ESMO OpenPub Date : 2024-11-21DOI: 10.1016/j.esmoop.2024.103990
Z Li, D Kang, S Xu, G Xi, L Li, L Zheng, W Guo, F Fu, C Wang, J Ma, X Han, S Xu, J Chen, J Chen
{"title":"Collagen signature adds prognostically significant information to staging for breast cancer.","authors":"Z Li, D Kang, S Xu, G Xi, L Li, L Zheng, W Guo, F Fu, C Wang, J Ma, X Han, S Xu, J Chen, J Chen","doi":"10.1016/j.esmoop.2024.103990","DOIUrl":"https://doi.org/10.1016/j.esmoop.2024.103990","url":null,"abstract":"<p><strong>Background: </strong>Tumor-associated collagen signature (TACS) is an independent prognostic factor for breast cancer. However, it is unclear whether the complete collagen signature, including TACS, the TACS-based collagen microscopic features (TCMF1), and the TACS-based nuclear features (TCMF2), can provide additional prognostic information for the current tumor-node-metastasis (TNM) staging system.</p><p><strong>Patients and methods: </strong>We included 941 patients with breast cancer from three cohorts: the training (n = 355), internal (n = 334), and external validation cohorts (n = 252). TACS and TCMF1 were obtained by multiphoton microscopy (MPM). TCMF2 was extracted on the hematoxylin and eosin images colocated with MPM images. They were linearly combined to establish a complete collagen signature score for reclassifying current TNM staging into stage Ⅰ (II and Ⅲ)/low risk and stage Ⅰ (II and Ⅲ)/high risk.</p><p><strong>Results: </strong>The low-risk collagen signatures 'downstaged' patients in stage II or Ⅲ, while the high-risk collagen signatures 'upstaged' patients with stage Ⅰ tumors. After incorporating the complete collagen signature into the current TNM staging system, the modified staging system had a higher ability to stratify patients [referent, Ⅰ-new; Ⅱ-new, hazard ratio (HR) 8.655, 6.136, and 4.699 in the training, internal validation, and external validation cohorts, respectively; Ⅲ-new, HR 14.855, 11.201, and 13.245 in the corresponding three cohorts, respectively] than the current TNM staging system (referent, Ⅰ; Ⅱ, HR 1.642, 1.853, and 1.371 in the corresponding three cohorts, respectively; Ⅲ, HR 4.131, 4.283, and 3.711 in the corresponding three cohorts, respectively). Furthermore, the modified staging system showed a higher area under the curve than the current TNM staging system (training cohort: 0.843 versus 0.683; internal validation cohort: 0.792 versus 0.661; and external validation cohort: 0.793 versus 0.646).</p><p><strong>Conclusions: </strong>The complete collagen signature is an independent predictor of survival outcomes in breast cancer. It adds significant information about the biological behavior of the disease to staging for breast cancer.</p>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"103990"},"PeriodicalIF":7.1,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ESMO OpenPub Date : 2024-11-18DOI: 10.1016/j.esmoop.2024.103999
H Taban, Y Ergun
{"title":"Challenges in using tumor mutational burden as a post-treatment biomarker.","authors":"H Taban, Y Ergun","doi":"10.1016/j.esmoop.2024.103999","DOIUrl":"https://doi.org/10.1016/j.esmoop.2024.103999","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"103999"},"PeriodicalIF":7.1,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ESMO OpenPub Date : 2024-11-18DOI: 10.1016/j.esmoop.2024.103988
G Roth, A Pellat, G Piessen, K le Malicot, L Schwarz, C Gallois, D Tougeron, V Hautefeuille, M Jary, S Benoist, M Amil, R Desgrippes, M Muller, T Lecomte, M Guillet, C Locher, C Genet, S Manfredi, O Bouché, J Taieb
