bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract PS11-22: Lipophilic statins for prolonging dormancy and overall survival: A real-world retrospective investigation
Authors: Marti Juan Luis Gomez , Wells Alan 
Published: February 2021

Abstract
Background: Micrometastases from breast cancer (BC) might undergo quiescence following adjuvant therapies. Oftentimes they reactivate, prompting metastatic relapse and aggressive, uncurable disease. It is necessary to find alternative, safe therapies that could be used as adjuvants for delaying the dormancy process and reduce metastatic breast cancer (MBC) progression. Prior epidemiological studies found prolonged overall survival from chronic statin use. However, the effectiveness of statin use through different stages of progression, including advanced MBC, has not yet been defined. Methods: A real-world, retrospective analysis of 1,016 deceased patients with MBC treated from 1999-2019 at the University of Pittsburgh Medical Center (UPMC). Lipophilic statin (atorvastatin and simvastatin) use and dosing were retrieved from medical records through an IRB-approved R3 request and merged with already available clinical variables. A total of 122 patients were included in the analysis as the statin use group. This included patients who were prescribed statins through the course of their breast cancer. For measuring time to relapse, only patients with statin prescription before being diagnosed with MBC were selected. Log-ranks were used to compute survival. Uni- and multi-variate Cox hazard models were also applied. Statistical analysis was computed using the package ggpubr on R v3.6.3.Results: Women who used statins were older at the time of detection of primary (60 vs 52 years of age, respectively) and MBC (66 vs 56 years of age, respectively). An almost 2-fold reduction was found in the onset of liver metastasis as first relapse in the statin group, compared to general population (5.7% vs 10.4%, respectively). Increased overall survival (OS) was found among statin users who had ER (+) (p&lt;0.05), and HER2 (-) (p&lt;0.05) BC. Statins were associated with an increase in time from diagnosis until relapse, in ER (+) (p=0.03) and HER2(-) (p=0.02) patients with BC. Patients with ER (-), HER2 (-) MBC also seemed to partially benefit from statin use (p=0.09). Multivariate analysis adjusted for age, ER-status, statin use, and adjuvant chemotherapy also predicted increased OS for patients using statins. No differences in survival were seen when measuring time from metastatic diagnosis to death, suggesting that statins may be effective in prolonging dormancy but lack benefit against relapsing MBC.Conclusion: Lipophilic statins may prolong dormancy and overall survival but not slow the progression of relapsing metastatic breast cancer.
Citation Format: Juan Luis Gomez Marti, Alan Wells. Lipophilic statins for prolonging dormancy and overall survival: A real-world retrospective investigation [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS11-22.
Abstract PS11-23: Current landscape in phase 3 trials in breast cancer at major oncology conferences
Authors: Bretas Gustavo Oliveira , Bines José , Saad Everardo Delforge 
Published: February 2021

Abstract
Background: The oral presentation of studies at conferences may impact treatment practice even before the publication or regulatory approval. Methodological aspects and reporting patterns are evolving, and an assessment of these features may help understand the current landscape and the way forward. Methods: We analyzed the characteristics of primary analyses of phase 3 trials from oral sessions presented at ASCO, ESMO and SABCS 2017-19 and the timing of their subsequent publications. We excluded non-inferiority trials and duplicate presentations within the period. Results: Of 36 unique trials, 19/10/7 had a first author from Europe/United States/Asia or elsewhere, and 21/15 were in the (neo)adjuvant/palliative settings. All but one trial had 2 arms. The number of patients enrolled ranged from 226 to 4884 (median, 646). All but 2 trials were on systemic therapy, with 16 dedicated exclusively to hormone-receptor+, 8 to HER2+ and 6 to triple-negative disease. According to the authors, 23 (63.9%, 95% CI, 46.2 to 79.2%) trials were positive, and 13 were negative. For only 2 of the negative trials was the conclusion not entirely consistent with results. When sponsor information was available, 18/21 industry vs 4/14 academic trials were positive (P=0.002). Paradoxically, negative trials were larger than positive trials (medians of 2639 and 585 patients; P=0.002), perhaps because all but one of 13 negative trials were in the (neo)adjuvant setting, vs 9/23 among positive trials (P=0.004). The time to publication was significantly shorter for positive than negative trials (medians of 215 vs 785 days; HR=0.32; P=0.013). Of 30 trials with time-to-event endpoints, the ratio between observed:expected HR could be computed for 24: the mean was 0.88 for 15 positive and 1.43 for 9 negative trials (P=0.004; 1.09 overall). Conclusion: In recent phase 3 trials in breast cancer, positive trials are more likely than negative trials to be industry-sponsored, to assess the metastatic setting, and to be published earlier. These results also suggest that the treatment effect has been underestimated in positive trials. Research is ongoing to elucidate potential determinants of the latter hypothesis.
