bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of breast-conserving surgery incisions on aesthetics, satisfaction, and complications: A prospective study.
Authors: Liu Weijing , Chen Ruixian , Yang Ruoning , Huang Ya , Wu Yunhao , Zhao Xin , Meng Xiangyue , Zhang Zhihao , Ouyang Dengjie , Li Qintong , Luo Ting , Sun Xin , Chen Jie 
Published: July 2024

e12603 Background: Breast-conserving (BCS) is favored for its aesthetics benefits and minimal invasiveness. Ensuring tumor safety is essential, but so are post-surgery appearance, satisfaction, and complications. Incision selection for BCS influences both operability of procedures and postoperative results. This study aims to investigate the impact of different incisions on the aesthetic outcome, patient satisfaction, and postoperative complications of BCS. Methods: A prospective single-center cohort study was conducted from July 2020 on breast cancer patients who underwent BCS. The Breast-Q questionnaire and the Aesthetic Items Scale (AIS) were used to assess breast aesthetics and satisfaction outcomes at different times before and after surgery. Complications evaluated include incision dehiscence, subcutaneous hydrops, and nipple-areolar complex (NAC) ischemia, which were recorded once postoperatively and classified according to the Clavien-Dindo classification. Results: A total of 429 patients were enrolled in this study: 247 with a periareolar incision, 30 with a crescentic periareolar incision, 41 with a curvilinear incision, and 111 with a radial incision. Compared to traditional radial incisions, the periareolar and crescent incisions showed significantly better results in psychological well-being, sexual well-being, satisfaction with breasts, and AIS scores at 1-, 3-, and 6-months post-operation. The crescentic incision demonstrated a notable advantage in physical well-being: chest at the 6-month. In contrast, no significant difference was observed between the curvilinear and radial incisions in terms of these outcomes. The overall complication rates for periareolar, crescentic periareolar, curvilinear, and radial incisions were 11.3%, 16.7%, 9.8%, and 7.2%, respectively, indicating no significant differences. Similarly, the rates of NAC ischemia for the periareolar (5.7%) and crescentic (3.3%) incisions did not significantly differ. All complications were graded in categories I to III, and the distribution showed no statistically significant differences among the four groups. Conclusions: Among various incisions, periareolar and crescentic incisions demonstrated superior outcomes in postoperative follow-up, with a comparable incidence of complications to other incisions. These findings may provide valuable surgical decision-making guidance for achieving optimal aesthetic and clinical outcomes in BCS.
Optimization of surgical management of the axilla since MonarchE trial.
Authors: Jankowski Clémentine , Ladoire Sylvain , Coutant Charles 
Published: July 2024

e12604 Background: Results of monarchE trial (1) have changed adjuvant therapy recommendations for estrogen-receptor-positive (ER+), HER-2 non amplified early breast cancer. Abemaciclib when combined with endocrine therapy has demonstrated a significant improvement in interval disease free survival for patients at high risk of recurrence defined by 4 or more positive nodes or 1 to 3 nodes and either tumor size ≥ 5cm or histologic grade 3. Given the importance of the extent of nodal disease in this study, surgical management of the axilla has resurfaced as a question asked at multidisciplinary tumor boards. Methods: Using data from a prospective historical cohort (2) in which patients underwent both sentinel node (SN) dissection and axillary node dissection (ALND), we assessed the proportion of patients in whom the absence of ALND indication would have led to a lack of awareness of "high-risk" status, and therefore of the indication for adjuvant Abemaciclib. In addition, we evaluated the contribution of the Katz nomogram (that predict pN2/N3 stage) (3) to guide possible indications for complementary ALND in patients with no indication for ALND according to current guidelines. Results: Among the 536 patients, 88 were excluded (54 were ER- and 34 had isolated cells in SLN). Among the remaining 448, 19.2% (86) already had an indication for abemaciclib (78 grade 3 and 8 with size ≥5cm). Ten patients with 3 SLN+ had an indication for ALND. Overall, among patients with 1 or 2 SLN+, only 8% (28/352) were pN2/N3 (14/279 with 1SLN+ and 14/73 with 2SLN+). When the ratio (number of SLN+/total number of SLN sampled) was less than 1, only 3.9% (9/231) were pN2/N3. The pN2/N3 rate was 16% (19/121) when the ratio was greater than 1. Patients with 1 or 2 SLN + met the ACOSOG Z0011 criteria so none would benefit from an ALND, but 8% (28/352) of patients at high risk will not receive Abemaciclib. When using the Katz nomogram with a threshold ≤5%, this rate decreases to 3.3% (7/352) but 116 patients will have an ALND with no benefit. With a threshold ≤20%, 5% (16/352) patients at high risk will not receive Abemaciclib but 21 patients will have an ALND with no benefit. Conclusions: The indications for adjuvant abemaciclib should not lead to surgical escalation in the surgical management of the axilla. 1.Johnston SRD et al. Lancet Oncology. 2023. 2. Katz A et al. J Clin Oncol. 2008 3. Werkoff G et al. J Clin Oncol. 2009.
