bluuebunny/crossref_metadata_2025_split huggingface dataset:
Optimal neoadjuvant treatment and prognostic factors in patients with HR-positive/HER2-positive early or locally advanced breast cancer: A national real-world study in China.
Authors: Liu Zhenzhen , Zhu Jiujun , Wang Chengzheng , Lu Zhenduo , Chen Xiuchun , Li Lianfang , Sun Xianfu , Zhang Chongjian , Qiao Jianghua , Yan Min 
Published: July 2024

e12514 Background: Few data have been reported regarding breast cancer (BC) population characterized by HR+/HER2+ especially in a real-world setting in China. This analysis aimed at identifying differences in short-term treatment outcomes of different neoadjuvant therapy (NAT) regimens, effects of the demographics and clinical features on short-term outcomes of NAT, and further understanding the prognostic factors related to those outcomes in HR+/HER2+ early (EBC) or locally advanced BC (LABC) pts by using dataset from National Cancer Information Database (NCID) in China. Methods: This retrospective, multicenter, real-world study used electronic medical record data from NCID. We analyzed HR+/HER2+ EBC or LABC Chinese pts who were initially diagnosed between Jan 1, 2019 and May 31, 2022 and received NAT followed by surgery during study period. Primary endpoints included total pathological complete response (tpCR) and breast pCR (bpCR). Secondary endpoints included disease-free survival (DFS) and event-free survival (EFS). Results: 3792 pts from NCID covering 51 hospitals, 26 provinces met inclusion criteria and were included. After controlling for age and post-surgery N staging, 1-, 2- and 3-yr DFS was similar between trastuzumab (T) and T+pertuzumab (P) NAT subgroup (92.79%, 87.20% and 83.32% vs 94.83%, 88.82% and 87.88%; p=0.1120). 1-, 2- and 3-yr EFS was higher in T+P subgroup (T vs T+P: 85.24%, 82.35%, 77.01% vs 90.86%, 89.65%, 82.78%; p = 0.0003). Logistic regression multivariate analysis showed improved tpCR and bpCR was independently positively associated with receiving T+P NAT (vs T: both p < 0.0001), platinum NAT (vs anthracycline: p = 0.0071 and 0.0122, resp.), while negatively associated with receiving no targeted therapy (vs T: p = 0.0002 and < 0.0001, resp.), ≥ 65 yrs (vs > 40 yrs, < 64 yrs: p = 0.0116 and 0.0290, resp.), or post-surgery ER positive (vs negative: both p < 0.0001). Conclusions: HR+/HER2+ EBC or LABC gained short- and long-term benefit from HER2 dual-blockade therapy in clinical practice. Prognostic factors for improved tpCR and bpCR included T+P and platinum NAT, whereas ≥ 65 yrs and post-surgery ER+ were predictive of decreased tpCR and bpCR. [Table: see text]
Cost-effectiveness of adjuvant abemaciclib and ribociclib in high-risk, hormone receptor–positive, early breast cancer in India.
Authors: Sra Manraj Singh , Sasi Archana , Batra Atul , Bakhshi Sameer , Ganguly Shuvadeep 
Published: July 2024

e12516 Background: Incorporating adjuvant cyclin-dependent kinase (CDK) 4/6 inhibitors abemaciclib and ribociclib along with endocrine therapy has been shown to improve invasive disease-free survival (iDFS) for hormone receptor-positive (HR+) human epidermal receptor 2 negative (HER2-) early breast cancer (EBC). This study assesses the cost-effectiveness of this strategy, along with adjuvant aromatase inhibitors (AI) from an Indian perspective. Methods: A Markov chain model evaluated the cost-effectiveness of abemaciclib and ribociclib with letrozole compared to letrozole alone for HR+/HER2- EBC from a payer perspective in India. Key measures included lifetime quality-adjusted life years (QALY), life-years (LY), and total costs. This study explores two scenarios for effectiveness: a best-case (BC) scenario, where the benefit of CDK4/6 inhibitors in improving iDFS lasts a lifetime, and a worst-case (WC) scenario, where benefits disappear after 5 years. Probabilistic sensitivity analyses (PSA) were used to account for simulation uncertainty. Results: In the BC scenario, abemaciclib added 2.17 QALY and 4.96 LY, costing $27,756.65 more. Ribociclib in the BC scenario added 0.98 QALY and 2.58 LY, with added costs of $20,494.6. The incremental cost-effectiveness ratio for abemaciclib and ribociclib surpassed the willingness to pay threshold for in India in both scenarios (Table). At current market prices there is 0% probability of cost-effectiveness of abemaciclib and ribociclib. The cost of abemaciclib and ribociclib needs to be reduce by 78.61% and 87.19%, respectively to achieve cost-effectiveness. Conclusions: The combination of adjuvant abemaciclib or ribociclib with letrozole is not cost-effective for HR+/HER2- EBC in India in either the best or worst-case scenario.[Table: see text]
The efficacy of primary progesterone on survival in early breast cancer: A real world scenario.
Authors: Joshi Shalaka Prakash , Engineer Mitchelle , Vanmali Vaibhav , Siddique Shabina , Hawaldar Rohini W. , Badwe Rajendra A. 
Published: July 2024