Citation Format: Gustavo Oliveira Bretas, José Bines, Everardo Delforge Saad. Current landscape in phase 3 trials in breast cancer at major oncology conferences [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS11-23.
Abstract PS11-31: Survival among female breast cancer patients who have survived a previous cancer
Authors: Pruitt Sandi L , Zhu Hong , Heitjan Daniel , Gerber David E , Maddineni Bhumika , Xiong Danyi , Halm Ethan , Murphy Caitlin 
Published: February 2021

Abstract
Background A growing number of women newly diagnosed with breast cancer have survived a previous cancer. Although little is known about their prognosis, this population is frequently excluded from clinical trials. Additional evidence about the survival of this population is needed, so that trial sponsors and investigators can create evidence-based trial eligibility criteria. Among women newly diagnosed with breast cancer, we examined the impact of previous cancer on overall and cancer-specific survival. Methods This population-based cohort study included patients age ≥66 years and diagnosed with breast cancer between 2005-2015 in linked SEER-Medicare data. Separately by breast cancer stage, we estimated overall survival using Cox regression and cause-specific survival using competing risk regression for women with and without previous cancer, adjusting for numerous covariates and competing risk of death from previous cancer, other causes, or the incident breast cancer. Results Of 138,576 women diagnosed with incident breast cancer, 10,822 (8%) had a previous cancer of another organ site. Many of these (n=5,014, 46.3%) were diagnosed ≤5 years of breast cancer. For all breast cancer stages except IV in which there was no significant survival difference, women with vs. without previous cancer had worse overall survival. This survival disadvantage was driven by deaths due to the previous cancer and other causes. In contrast, women with previous cancer generally had favorable breast-cancer specific survival; however this varied somewhat by stage and over time. Conclusions Many women newly diagnosed with breast cancer are already cancer survivors. These women had generally worse overall survival, worse survival from other causes, but their disease-specific survival varied depending on their breast cancer stage and over time.
Citation Format: Sandi L Pruitt, Hong Zhu, Daniel Heitjan, David E Gerber, Bhumika Maddineni, Danyi Xiong, Ethan Halm, Caitlin Murphy. Survival among female breast cancer patients who have survived a previous cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS11-31.
Abstract PS11-41: A spatially resolved single cell atlas of the human breast
Authors: Kessenbrock Kai 
Published: February 2021

Abstract
The human breast consists of lobules connected to an intricate network of ducts that are surrounded by fatty tissues, designed to produce and transport milk to nourish offspring. Histopathology has identified 10 major cell types based on morphological features but have provided limited information on cell states - the transcriptional programs of cell types that reflect different biological functions. In this study we have generated an unbiased ‘cell atlas’ of the normal human breast to define the cell types and cell states using single cell RNA sequencing and spatial transcriptomics methods. We performed 3’ microdroplet based single cell and nuclei RNA sequencing of 248,687 stromal cells and 89,301 nuclei from 35 women with pathologically normal breast tissues that were collected from mastectomies and reduction mammoplasties. Unbiased expression analysis identified four major cell types: adipocytes, epithelial cells (luminal and basal), fibroblasts and endothelial cells and defined their transcriptional programs. Additionally, 8 minor cell types were identified in the breast, including macrophages, T-cells, natural killer cells, mast cells, pericytes, apocrine cells, neurons and smooth muscle cells. Our data revealed hundreds of novel markers of these cell types and defined their transcriptional programs and cell states. Most cell types had multiple transcriptional programs including luminal epithelial cells (hormone receptor positive and secretory), basal epithelial cells (myoepithelial or basal), endothelial cells (E1, E2, E3), myeloid cells, T-cells and fibroblasts (F1-F4) and provided insight into developmental lineages. We further delineated the spatial organization of these cell types and cell states within the tissue architecture via a 34 antibody CODEX ultra-high plex immunofluorescence imaging experiment. Antibodies were targeted against epithelial, endothelial and immune cells and imaging data were acquired at single cell resolution from breast tissues measuring up to 35mm2. Cell phenotypes were independently clustered, correlated to transcriptomic data and cellular neighborhoods were mapped using nearest neighbor approximations. The breast cell atlas data provides an invaluable normal reference for the research community to understand how normal cell types are reprogrammed in diseases such as breast cancer.
