bluuebunny/crossref_metadata_2025_split huggingface dataset:
BRIGHTSTAR: A pilot trial of local consolidative therapy (LCT) with brigatinib in tyrosine kinase inhibitor (TKI)-naïve ALK-rearranged advanced NSCLC.
Authors: Elamin Yasir , Gandhi Saumil , Antonoff Mara , Mott Frank , Gibbons Don Lynn , Le Xiuning , Negrao Marcelo Vailati , Sepesi Boris , Karam Jose A. , Cascone Tina , Wang Linghua , Blumenschein George , Glisson Bonnie S. , Tsao Anne S. , Heymach John 
Published: May 2020

9624 Background: Approximately, 95% of patients who have an initial response to ALK-TKIs exhibit an incomplete response resulting in residual disease that enables the emergence of acquired resistance. Eliminating residual disease using LCT may delay resistance emergence and improve clinical outcomes. Methods: This is a single center investigator-initiated trial that assesses the safety, feasibility and efficacy of brigatinib with LCT. Eligible patients have TKI-naïve ALK rearranged advanced NSCLC with any number of metastases. Patients treated with brigatinib for an induction period of 8 weeks followed by LCT with radiation and/or surgery. Results: Between 12/2018 and 01/2020, 17 out of 24 planned patients were enrolled. Median age 55 (range 33-73). At study entry, 15 patients had polymetastatic disease ( > 3 sites) while 2 had oligometastatic disease. As of February 1, 2020, 16 patients were evaluated for response and completed LCT while 1 patient remained on induction brigatinib. The disease control rate was 100% with an objective response rate of 94% (n = 15). Median follow up was 8 months (range 3-13) with no patients with disease progression to date. LCT used was radiation (n = 11), surgery (n = 3), surgery and radiation (n = 2). Among 5 patients who had surgery, 4 had lobectomy and mediastinal lymph node dissection (MLND), 1 had wedge resection with MLND, and 1 had adrenalectomy. Of these, 2 had complete pathological response and 1 had complete pathological response at the primary tumor. There were no grade ≥2 adverse events (AEs) related to LCT, including in 7 patients treated with concurrent brigatinib and radiation, and 6 patients treated with radiation while brigatinib was held. All patients continued brigatinib after LCT. Brigatinib-related severe AEs included grade 3: increased blood levels of creatine kinase, lipase, alanine aminotransferase, amylase (n = 1 each) and nausea (n = 1). One patient had grade 2 pneumonitis after 2 weeks of starting brigatinib, this resolved with steroids and brigatinib was resumed at a lower dose. Conclusions: Brigatinib with LCT is safe and feasible in patients with ALK-rearranged advanced NSCLC irrespective of number of metastatic sites. Brigatinib and LCT may be an effective therapeutic strategy in this subset of NSCLC patients. Clinical trial information: NCT03707938 .
Analysis of the prognostic factors of triple-negative breast cancer and the clinical efficacy of postoperative radiotherapy in early cases.
Authors: Cheng XT , Zhang Y , Zuo XX , Yang J , Dong ML , Liu K , Mi Y , Shi Yg 
Published: May 2020