e12522 Background: Surgery performed during progestogenic milieu improves survival in breast cancer patients. We previously proved efficacy of pre-operative progesterone in high-risk, operable breast cancer. In another multicenter randomized trial, intra-operative peri-tumoral local anesthetic injection showed 29% reduction in mortality. In this study, several patients had also received progesterone injection since this is adopted as standard of care across some centers including ours. We assessed the effectiveness of pre-operative progesterone in patients who were randomized in the local anesthetic study. Methods: We analyzed 1583 patients randomized on the local anesthetic study during December 2011-October 2018 with respect to receipt of progesterone. All patient who had breast lump of ≥2cm and/or node positive were eligible to receive progesterone injection before surgery. Kaplan Meier curves were plotted along with Cox regression analysis to study factors affecting disease-free and overall survival. Results: Of 1583, 454 patients did not receive, and 1129 patients received progesterone before surgery. The median age of whole cohort was 51 years, median pT size was 3 cm, 45% were node positive, 60% ER/PR+ and 24%TNBC. At median follow-up of 68 (0·5-72) months in surviving patients, there were a total of 292 DFS events (progesterone arm-193, no-progesterone arm-99). The 5-year disease-free survival (DFS) was 86.5% in the progesterone arm and 79.2% in the no-progesterone arm (HR-0.57,0.45-0.73, P<0.001). The 5-year overall survival (OS) was 90.5% in the progesterone arm and 82.8% in the no-progesterone arm (HR-0.47,0.36-0.63,P<0.001). On Cox Regression analysis (Table), administration of progesterone injection was an independent prognostic factor for DFS (HR-0.53,0-41-0.70, p<0.001) and OS (HR-0.44,0-32-0.60, p<0.001) both. Conclusions: The receipt of pre-operative progesterone improved outcomes in the setting of another randomized trial. It should be administered to all high risk (T2/N1) breast cancer patients who are planned for surgery first. [Table: see text]
Real-world (RW) risk of recurrence among patients (pts) diagnosed with stage II-III HR+/HER2− early breast cancer (EBC) treated with endocrine therapy (ET) in the US.
Authors: Razavi Pedram , Ahmed Mehnaj , Roush Ashley , Parikh Rohan , Hitchens Abigail , Shen Sherry , Safonov Anton , Jhaveri Komal L. , Robson Mark E. , Peacock Nancy Walker , Ma Yanjun , Santarsiero Elizabeth Chertow , Ganapathy Vaidyanathan , Shah Rohan M. , Amefule Adaeze Q. , Lteif Agnes , Blakely L. Johnetta 
Published: July 2024