Citation Format: Kai Kessenbrock. A spatially resolved single cell atlas of the human breast [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS11-41.
Abstract PS12-22: Maintenance therapy with everolimus plus aromatase inhibitors vs aromatase inhibitors as after first-line chemotherapy in HR+/HER2- metastatic breast cancer: Updated analyses of the phase III randomized MAIN-A trial
Authors: Guarneri Valentina , Cinieri Saverio , Dieci Maria Vittoria , Bengala Carmelo , Mariani Gabriella , Bisagni Giancarlo , Frassoldati Antonio , Zamagni Claudio , Orlando Laura , Giorgi Carlo Alberto , De Salvo Gian Luca , Conte PierFranco 
Published: February 2021

Abstract
Background Despite endocrine therapy is the mainstay of treatment for HR+/HER2- metastatic breast cancer (MBC), patients with high disease burden or those at risk of visceral crisis are still offered first-line chemotherapy (CT). Chemotherapy is generally followed by maintenance hormonal therapy. The MAIN-A study is an investigator-driven, randomized phase III trial designed to compare maintenance everolimus (EVE) combined with aromatase inhibitors (AI) versus AI alone in pts with disease control after first-line CT.Methods Postmenopausal pts achieving disease control (stable disease, partial response or complete response) after first-line CT were randomly assigned to EVE 10 mg po daily plus AI or to AI alone. Primary aim was PFS in the ITT. We present here overall survival (OS) results and the impact of tumor characteristics on PFS.Results 110 pts were randomized to EVE+AI (n=52) or to AI (n= 58). Primary aim results have been already presented (Guarneri V, ESMO Breast 2019), showing a non-significant prolongation of median PFS in the ITT population for EVE+AI (9.9 mos vs 7.2 mos, HR 0.764, 95% CI 0.501-1.164. Patients with visceral metastases tended to experience shorter PFS as compared with patients with patients with bone/soft tissues metastases (median 11.1 mos vs 6.4 mos, p=0.0746). The levels of estrogen receptor expression (&gt;or&lt; 50%) did not impact PFS, overall and by treatment arm. At the time of this writing, a total of 61 death events have been recorded. No difference in OS was observed between the two arms (median 33.9 mos for EVE+AI vs 33.5 mos for AI, HR 0.97, 95% CI 0.59-1.61).Conclusions Maintenance EVE+AI did not significantly impact on the outcome of metastatic breast cancer patients deemed suitable for first line chemotherapy.
Citation Format: Valentina Guarneri, Saverio Cinieri, Maria Vittoria Dieci, Carmelo Bengala, Gabriella Mariani, Giancarlo Bisagni, Antonio Frassoldati, Claudio Zamagni, Laura Orlando, Carlo Alberto Giorgi, Gian Luca De Salvo, PierFranco Conte. Maintenance therapy with everolimus plus aromatase inhibitors vs aromatase inhibitors as after first-line chemotherapy in HR+/HER2- metastatic breast cancer: Updated analyses of the phase III randomized MAIN-A trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS12-22.
