bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract ES8-3: Everything Comes at a Price - Toxicity, Cost and Adherence to Endocrine Therapy
Authors: Hershman DL 
Published: March 2020

Abstract
Despite the proven efficacy of aromatase inhibitors (AIs) for the treatment of hormone-sensitive breast cancer (BC) adherence to therapy for the full duration of 5-years is suboptimal. Adherence is likely even lower for extended adjuvant therapy for up to 10-years. Issues related to non-adherence are increasingly important, as analyses from prospective randomized trials show compliance to endocrine therapy is associated with improved disease-free survival. The reasons for non-adherence to hormonal therapy are multifactorial. Barriers to compliance include patient, physician, medication and system related variables and poor compliance is usually associated with a combination of these factors. Characteristics associated with non-adherence include very high and low age, minority race, being single, increased number of comorbidities, lack of knowledge about efficacy of AI therapy, history of non-adherence to other chronic medications, limited insurance status, and higher out of pocket costs.
Side effects from hormonal therapy is the most common reason for early discontinuation. AI arthralgia has been estimated to affect 45-60% of patients, many of whom report severe or continuous pain. One study reported an overall AI discontinuation rate of 32.4% within 2 years due to adverse effects, 24.3% specifically due to musculoskeletal symptoms, which was the primary reason for discontinuation. There is no consensus on the best treatment for AI arthralgia. The most commonly used therapy is NSAIDs, although there are no formal data testing their efficacy for AI arthralgia, and they are associated with potentially severe adverse effects. Randomized controlled trials have shown benefits from exercise (aerobic and strength training exercises), acupuncture, omega-3-fatty acids and duloxetine compared to placebo for AI arthralgia. Studies have also demonstrated improvement in symptoms over time even among patients receiving placebo. Various educational interventions have also been studied to improve adherence. A systematic review of behavioral interventions to enhance adherence to hormone therapy found five articles that met inclusion criteria and none reported the interventions significantly enhanced adherence compared to usual care. All evaluated educational interventions with or without reminders or navigation. In addition, a multicenter randomized clinical trial of patients with early stage breast cancer on AI’s found that bi-weekly unidirectional text messages for 36 months focused on overcoming potential barriers to medication adherence did not result in improved adherence to hormonal therapy. It is likely that improving long-term adherence will likely require sustained behavioral interventions and support.
Citation Format: DL Hershman. Everything Comes at a Price - Toxicity, Cost and Adherence to Endocrine Therapy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr ES8-3.
Abstract ML: What would Bill think?
Authors: Sparano JA 
Published: March 2020

Abstract
Since the untimely passing of Bill McGuire in 1992, breast cancer mortality rates have declined by approximately 40% despite stable incidence rates, largely due to mammographic screening and broader application of systemic adjuvant therapy in early stage disease. Continued progress is likely given recently reported clinical trials demonstrating improved survival in metastatic disease, including immune checkpoint blockade in triple negative disease, CDK4/6 inhibitors in ER-positive disease, and second-generation immunconjugates in HER2-positive disease. This remarkable progress in reducing breast cancer mortality has come with a price - broader use of adjuvant chemotherapy in patients with early stage disease who might have been adequately treated and perhaps cured without chemotherapy, and the short and long term side effects that may accompany it - which raises the question - what would Bill think of our progress? How would he challenge us to do better?This lecture will focus on three distinct topics that address some potential challenges: (1) How can gene expression profiles and other diagnostic tests be used to guide the use of adjuvant systemic therapy? (2) is time for reappraisal of active surveillance to detect impending recurrence and prevent it? (3) Are there diagnostic and therapeutic strategies that can be used to identify tumors at highest risk of systemic dissemination, and novel therapeutic strategies that block dissemination?
Citation Format: JA Sparano. What would Bill think? [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr ML.
Abstract MS2-2: Targeting the cell cycle - Beyond CDK4/6 inhibition
Authors: Jeselsohn R 
Published: March 2020

