHealth, accompanied by a marked improvement in their technical equipment. This study reveals that the essential prerequisites for digital therapy support now appear to be prevalent among breast cancer patients.</div></div>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":"24 8","pages":"Pages e690-e700"},"PeriodicalIF":2.9,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142145250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-06DOI: 10.1016/j.clbc.2024.08.003
Christina M S Hassing, Tove Holst Filtenborg Tvedskov, Niels Kroman, Ann Søegaard Knoop, Anne-Vibeke Lænkholm
Background: De-escalation of adjuvant treatment in patients with T1abN0 breast cancer is discussed internationally. Identification of new prognostic factors in these patients may assist this de-escalation. The PAM50 signature and tumor inflammation signature (TIS), Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) signatures are possible prognostic factors for recurrence.
Materials and methods: Danish patients with T1abN0 breast cancer diagnosed between 2007-2016 were identified, the NanoString Breast Cancer 360 Panel was performed on tissue samples from cases with recurrence matched 1:1 with controls without recurrence (n = 234). The association between gene signatures and recurrence was analyzed with conditional logistic regression.
Results: Patients with the basal-like subtype had higher values of TIS, PD-1 and PD-L1 scores compared with other subtypes. Patients with higher PD-L1 score had significantly lower odds of recurrence (odds ratio [OR] 0.61, P = .01). Likewise, an increased TIS score was associated to lower, but nonsignificant odds of recurrence (OR 0.76, P = .07). Patients with human epidermal growth factor receptor 2 (HER2)-enriched subtype had significantly higher odds of recurrence compared with patients with luminal A subtype (OR 4.8, P = .03).
Discussion: PAM50 and immune-related signatures provide important prognostic information in patients with T1abN0 breast cancer, which may refine the risk assessment in these patients.
{"title":"Evaluating the Prognostic Role of the PAM50 Signature and Selected Immune-Related Signatures for Recurrence in Patients With T1abN0 Breast Cancer.","authors":"Christina M S Hassing, Tove Holst Filtenborg Tvedskov, Niels Kroman, Ann Søegaard Knoop, Anne-Vibeke Lænkholm","doi":"10.1016/j.clbc.2024.08.003","DOIUrl":"https://doi.org/10.1016/j.clbc.2024.08.003","url":null,"abstract":"<p><strong>Background: </strong>De-escalation of adjuvant treatment in patients with T1abN0 breast cancer is discussed internationally. Identification of new prognostic factors in these patients may assist this de-escalation. The PAM50 signature and tumor inflammation signature (TIS), Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) signatures are possible prognostic factors for recurrence.</p><p><strong>Materials and methods: </strong>Danish patients with T1abN0 breast cancer diagnosed between 2007-2016 were identified, the NanoString Breast Cancer 360 Panel was performed on tissue samples from cases with recurrence matched 1:1 with controls without recurrence (n = 234). The association between gene signatures and recurrence was analyzed with conditional logistic regression.</p><p><strong>Results: </strong>Patients with the basal-like subtype had higher values of TIS, PD-1 and PD-L1 scores compared with other subtypes. Patients with higher PD-L1 score had significantly lower odds of recurrence (odds ratio [OR] 0.61, P = .01). Likewise, an increased TIS score was associated to lower, but nonsignificant odds of recurrence (OR 0.76, P = .07). Patients with human epidermal growth factor receptor 2 (HER2)-enriched subtype had significantly higher odds of recurrence compared with patients with luminal A subtype (OR 4.8, P = .03).</p><p><strong>Discussion: </strong>PAM50 and immune-related signatures provide important prognostic information in patients with T1abN0 breast cancer, which may refine the risk assessment in these patients.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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