bluuebunny/crossref_metadata_2025_split huggingface dataset:
Overall breast cancer survival and prognostic factors.
Authors: Benzebda Hanane , Ghomari Soumeyya Bezzar 
Published: June 2023

e12525 Background: Breast cancer is a frequent and heterogeneous disease where several clinical, histological and molecular factors determine its prognosis. Our objective is to estimate the prognostic factors influencing overall survival (OS) in patients with breast cancer. Methods: We conducted our first descriptive and analytical single-center study with a retrospective collection of data on files from the Medical Oncology department in University Hospital Center Tlemcen, including patients who died in 2020-2021 and were treated for breast cancer in order to estimate overall survival and determine prognostic factors. The study of survival was carried out by the Kaplan Meier method, and the comparison between the different classes of a variable was carried out by the log rank test. The study of prognostic factors associated with survival was carried out using the Cox model. Results: One hundred twenty-four patients were included. The average age was 50 years [30-87]. The median overall survival in our study, was 48 months [37-58].Seventy-four patients (57.9%) were diagnosed at a localized stage, 50 (40.3%) at a metastatic stage (p = 0.0001; CI: 95%). More than half of the patients, were under 50 years old, 36 were between 50 and 65 years old, and 22 were ≥ 65 years old (p = 0.8; CI: 95%). Forty-seven patients (37.6%) had a tumor located in the right breast, 67 (53.6%) in the left breast and 7 patients (5.6%) had bilateral breast cancer (p = 0.8). Seventy-nine patients (63.7%) underwent a radical mastectomy type Patey, 3 (2.4%) conservative surgery, 9 (7.3%)palliative mastectomy and 33 (26.6%) were not operated (p = 0.02; CI: 95%). The histological type was non-specific infiltrating ductal carcinoma in 93 patients (75.6%) and invasive lobular carcinoma in 14 patients(11.4%) (p = 0.04). Sixty-seven patients (53.6%) had a grade 2 and 38(30.4%) grade 3 (p = 0.08). Tumor size was T0 (0.9%), T1 (8.4%), T2 (44.9%), T3 (13.1%), T4 (32.7%) (p = 0.02). Lymph node involvement was N0 (19.4%), N1 (28.7%), N2 (35.2%), N3 (16.7%) (p = 0.054). In immunohistochemistry; 22 (45.8%) patients had a Ki67 > 20% and 26 patients (54.2%) had a Ki67 ≤ 20% with (p = 0.22). Twenty patients (16%) had a positive HER2 (p = 0.7). Seventy-one patients (61.2%) had positive hormone receptors with a median OS of 57 months [34.79] (p = 0.0001). High expression of estrogen hormone receptors (≥ 50%) had no impact on overall survival (p = 0.06) while high expression of progesterone hormone receptors was associated with better overall survival (p = 0.01). Conclusions: Breast cancer is a frequent and heterogeneous disease with several factors influencing its prognosis. The initial stage of the disease, a radical surgery, the infiltrating ductal histological type, the tumor size and the level of expression of the progesterone receptors were correlated with a better survival in our study.
Use of AI-based second harmonic generation digital pathology for predicting patient survival for triple negative breast cancer patients.