Abstract
Over the past several years three CDK4/6 inhibitors were approved for the treatment of metastatic ER+ breast cancer. This class of drug has had a major impact on patient outcomes and more recent analyses showed improvement in overall survival in addition to a significant delay in the need for chemotherapy and increase in progression free survival. Despite the remarkable clinical benefit, there are patients who have primary resistance to CDK4/6 inhibitors and the majority of patients will ultimately develop resistance to this class of drugs. Multiple pre-clinical studies and some clinical data have provided insights to the mechanisms of resistance to CDK4/6 inhibitors guiding the development of clinical trials after progression on a CDK4/6 inhibitor. In this presentation, I will review the mechanisms of resistance to CDK4/6 inhibitors and the ongoing clinical trials investigating novel therapeutic strategies to enhance responses to CDK4/6 inhibitors and for treatment after the acquisition of resistance to CDK4/6 inhibitors.
Citation Format: R Jeselsohn. Targeting the cell cycle - Beyond CDK4/6 inhibition [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr MS2-2.
Abstract OT1-01-06: A pilot study utilizing a HER2 directed dendritic cell vaccine during neoadjuvant therapy of HER2+ breast cancer
Authors: Soliman Hatem , Hogue Deanna , Han Hyo , Khong Hung , Costa Ricardo , Armaghani Avan , Muller Axia Soyano , Khakpour Nazanin , Lee Marie C , Kiluk John , Czerniecki Brian 
Published: March 2020

Abstract
Background: During the natural progression of early breast cancer, it has been demonstrated that the protective host immune response against HER2 is lost early on. Using a type 1 dendritic cell (DC1) vaccine loaded with HER2 peptides has been shown to be effective in restoring anti HER2 immune responsiveness and can lead to regression of very early non-invasive breast cancers. Prior investigations conducted by our group has suggested DC vaccines may sensitize cancers to subsequent systemic chemotherapy, and the Geparnuevo trial also suggested a prechemotherapy dosing with checkpoint therapy may improve pathologic complete response (pCR) rates in TNBC. We launched a pilot study to demonstrate safety, feasibility, and preliminary efficacy of administering the DC1 HER2 vaccine for 3 weeks prior to the initiation of neoadjuvant systemic therapy for stage II-III ER-HER2+ breast cancer. Methods: This single site study is a pilot design with a safety run in phase (n = 12) followed by an expansion cohort of 18 patients. Patients with stage II-III ER-HER2+ breast cancer who are eligible to receive neoadjuvant HER2 based chemotherapy (TCHP) can enroll. The safety run in evaluates two schedules of DC1 vaccination (ARM A = once weekly x 3 weeks and ARM B = twice weekly x 3 weeks) and will enroll six patients in each arm. After the first 3 weeks of DC1 neoadjuvant chemotherapy will be administered using standard docetaxel, carboplatin, trastuzumab, and pertuzumab given intravenously once every 3 weeks for 6 cycles. Booster vaccines will be given at weeks 25, 56, 80, and 104 and immune monitoring will be performed at these timepoints. The safety run in will evaluate safety using CTCAE 4.03 criteria along with the immunogenicity of each arm measured by ELISPOT. The arm with the best immune response at 3 weeks will be selected to proceed forward during the expansion cohort using an endpoint of pCR. Secondary endpoints will be recurrence free survival rate at 3 years and immune response. The pilot design is hypothesis generating but is likely able to detect a significant difference in pCR if the true rate is 75% assuming a historical rate of 55%. Accrual to the safety run in phase is complete and the expansion phase is underway using the twice weekly vaccination schedule.
Citation Format: Hatem Soliman, Deanna Hogue, Hyo Han, Hung Khong, Ricardo Costa, Avan Armaghani, Axia Soyano Muller, Nazanin Khakpour, Marie C Lee, John Kiluk, Brian Czerniecki. A pilot study utilizing a HER2 directed dendritic cell vaccine during neoadjuvant therapy of HER2+ breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT1-01-06.
Abstract OT2-01-05: A prospective real-world national study to evaluate the efficacy and safety of adjuvant biosimilar trastuzumab in the treatment of HER2-positive breast cancer
Authors: Alves Leandro , Gagliato Débora , de Paula Mayara , Cardoso Ana Carolina , Alcantara Alexandre , Precivale Maristela , Castilho Vivienne 
Published: March 2020