e12502 Background: To explore the prognostic value of pretherapeutic peripheral blood parameters and breast imaging-reporting and data system (BI-RADS) classification of triple-negative breast cancer (TNBC) and the effect of postoperative radiotherapy in early cases. Methods: A total of 278 TNBC patients’ medical records between January 2013 and December 2018 were retrospectively collected, including white blood cells, neutrophils, lymphocytes, platelets, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), serum tumor markers, BI-RADS classification, TNM staging and therapeutic methods. We used the log-rank test and Kaplan-Meier curves to assess the progression-free survival (PFS) of enrolled patients. Multivariate prognostic analysis was performed by the Cox regression model. Results: The median PFS of all 278 patients was 20 months (4-72 months) at the end of follow-up. Operable patients who obtained adjuvant chemotherapy had a better median PFS (20 vs 18.5 months, P= 0.018, HR = 5.943, 95% CI: 1.36-25.92) than those without. Lymph node metastasis (52%) and chest well relapse (28%) were the critical failure forms followed by other metastases (12% lungs, 9.3% bones, 4% liver and 2.7% brain) with p value less than 0.001. Multivariate analysis indicated that platelet counts > 113.5×109/L (p = 0.024), PLR ≤ 111.7 (p = 0.036) and CA15-3 ≤ 8.4 U/mL (p = 0.003) were significantly associated with the favourable prognosis of PFS in TNBC patients. Furthermore, BI-RADS of grade 2-4 had a better median PFS compared with grade of 5-6(20 vs 17.5 months, p = 0.008, HR = 2.154, 95% CI: 1.219-3.805). In subgroup analysis, forty-three early cases with pN1 stage earned additional benefits from postoperative radiotherapy in terms of low risk of distant metastasis and recurrence (p = 0.014). Residual tumor after surgery was another important factor of poor prognosis (p = 0.029). Conclusions: Adjuvant chemotherapy improved median PFS for operable TNBC patients and pretherapeutic platelets, PLR, CA15-3 and BI-RADS were the independent prognostic factors of survival. Lymph node metastasis and chest well relapse were the main patterns of treatment failure. Radiotherapy could reduce the risk of disease progression for postoperative patients with N1 stage.
Baseline skeletal muscle density and adverse outcomes during chemotherapy for early breast cancer.
Authors: Aleixo Gabriel , Deal Allison Mary , Nyrop Kirsten A. , Muss Hyman B. , Williams Grant Richard , Damone Emily , Yu Hyeon , Shachar Shlomit S. 
Published: May 2020

e12506 Background: Skeletal Muscle Density (SMD) is the amount of fat infiltration in the muscle, Low SMD (myosteatosis), is associated with chemotherapy toxicity in women with breast cancer (BC); however, cut points are not consistent across studies. We investigated the association of alternative cut-points for low SMD at BC diagnosis and adverse outcomes during chemotherapy in women with early BC. Methods: This is a retrospective chart review. Axial CT images were evaluated at the L3 level to calculate average SMD in Hounsfield Units (HU). Three cut points (Table) classified patients as low versus normal SMD. T-test was used to calculate the relative risk (RR) for adverse events. Results: In 340 patients, the mean age was 51. Table shows RR for three adverse events (dose reduction, early treatment discontinuation, hospitalization) for each of the three cut points. Conclusions: All three cut-points described in the literature are reliable for stratification of patients with EBC for myosteatosis and associated chemotherapy-related adverse events. [Table: see text]
Recurrence risk stratification by Dutch clinical risk criteria for early-stage luminal breast cancer patients in Taiwan: A population-based analysis.
Authors: Lei Lei , Chan Han-Ching , Jia Wang Xiao , Lu Tzu-Pin , Cheng Skye Hung-Chun 
Published: May 2020

e12509 Background: Dutch clinical risk criteria (low-risk definition: age > 35 years and (grade 1 with tumor ≤3cm, grade 2 with tumor ≤2cm, or grade 3 with tumor ≤1cm) have been used to stratify the benefit of MammaPrint and Oncotype DX for the decision-making regarding adjuvant chemotherapy for early-stage luminal breast cancer. We propose that the criteria could help to identify low-risk patients who could barely benefit from multi-gene testing. Methods: Breast cancer patients from Taiwan Cancer Database initially treated with primary surgeries between 2008 and 2012 who met the following criteria: (1) pathologic node-negative, (2) hormone receptor-positive, (3) HER2-negative, (4) undergone hormonal therapy, and (5) a minimum follow-up time of 5-year if free from any event, were enrolled in this study. Out of the total 2679 eligible patients, 1074 (40.1%) patients received adjuvant chemotherapy in addition to endocrine therapy. The study endpoints included breast cancer-specific survival (BCSS) and overall survival (OS). Kaplan-Meier statistics estimated the difference between clinical outcomes in low- and high-risk groups. Results: The median follow-up time of BSCC and OS was 5.9 years (range, 0-7 years) and 5.8 years (range, 0-7 years), respectively. There were statistical significances of 5-year BCSS (n = 2679) and 5-year OS (n = 2636) between low-risk and high-risk groups (in both endpoints, P < 0.0001). According to the Dutch criteria, low-risk patients with and without adjuvant chemotherapy had a 5-year BCSS of 99.0% vs. 99.2% and a 5-year OS of 98.4% vs. 97.4%, respectively. High-risk patients with and without adjuvant chemotherapy had a 5-year BCSS of 97.7% vs. 98.1% and a 5-year OS of 96.4% vs. 95.3%, respectively. Conclusions: The benefit of chemotherapy in low-risk patients classified by Dutch criteria might be very small since the breast cancer mortality was less than 1% with a minimum of 5-year follow-up. Dutch criteria cannot identify high-risk patients who would benefit from chemotherapy. We assumed that multi-gene testing in low-risk patients would not be cost-effective.
Development of cardiac events in postmenopausal breast cancer patients treated with Aromatase inhibitor (AI) and Selective estrogen receptor modulator (SERM).
Authors: Parajuli Priyanka , Regmi Manjari Rani , Maini Ruby , Lara Garcia Odalys Estefania , Tandan Nitin , Mirihagalle Noupama , Cheema Asad , Abedrabo Sabree , Niaz Zurain , Koester Cameron , Sahib Hamsa , Bhandari Bishal , Johnson Alexander , Ibrahim Abdisamad M. , Delfino Kristin , Robinson Kathy , Desai Meghna R. , Kulkarni Abhishek 
Published: May 2020

