Clinical breast cancer最新文献

{"title":"Evaluating the Association between Body Mass Indices and the 21-Gene Recurrence Score: A Systematic Review and Network Meta-Analysis.","authors":"Ciara Hunt, Matthew G Davey, Ryan Wilson, Juliette Buckley, Bridget Anne Merrigan, Chwanrow Baban, Shona Tormey","doi":"10.1016/j.clbc.2025.05.006","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.006","url":null,"abstract":"<p><strong>Background: </strong>Preconceptions exist regarding the association between obesity and the propensity to develop estrogen receptor positive (ER+) cancer. There is limited data assessing the impact of body mass index (BMI) on 21-gene recurrence score (RS) results.</p><p><strong>Aim: </strong>To perform a systematic review and network meta-analysis to assess whether increased BMI is associated with low RS in estrogen receptor positive (ER+) breast cancer.</p><p><strong>Methods: </strong>A systematic review was performed as per PRISMA guidelines. Descriptive statistics were used as appropriate. Meta-analyses were performed using the Review Manager v5.4 and NMA performed using shiny.</p><p><strong>Results: </strong>6 studies with 3523 patients were included. The mean age was 61 years and mean RS was 16.6 and BMI was 25.8_. When applying traditional RS cut-offs 66.4% of patients had a RS < 18 (3529 out of 5312), 27.6% had RS 18-30 (1466 out of 5412) and 6.0% had a RS of > 30 (317 out of 5312). At meta-analysis, patients with RS 18-30 (risk ratio (RR): 1.15, 95% confidence interval (CI), 0.91-1.46) and RS > 30 (RR: 1.03 95% CI, 0.79-1.35) were not associated with lower BMI. When applying TAILORx cut-offs, 24.2% of patients had a RS < 11 (996 out of 4124), 63.1% had a RS 11-25 (2604 out of 4124) and 12.7% had a RS > 25 (524 out of 4124). At meta-analysis, patients with RS 11-25 (RR: 1.57, 95% CI, 0.77-3.75) and RS > 25 (RR: 1.58, 95% CI, 0.71-3.77) were also not associated with lower BMI.</p><p><strong>Conclusion: </strong>This study failed to identify a significant association between BMI and RS group.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246742","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}

{"title":"A Phase 2, Open Label, Multicenter, Single Arm Trial Evaluating the Activity and Safety of Abemaciclib + Aromatase Inhibitors (AIs) as Second-Line Treatment After First-Line Fulvestrant in Hormone-Receptor-Positive (HR+), Human-Epidermal-Growth-Factor-Receptor-Negative (HER2-) Metastatic Breast Cancer (MBC) Patients. Final Results of HERMIONE-7 Trial.","authors":"Cazzaniga Marina Elena, Pepe Francesca Fulvia, Rossi Emanuela, Coltelli Luigi, Beano Alessandra, Valerio Maria Rosaria, Ferro Antonella, Zustovich Fable, Moretti Gabriella, Toniolo Davide, Cordani Nicoletta, Galimberti Stefania, Capici Serena","doi":"10.1016/j.clbc.2025.05.003","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.003","url":null,"abstract":"<p><strong>Background and purpose: </strong>CDK 4/6 inhibitors with ET are the recommended choice as 1st-line therapy in HR+/HER2- MBC patients, however ET alone could remain an option for some of them. HERMIONE-7 is a multicenter, single-arm, Phase II study, aimed to evaluate Abemaciclib 150 mg BID + AIs, in patients who progressed on 1st line Fulvestrant.</p><p><strong>Materials and methods: </strong>Primary aim was the efficacy of Abemaciclib + AIs in terms of Clinical Benefit Rate (CBR), secondary aims were Time to Progression (TTP), Overall Response Rate (ORR), duration of response (DOR), and safety.</p><p><strong>Results: </strong>From April 2020 to January 2022, we enrolled 31 patients. Median age was 72 years (range 47-86), 55% had < 2 comorbidities, mainly hypertension (12, 38.7%). Clinical Benefit Rate was 69% (95% CI, 49-85) and ORR was 21% (95%CI, 8-40). 1-year TTP and OS rates were 53.8% (95% CI, 38.6-74.9%) and 69.5% (95% CI, 54.8%-88.5%), respectively. Main adverse events remain diarrhea (80.6%), fatigue (54.8%) and nausea (35.5%), 3 patients (10.7%) had non drug-related fatal events.</p><p><strong>Conclusions: </strong>HERMIONE-7 study showed that 2nd-line treatment with Abemaciclib + AIs is a feasible option in MBC patients who progressed on Fulvestrant in 1st-line setting and could be an alternative especially in terms of optimizing the cost-benefit ratio in some Countries.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274291","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}