A proof-of-concept study of LXP5268 as an add-on neoadjuvant chemotherapy in patients with early-stage triple-negative breast cancer.
Authors: Liu Liang Chih , Way Tzong-Der , Lin Chin-Hua , Chen Ya-Hui , Kuo Pin-Hung , Tseng Chung-Hsin , Chen Chiu-Heng 
Published: July 2024

e12607 Background: Triple-negative breast cancer (TNBC) is a heterogeneous and aggressive subtype characterized by a high risk of mortality and a poor prognosis. The 2019 ASCO and St. Gallen International Consensus Guidelines strongly recommend neoadjuvant chemotherapy (NACT) for early-stage TNBC. Previous studies indicated that NACT improved overall and disease-free survival in early-stage TNBC. LXP5268, a drug in the 505(b)(2) category, has demonstrated efficacy in reducing tumor size in animal models. Our study aims to assess whether combining LXP5268 with NACT enhances anti-tumor efficacy and tumor shrinkage rates in early-stage TNBC patients. Methods: Enrolled patients had untreated stage II-III TNBC. NACT consisted of docetaxel every 3 weeks for four cycles, followed by epirubicin plus cyclophosphamide every 3 weeks for an additional four cycles (24 weeks total). In the LXP5268 add-on NACT (LXP5268+NACT) group, patients took LXP5268 orally once daily with NACT. After treatment, we analyzed tumor objective response rate (ORR), shrinkage rate by CT images, and adverse events (AEs) diagnosed by the principal investigator. Whole-exome sequencing (WES) was performed on 6 subjects in the LXP5268+NACT group, identifying potential germline variants and biomarkers, clinically interpreted following ACMG/AMP 2015 guidelines. Results: Both groups had similar baseline characteristics. LXP5268+NACT subjects (54.8 ± 7.2 years) and NACT subjects (59.3 ± 9.8 years) showed significant age differences ( p<0.001). The ORR was 100% in both the LXP5268+NACT group (3 pathological complete response, pCR and 4 pathological partial response, pPR) and NACT group (6 pPR). The tumor shrinkage rate was significantly higher in the LXP5268+NACT group at 77.3% ± 21.8 compared to 43.4% ± 12.8 in the NACT group ( p< 0.001). Moreover, subjects in the LXP5268+NACT group with a tumor reduction exceeding 50% surpassed those in the NACT group. AEs included neutropenia (85.7%), constipation (66.7%), and insomnia (66.7%), all grade 1. Interestingly, mutation in XIRP2 correlated with higher tumor shrinkage rate. Conclusions: LXP5268 combined with NACT was more effective than NACT alone for early-stage TNBC, without increasing AEs. These results highlight LXP5268's potential in TNBC therapy. Previous studies indicated XIRP2 mutations in metastatic breast cancer. LXP5268+NACT achieved pCR in XIRP2-mutated patients. Future clinical trials will expand to enhance result verification accuracy. Clinical trial information: CMUH106-REC3-145.
Real life data of KEYNOTE 522: The Cleveland Clinic experience.