e12533 Background: Despite improved management of HR+/HER2− EBC, pts experience recurrences while on or up to decades after ending standard-of-care (SOC) ET. Addition of adjuvant (adj) cyclin-dependent kinase 4/6 inhibitors (CDK4/6is), ribociclib and abemaciclib, to SOC ET resulted in significant improvement of outcomes in pts with HR+/HER2− EBC at risk of recurrence. In NATALEE, ribociclib showed invasive disease-free survival (iDFS) benefit in a broader population, including select node-negative (N0) disease. This RW study describes short-term recurrence in pts with HR+/HER2− stage II-III EBC treated with SOC adj ET ± chemotherapy (CT) in the last decade in the US, prior to use of adj CDK4/6is. Methods: A medical record review from large academic (Memorial Sloan Kettering Cancer Center) and community (Tennessee Oncology) oncology practices was conducted. Adult women with stage II-III HR+/HER2− BC (AJCC 8) who underwent surgical resection and initiated adj ET between Jan 2012 and Dec 2018 were included. Pts were randomly selected for equal distribution by year of adj ET initiation. Study measures were summarized descriptively. Kaplan-Meier method was used to estimate 3-, 5-, and 7-y iDFS and distant disease–free survival (DDFS). Results: Medical charts of 992 pts were analyzed (median follow-up from initiation of adj ET, 6.3 y). Median age was 58 y. Most pts (76.7%) had stage II disease at diagnosis, 64.0% received CT, and 34.2% were premenopausal. In total, 35.8% of pts were N0. Among all N0 pts, ≈41.4% had high-risk tumor features, as defined by NATALEE: >5 cm, 9.3%; 2-5 cm with G3, 25.9%; 2-5 cm with G2 + high genomic risk, estimated at 6.2%. N1(1-3) and N2/N3 (≥4) involvement was seen in 46.8% and 17.4% of pts, respectively. Analyses of iDFS/DDFS showed cumulative risk of invasive disease recurrence, predominantly distant disease, over 7 y in 21.4% across all stage II/III pts and 25.7% among the N0 pts meeting NATALEE criteria. Conclusions: This RW analysis from 2 major academic and community centers in the US confirms pts with stage II-III HR+/HER2− EBC, including select pts with N0 disease, experience considerable risk of recurrence, as early as during the adj treatment period cumulating over time. These findings warrant the consideration for tolerable treatment escalation for pts with stage II-III HR+/HER2− EBC.
An overview of psychological analysis of patients with breast cancer undergoing total mastectomy and breast conservation surgery and its impact on objectified body consciousness at a tertiary care cancer centre.
Authors: Somashekhar S.P. , Jaiswal Richa , Rajgopal Ashwin K. , Fernandes Aaron Marian , Chandrashekar Rohit Kumar C. 
Published: July 2024

e12537 Background: Breast cancer is the most common cancer among females, and surgery plays a central role in its treatment. Surgical treatments may have a negative psychological impact on women’s mental health regarding their body image. The purpose of this study was to compare the psychological health insights pertaining to objectified body consciousness scores before and after the surgery and also to observe whether these scores were comparable across the surgery types. Methods: This retrospective qualitative study included 706 breast carcinoma patients who underwent either Breast Conservation Surgery or Total Mastectomy at Manipal Cancer Centre, between the years 2020-2021. A validated questionnaire of Objectified Body Consciousness was used to obtain responses at diagnosis and at 6 months postsurgery and final scores were calculated for both instances. Two sample t- tests/analysis of variance and Chi-square tests were used to compare continuous and categorical variables respectively. Results: Out of total 706 breast cancer patients, 402 patients underwent Breast Conservation Surgery and 304 underwent Total Mastectomy procedure. A statistically significant change was seen in the mean Objectified Body Consciousness Score (14.22±15.44) for all patients when compared pre-operatively (72.72±11.38) and postoperatively (60.15±17.58). This change was higher in the Total Mastectomy group (29.38±11.53). Also, statistically significant rise in scores was seen with increasing age. There was a statistically significant difference between BCS and Total Mastectomy groups with respect to the distribution of age group, marital status, types of cancer, stage and grade of cancer, NACT administration and postoperative mean objectified body consciousness scores of patients (p-value <0.05). Conclusions: We could affirmatively conclude in our study that younger breast cancer patients and all patients who underwent a total mastectomy, had more psychological apprehension with the body image post-surgery, signifying these groups should be encouraged by healthcare professionals to reach out for counselling at the earliest. Knowing the pre-operative Objectified Body Consciousness scores and the type of surgery the patient is going to undergo, will help us to streamline categorical psycho-educational programs for each group and personalise our healthcare professionals to encourage women to reach out to social support groups and directed counselling at the earliest. This will help women adapt to their transformed life and be mentally prepared for the changes that are expected post-surgery.
Major pathologic response and long-term clinical benefit in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer after neoadjuvant chemotherapy.
Authors: ji Lei , Chen Xi , Qian Xiaoyan , Xiao Min , Li Qing , Li Qiao , Wang Jiayu , Fan Ying , Luo Yang , Chen Shanshan , Ma Fei , Xu Binghe , Zhang Pin 
Published: July 2024