{"title":"The Construction of a New Prognostic Model of Breast Cancer and the Exploration of Drug Sensitivity Based on Machine Learning for Glycosylation-Related Genes.","authors":"Jia-Ning Zhang, Xi-Rui Zhou, Zi-Lu Yi, Xin-Yu Tian, Hong Liu","doi":"10.1016/j.clbc.2025.05.004","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.004","url":null,"abstract":"<p><strong>Aims: </strong>Breast cancer has become the number 1 killer threatening women's health. In recent years, glycosylation modification has played an increasingly important role in tumor progression. The aim of this study was to explore the key genes that may be involved in glycosylation modification, establish prognostic models, and further explore their biological functions.</p><p><strong>Methods: </strong>Using data from TCGA and GEO databases, differentially expressed genes (DEGs) were identified. Subsequently, Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses were conducted to characterize the functions of the DEGs. LASSO regression analysis was performed to narrow down hub genes. Additionally, single-cell analysis, protein-protein interaction (PPI) network analysis, immune correlation analysis, drug sensitivity analysis, and molecular docking were carried out to investigate the functions of these hub genes.</p><p><strong>Results: </strong>Initially, we identified 110 differentially expressed prognostic genes, among which 89 were potentially associated with glycosylation modification. Enrichment analysis revealed their involvement in oxytocin signaling, chemical carcinogen-DNA adduct formation, and C-type lectin receptor pathways. LASSO regression (Least Absolute Shrinkage and Selection Operator) analysis further refined the selection to 24 hub genes, which exhibited specific genetic interactions. Notably, the expression levels of these genes showed significant associations with various immune cells. Drug sensitivity analysis of the hub genes highlighted methotrexate as a potential therapeutic candidate. Finally, molecular docking demonstrated strong binding affinities between the target receptors and ligands.</p><p><strong>Conclusions: </strong>In conclusion, we screened glycosylation-related Hub genes, constructed prognostic models, explored their biological functions, and proposed new insights for diagnosing and treating breast cancer.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144233323","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}

{"title":"Prognostic Analysis of Hormone Receptors and HER2 in Breast Squamous Cell Carcinoma: A Matched Study Using the SEER Database.","authors":"Miao Wang, Kehua Hu, Yanping Gao, Xiaowan Guo, Jie Li, Yaoxiong Xia, Hui Qiu, Qiuji Wu","doi":"10.1016/j.clbc.2025.04.015","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.04.015","url":null,"abstract":"<p><strong>Objective: </strong>To determine the prognostic differences between breast squamous cell carcinoma (BSCC) and breast infiltrating ductal adenocarcinoma (BIDC) by receptor subtype.</p><p><strong>Materials and methods: </strong>We extracted data from the SEER Registry for adult women diagnosed with BSCC and BIDC from 2010 to 2020. Kaplan-Meier curves and log-rank tests assessed survival differences. Propensity score matching analysis (PSM) was used to match subjects with similar characteristics. Cox proportional hazard regression models identified survival predictors.</p><p><strong>Results: </strong>BSCC patients were older (> 60 years: 60.6% vs. 52.4%, P = .037), had higher TNBC incidence (64.0% vs. 12.2%, P = .001), and higher metastasis rates (48% vs. 33.3%, P < .001) compared to BIDC. Marriage rate was lower in BSCC patients (44.6% vs. 54.9%, P = .009). BSCC patients had worse OS and CSS (P < .001). In non-TNBC, BSCC showed poor survival before and after PSM (P < .05). In TNBC, BSCC had worse OS than BIDC (P < .001), but similar CSS before PSM. After PSM, no survival difference was observed. Stage was a significant prognostic factor for BSCC (P < .001), while receptor subtype was not (P > .05).</p><p><strong>Conclusion: </strong>BSCC has a higher TNBC incidence and poorer survival in non-TNBC populations compared to BIDC. BSCC-TNBC patients have similar survival to BIDC-TNBC. Stage is a crucial prognostic factor for BSCC, more so than receptor subtype.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224521","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}