{"title":"A simple prognostic score to predict recurrence after pancreaticoduodenectomy for ampullary carcinoma: results from the French prospective FFCD-AC cohort.","authors":"G Roth, A Pellat, G Piessen, K le Malicot, L Schwarz, C Gallois, D Tougeron, V Hautefeuille, M Jary, S Benoist, M Amil, R Desgrippes, M Muller, T Lecomte, M Guillet, C Locher, C Genet, S Manfredi, O Bouché, J Taieb","doi":"10.1016/j.esmoop.2024.103988","DOIUrl":"https://doi.org/10.1016/j.esmoop.2024.103988","url":null,"abstract":"<p><strong>Background: </strong>Ampullary carcinoma (AC) is a rare and severe gastrointestinal cancer with a disease recurrence rate of around 40% after curative-intent surgery and for which the main prognostic factors and adjuvant treatment decision remain a matter of debate.</p><p><strong>Patients and methods: </strong>The FFCD-AC cohort is a French nationwide prospective cohort, which included patients with non-metastatic resected AC. The primary objective of this study was to describe prognostic factors associated with disease-free survival (DFS) and overall survival (OS) after pancreaticoduodenectomy (PD) so as to propose a user-friendly score to better estimate the risk of recurrence. The secondary objective was to study the benefit of adjuvant therapy in terms of DFS and OS.</p><p><strong>Results: </strong>Three hundred and seventy patients with resected AC were included. Median follow-up was 40.6 months. Median age was 68.5 years (32.0-87.0 years), 53.8% of patients were male and 56.1%/37.4%/6.5% had an Eastern Cooperative Oncology Group performance status 0/1/2, respectively. Pathological subtype was intestinal/pancreatobiliary/mixed-undetermined in 29.5%/40.5%/30.0% of patients, respectively. Adjuvant chemotherapy was carried out in 61% of patients. In multivariable analysis, stage III tumor [hazard ratio (HR) 2.86, (95% confidence interval {95% CI}: 1.89-4.17), P < 0.0001], high tumor grade [HR 2.51, (95% CI: 1.42-4.43), P = 0.002] and non-intestinal subtype [HR 1.58, (95% CI: 1.00-2.49), P = 0.052] were associated with shorter DFS. A score based on these three parameters divided patients into low (n = 83), intermediate (n = 133) and high risk (n = 96) with median DFS not reached (NR)/73.1/15.2 months and a median OS NR/86.1/38.2 months, respectively. After propensity score matching, adjuvant chemotherapy was associated with longer DFS [HR 0.57, (95% CI: 0.45-0.72), P < 0.0001] in the cohort.</p><p><strong>Conclusion: </strong>Our integrated score based on three easy-to-collect items-lymph node invasion, tumor grade and non-intestinal subtypes-seems highly prognostic in resected AC and needs to be confirmed in an external validation dataset to help adjuvant treatment decision making.</p>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"103988"},"PeriodicalIF":7.1,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
ESMO OpenPub Date : 2024-11-16DOI: 10.1016/j.esmoop.2024.103987
S.M. Tolaney , N. Tung , A.C. Wolff , A. DeMichele , J.M. Cejalvo , O. Martínez-Sáez , T. Pascual , A.G. Waks , M. Martín , E. Ciruelos , N. Harbeck , L.A. Carey , J. Cortés , G. Curigliano , A. Prat
{"title":"HER2DX genomic test in early-stage HER2-positive breast cancer","authors":"S.M. Tolaney , N. Tung , A.C. Wolff , A. DeMichele , J.M. Cejalvo , O. Martínez-Sáez , T. Pascual , A.G. Waks , M. Martín , E. Ciruelos , N. Harbeck , L.A. Carey , J. Cortés , G. Curigliano , A. Prat","doi":"10.1016/j.esmoop.2024.103987","DOIUrl":"10.1016/j.esmoop.2024.103987","url":null,"abstract":"<div><div>Therapies targeting human epidermal growth factor receptor 2 (HER2)-positive breast cancer significantly impact patient outcomes, quality of life, and health care systems. While chemotherapy and trastuzumab improve survival in early-stage HER2-positive breast cancer, variability in clinical and biological characteristics leads to different response to therapies and outcomes. Clinical guidelines provide general recommendations, but significant uncertainty persists in identifying an optimal treatment plan for individual patients. The HER2DX genomic test informs treatment decisions for stage 1-3 HER2-positive breast cancer by integrating biological factors and clinical factors (tumor size and nodal status). It provides three scores relevant to patient management: long-term prognosis (risk score), likelihood of achieving pathological complete response (pCR