Abstract
Background: Treatment with anti-HER2 therapy significantly improved survival outcomes in patients with HER2-positive Breast Cancer (BC). In Brazil, Trastuzumab was the first biosimilar approved in the treatment of patients with breast (any disease setting) and advanced gastric cancer with overexpression of HER2. Increase access to this important treatment may be enhanced with biosimilar approval. The aim of this Real-World study is to assess the efficacy and safety of adjuvant biosimilar trastuzumab in Brazilian patients with early HER2+ BC. Methods: This is a national, multicenter, observational prospective, real-world study in a variety of Brazilian institutions. A hundred and seventy adult patients, with diagnosis of early stage HER2-positive breast cancer, who received at least one dose of biosimilar trastuzumab (Zedora) as adjuvant therapy will be included. Patients will be followed for 5 years after the use of biosimilar trastuzumab (Zedora), unless recurrence or death. Safety outcomes will be recorded. Efficacy outcomes include invasive relapse-free survival (IRFS) rate at 18, 24, 30 and 36 months treatment initiation. Given the inexistence of a specific hypothesis to be tested, sample size was based on the accuracy of the two-sided 95% confidence interval (95% CI) for the invasive disease relapse-free survival rate. Results: In development countries such as as Brazil, oncology treatments with biological drugs have high costs and represent an import ibarrier to patients access to anti HER2 therapy. The use of biosimilars may result in significant health care savings. Conclusions: Considering the HERITAGE study, in which biosimilarity was clearly demonstrated between the reference monoclonal antibody and the biosimilar, we do expect to find the same safety and efficacy profile.
Citation Format: Leandro Alves, Débora Gagliato, Mayara de Paula, Ana Carolina Cardoso, Alexandre Alcantara, Maristela Precivale, Vivienne Castilho. A prospective real-world national study to evaluate the efficacy and safety of adjuvant biosimilar trastuzumab in the treatment of HER2-positive breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT2-01-05.
Abstract P1-01-10: Positron emission mammography in assessment of the clinicopathological characteristics of breast cancers
Authors: Ito Jun , Sato Toshihiko 
Published: March 2020

Abstract
Background: Breast cancer is the most prevalent malignant neoplasm in women. Early detection and personalized treatment are very important to decrease mortality. Positron emission mammography(PEM) is a newly developed breast imaging technology using the positron emission tomography(PET) radiopharmaceutical 18F-fluoro-deoxy-D-glucose(18FDG). We investigated the correlation between PEM and known prognostic markers, including estrogen receptor(ER), progesterone receptor(PR), human epidermal growth factor receptor(HER2) status, tumor histology, nuclear grade, and the number of Ki-67-positive tumor cells/10 HPF(Ki-67 index). Methods: Fifty-eight patients were included in this study. PEM imaging was performed on a commercially available PEM unit. Maximum PEM uptake value(PUVmax) and lesion-to-background(LTB) ratio were determined. All resected specimens were evaluated by our institution’s pathology department. PUVmax and LTB ratios were compared with ER and PR status, tumor histology, and nuclear grades. The correlation coefficients between maximum PEM uptake value or LTB and the Ki-67 index were calculated. Results: PUVmax values were significantly different between ductal carcinoma in situ and invasive ductal carcinoma(P = 0.033). PUVmax and LTB showed significant differences between nuclear grade 1 and nuclear grade 3(PUVmax: P = 0.027, LTB: 0.0043). PUVmax, LTB, and Ki-67 index correlated significantly; PUVmax and Ki-67 index: correlation coefficient = 0.558, P = 0.000125; LTB and Ki-67 index: correlation coefficient = 0.572, P = 0.000075. Conclusions: PUVmax and LTB showed remarkable correlation with nuclear grades and the Ki-67 index, suggesting PEM’s utility in assessing the clinicopathological characteristics of breast cancer.
Citation Format: Jun Ito, Toshihiko Sato. Positron emission mammography in assessment of the clinicopathological characteristics of breast cancers [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-01-10.
Abstract P1-13-02: Dynamic changes in high-sensitivity cardiac troponin I in response to anthracycline-based chemotherapy-The Cardiac Care Trial pilot data
Authors: Oikonomidou Olga , Tzolos Evangelos , Adamson Philip D , Hall Peter S , MacPherson Iain R , MacLean Morag , Lewis Steff , McVicars Heather , Newby David E , Mills Nicholas L , Lang Ninian , Henriksen Peter A 
Published: March 2020