{"title":"Improved Breast Cancer Detection with Artificial Intelligence in a Real-World Digital Breast Tomosynthesis Screening Program.","authors":"Joshua A Nepute, Meridith Peratikos, Alicia Y Toledano, John P Salvas, Haley Delks, Julie L Shisler, Jeffrey W Hoffmeister, Colleen M Madden","doi":"10.1016/j.clbc.2025.05.007","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.007","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of this study is to compare radiologists' breast cancer screening performance before and after the implementation of an artificial intelligence (AI) detection system for digital breast tomosynthesis (DBT).</p><p><strong>Materials and methods: </strong>This retrospective study included 4 radiologists reading DBT screening mammograms across 3 clinical sites during 2 distinct time periods. The pre-AI time period from September 1, 2018 to August 31, 2019 included 10,322 standard DBT interpretations with a computer-aided detection system. The post-AI from January 1 to March 18, 2020 and May 4 to December 31, 2020 included 6,407 DBT interpretations with concurrent use of a deep learning AI support system. Endpoints included cancer detection rate (CDR), abnormal interpretation rate (AIR), and positive predictive values for cancer among screenings with abnormal interpretation (PPV1) and biopsies performed (PPV3). Estimates and 95% confidence intervals (CIs) for each radiologist were calculated for each time point and the difference across time periods.</p><p><strong>Results: </strong>The CDR per 1000 exams increased from 3.7 without AI to 6.1 with AI (difference 2.4, P = .008, 95% CI: 0.6, 4.2). The AIR was 8.2% without AI and 6.5% with AI (difference -1.7, P < .001, 95% CI: -2.5, -0.8). The PPV1 increased from 4.2% to 8.8% with AI implementation (difference 4.6, P < .001, 95% CI: 3.0, 6.3) and PPV3 increased from 32.3% to 56.5% with AI support (difference 24.2, P = .033, 95% CI: 2.0, 46.4).</p><p><strong>Conclusion: </strong>Real-world interpretation of DBT after implementation of an AI detection system resulted in increased CDR, reduced AIR, and significantly increased PPV1 and PPV3.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144233322","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}

{"title":"Metabolomics Biomarkers for Breast Cancer: An updated perspective.","authors":"Christina Jane Vellan, Vijayakumar Natesan, Jaime Jacqueline Jayapalan","doi":"10.1016/j.clbc.2025.05.005","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.005","url":null,"abstract":"<p><p>Breast cancer (BC) remains a significant global health concern, emphasising the need for accurate diagnostic and prognostic tools. Metabolomics, the study of small molecules involved in cellular processes, has emerged as a promising approach for identifying BC biomarkers. This review provides an updated overview of metabolomic biomarkers for BC, focusing on early detection, diagnosis, prognosis prediction, and subtype-specific markers. It covers the various sources of biological samples used in biomarker investigations and common methodologies such as liquid chromatography-mass spectrometry and nuclear magnetic resonance. This review also highlights key classes of metabolites, including amino acids, lipids, and carbohydrates, which exhibit consistent alterations in BC patients and are integral to crucial oncogenic pathways, such as energy metabolism, redox balance, immune modulation, and membrane remodeling. Notably, several metabolite panels have demonstrated high sensitivity and specificity, showing promise for effectively stratifying patients according to tumor subtype. Despite the promising potential of metabolomics, challenges remain in standardizing analytical techniques, validating biomarkers, and integrating metabolomics with other omics approaches. Addressing these will be essential for harnessing the full potential of metabolomics in advancing precision oncology for BC.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144181147","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}