Authors: Tai Dean , Ren Yayun , Chng Elaine , Akbary Kutbuddin , Kuo Wen-Hung , Huang Kai-Wen Sky 
Published: June 2023

e12526 Background: Extracellular matrix (ECM) in the stromal region has been known to be associated with tumorigenesis and metastasis in breast cancers. About 10-20% of all breast cancers are triple-negative breast cancers (TNBC), considered to be more aggressive with poorer prognosis than other types of breast cancer. AI-based Second Harmonic Generation (SHG) digital pathology, which is a fully quantitative fibrosis assessment, has been widely used innon-alcoholic steatohepatitis (NASH) and is FDA approved primary endpoint in NASH phase 2 clinical trials. In oncology, AI-based SHG digital pathology has demonstrated its relevance in survival prognosis for hepatocellular carcinoma and renal cell carcinoma after surgical treatment, based on analysis of tumor and non-tumor tissue collagen parameters. In this study, we study its potential applications for survival prognosis of TNBC patients. Methods: 68 patients with TNBC were treated by breast-cancer excision surgery. Tumor and non-tumor tissue from excised mass was imaged by SHG microscope (Genesis200, HistoIndex Pte. Ltd., Singapore). Regular follow-up was performed for patients post-operatively. A total of 33 collagen morphology features for collagen strings were quantified, such as length/width of strings, number of long/short/thick/thin strings, from tumour and non-tumour tissues. We used these collagen parameters to build two survival prediction models (RFS-index and OS-index) to predict patient’s recurrence-free survival (RFS) and overall survival (OS) years. The models were validated using the leave-one-out method. Results: Both RFS-index and OS-index were created using 10 specific collagen parameters chosen by sequential selection methods from overall 33 collagen parameters evaluated. 9 out of 10 parameters were selected from non-tumour tissue. The RFS-index can differentiate patients with RFS≥3 years (n = 36) and RFS < 3 years (p < 0.001) with cut-off value of RFS-index = 0.50. The OS-index can differentiate patients with OS≥5 years (n = 42) and OS < 5 years (p < 0.001) with cut-off value of RFS-index = 0.55. The log-rank test showed RFS-index (p = 0.026) and OS-index (p < 0.001) can be used for prediction of disease-free and overall survival based on collagen parameters. Conclusions: SHG based AI-aided quantitative assessment of ECM collagen has been shown to correlate with survival rates of TNBC patients. This is a proof of concept study applying AI based digital pathology in helping predict survival rates for TNBC patients based on tumor and non-tumor tissue ECM collagen parameters. This could help identify patients with a higher risk of recurrence of disease and lower overall survival rates. Such patients can be followed-up more carefully, and be considered for earlier treatment interventions to improve their survival outcomes.
Subcutaneous versus endovenous trastuzumab: Real world data from a reference cancer center in Peru.
Authors: Otoya Iris , Valdivieso Natalia , Roque Katia , Morante Zaida , Vidaurre Tatiana , Neciosup Silvia P. , Gomez Henry Leonidas 
Published: June 2023

e12527 Background: HER2 receptor amplification/overexpression is identified in approximately 20% of invasive breast neoplasms; it is characterized by biologically aggressive behavior and worse prognosis compared to HER2-negative tumors. Trastuzumab, a humanized monoclonal antibody, was approved for therapeutic use in HER2-positive breast cancer. The objective of this study is to compare the acquisition costs, costs, and preparation and application times of trastuzumab presentations. Methods: Descriptive and retrospective study in female patients aged 18 years and older with a diagnosis of HER 2 positive early breast cancer who received subcutaneous or intravenous trastuzumab during the years 2019-2021. The study setting was the National Institute of Neoplastic Diseases (INEN)- Lima/Peru. We created a simple spreadsheet model to evaluate costs (expressed in soles). The analysis included the calculation of patient time in the chemotherapy chair, preparation time and treatment administration time. Results: The cost of the subcutaneous presentation was S/4212 and S/4348 for the intravenous presentation. The cost of the complete treatment was S/75816 for the subcutaneous presentation and S/82612 for the intravenous presentation. The cost of the supplies used in the preparation of 18 cycles of treatment for the subcutaneous presentation was S/ 20.7 and for the intravenous presentation S/ 399.96; likewise, the cost of the supplies used in the administration of 18 cycles of treatment for subcutaneous trastuzumab was S/ 34.02 and for the intravenous presentation was S/ 1094.4. The cost of using a chemotherapy chair for 18 cycles for subcutaneous presentation was S/36 and for intravenous presentation S/663. The time used in the application of 1 cycle of subcutaneous presentation was 30 minutes for the first application and 15 minutes for subsequent applications; the time used in the application of each cycle for endovenous presentation was 6 hours for the first application and 2 hours for subsequent applications. The administration of 18 cycles for subcutaneous presentation was S/ 732.45 and for intravenous presentation S/ 6168. The trastuzumab formulation for subcutaneous application is a ready-to-use solution, so it did not generate preparation costs. The preparation time for one cycle of intravenous presentation was 15 minutes and meant an investment of S/693.90 for the preparation of 18 cycles (cost of preparation personnel time). Conclusions: The use of subcutaneous trastuzumab generates less costs associated with an overall savings of 16.36%, its use implies less time for preparation and application, as well as a reduction in patient chair time. These time reductions translate into economic savings, a more efficient use of resources and a reduction in waiting time for appointments in the chemotherapy service and a greater capacity of the oncology service to treat a greater number of patients.