Authors: Lytvynova Olga M. , Jwayyed Jenna , Awada Hussein , Birkholz Tyler , Cheema Asfand Yar , Fargo Kelly , Daw Hamed , Pratt Debra A , Maiti Baidehi 
Published: July 2024

e12612 Background: Triple-negative breast cancer (TNBC) constitutes approximately 15% of all breast cancers and predominantly affects younger women with a disproportionate impact on Black and Hispanic ethnicities. Historically, neoadjuvant therapy centered around chemotherapy alone. However, the KEYNOTE 522 trial has demonstrated improved outcomes with the incorporation of the PD-1 inhibitor Pembrolizumab alongside neoadjuvant chemotherapy. Methods: A retrospective cohort analysis of 106 patients treated with the KEYNOTE 522 regimen within Cleveland Clinic from January 2020 to July 2023. The objective is to evaluate the real-life experience, particularly concerning treatment tolerance and pathologic complete response rates (PCR). Results: Among the 106 female patients, 6.6% completed full neoadjuvant therapy without reporting adverse events (AE), achieving a 71.42% PCR rate. Complications were reported in various subgroups: 54.72% associated with paclitaxel and carboplatin, with discontinuation rates of 60.34%, reduction rates of 33.02%, and full continuation rates of 6.9%. The most prevalent AE included cytopenia (46.55%) and febrile neutropenia, along with other infections (27.59%). For patients discontinuing paclitaxel and carboplatin, the PCR was 68.57%, while with dose reductions, it was 68.75%. Complications related to doxorubicin and cyclophosphamide were reported in 16.04% of patients, with 47.06% either discontinuing or reducing dose, and 5.88% continuing full therapy. Febrile neutropenia, along with other infections (64.71%) and cytopenia (23.53%) were the prominent AE. The PCR for patients discontinuing or reduced doxorubicin and cyclophosphamide was 62.50%. Pembrolizumab-related complications were reported in 16.98% of patients, with a 50% discontinuation rate. The most common AE was dermatologic toxicities (27.78%). The PCR for patients discontinuing pembrolizumab was 83.33% versus 62.5% for those continuing full therapy. Conclusions: This retrospective analysis highlights infections and cytopenias as the primary adverse reactions. Notably, the dose reduction or discontinuation of agents did result in a deterioration of PCR rate compared to patients completing full therapy. Remarkably, PCR was improved for the pembrolizumab discontinuation group, perhaps suggesting a correlation between autoimmune toxicities and improved response. Additional prospective study with larger sample size is needed to understand whether all patients benefit from completing the Keynote 522 regimen. [Table: see text]
Efficacy and biomarker analysis of carboplatin plus taxanes neoadjuvant chemotherapy in triple-negative breast cancer: A prospective multicenter cohort study.
Authors: Chen Xi , Xiu Meng , Kang Hua , Zhang Yan , Yang Hua , Cheng Xueyan , Li Qiao , Li Qing , Wang Jiayu , Lan Bo , Chen Shanshan , Xiao Min , Qian Xiaoyan , Hua Bin , Xu Binghe , Zhang Pin 
Published: July 2024

e12619 Background: The efficacy and survival data of carboplatin plus taxane (anthracycline-free) neoadjuvant chemotherapy (NAC) in triple-negative breast cancer (TNBC) was lack of a large-sample study. The predictive biomarker of efficacy based on cell-free DNA (cfDNA) whole-methylome sequencing (WMS) has not been reported yet. Methods: The prospective multi-center cohort study was conducted in four hospitals of Chinabetween 2016 and 2023. Stage II-III TNBC patients were enrolled to receive NAC of carboplatin (AUC 5) every 3 weeks or carboplatin (AUC 4) every 2 weeks plus taxane(standard dose) for 4-6 cycles. Primary study endpoint were pathological complete response (pCR) and relapse-free survival (RFS). Plasma samples were prospectively collected at baseline (T1) and after NAC(T2). Chromosomal aneuploidy of featured fragments (CAFF),fragment size index (FSI) and methylation density score (MD) of cfDNA were detected with WMS. Results: A total of 267 patients were included in the study. The median age was 49 years, 156 patients (58.4%) were stage III disease. 147 patients (55.1%) received the triweekly NAC. 263 patients underwent breast surgery after NAC and 106 patients (40.3%) achieved pCR. The pCR were similar in biweekly or triweekly groups (39.8% vs 40.7%, P=0.89). The 3-year RFS and overall survival (OS) were 77.9%, 87.6%, respectively. Patients who achieved pCR had a significant better RFS (95.5%) and OS (97.7%) than those non-pCR (76.6%, P<0.001; 81.2%, P<0.001). A total of 66 patients with 120 plasma samples (64 samples at T1, 56 samples at T2) were included in WMS analysis. Patients with CAFF, FSI or MD positive at T1 had a higher tumor burden (stage III or cN2-3, all P values <0.05). The proportion of patients with FSI negative at T2 was significantly higher in pCR group compared to non-pCR(86.2% vs 59.3%, P=0.034). There is a similar tendency in patients with CAFF negative. Patients with MD positive at T1 was significantly associated with poor RFS compared to MD negative (HR = 7.36, 95% CI: 0.93-58.75, Log-rank P=0.028). A linear SVM model based on FSI, CAFF, combining with immune cell (effector memory CD8 T cells, immature B cells) and clinical features was developed to predict pCR, with AUC = 0.90 for training dataset and AUC = 0.86 for testing data. Conclusions: Our large-sample study further confirmed that carboplatin plus taxanes (anthracycline-free) NAC in TNBC is an effective option with clinical applicability. Biomarkers based on cfDNA WMS may offer some predictive and prognostic value which needed to be further investigated.