{"title":"Ultrasound Radiomics-Based Machine Learning and SHapley Additive exPlanations Method Predicting Pathological Prognostic Stage in Breast Cancer: A Bicentric and Validation Study.","authors":"Lei Chen, YiXi Su, Yaoqin Wang, Yue Yu, Danfeng Huang, Meilian Zhang, Xiaoshuang Chen, Xu Ye, Yimi He, Ensheng Xue, Liwu Lin, Zhikui Chen","doi":"10.1016/j.clbc.2025.05.001","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.05.001","url":null,"abstract":"<p><strong>Purpose: </strong>To build and validate ultrasound (US) radiomics-based machine learning (ML) models to predict the pathological prognostic stage of breast cancer (BCa).</p><p><strong>Methods: </strong>We retrospectively included 578 BCa patients from two hospitals (468 and 110 in the training and test sets, respectively). For each patient, the pathological prognostic stage was determined. US radiomics features were extracted, preprocessed, and selected. Five US radiomics-based ML models were built to distinguish between pathological prognostic stage II-III and 0-I groups. The fusion model was built by combining the optimal radiomics model with clinical indicators. Receiver operating characteristic (ROC) curve analysis was applied to evaluate the performance of the models. SHapley Additive exPlanations (SHAP) method was used to interpret the models.</p><p><strong>Results: </strong>For each lesion, 1333 US radiomics features were extracted and 11 features were finally selected to build models. The MLP model achieved optimal performance with the AUC of 0.893 and 0.806 in the training and test sets, respectively. The AUC of the fusion model was 0.913 and 0.823 in training and test sets, respectively. The squareroot_glszm_GrayLevelNonUniformity and wavelet-LHH_gldm_DependenceVariance were the most important features of the MLP model and fusion model, respectively.</p><p><strong>Conclusions: </strong>US radiomics-based ML is helpful for preoperatively predicting the pathological prognostic stage of BCa, which has potential reference value for making individualized treatment strategies and predicting disease prognosis in clinical practice.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224522","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}

{"title":"Prognostic Ability of the Indication for Adjuvant Systemic Therapy Based on Preoperative Biopsy and the Surgical Excision Specimen in Cases of Small Breast Tumors (CONSCIENCE): A Retrospective Cohort Study.","authors":"Sophie M Wooldrik, Suzanne Wilhelmus, Thijs van Dalen, Gerson M Struik, Erwin Birnie, Cornelis Verhoef, Taco M A L Klem","doi":"10.1016/j.clbc.2025.04.018","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.04.018","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the agreement between clinical and pathological assessments of tumor size and grade in patients with small, luminal type breast cancer.</p><p><strong>Methods: </strong>This retrospective monocenter cohort study included women treated for clinical stage 1, estrogen receptor positive, HER2 negative breast cancer between January 2020 and July 2023. Preoperative and postoperative assessments of tumor size, malignancy grade and lymph node status were compared. The impact on the indication to administer systemic therapy was evaluated. Statistical analyses included agreement estimates expressed as proportions with 95% confidence intervals.</p><p><strong>Results: </strong>292 patients were examined preoperatively and postoperatively. Agreement for tumor grade was 81% (95% CI [76-85]) and for tumor size based on ultrasonography (US) 75% (95% CI [70-80]. Tumor size was more likely underestimated than overestimated by US (17% vs 8%). Twelve percent of cN0 patients had a SLN containing metastases. The preoperative assessment for adjuvant chemotherapy aligned with postoperative recommendations in 93% of patients and for adjuvant endocrine therapy in 75%. Preoperative underestimation of the indication to administer chemotherapy and endocrine therapy occurred in 7% and 18% of all patients respectively. A positive SLN contributed to these proportions of underestimated systemic treatment indications in half of these groups.</p><p><strong>Conclusion: </strong>Our study demonstrates disagreement between preoperative and postoperative assessment of malignancy grade and tumor size in approximately one fifth of the patients. Absence of postoperative information of primary tumor characteristics would have led erroneously to omission of adjuvant chemotherapy in less than 5% of the patients.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144181236","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}