e12608 Background: Rates of pathological complete response (pCR) are much lower in patients with hormone receptor–positive (HR+) /HER2-negative (HER2-) breast cancer than in those with HER2-positive and triple-negative breast cancer (TNBC). The majority of HR+/HER2- breast cancer patients can also achieve long-term survival despite not attaining pCR, indicating limited prognostic value of pCR in this population. This study aimed to identify novel pathologic end points for predicting long-term outcomes in HR+/HER2- breast cancer after neoadjuvant chemotherapy. Methods: We analyzed HR+/HER2- breast cancer patients with stage II-III tumors who underwent curative surgery after neoadjuvant chemotherapy from three hospitals. Major pathologic response (MPR), defined as the presence of Miller-Payne grades 3-5 and positive lymph node ratio of ≤10%, was used as a pathological evaluation indicator. MPR evaluates the extent of residual invasive carcinoma in both the breast and axillary lymph nodes following neoadjuvant therapy. We assessed the association between MPR and event-free survival (EFS) and performed Multivariable Cox regression to identify independent factors associated with EFS. Results: From January 2010 to December 2020, 386 patients were included in the final analysis. The median age was 46 years. 244 patients (63.2%) were premenopausal, with 271 (70.2%) patients diagnosed with stage III disease. The predominant neoadjuvant chemotherapy regimen was anthracycline combined taxane (79.3%). 28 patients (7.3%) achieved pCR and 118 patients (30.6%) achieved MPR. The median duration of follow-up was 54.4 months. Multivariate analysis showed that PR expression, Clinical stage, Miller–Payne grades and Positive lymph node ratio were independent prognostic factors for EFS (all P values <0.05). The prognostic effect of MPR remained in multivariable models (hazard ratio (HR), 0.45; 95% confidence interval (CI), 0.26–0.76; P = 0.008), with 5-year EFS of 87% vs. 68% in the non-MPR group. In non-pCR patients, those who achieved MPR exhibited a similar EFS compared with pCR patients (HR, 2.25; 95% CI, 0.51–9.84; P = 0.28). Conclusions: MPR was a novel pathologic end point for prognostic evaluation in HR+/HER2- breast cancer after neoadjuvant chemotherapy. Compared to pCR, MPR may hold greater applicability in the prognosis evaluation.
A propensity-matched analysis of the efficacy and safety of neoadjuvant inetetamab and pertuzumab with paclitaxel and carboplatin (TCbIP) on locally advanced HER2-positive breast cancer.
Authors: Jiang Mingxia , Chai Yue , Liu Jiaxuan , He Maiyue , Wang Yipeng , Xue Yang , Xing Zeyu , Zhang Mengqi , Zhou Shihan , Ma Fei , Wang Jiayu , Yuan Peng , Xu Binghe , Li Qiao 
Published: July 2024

e12609 Background: Inetetamab is an Fc segment-modified innovative anti-HER2 monoclonal antibody. It has been proven to be effective and safe in HER2-positive advanced breast cancer. However, its efficacy and safety in the neoadjuvant treatment of HER2-positive locally advanced breast cancer (LABC) remains to be validated. This study aimed to evaluate the efficacy and safety of Inetetamab-based neoadjuvant therapy (TCbIP). Methods: In this prospective cohort study, we investigated the efficacy and safety of TCbIP in neoadjuvant therapy for HER2-positive LABC, and compared with TCbHP regimen (trastuzumab combined with pertuzumab, paclitaxel, and carboplatin) with propensity score matching (PSM). Thirty-four patients (clinical stage IIA-IIIC, HER2-positive LABC) were prospectively enrolled in this study and treated with the TCbIP regimen. The primary endpoint was total pathological complete response (tpCR). Adverse events (AEs), objective response rate (ORR), and near-pCR were key secondary endpoints. Results: The pCR rate of 28 patients who finished surgery was 60.7%, and was comparable and slightly higher (60.7% vs. 53.6%, P = 0.510) than the TCbHP group in PSM. The ORR was 96.4% and DCR reached 100.0%. The most common ≥grade 3 AE was neutropenia (21.4% vs. 11.9%, P = 0.350). No significant reduction in left ventricular ejection fraction was observed, and no patient withdrew from treatment due to AEs. Conclusions: Neoadjuvant therapy with TCbIP resulted in good efficacy and safety in patients with HER2-positive LABC, and might be another promising option for neoadjuvant treatment. Clinical trial information: NCT05749016 .
Use of an AI-powered visualization platform to support precision clinical decision-making in patients with breast cancer undergoing neoadjuvant chemotherapy.
Authors: Reid Vincent , Weitz Michelle , Biancalana Matthew , Cole John A. , Rosen Barry 
Published: July 2024