Plasma microRNA signature as a potential early detection biomarker in breast cancer.
Authors: Simian Marina , Farré Paula Lucia , Duca Rocío , Graña Karen , Magi Gaston , Moro Juana , Scalise Georgina , Guscelli Carla , Casalnuovo Monica Lis , Bayo Sergio , Batagelj Emilio Jose , Zaslavsky Camila , Stigliano Javier , Casimo Carolina , Avila Monica , Benedetti Agustina , Lettieri Graciela , Torlaschi Megan , Diaz Bessone María Inés , De Siervi Adriana 
Published: July 2024

e13780 Background: The 5-year survival rate for women with stage I breast cancer (BC) is 99%, falling to 27% if the disease is diagnosed in stage IV. This demonstrates the importance of early detection for the effectiveness of BC treatment. Among the new diagnostic strategies, the use of liquid biopsies is emerging as a promising alternative for early cancer detection and patient follow-up. miRNAs are small non-coding RNA molecules useful as biomarkers, since they can be found in body fluids. Oncoliq’s approach focuses on the relative quantification of a panel of circulating miRNA biomarkers for the early detection of BC using predictive models built with machine learning techniques. Methods: The aim of this work was to identify a highly sensitive miRNA combination based on liquid biopsies together with predictive models, to generate an assay for BC early detection which we named Oncoliq breast. Human plasma samples (n=239) from BC patients and healthy donors (HD) were divided into two cohorts: exploratory (n=66) and validation (n=173). The exploratory cohort was used for the identification of miRNAs using expression microarrays and miRNA-seq. The validation cohort was used for the analytical validation of potential candidates by RT-qPCR. Results: Using ROC curve analysis, 11 miRNAs were identified as potential biomarkers. By RT-qPCR, we validated the expression of the 11 miRNAs. All of them were significantly increased in BC patient samples (n=100) compared to HD (n=73), in accordance with expression microarrays and miRNA-seq results. Using machine learning we established 7 predictive models that combine these miRNAs. After running all the predictive models using logistic regression, the metrics associated with each one were calculated. From these, model 7 showed a sensitivity of 90%, a specificity of 73% and an accuracy of 83%. Conclusions: MiRNAs show satisfactory advantages as biomarkers as they can circulate in body fluids, such as blood and urine. In the presence of diseases such as BC, the level of some specific miRNAs might be altered and this change can be harnessed for detection, diagnosis and prognosis. Here, we generated a panel of 11 miRNAs that showed increased expression in plasma samples from women diagnosed with BC. Oncoliq breast is a promising low cost and highly sensitive novel liquid biopsy test based on circulating miRNAs for BC screening.
The feasibility and preliminary efficacy of a locally developed digital health intervention in improving breast cancer survivor’s quality of life (QOL): Qualitative and quantitative analysis result.