{"title":"Clinical outcomes by histologic pattern of early-stage metaplastic breast cancer: A single-institution retrospective study.","authors":"Ashley Matusz-Fisher, Annabel Chen, Erin E Donahue, Courtney R Schepel, Michelle L Wallander, Chad A Livasy, Richard L White, Antoinette R Tan, Lejla Hadzikadic-Gusic","doi":"10.1016/j.clbc.2025.04.022","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.04.022","url":null,"abstract":"<p><strong>Purpose: </strong>Metaplastic breast cancer (MpBC) is a rare, aggressive type of breast cancer composed of several histologic patterns. This study evaluated outcomes among the MpBC histologic patterns, which include spindle cell/sarcomatous, squamous, heterologous mesenchymal, and mixed.</p><p><strong>Patients and methods: </strong>A retrospective chart review identified patients with early-stage MpBC diagnosed between January 1, 2010, and September 1, 2021. A matched control patient cohort with nonmetaplastic triple-negative breast cancer (TNBC) was selected. Associations between MpBC histologic patterns and disease characteristics were evaluated using chi-squared and Wilcoxon tests. Kaplan-Meier estimates and log rank tests assessed differences in recurrence-free survival (RFS) and overall survival (OS).</p><p><strong>Results: </strong>In the MpBC cohort (n = 106), histologic patterns included spindle cell/sarcomatous (34%), squamous (16%), heterologous mesenchymal (31%), mixed (18%), and other (1%). In patients with MpBC who received neoadjuvant chemotherapy (n = 32), residual cancer burden (RCB) was not found to be significantly different between the spindle cell/sarcomatous pattern versus other patterns (P = .81). In the entire MpBC cohort, patients with the spindle cell/sarcomatous pattern had inferior RFS (P = .02) and OS (P = .004) compared to patients with other patterns. There was no significant difference in RFS (P = .90) or OS (P = .90) between the MpBC and TNBC cohort.</p><p><strong>Conclusion: </strong>RCB did not differ among the MpBC histologic patterns, but outcomes were inferior in patients with the spindle cell/sarcomatous pattern. Outcomes were also inferior in patients with MpBC receiving neoadjuvant versus adjuvant chemotherapy. Our study did not find a difference in outcomes between patients with MpBC versus nonmetaplastic TNBC. More investigation with larger sample sizes and biomarkers is warranted.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144157117","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}

{"title":"Long-Term Safety and Efficacy of the Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-Positive Early Breast Cancer in PHranceSCa, a Randomized, Open-Label Phase II Study.","authors":"Joyce O'Shaughnessy, Susana Sousa, Josefina Cruz, Dame Lesley Fallowfield, Päivi Auvinen, Catarina Pulido, Ana Cvetanovic, Sharon Wilks, Leonor Ribeiro, Mauricio Burotto, Thomas Boulet, Valentine Revelant, Nathalie Theron, Peter Trask, Laurentia Wahyudi, Zuzana Kirchmayer Machackova, Ljiljana Stamatovic","doi":"10.1016/j.clbc.2025.04.016","DOIUrl":"https://doi.org/10.1016/j.clbc.2025.04.016","url":null,"abstract":"<p><strong>Background: </strong>We assessed long-term safety, efficacy, and health-related quality of life during the continuation phase after 3 years' follow-up in PHranceSCa (NCT03674112).</p><p><strong>Patients and methods: </strong>This was a randomized, open-label, international, multicenter, crossover, Phase II study in adjuvant HER2-positive early breast cancer. One hundred fifty nine patients received 3 cycles of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC), then 3 of intravenous pertuzumab and trastuzumab (P + H IV), or vice versa. Postcrossover, patients continued preferred treatment (≤ 18 cycles total).</p><p><strong>Results: </strong>Most adverse events, including all cardiac events (n = 2) and anaphylaxis/hypersensitivity (n = 3) were grade 1/2. None were grade 4/5. Grade 1/2 local injection-site reactions occurred in 13 patients (9.4%) receiving PH FDC SC. Other events occurred at comparable rates between arms. The overall event-free rate for invasive disease-free survival was 94.17% (95% confidence interval, 90.47-97.87) at 3 years; overall survival was 98.71% (96.92-100). Meaningful changes from baseline in health-related quality of life included improvements in role and social functioning, and reductions in financial difficulty.</p><p><strong>Conclusion: </strong>PH FDC SC was well tolerated, with safety consistent with that of P + H IV (except local injection-site reactions) and no grade ≥ 3 anaphylaxis/hypersensitivity or new safety signals in the continuation period. Immature efficacy data showed high event-free rates, consistent with the known clinical benefit of pertuzumab and trastuzumab (although follow-up was relatively short at 3 years). PHranceSCa adds to the totality of evidence reinforcing the long-term clinical benefit and safety of pertuzumab and trastuzumab.</p>","PeriodicalId":10197,"journal":{"name":"Clinical breast cancer","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215102","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}