e12618 Background: Chemotherapy to reduce cancer burden and tumor size ("downstaging") is widely used in neoadjuvant treatment of early-stage breast cancer (ESBC) and can have a dramatic impact on selection of further treatment courses, including surgery. The resulting decision-making process between physicians and cancer patients requires detailed and effective communication of the patient's disease status, and clear presentation of this information in Tumor Board settings. Artificial intelligence (AI) -powered visualization platforms offer the potential to aid in evaluating breast tumor location and morphology, and accordingly optimize treatment. Additionally, these tools offer enhanced communication with patients regarding future treatment options, particularly serving as clinical decision support (CDS) tools. Methods: We assessed the performance of an AI platform that employs dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) to render three-dimensional (3D) visualizations of breast tumors and 5 additional chest tissues on an independent validation dataset comprise of 100 ESBC cases with ground-truth tumor labels vetted by 2 breast-specialized radiologists. The platform provides 3D depictions of the tumor and its multi-tissue context, as well as functionalities for quantifying tumor morphology, tumor-to-landmark structure distances, excision volumes, and approximate surgical margins. We subsequently evaluated the tool's utility in a real-world setting to understand how the tool impacts clinical decision-making and patient communication, specifically around surgical planning in the context of neoadjuvant chemotherapy (NACT). Results: The platform generated accurate 3D tumor maps, as evidenced by a median Dice score of 75.6% and a median Hausdorff distances of 15.1 mm relative to the radiologist validation set. The automatic longest tumor dimension calculations were linearly correlated with radiologist direct measurements (Pearson correlation coefficient = 0.78) and had a median absolute difference of 6.3 mm. We found strong overlap between the platform’s ground-truth convex hulls, as shown by a median Dice score of 81.5%. When used by a skilled breast-specialized surgeon, the tool enabled rapid and intuitive patient-physician communication of the location and extent of disease, and potential degrees of downstaging to breast-conserving surgery. Conclusions: Detailed 3D tumor and surrounding multi-tissue depictions offer both qualitative and quantitative comprehension of cancer topology and may aid in formulating an optimal treatment approach for breast cancer treatment. We show that detailed depictions enhance communication between physicians and patients and may aid in streamlining decision-making.
Achieving World Health Organization Global Breast Cancer Initiative targets: A situational analysis and action plan in Nigeria.
Authors: Romanoff Anya , Olasehinde Olalekan , Okereke Chukwuma Eze , Agodirin Olayide S , Ali Nuhu , Irowa Omorodion , Muhammad Abubakar Bala , Sunday Nweke Nneka , Wuraola Funmilola Olanike , Owoade Israel Adeyemi , Kahn Rivka , Kalvin Hannah L , Lynch Kathleen , Di Bernardo Matteo , Fitzgerald Grace , Mango Victoria , Vreeman Rachel , Anderson Benjamin O. , Kingham T. Peter , Alatise Olusegun Isaac ,   African Research Group for Oncology (ARGO) Consortium
Published: July 2024

e13782 Background: Breast cancer [BC] is the leading cause of cancer incidence and mortality in Nigerian women, with five-year survival of 44% vs. 90% in the US. The World Health Organization [WHO], through the Global Breast Cancer Initiative [GBCI], endorses a 3-pillar program that promotes early-stage detection, timely diagnosis, and expeditious treatment. We performed a situational analysis to understand predictors of achieving WHO targets in Nigeria as a basis for implementing an action plan. Methods: We conducted a cross-sectional study using a prospective multi-institutional BC patient database in Nigeria (funded by ASCO), which was expanded sequentially from a single institution in May 2022 to seven institutions representing all geopolitical zones by May 2023. All newly diagnosed BC patients enrolled in the database from 2022-2024 were included. We analyzed univariate associations with WHO GBCI key performance indicators [KPIs] using logistic regression and global p-values. Results: Five-hundred and seventy-one patients were included. Median age was 48 years (IQR 40,56). Conclusions: The utilization of a multi-institutional BC database inclusive of all geopolitical zones in Nigeria provides vital insight for monitoring progress toward WHO targets. Our findings suggest that breast health clinical encounters (through CBE or mammogram) prior to developing BC are associated with reduced diagnostic delays and early-stage BC diagnosis. For those with BC, multiple touchpoints with the healthcare system are associated with increased delays and late-stage diagnosis, which justifies the need for developing patient navigation programs. [Table: see text]