e12529 Background: Breast cancer is the most common cancer diagnosed in women. Cardiovascular diseases (CVD), alternatively, is the leading cause of mortality in women worldwide. Adjuvant endocrine therapy including AI and SERM is offered to almost 75% of patients with estrogen receptor–positive (ER+) disease and potentially raises concerns for negative effects in cardiovascular health. Our study aims to evaluate cardiac events including acute coronary syndrome (ACS) and heart failure requiring hospitalization (HF) in post-menopausal patients treated with AI and SERM. Methods: An institutional database of 478 patients with histologically confirmed hormone receptor positive breast cancer diagnosed between 01/01/2014 to 12/31/2017 was reviewed after IRB approval. Development of ACS and heart failure requiring hospitalization upon initiating AI or SERM was considered an adverse cardiac event. Statistical analysis was performed with SAS v9.4. software. Chi Square (or Fisher’s Exact test) was used to test associations between various medication and cardiac events. Student’s T-test (or non-parametric equivalent when violations occurred) was used to assess if there was a difference in delta between those on and those not on medication categories. All significance was assumed at the p < 0.05 level. Results: Of 478 patients who met the inclusion criteria, 336 (70%) patients were postmenopausal. Of the 336 patients, 55% (n = 185) and 22% (n = 77) were offered therapy with AI and SERM, respectively. 6.49 % (n = 12) developed cardiac event with AI compared to 7.10 % (n = 13) who were not on AI therapy, (p = 0.814). Similarly, 6.49 % (n = 5) developed cardiac event with SERM compared to 6.87 % (n = 20) who were not on SERM therapy, (p = 0.9064). Moreover, an interesting finding in patients treated with SERM therapy compared to those not on SERM therapy was the delta of left ventricular ejection fraction (LVEF). Median LVEF of 3.5% (0 to 21%) was noted in patients treated with SERM compared to a median LVEF of 5% (0 to 55%) in patients who were not treated with SERM, p = 0.048. Conclusions: Our findings revealed AI and SERM therapy did not increase adverse cardiac events in our patient cohort. Cardiac safety of the patients is less likely to be compromised with AI and SERM therapy and therefore, should be initiated early in the course of treatment for better patient outcome. Furthermore, since SERM therapy can possibly have an effect in the LVEF of patients, a frequent evaluation LVEF is warranted to prevent any unwarranted complications.
Neoadjuvant chemotherapy versus adjuvant chemotherapy in breast cancer patients: Analysis of breast conserving rate and de-escalation of axillary surgery in 5,141 Korean women.
Authors: Lee Young Joo , Kim Jisun , Gwark Sung-chan 
Published: May 2020