Authors: Bin Ramlee Mohd Hanafi , Abdul Satar Nur Fadhlina 
Published: July 2024

e13803 Background: Breast cancer is the most prevalent cancer type amongst females of all ages and the highest reported cancer cases in Malaysia. Breast cancer survivors may have distinctive struggles. Inadequate recovery preparation can have a detrimental effect on the quality of life of breast cancer survivors. Digital health interventions (DHI) can enhance patient rehabilitation. Methods: This is an open-label feasibility study conducted at the University of Malaya Medical Center. The study involved 40 patients diagnosed with stage I-III breast cancer. They were randomly assigned to either the intervention group (12-week program with DHI) or the control group (follow-up at UMMC). Unfortunately, 3 patients withdrew from the intervention group during the study. This resulted in a study size of 17 in the intervention group and 20 in the control group. At the end of the 12-week period, we conducted individual interviews to explore the experiences of DHI users. The primary endpoint of this study was to evaluate the feasibility and acceptability of the smartphone application in enhancing the quality of life for breast cancer survivors. Secondary objectives included estimating the variability of body mass index, health, and physical and psychological status. Results: The study showed the engagement of breast cancer survivors with our Digital Health Intervention (DHI), indicating a 100% retention rate over a 12-week period. This emphasizes the accessibility of DHI, as shown by users logging in at least once within 12 weeks. Quantitative data analysis reveals that the DHI app's engagement rates are 53%, implying that users are logging in at least once a week and over 30% throughout the study period. Farago's study shows a 27-30% user retention rate for medical and health apps within 90 days. (5) Clinical outcome for both control and experimental shown not significant result with p>0.05, however we can appreciate absolute changes in intervention arm BMI. Qualitatively, we are able to code to utility and usability of the DHI apps. Users enjoyed the exercise module, valued admin support, and found the app intuitive. Users were engaged in exercise, diet, and psychology, while disengagement was associated with other social media platforms and personal motivation levels. Conclusions: Study showed a 100% retention rate and a promising 53% engagement rate, showing success in health app engagement. The feasibility study intentionally used a small sample for specific disease and patient demographics. Users reflect on app relevance in exercise, diet, and psychology. In summary, assessing the effectiveness of DHI in providing comprehensive support to cancer survivors requires larger-scale studies.
Remote patient monitoring for early detection of immune checkpoint inhibitor therapy-related pneumonitis in high-risk patients: A pilot-feasibility study.
Authors: Hazim Antonious Ziad , Ruan Gordon , Pritchett Joshua , Anderson Bobby , Leventakos Konstantinos , Egan Ashley 
Published: July 2024

e13806 Background: Immune checkpoint inhibitor therapy-related (ICI) pneumonitis poses a significant challenge for patients with cancer. It is associated with increased clinical morbidity and mortality, often resulting in prolonged hospital stays and delays and/or discontinuation of cancer-directed treatment. Early detection and prompt treatment of ICI pneumonitis is critical to improve patient outcomes. Therefore, our institution implemented a remote patient monitoring (RPM) program leveraging in-home, electronic health record-integrated technology and virtual centralized nursing to monitor vital signs and patient symptoms in “high-risk” patients treated with immunotherapy. Methods: Patients receiving immunotherapy deemed to be “high-risk” for ICI pneumonitis seen at Mayo Clinic Rochester, Minnesota were offered enrollment in the RPM program beginning in June 2023. High-risk patients included those with pre-existing lung disease (chronic obstructive pulmonary disease, interstitial lung disease); those with a history of resolved ICI pneumonitis being rechallenged with immunotherapy; and those with grade 1 ICI pneumonitis continuing immunotherapy. Eligible patients who agreed to participate in the program were provided a kit consisting of RPM technology and electronic symptom questionnaires. The kit included an armband for continuous vital sign monitoring, a blood pressure monitor, a scale to measure weight, and a pre-connected cellular-enabled tablet for questionnaire answering. RPM data utilized real-time electronic health system integration and predetermined parameters to alert RPM nurses. Pre-specified escalation care pathways were then used to respond and escalate care, as necessary. The primary outcome of this pilot study was to assess the feasibility of implementing an RPM program in this patient population with a secondary outcome to determine the ability to detect ICI pneumonitis before significant clinical symptoms. Results: Sixteen patients were enrolled of whom 5 declined participation (2 due to inconvenience and 3 for unclear reasons) resulting in 11 patients who underwent monitoring. Five patients graduated monitoring without detection of ICI pneumonitis within a 4-month timeframe. Six patients are currently undergoing RPM. 372 alerts occurred of which 8 (2%) were escalated to physician review. These alerts included elevated heart rate in 4, shortness of breath in 3, and elevated blood pressure in 1. One patient was triaged to an emergency department and diagnosed with grade 2 ICI pneumonitis. Conclusions: We show that RPM in patients who are at high-risk for developing ICI pneumonitis can be effectively integrated into a care model and monitor pneumonitis related symptoms. Further studies are needed to prove whether RPM is beneficial in this population including other ICI toxicities.