score), and <em>ERBB2</em> mRNA expression (ERBB2 score). This article offers an expert overview of HER2DX, covering score interpretation, clinical applications, ongoing studies, and future directions. By analyzing the genomic profiles of HER2-positive tumors, HER2DX provides independent information regarding therapeutic responses and disease prognosis, thereby enabling physicians to navigate the increasing complexity of managing patients with HER2-positive early breast cancer. Key findings show that HER2DX predicts relapse-free survival and probability of pCR to a variety of neoadjuvant therapy regimens, which aids in personalizing treatment plans that could reduce over-treatment and under-treatment. The article underscores expert recommendations to help integrate HER2DX into clinical practice, aiming to enhance decision making and clinical outcomes.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 12","pages":"Article 103987"},"PeriodicalIF":7.1,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142652310","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}
ESMO OpenPub Date : 2024-11-01DOI: 10.1016/j.esmoop.2024.103969
S.-Y. Jun , S. An , S.-M. Hong , J.-Y. Kim , K.-P. Kim
{"title":"Prognostic value of tumor-infiltrating lymphocytes in distal extrahepatic bile duct carcinoma","authors":"S.-Y. Jun , S. An , S.-M. Hong , J.-Y. Kim , K.-P. Kim","doi":"10.1016/j.esmoop.2024.103969","DOIUrl":"10.1016/j.esmoop.2024.103969","url":null,"abstract":"<div><h3>Background</h3><div>The assessment of tumor-infiltrating lymphocytes (TILs) has led to the development of various immunotherapies beyond their predictive potential in gastrointestinal malignancies. However, the clinicopathologic and prognostic values of TILs have yet to be well elucidated in distal extrahepatic bile duct carcinoma (DBDC).</div></div><div><h3>Patients and methods</h3><div>We evaluated stromal TILs (sTILs) and intraepithelial TILs (iTILs) in 405 surgically resected DBDCs to analyze their correlations with overall survival (OS) and recurrence-free survival (RFS) and with clinicopathologic parameters according to the eighth edition of the American Joint Committee on Cancer scheme.</div></div><div><h3>Results</h3><div>High levels of sTIL density (sTIL<sup>High</sup>; >5%) and iTIL count (iTIL<sup>High</sup>; >3) were found in 245 (61%) and 74 cases (18%), respectively. sTIL<sup>High</sup> was more commonly found in larger tumors (<em>P</em> = 0.048) diffusely involving both intra- and extrapancreatic bile ducts (<em>P</em> = 0.013), in tumors with lower T category (<em>P</em> = 0.002), and in tumors without pancreatic (<em>P</em> = 0.003) or duodenal invasion (<em>P</em> < 0.001). iTIL<sup>High</sup> was associated with tumors with papillary or nodular growth pattern (<em>P</em> < 0.001) without perineural invasion (<em>P</em> = 0.006). Both sTIL<sup>High</sup> and iTIL<sup>High</sup> significantly predicted better OS (<em>P</em> = 0.009 and 0.036, respectively) and RFS (<em>P</em> = 0.003 and 0.026, respectively). sTIL consistently provided prognostic predictability in OS, even when tested with different quantitative cut-offs and prognostically stratified OS (<em>P</em> = 0.006) and RFS (<em>P</em> = 0.005) on multivariate analysis. The survival benefit of sTIL<sup>High</sup> persisted regardless of the stage in both OS (<em>P =</em> 0.010 for lower stages I and II and <em>P</em> = 0.001 for higher stages III and IV) and RFS (<em>P =</em> 0.004 and 0.025 for lower- and higher-stage tumors, respectively).</div></div><div><h3>Conclusions</h3><div>sTILs were superior to iTILs in predicting survival, and it was shown to be a strong prognosticator for DBDC patients regardless of the stage. The utility of sTILs may extend beyond prognostication to aid in predicting therapeutic responses in DBDC patients.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 11","pages":"Article 103969"},"PeriodicalIF":7.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593152","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}