Abstract
BACKGROUND Treatment advances have improved cancer-related outcomes and shifted interest towards minimising long-term iatrogenic complications, particularly chemotherapy-related cardiotoxicity. High-sensitivity cardiac troponin I (hs-cTnI) assays accurately quantify very low concentrations of plasma troponin and enable early detection of cardiomyocyte injury prior to development of myocardial dysfunction. The profile of hs-cTnI in response to anthracycline-based treatment has not previously been described. PATIENTS AND METHODS This was a multi-centre prospective observational cohort study. Female patients with newly-diagnosed invasive breast cancer scheduled to receive adjuvant or neo-adjuvant anthracycline-based (epirubicin) chemotherapy were recruited. Blood sampling was performed before, during and 24 hours after each treatment cycle. Plasma hs-cTnI concentrations were measured using the Abbott ARCHITECTSTAT assay (limit of detection 1.2 ng/L, coefficient of variation ≤10% at 4.7 ng/L, 99th centile upper reference limit in women 16 ng/L). RESULTS We recruited 78 women with a mean (standard deviation) age of 53.6 (9.6). The median (IQR) baseline troponin concentration was 1 (1 to 4) ng/L and median (IQR) cumulative epirubicin dose was 394 (300 to 405) mg/m2. Following an initial 33% fall 24 hours following anthracycline dosing (p &lt;0.001), hs-cTnI concentrations increased by a median of 50% (p&lt;0.001) with each successive treatment cycle. In total, 45 patients had troponin measured immediately prior to the sixth treatment cycle of whom 21 (46.6%) had hs-cTnI concentrations ≥16 ng/L indicating myocardial injury. Plasma hs-cTnI concentrations prior to the second treatment cycle were a strong predictor of subsequent myocardial injury. CONCLUSIONS Cardiotoxicity arising from anthracycline therapy is detectable in the earliest stages of breast cancer treatment and is cumulative with each treatment cycle. More than one third of patients will develop biochemical evidence of chronic myocardial injury with plasma hs-cTnI concentrations above the 99th centile upper reference limit. This injury is most reliably determined from blood sampling performed before rather than during or after each treatment cycle.
Citation Format: Olga Oikonomidou, Evangelos Tzolos, Philip D Adamson, Peter S Hall, Iain R MacPherson, Morag MacLean, Steff Lewis, Heather McVicars, David E Newby, Nicholas L Mills, Ninian Lang, Peter A Henriksen. Dynamic changes in high-sensitivity cardiac troponin I in response to anthracycline-based chemotherapy-The Cardiac Care Trial pilot data [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-13-02.
Abstract P1-20-10: The role of micro-CT in imaging breast cancer specimens
Authors: Tiwari Ankur , DiCorpo Daniel , Hughes Kevin , Michaelson James 
Published: March 2020