Abstract PS13-12: Apatinib combined with taxanes and platinum neoadjuvant chemotherapy for patients with triple-negative and HER2-positive breast cancer: A multicenter, randomized, open-label, phase II trial
Authors: Liu Yunjiang , Zhang Xiangmei , Wang Li , Cao Miao , Zhang Shuo , Zhang Hui , Zhou Yarong , Wang Jintian 
Published: February 2021

Abstract
Background: Apatinib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR2), has demonstrated a promising efficacy in patients with metastatic breast cancer. For triple-negative and HER2-positive subtypes, increasing the pathological complete response (pCR) of neoadjuvant therapy may benefit their clinical outcomes. Here, we assessed whether the combination of Apatinib with neoadjuvant chemotherapy elevate the pCR rate in locally advanced breast cancer. Method: In this multicenter, open-label trial, we randomized 53 patients into TP neoadjuvant chemotherapy (docetaxel 75 mg/m2 or nab-paclitaxel 260 mg/m2 or paclitaxel liposome 175 mg/m2 day 1, and carboplatin AUC=6 or cisplatin 75 mg/m2 or lobaplatin 30 mg/m2 day 1), or combined with apatinib (500mg day 1-21) . Trastuzumab was added to neoadjuvant therapy in HER2-positive subtype. Six cycles were repeated every 3 weeks. Results: In total patients with stage IIb-IIIc triple-negative and HER2-positive breast cancer, the addition of apatinib to TP neoadjuvant chemotherapy (Apa+TP) significantly increased the pCR rate (70.8%, 17/24), compared with TP along (41.4%, 12/29), P=0.032. When separating patients into triple-negative (Apa+TP 66.7% (8/12) vs. TP 42.9% (3/7)) and HER2-positve (Apa+TP 75% (9/12) vs. TP 40.9% (9/22)) subtypes, the effect of apatinib on pCR was also improved though no significant differences were found (P=0.377; P=0.080 separately) compared with control group. The most common Grade 3-4 adverse events (AE) included hypertension (Apa+TP 12.5% vs. TP 0%, P=0.173), hand-foot syndrome (Apa+TP 8.3% vs. TP 0%, P=0.389) and erythra (Apa+TP 4.2% vs. TP 0%, P=0.924). No significant differences of toxic effects were found between Apa+TP and control group. Conclusion: Apatinib combined with TP neoadjuvant chemotherapy significantly increased the pCR rate in patients with locally advanced triple-negative and HER2-positive breast cancer, indicating an applicable strategy in the future.
EfficacyTriple-negative breast cancer efficacyHer2-positive breast cancer efficacySafety
Citation Format: Yunjiang Liu, Xiangmei Zhang, Li Wang, Miao Cao, Shuo Zhang, Hui Zhang, Yarong Zhou, Jintian Wang. Apatinib combined with taxanes and platinum neoadjuvant chemotherapy for patients with triple-negative and HER2-positive breast cancer: A multicenter, randomized, open-label, phase II trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-12.
Abstract PS13-36: Prevention of chemotherapy-induced alopecia: A prospective study in breast and ovarian cancer patients
Authors: Papadopoulos Lia A , Chua Susan , Goss Geraldine , Johnson Jane , Ling Aaron , Devitt Bianca 
Published: February 2021

Abstract
Background: Scalp cooling minimises chemotherapy-induced alopecia (CIA) which may reduce distress, improve quality of life and body image. This study assesses scalp-cooling efficacy in women receiving chemotherapy for early and advanced breast and ovarian cancer. Methods: Women with breast or ovarian cancer undergoing chemotherapy and scalp cooling at two intuitions were enrolled prospectively. Data collected included demographics, chemotherapy agent(s), hair loss and reasons for discontinuing scalp cooling. Successful hair preservation (SHP) was defined as Dean’s scale grade 0-2 (&lt;!–=50%) hair loss without desire for head-cover use at the completion of chemotherapy. Results were analysed using descriptive statistics. Results: 188 patients were enrolled, mean age 54 [28-83] . 90 women (48%) achieved SHP. 120 (64%) completed scalp cooling. Reasons for discontinuation included: intolerance 34 (49%), perceived loss of hair in 28 (41%) and extra chair time in 6 (9%). 14% continued scalp cooling despite significant hair loss (&gt;50%) SHP was significantly higher in non-anthracycline regimens; 62% (70/112) compared with anthracycline-containing regimens; 24% (18/74), p&lt;0.0001. Single-agent taxane regimen achieved highest SHP in 70% (31/44)and in carboplatin/Paclitaxel regimen; 80% (16 of 20). SHP was lower in Docetaxel-Cyclophosphamide; 48% (21/44), in FEC-D; 27% (20/74) and in AC-T; 26% (16 of 62). SHP rates did not differ between ethnicities; 47% (15/32) in Asian and 47% (75/156) of non-Asian ethnicities, p=0.90. In non-anthracycline regimens SHP was numerically, but non-significantly higher in younger age (&lt;65) 65% (52/81) compared with older age (&gt;/=65) 57% (17/29). Conclusion: Among women receiving chemotherapy for early or advanced breast and ovarian cancer, scalp cooling offers a chance to prevent CIA with most success in taxane +/- carboplatin regimens.