ESMO OpenPub Date : 2024-11-01DOI: 10.1016/j.esmoop.2024.103978
S. Genta , D.V. Araujo , K. Hueniken , C. Pipinikas , R. Ventura , P. Rojas , G. Jones , M.O. Butler , S.D. Saibil , C. Yu , A. Easson , A. Covelli , M.B. Sauder , C. Fournier , Z. Saeed Kamil , P. Rogalla , D.P. Arteaga , O. Vornicova , P. Spiliopoulou , T.P. Muniz , A. Spreafico
{"title":"Bespoke ctDNA for longitudinal detection of molecular residual disease in high-risk melanoma patients","authors":"S. Genta , D.V. Araujo , K. Hueniken , C. Pipinikas , R. Ventura , P. Rojas , G. Jones , M.O. Butler , S.D. Saibil , C. Yu , A. Easson , A. Covelli , M.B. Sauder , C. Fournier , Z. Saeed Kamil , P. Rogalla , D.P. Arteaga , O. Vornicova , P. Spiliopoulou , T.P. Muniz , A. Spreafico","doi":"10.1016/j.esmoop.2024.103978","DOIUrl":"10.1016/j.esmoop.2024.103978","url":null,"abstract":"<div><h3>Background</h3><div>Locally advanced melanoma has a variable prognosis. Currently, there are no reliable criteria to stratify the risk of disease relapse and identify those patients who will benefit the most from adjuvant therapies. Circulating tumor DNA (ctDNA) is an emerging biomarker measuring the presence of tumor-derived DNA in blood.</div></div><div><h3>Patients and methods</h3><div>We used a bespoke, tumor-informed assay (RaDaR®, NeoGenomics, Inc.) to detect ctDNA in 276 prospectively collected plasma samples from 66 melanoma patients receiving definitive treatment. Collection time points included landmark (after completion of local treatment) and every 3-6 months for up to 2 years.</div></div><div><h3>Results</h3><div>ctDNA was detected in at least one plasma sample in 19 patients (29%), including 6/65 (9%) at landmark (post-surgical sample). Positive ctDNA at landmark was associated with shorter overall survival (OS; median OS 22.7 months versus not reached, log-rank <em>P</em> value = 0.01) and a trend towards a shorter relapse-free survival (RFS; median RFS 15.7 months versus not reached, log-rank <em>P</em> value = 0.07). In 10 patients, ctDNA detection preceded disease relapse by a median of 128 days (range 8-406 days).</div></div><div><h3>Conclusions</h3><div>Our data indicate that ctDNA detection after surgery can identify patients with worse prognosis, and serial ctDNA measurements may enable earlier identification of disease recurrence.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 11","pages":"Article 103978"},"PeriodicalIF":7.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644215","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}
ESMO OpenPub Date : 2024-11-01DOI: 10.1016/j.esmoop.2024.103985
B.M. Russell , D.E.C. Fein , J. Bellmunt
{"title":"Determining fitness for enfortumab vedotin and pembrolizumab in metastatic bladder cancer: the time to move beyond isolated comorbidity assessments","authors":"B.M. Russell , D.E.C. Fein , J. Bellmunt","doi":"10.1016/j.esmoop.2024.103985","DOIUrl":"10.1016/j.esmoop.2024.103985","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 11","pages":"Article 103985"},"PeriodicalIF":7.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616909","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}
ESMO OpenPub Date : 2024-11-01DOI: 10.1016/j.esmoop.2024.103971
Z. Zhu , X. Pan
{"title":"Cancer care equality: for the interests of patients with cancer","authors":"Z. Zhu , X. Pan","doi":"10.1016/j.esmoop.2024.103971","DOIUrl":"10.1016/j.esmoop.2024.103971","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 11","pages":"Article 103971"},"PeriodicalIF":7.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142578093","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}
ESMO OpenPub Date : 2024-11-01DOI: 10.1016/j.esmoop.2024.103974
B.C. Schmidt , A.-K. Afflerbach , P. Ludewig , P. Dirksen , F.-O. Paulsen , T. Magnus , M. Alawi , U. Schüller , K. Weisel , C. Bokemeyer , M. Christopeit