e12531 Background: Neoadjuvant chemotherapy (NCT) in breast cancer has several advantages such as more breast conservation surgery (BCS) rate and de-escalation of extent of axillary surgery. Actual practice change in this area compared with adjuvant chemotherapy (ACT) is not well established. Methods: We retrospectively analyzed 5,141 women diagnosed with breast cancer from 2009 to 2013, treated with chemotherapy before or after definite surgery. BCS rate and axillary surgery categories (sentinel lymph node biopsy (SNB), axillary lymphnode dissection (ALND) or SNB followed by ALND) are compared between two groups. Results: Among 5,141 patients, 3930 (76.4%) women had ACT and 1211 (23.6%) had NCT. Median age at diagnosis was 48 (range 22-83). BCR rate was lower in T2 (57.1% vs 64.1%), T3 (12.6% vs 20.9%) group between ACT vs NCT ( p=0.03, 0.001), no difference was shown in T1 and T4 tumors. SNB try (SNB only or SNB followed by ALND) rate was still higher in ACT group with cN0 (98.4% vs 95.4%), cN1 (89.3% vs 73.5%), cN2 (77.9% vs 62.1%) tumors ( p=0.001, <0.001, 0.003, respectively). SNB only rate which means that patients spared ALND, was lower in ACT group with all cN stage (cN1; 17.5% vs 29.2%, cN2; 3.2% vs 5.9%, cN3; 5.1% vs 20.5%, all p=0.000) except cN0 (95.6% vs 81.4%, p<0.001). Axillary surgery rate analyzed with pathologic N stage showed more ALNDs attempted even after achieving pathologic complete nodal response or minimal residual N disease (ypN0: 4.4% vs 27.2%, ypN0(i) & ypN1mi; 26.2% vs 57.6%, p<0.001, =0.001 respectively). In contrast however, average of total axillary nodes retrieved by cN stage were statistically lower in NCT group in clinically positive tumors (N1; 15.3 vs 12.7, N2; 19.1 vs 14.6, N3; 25.1 vs 15.6, all p<0.001). Conclusions: NCT had shown advantage to perform more BCS than ACT in T2, T3 tumors. SNB attempts in NCT was comparable to ACT. Still, patients with NCT received more aggressive axillary surgery than ACT shown by axillary surgery category irrespective of negative SNB results.
Omitting chemotherapy in more patients with early breast cancer in the post-TAILORx era.
Authors: Markopoulos Christos , Sariyanni Zoi Andromahi , Ziogas Dimitrios C. , Antonopoulou Zoh , Tsoulos Nikolaos 
Published: May 2020

e12534 Background: The purpose of this analysis is to evaluate how many patients previously treated according to OncotypeDX Recurrence Score (RS) could have been spared of Chemotherapy if the TAILORx RS data had been taken into account in the clinical treatment decisions. Methods: A series of 182 patients, 34-74 years of age with early breast cancer, treated in our Breast Unit during the last 10 years, for whom treatment decisions were based on OncotypeDX RS. The Recurrence Scores of all these patients were obtained and the actual treatment decisions that were made based on the pre-TAILORx cut-offs of RS 18 and 31 were recorded. These decisions were then re-evaluated based on the after TAILORx cut-off scores, by taking also into consideration the patients’ age. Descriptive statistics were used as well as logistic regression models to estimate the potential change in treatment decisions based on the new Oncotype Dx cut-offs. Results: In the cohort of patients we analyzed that underwent Oncotype Dx testing, 34.1% (62/182) received Chemotherapy, based on the initial pre-TAILORX cut-offs of the RS. When utilizing the new cut-offs (after TAILORx results) in combination with age, we have estimated that, for the patients > 50 years of age, a 12.7% was potentially over-treated and for those ≤50 years old, 9.1% was potentially over-treated since they have received chemotherapy with a RS below 16; additionally, 30.8% of the patients of that age that have RS between 16 and 20 have received chemotherapy even though the average chemotherapy benefit for this group is 1.6% and can go up to 6.7% if they have a high clinical risk as it was defined by the investigators of the TAILORx trial. Finally, 84,6% of patients ≤50 years old with RS between 21-25 received chemotherapy with a 6.5% potential benefit demonstrated in the TAILORx trial. Conclusions: Our analysis suggests that, by using the cut-offs of TAILORx trial, adjuvant chemotherapy could had been omitted in at least a further 11.5% of patients with early breast cancer, reassuring their quality of life without declining their prognosis.
Practice-changing use of the 21-gene oncotype DX breast recurrence score test in Latin American hospitals.
Authors: Gomez Henry Leonidas , Bargallo-Rocha Juan Enrique , Billinghurst Roberto Jorge , Núñez de Pierro Aníbal Roberto , Coló Federico Andrés , Benitez Gil Lisandro Luis , Allemand Carola , McLean Ignacio Leonardo , Lema-Medina Mauricio , Herazo-Maya Fernando , Terrier Francisco Jose , Gerson Cwilich Raquel , León Rivera Mauricio , Falcon Silvia Gabriela , Castaño Roberto Eduardo , Oliveira Sergio Cordeiro , Jakubowski Debbie M , Chao Calvin Y. 
Published: May 2020