Abstract
Background: The goal of breast cancer surgery is to remove all cancer with a minimum of normal tissue, but the absence of full 3-dimensional information on the surgical specimen makes this difficult to achieve. Method: Micro CT is a high resolution, X-ray, 3D imaging method, used principally in material science and industry but little used in medicine. Results: We imaged and analyzed 173 partial mastectomies by Micro-CT (129 ductal carcinomas, 14 lobular carcinomas, 28 DCIS). Imaging was simple and rapid. Size of cancer image on Micro-CT was very similar to the size of cancer at specimen dissection. Micro-CT images of surgical specimens in cassettes revealed sizes and shapes very similar to cancer later seen on the slide. Micro CT images of multicentric/multifocal cancers appeared as separate, clearly non-contiguous, masses. Additional image realization was carried out with image analysis software, with which we created a variety of three-dimensional image visualizations seen by rotation, slicing, and various degrees of transparentness, achieved by volume rendering with adjustment of opacity and maximum intensity projection imaging modified by the transfer function, making viewing through the 3D mass possible. Video can be seen at https://youtu.be/1hyNmFDidO4. Micro-CT assessment found cancer to touch edge in 134 (77%) of cases, while assessment of the microscope slides revealed positivity in 114 (66%) of cases. Cases judged by the pathologist to be margin positive were margin positive by Micro CT 93% the time. Cancer occupied 0.45% of surface area for “Micro-CT-Only-Positive Cases” but more than three times as much space, at 1.55% when both the pathologist and the Micro-CT suggested cancer at the edge. Conclusions: Micro-CT provides full 3D images of partial mastectomy specimens, allowing one to identify, in a few minutes, and thus while the patient is in OR, margin positive cases, with information on where cancer touches the edge, in a fashion more accurate than possible from the histology slides alone.
Citation Format: Ankur Tiwari, Daniel DiCorpo, Kevin Hughes, James Michaelson. The role of micro-CT in imaging breast cancer specimens [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-20-10.
Abstract P1-20-28: Intraoperative margin status in breast conserving surgery - A novel 3D evaluation using tomosynthesis
Authors: Nakad Bothaina , Matter Ibrahim , Simovici Paula , Milevsky Daria , Greg Oksana , Sroka Gideon , Brodsky Asia 
Published: March 2020

Abstract
Background: Margin status remains a debatable issue in breast cancer surgery, accounting for a 10-40% re-excision rate. Accurate intraoperative assessment of margin status enables one step surgery, lowers re-excision rates and offers better surgical and cosmetic outcomes for the patient. We present a novel 3D intraoperative evaluation using Screen Vision and Computed Tomosynthesis.
Methods: Our standard suture-guided orientations for a lumpectomy in 36 patients (SG group) undergoing BCS was compared to the new 3D orientation using the Screen Vision, a plastic box, with a two-dimensional axis system combined with three-dimensional tomosynthesis, in the first 26 patients operated with this technique (3D group). We defined clear margins as “no ink on tumor” for invasive carcinoma, and more than 2 mm distance for ductal carcinoma in situ. The margin status and the re-excision rates were recorded, for both benign and malignant lesions.
Results: The margin-expansion rate in the first operation according to intra-operative margin status imaging, was 6/36 (16%) in the SG group compared to 9/26 (34%) in the 3D group. Additional margin-expansion according to clinical suspect in spite of negative imaging status was performed in 14/36 (28%) in the SG group and 8/26 (30%) in the 3D group. The re-lumpectomy rate was 4/36 (11%) in the SG group and 2/26 (7%) in the 3D group.
Conclusions: This method of combined Screen Vision and computed tomosynthesis presents easier orientation of surgical specimens, with better intra-operative analysis of surgical margins. It might have a role in improving intra-operative margin status imaging, with subsequent lowering of re-lumpectomy rates.
Citation Format: Bothaina Nakad, Ibrahim Matter, Paula Simovici, Daria Milevsky, Oksana Greg, Gideon Sroka, Asia Brodsky. Intraoperative margin status in breast conserving surgery - A novel 3D evaluation using tomosynthesis [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-20-28.