{"title":"Diagnosing intravascular B-cell lymphoma using nanopore sequencing of cell-free DNA from cerebrospinal fluid","authors":"B.C. Schmidt , A.-K. Afflerbach , P. Ludewig , P. Dirksen , F.-O. Paulsen , T. Magnus , M. Alawi , U. Schüller , K. Weisel , C. Bokemeyer , M. Christopeit","doi":"10.1016/j.esmoop.2024.103974","DOIUrl":"10.1016/j.esmoop.2024.103974","url":null,"abstract":"","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 11","pages":"Article 103974"},"PeriodicalIF":7.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544502","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}
ESMO OpenPub Date : 2024-11-01DOI: 10.1016/j.esmoop.2024.103973
A.S. Raghavendra , D.B. Zakon , Q. Jin , A. Strahan , M. Grimm , M.E. Hughes , M. Cherian , J. Vincuilla , T. Parker , P. Tarantino , E.A. Mittendorf , T.A. King , V. Valero , D. Tripathy , S.M. Tolaney , N. Tayob , N.U. Lin , D.G. Stover , C.H. Barcenas , A.C. Garrido-Castro
{"title":"Clinical outcomes of early-stage triple-negative breast cancer after neoadjuvant chemotherapy according to HER2-low status☆","authors":"A.S. Raghavendra , D.B. Zakon , Q. Jin , A. Strahan , M. Grimm , M.E. Hughes , M. Cherian , J. Vincuilla , T. Parker , P. Tarantino , E.A. Mittendorf , T.A. King , V. Valero , D. Tripathy , S.M. Tolaney , N. Tayob , N.U. Lin , D.G. Stover , C.H. Barcenas , A.C. Garrido-Castro","doi":"10.1016/j.esmoop.2024.103973","DOIUrl":"10.1016/j.esmoop.2024.103973","url":null,"abstract":"<div><h3>Background</h3><div>The impact of human epidermal growth factor receptor 2 (HER2) expression determined by immunohistochemistry (IHC) on outcomes in early-stage triple-negative breast cancer (eTNBC) is unclear. Using a large, multi-institutional cohort, we evaluated outcomes by HER2 IHC status in patients with eTNBC who received neoadjuvant therapy (NAT).</div></div><div><h3>Patients and methods</h3><div>Patients with stage I-III TNBC who received NAT and underwent surgery from January 2016 to June 2019 were identified from three databases. HER2 expression was defined as low (IHC1+ or 2+/FISH not amplified) or HER2 IHC score 0 by local testing at diagnosis. Pathological complete response (pCR) rates were compared using logistic regression adjusted for multiple factors. Survival outcomes were estimated using Kaplan–Meier and Cox proportional hazards models.</div></div><div><h3>Results</h3><div>Among 977 consecutive patients, 388 (39.7%) had HER2-low and 589 (60.3%) had HER2 IHC score 0 tumors. Median age at eTNBC diagnosis was 50.3 years (range 21.0-83.4 years). At baseline, clinical nodal positivity rate was significantly higher in HER2-low (55.0%) versus HER2 IHC score 0 tumors (46.6%) (<em>P</em> = 0.011); pCR rates were similar (32.0% versus 32.6%; adjusted <em>P</em> = 0.924). At a median follow-up of 3.5 years, recurrence-free survival (RFS) did not vary significantly between HER2-low versus HER2 IHC score 0 among patients with pCR (adjusted <em>P</em> = 0.368) or residual disease (RD) after NAT (adjusted <em>P</em> = 0.573). Distant RFS and overall survival (OS) did not differ by HER2 category for patients with pCR [distant RFS (DRFS), adjusted <em>P</em> = 0.509; OS, adjusted <em>P</em> = 0.514] or RD (DRFS, adjusted <em>P</em> = 0.812; OS, <em>P</em> = 0.285). Discordance of tumor HER2 status was seen in 31.1% of HER2 IHC score 0 cases, with HER2 expression observed post-treatment; 34.8% of HER2-low cases showed discordance, with absent HER2 expression in RD.</div></div><div><h3>Conclusions</h3><div>In this large cohort of patients with eTNBC treated with NAT, HER2-low status was not associated with pCR or survival after adjusting for clinical factors. The discordance in HER2 IHC pre- and post-NAT likely reflects challenges in HER2 quantification and heterogeneity.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"9 11","pages":"Article 103973"},"PeriodicalIF":7.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142577984","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}