e12539 Background: The 21-gene test is clinically validated to predict chemotherapy (CT) benefit in node-negative (N0) and node-positive (up to 3 axillary nodes, N+) HR+, HER2− early-stage breast cancer (ESBC). TAILORx showed no CT benefit overall in N0 patients with RS 0-25, but younger patients with RS 16-25 might have some. Clinical guidelines worldwide incorporate the 21-gene test; still, the impact of the test on treatment decisions is unclear in Latin America, where patients often present younger and with more advanced disease. We present a physician survey of the impact of Recurrence Score results on treatment decisions in clinical practice in Latin America. Methods: This multicenter, non-therapeutic, prospective survey enrolled consecutive patients who had 21-gene testing during routine care at 14 community and academic sites in Argentina, Colombia, Mexico, and Peru. Tests were paid for by patients. The physician survey captured patient and tumor characteristics and treatment decisions by physicians pre- and post-assay result. The survey included patients treated before and after TAILORx results reported in 6/2018. Overall net percent change in CT recommendation and 95% Clopper Pearson confidence intervals (CI) were estimated. The proportion with a change between pre-assay treatment recommendation and actual treatment received was calculated overall and by Recurrence Score groups per TAILORx. Results: Between 3/2015 and 12/2019, the survey was completed for 647 patients. 20% had N+ ESBC. Mean patient age was 54 y (24-85 y); 55% were postmenopausal. 17%/63%/20% had grade 1/2/3 tumors; 70%/30% had tumors ≤2/ > 2 cm in size. Recurrence Score results were: 20% RS 0-10, 56% RS 11-25, and 24% RS 26-100. Overall, CT recommendations fell from 325 patients pre-assay to 199 patients post-assay, a 39% decrease (95% CI 33.4 to 44.3) (36% decrease in N0; 46% decrease in N+). The direction of change was consistent with Recurrence Score results. Among N0 patients, the decrease in CT recommendations was 28% (95% CI 18.9 to 39.5) before TAILORx reported and 36% (95% CI 28.4 to 43.7) after. Conclusions: This large survey of 21-gene test practice patterns was the first conducted in Latin America and showed the relevance of 21-gene testing in low- and medium-resource countries to minimize CT over- and underuse in ESBC. Our results showed substantial reductions in CT use overall. After TAILORx, CT use was further reduced, indicating the practice-changing potential of that study.
Assessment of the sexual health of breast cancer survivors and their interest in discussing their difficulties with their doctors during follow-up.
Authors: Camejo Natalia , Castillo Cecilia , Hernandez Ana laura , Artagaveytia Nora , Amarillo Dahiana , Delgado Lucia Beatriz 
Published: May 2020

e12542 Background: Sexual dysfunction from breast cancer and its various therapies is present in up to 60% of the breast cancer patients. Sexuality remains a neglected issue; doctors often ignore it, claiming they lack the time, knowledge or expertise required to address it. Objectives: To evaluate the sexuality of breast cancer survivors, inquire about the degree of interest in receiving help to resolve sexual dysfunctions related to the diagnosis and treatment of the disease and the level of satisfaction with the care received. Methods: One hundred twenty eigth patients with early breast cancer treated at the Mastology Unit of the Hospital de Clínicas were enrrolled. The study was approved by the hospital’s Ethics Committee. The selected questionnaire is the one used at the University of Chicago Medical Oncology Clinic. Results: Most patients were over 50 years old (96 patients) and had a sexual partner (87 patients), 98 patients (76.5%) had been sexually active within the last 12 months and 85 (86.7%) reported having sexual problems. Moreover, most patients (67/128, 68.3%) responded that sexuality was important in their lives; 85 (86.6%) were interested in receiving support to treat their sexual difficulties, and 72 (73.4%) saw the feasibility of addressing them with a doctor. However, only 29 (29.6%) had sought medical help for that purpose, and most were unhappy with the care received. Seventy-nine patients (80.6%) would be willing to participate in a program aimed at confronting their sexual problems. Conclusions: Our results reveal the need to address the sexual problems of patients diagnosed and treated for breast cancer as part of their medical care. Future studies should focus on developing and evaluating the success of specific interventions in the management of these patients’ sexual dysfunction and - even more importantly - designing strategies for its prevention.