A prospective real-world study to assess the effectiveness and safety of trastuzumab biosimilar in the adjuvant treatment of HER2-positive breast cancer: Preliminary safety results.
Authors: Cardoso Ana Carolina Ferreira , Gagliato Debora De Melo , Brito Natália Mesquita , Lapa Maura Gonzaga , Santos Renata Virgínia Cavalcanti , Magaton Erida , Castilho Vivienne Carduz 
Published: June 2023

e12532 Background: The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) define a biosimilar as a biological molecule product that is highly similar to and has no clinically meaningful differences from an existing approved reference product. The trastuzumab biosimilar was the first oncology biosimilar approved in Brazil for HER2-positive breast cancer (BC) and advanced gastric cancer treatment. This study aimed to assess the effectiveness and safety of trastuzumab biosimilar (named as Zedora in Brazil) in the adjuvant setting among HER2-positive BC patients. Methods: This is a national, multicentric, observational, and prospective real-world study. Patients with early-stage HER2-positive BC who received at least one dose of trastuzumab biosimilar as adjuvant therapy were eligible. At the present date, 162 of 170 planned patients were recruited. Here, we present the preliminary safety data of the first 59 patients recruited in the study. The safety endpoint is the occurrence of adverse events (AEs), and the safety population included all patients who received at least one dose of trastuzumab biosimilar. We analyzed the AEs collected from the signature of the consent form until the end of adjuvant treatment. Results: Baseline patient characteristics among the 59 evaluated patients included a mean age of 51.7 ± 12.9 years, with 79.7% of them having a node-negative disease. Most patients had hormone-receptor-positive tumors (67.8% estrogen-receptor-positive and 55.9% progesterone-receptor-positive). The number of patients undergoing conservative surgery (67.8%) was higher than mastectomy (32.2%). The most frequent histological BC subtype was invasive ductal carcinoma (98.3%). All 59 participants received adjuvant anti-HER2 therapy, that included trastuzumab biosimilar administration trastuzumab biosimilar + pertuzumab (22.0%), and only two patients were receiving reference trastuzumab, which was switched to trastuzumab biosimilar upon entry into the study. The duration of adjuvant anti-HER2 therapy was 10.2 ± 2.2 months, ranging from 5.8 to 13.9 months. This time corresponds to, on average, 14 ± 3.2 cycles of 21 days. In total, 78.0% of the patients had at least one AE, four of them were serious AEs (6.8%), including three of severe intensity and one life-threatening. Table 1 lists the most reported AEs according to SOC (System Organ Class). Conclusions: The nature and severity of AEs observed to trastuzumab biosimilar were consistent with the known safety profile of trastuzumab. Clinical trial information: NCT03892655 . [Table: see text]
Relation assessment between TAN and AR with the survival of breast cancer patients.
Authors: Moghimi Minoosh , Tavakkolian Pouria , Ahmadi Farzane , Mansouri Reza , Khodadadi Kasra 
Published: June 2023

e12542 Background: Considering the importance of the relationship between biomarkers and survival in breast cancer patients, finding this relationship can play a key role in understanding disease behavior, determining prognosis and even identifying targeted treatments. This study was conducted with the aim of investigating the relationship between TAN (Tumor associated neutrophil) and AR (Androgen receptor) with survival in patients with breast cancer. Methods: In this cohort study, 83 female patients with stage I- IV breast cancer were included. we investigated the relationship between TAN and AR with the three-year survival time. Patients were diagnosed between April 2018 and March 2021. Also, the latest follow-up was performed in December 2022. The Cox-hazard model was used to determine the factors influencing the survival time of patients. Results: Out of 83, follow-up was conducted for 81 women. The mean±SD age of diagnosis was 49.5±11.1 years. Sixteen (19.75%) of them died and the mean (95% C.I) for follow-up time was 32.78 (30.97-34.58) months. The one, two, and three survival rates were 0.95, 0.89, and 0.80, respectively. The mean survival time (month) for AR-TAN-, AR+TAN-, AR+TAN+, and AR-TAN+ was 35.75, 33.50, 32.36, and 28.58 respectively. The 3-year survival in the AR-TAN-, AR+TAN-, AR+TAN+ and AR-TAN+ groups was 0.88, 0.88, 0.79, and 0.50, respectively. Conclusions: AR positivity and TAN negativity are in favor of better three-year overall survival regardless of subtypes, however the differences were not statistically significant. The Survival status was significantly lower in the AR-TAN+ group compared to AR + TAN- group. These results are a promising way to the future studies. [Table: see text]
Prevalence of low HER2 expression in breast cancer patients: An Indian experience.