Further study is warranted into patients views on the trade-off of benefits and costs in this limited, resource intensive intervention.
Citation Format: Lia A Papadopoulos, Susan Chua, Geraldine Goss, Jane Johnson, Aaron Ling, Bianca Devitt. Prevention of chemotherapy-induced alopecia: A prospective study in breast and ovarian cancer patients [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-36.
Abstract PS14-04: A picture worth a thousand words - “classic” inflammatory breast cancer (IBC) appearance associated with overall survival
Authors: Balema Wintana , Liu Diane , Shen Yu , El-Zein Randa , Kai Megumi , Overmoyer Beth , Miller Kathy D , Le-Petross Carisa , Ueno Naoto T , Woodward Wendy A 
Published: February 2021

Abstract
Background: IBC is considered a clinical diagnosis characterized by rapid onset of diffuse skin changes in the setting of a breast cancer diagnosis. A wide variety of visual changes are accurately diagnosed as IBC. Here, we sought to determine whether the most subjectively “classic” appearing presentation (swollen, involved breast with nipple inversion and diffuse skin change) was associated with worse outcomes.
Method: We reviewed the images and charts of patients from the prospective IBC registry from the MD Anderson IBC Clinic. Breast medical photographs were reviewed by a non-expert and the visual presentation was scored as classic (as above), not classic, and in between. Comparative analyses were used to assess differences between patient groups using Chi-squared test, or Fisher’s exact test for categorical variables. Wilcoxon rank sum test was used for continuous measures. We used the Kaplan Meier estimator and the log-rank test to investigate association between scoring and survival distributions. Cox proportional hazard regression was employed to assess the impact of important covariates on the overall survival.
Results: We analyzed 245 IBC patients with median age 55 (range, 26-81), M0 vs. M1 status (157 and 88 patients, respectively), 68 TNBC vs. 177 non-TNBC patients. The classic presentation was significantly associated with smoking, post-menopausal status, and metastatic disease at presentation (P = 0.002, 0.018, and 0.004, respectively). Presentation was significantly associated with OS in univariate analysis (P &lt; 0.001). 10 year overall survival was 57% vs. 33% for classic (score 3) versus non-classic or in between presentation. The multivariable Cox regression model adjusting for clinical staging (P&lt;0.001) and TNBC status (P&lt;0.001) demonstrated classic presentation score was significantly associated with poorer OS time (HR 2.4, CI 1.6-3.6, p&lt;0.001).
Conclusions: A visual inspection of presentation photograph for “classic” appearance, obvious swelling, skin change, and nipple inversion, independently predicted poorer OS in IBC. Further work is warranted to understand the differences in classic and non-classic presentations, and the relationship between smoking and breast cancer presentation.
Citation Format: Wintana Balema, Diane Liu, Yu Shen, Randa El-Zein, Megumi Kai, Beth Overmoyer, Kathy D Miller, Carisa Le-Petross, Naoto T Ueno, Wendy A Woodward. A picture worth a thousand words - “classic” inflammatory breast cancer (IBC) appearance associated with overall survival [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS14-04.