Authors: Gogia Ajay , S G Nithin , Mathur Sandeep , Deo S.V.S. , Ganguly Shuvadeep , Batra Atul , Sharma Dayanand , Prasad Chandra Prakash 
Published: June 2023

e12543 Background: With the recent advent of trastuzumab deruxtecan and encouraging results of the DESTINY-Breast-04 trial, low HER2 expression has emerged as a clinically significant therapeutic biomarker. The prevalence of low HER2 expression is unexplored in Indian population. Methods: This is a single center ambispective observational study conducted over a period of 4 years (1st January 2019 to 31st January 2023) at Dr. B.R.A, I.R.C.H, All India Institute of Medical Sciences (AIIMS), New Delhi, India. Consecutive female breast cancer patients registered during the study period with available clinical-pathological details were eligible for study inclusion. The primary objective of the study was to assess the prevalence of HER2 low breast cancer. HER2 low was defined as having HER expression by immunohistochemistry (IHC) of 1+ or 2+ with no amplification of the HER2gene detected with a fluorescent in situ hybridization (FISH) assay. Patients were divided into three categories: HER-2 high (IHC3+, IHC2+/FISH+), HER-2 low (IHC 1+, IHC2+/FISH-), and HER2-0 (HER2 negative, IHC:0). Staging description of the cases were done as per anatomic TNM classification according to AJCC 7th edition. Results: A total of 2200 female breast cancer were registered during the study period, of which 1932 patients had available clinical-pathological details. Among 1932 patients, 600 patients (31%) had high HER2 expression and remaining 1332 patients had HER2 low/HER2-0 expression. Of the 1332 cases, the median age was 49 years (range 18–91 years). The stage distribution was stage I, 94 (7.06%); stage II, 409 (30.70%); stage III, 528 (39.64%); and stage IV, 301 (22.59%). Eight hundred patients (60.06%) were hormone positive, and 532 (39.94%) cases were hormone negative. The prevalence of HER2 low expression was 798 (59.9%). It was observed in 640 (80%) of hormone positive cases and 158 (29.69%) hormone-negative cases (p < 0.001). Rest 534 cases were HER2 0 [160 cases (20%) were hormone positive, and 374 cases (70.31%) were hormone negative]. Conclusions: This is the first study from India to document the prevalence of low HER2 expression in female breast cancers. We observed the prevalence to be around 60 % in our population, which is more in hormone receptor-positive breast cancer. The estimated prevalence is higher than that observed in Western population, and it underscores the need to systematically categorize these patients for therapeutic decision making at presentation.
Clinicopathologic features of early stage HER2-low breast cancer.
Authors: Nashed Rebecca , Barger Hannah , Fishman Brooke Taylor , Schlyer Dylan A. , Makani Neeharika Srivastava 
Published: June 2023

e12545 Background: Breast cancer (BC) is the leading cause of cancer deaths in women worldwide. Traditionally, BC is divided into 3 categories: hormone receptor positive (HR+) if tumors overexpress either estrogen or progesterone receptors, HER2-positive (Pos) if tumors overexpress the human epidermal growth factor receptor protein (HER2), and triple negative if tumors lack overexpression of HER2, ER, or PR. 15% of all BC are HER2-Pos, which has poorer outcomes when compared to HER2-Neg. Early HER2 targeted therapies only showed benefit for treating tumors with high enough HER2 overexpression. Thus, HER2-Pos refers to tumors which stained 3+ for HER2 on immunohistochemistry (IHC) or 2+ with a positive result on amplification of the HER2 gene by fluorescence in-situ hybridization (FISH). In the recent DESTINY-Breast04 study, the drug trastuzumab deruxtecan showed benefit in treating metastatic BC patients with low levels of HER2 overexpression. HER2-Low, now a clinically relevant group, is defined as 1+ by IHC or 2+ and FISH negative. However, early stage HER2-Low BC is treated the same as HER2-Neg by the current standard of care. Large registry trials have described the HER2-Low patient population, mostly in the metastatic setting. Our study aims to describe the prevalence, pathological and clinical aspects of HER2-Low when compared to HER2-Neg BC in early stage BC patients within a community practice setting in the United States. Methods: This retrospective study analyzed 1,106 patients of which 120 were excluded due to being HER2-Pos. 986 HER2-Neg and HER2-Low patients of stages I-III were included. Patients had diagnosis dates between January 1st, 2015 and December 31st, 2022. Categorical and continuous analyses (two-proportion Z test) were performed to describe differences between HER2-Low and HER2-Neg patients at the time of diagnosis in age, tumor histology and grade, and need for chemotherapy. Results: 49% of patients (n = 1,106) were found to be HER2-Low. 91% of HER2-low patients were HR+, compared to 87% of HER2-Neg who were HR+ (p = 0.04). HER2-Low patients were more likely than HER2-Neg to have ductal carcinoma (82% vs. 75%, p = 0.01) and to be classified as grade 2 (58% vs. 48%, p = 0.001). The median age of patients with HER2-Low was 69 compared to 70 in patients with HER2-Neg disease. 36% of HER2-Low patients needed chemotherapy (neoadjuvant or adjuvant) compared to 35% who were HER2-Neg (p = 0.74). Conclusions: Our study revealed that HER2-Low patients were more likely than HER2-Neg patients to be HR+, grade 2, and to have ductal histology. In this early stage BC population, there was no difference in need for chemotherapy between HER2-Low and HER2-Neg patients. Future studies with a more racially diverse patient population looking at parameters of progression-free survival and overall survival in HER2-Low early stage BC population should be pursued.
Estrogen receptor positive breast cancer in an Afro-Caribbean cohort.
Authors: Cimpeanu Emanuela , Wu Alexander H , Lin Bo , Azam Mariam , Ventura Ana M , Chiu Edwin , Taiwo Evelyn 
Published: June 2023

e12550 Background: Estrogen receptor-positive breast cancer (EBC) accounts for 78% of breast cancer (BC) cases in the United States, and with better prognosis compared to other BC subtypes. There is limited information on the incidence, presentation, and outcomes of BC in black women from the Caribbean. We describe the clinicopathologic features and treatment outcomes of EBC in this underrepresented immigrant patient population. Methods: This is a retrospective study conducted at Kings County Hospital, a public hospital in a Brooklyn, New York neighborhood with the second highest population of Afro-Caribbeans in the United States. Demographics and clinicopathological data of patients diagnosed with BC from 2015-2018 were collected from the hospital’s tumor registry. Descriptive statistics and Chi-square testing were used to analyze the data. Results: Of the 299 women with a BC diagnosis, 185 (62%) had EBC, with median age of 61, and median BMI of 29.9. Stratification by menopausal status revealed 75% of these patients were post-menopausal. 37% of pre-menopausal and 28% of post-menopausal women presented with lymph node involvement (LNI). At diagnosis, 61% of patients had localized disease, 30% regional LNI, and 9% distant metastases. Sub-analysis revealed 25%, 22%, 28%, 16% and 9% with stages 0, I, II, III and IV respectively. 39% of patients presented with Nottingham Grade 3, 50% with Grade 2, and 11% with Grade 1 disease. 25% of patients without LNI had Oncotype Dx testing. 22% of these had Recurrence Score (RS) less than 11, 50% RS 11-25, and 28% RS 26 or higher. Of the 27 patients who received neoadjuvant treatment, 22% had complete pathologic response, 37% had partial response, and 33% had disease progression. 81% of patients self-identified as Afro-Caribbean, 27% reported first- or second-degree relatives with a BC diagnosis and 22% first-degree relatives with non-breast malignancy. At time of data analysis, at median of 6 years, 75% of all patients were relapse and progression-free. Lasting response was correlated with cancer stage (p < 0.01) but independent of tumor grade and Oncotype Dx RS (p = 0.18 and p = 0.29, respectively). Conclusions: In our study, Afro-Caribbean women with EBC presented with high-grade tumors and high incidence of regional LNI. Pre-menopausal women had a higher incidence of nodal involvement. Notable was a strong family history of cancer implying inherited or familial cancer syndromes. Progression-free survival was lower than expected and correlates with disease stage, but not with low Oncotype Dx RS. Further research is warranted to investigate better prognostic tools for this population.