bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor–Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE
Authors: Johnston Stephen R. D. , Hegg Roberto , Im Seock-Ah , Park In Hae , Burdaeva Olga , Kurteva Galina , Press Michael F. , Tjulandin Sergei , Iwata Hiroji , Simon Sergio D. , Kenny Sarah , Sarp Severine , Izquierdo Miguel A. , Williams Lisa S. , Gradishar William J. 
Published: August 2020

PURPOSE Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET) improved clinical benefit in HER2-positive, hormone receptor (HR)–positive metastatic breast cancer (MBC) versus ET alone. Dual HER2 blockade enhances clinical benefit versus single HER2 blockade. The ALTERNATIVE study evaluated the efficacy and safety of dual HER2 blockade plus aromatase inhibitor (AI) in postmenopausal women with HER2-positive/HR-positive MBC who received prior ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy. This updated article reflects minor numerical corrections in some secondary efficacy analyses that resulted from programming errors and that do not change the major conclusions of the study. METHODS Patients were randomly assigned (1:1:1) to receive lapatinib (LAP) plus TRAS plus AI, TRAS plus AI, or LAP plus AI. Patients for whom chemotherapy was intended were excluded. The primary end point was progression-free survival (PFS; investigator assessed) with LAP plus TRAS plus AI versus TRAS plus AI. Secondary end points were PFS (comparison of other arms), overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and safety. RESULTS Three hundred fifty-five patients were included in this analysis: LAP plus TRAS plus AI (n = 120), TRAS plus AI (n = 117), and LAP plus AI (n = 118). Baseline characteristics were balanced. The study met its primary end point; superior PFS was observed with LAP plus TRAS plus AI versus TRAS plus AI (median PFS, 11 v 5.6 months; hazard ratio, 0.62 [95% CI, 0.45 to 0.88]; P = .0063). A consistent PFS benefit was observed in predefined subgroups. ORR, CBR, and OS also favored LAP plus TRAS plus AI. The median PFS with LAP plus AI versus TRAS plus AI was 8.3 versus 5.6 months (hazard ratio, 0.85 [95% CI, 0.62 to 1.17]; P = .3159). Common adverse events (AEs; ≥ 15%) with LAP plus TRAS plus AI, TRAS plus AI, and LAP plus AI were diarrhea (69%, 9%, and 51%, respectively), rash (36%, 2%, and 28%, respectively), nausea (22%, 9%, and 22%, respectively), and paronychia (30%, 0%, and 15%, respectively), mostly grade 1 or 2. Serious AEs were reported similarly across the 3 groups, and AEs leading to discontinuation were lower with LAP plus TRAS plus AI. CONCLUSION Dual HER2 blockade with LAP plus TRAS plus AI showed superior PFS benefit versus TRAS plus AI in patients with HER2-positive/HR-positive MBC. This combination offers an effective and safe chemotherapy-sparing alternative treatment regimen for this patient population.
Trastuzumab-mediated cardiotoxicity in the nontrial setting: Evaluation of patients receiving adjuvant trastuzumab at an academic centre
Authors: Withrow D. , Verma S. , Dent R. , Ahmed S. , Fralick J. , Dranitsaris G. , Petrella T. 
Published: August 2020

e11550 Background: Trastuzumab is effective in the treatment of HER-2 positive breast cancer. Although clinical trials have shown an increased risk of cardiotoxicity associated with trastuzumab, this risk has not been well studied in the non-trial setting. This study aims to examine (1) the incidence of cardiotoxicity associated with trastuzumab in the clinical setting (2) the relationship, if any, between risk factors and incidence of cardiotoxicity and (3) cardiac monitoring practices. Methods: A retrospective chart review was conducted of all patients receiving adjuvant trastuzumab therapy between August 2005 and May 2008, at a Canadian academic centre. The incidence of cardiotoxicity, defined as a significant reduction in left ventricular ejection fraction (drop of >10% leading to an ejection fraction of <50%) and/or New York Heart Association class III-IV CHF symptoms requiring trastuzumab delay or discontinuation was evaluated. Medical charts and patient surveys provided demographics, risk factors and cardiac toxicity for each patient. Results: 183 patients were included in the study. The average age of participating patients was 54.8 years and 51% of participants had node positive cancer. 72% were treated sequentially with Trastuzumab and 88% received anthracyclines. The incidence of cardiotoxicity was 6.0% (n=11). Upon univariate analysis, patient age was found to be the only variable significantly associated with the occurrence of cardiotoxicity (OR: 3.55, 95% CI 1.76–90.0). Left ventricular function was monitored by serial MUGA scan every 3.35 ±1.89 months as compared to the 3 month gold standard in clinical trials. Conclusions: In this study the incidence of cardiotoxicity was 6.0%. Patient age was the only significant variable associated with cardiotoxicity, as expected from previous studies. Clinically, this suggests that older patients may need more frequent monitoring for cardiac dysfunction via MUGA and/or ECHO scans. Future research needs to address the relationship between treatment regimens and the incidence of cardiotoxicity. Furthermore, we need to better define cardiotoxicity and the clinical significance of cardiac related symptoms. No significant financial relationships to disclose.
Significance of CA 27.29 (MUC 1 glycoprotein) levels in patients with breast cancer
Authors: Ghai V. , Harvey H. A. , Abbi K. K. , Barochia A. , Bhardwaj C. , Demers L. M. 
Published: August 2020

e11579 Background: ASCO guidelines do not support the use of CA 15–3 and CA 27.29 for monitoring patients for recurrence after primary breast cancer therapy. However, several well-designed studies have shown that an increase in CA 15–3 or CA 27.29 after primary and/or adjuvant therapy can predict recurrence an average of 5 to 6 months before other symptoms or tests. We wanted to assess the significance of measuring the tumor marker (CA 27.29 levels) to monitor the clinical progress of breast cancer. Methods: After IRB approval, we conducted a retrospective chart review of 392 patients with breast cancer who had regular monitoring of CA 27.29 levels following the diagnosis of breast cancer. A total of 2671 values of CA 27.29 were evaluated from our institution over the past 5 years (2003–2008). Patient CA 27.29 levels were correlated with clinical progression of the disease (diagnostic imaging and history and physical examinations). Results: Out of 330 patients with Stage I, II, and III after treatment with adjuvant therapy, 316 had no evidence of disease (NED) and had normal levels(<38) of CA 27.29. Out of the14 patients with clinical evidence of disease recurrence, 3 had persistently elevated levels. Of the 62 patients with stage IV breast cancer following cheomotherapy, 29 patients had clinical progression of disease with 20 (69%) patients showing increasing levels. Out of the 33 patients with no evidence of progression of disease only 4(12%) had increasing levels. Conclusions: Our trend analysis concludes that a normal CA 27.29 level in patients with Stage I, II, and III, after adjuvant treatment, correlates well with clinically NED status and might be of reassuring benefit to the patients. However, increasing levels of CA27.29 in metastatic disease correlate well with clinical progression of the disease. A large multicenter prospective study is warranted to further assess the role of CA 27.29 for disease monitoring in locally advanced and metastatic breast cancer. No significant financial relationships to disclose.
Sentinel node biopsy in Asian breast cancer patients: An observation study of 1,000 consecutive patients treated at a single institute
Authors: Kawaguchi H. , Shigematsu H. , Koga C. , Mori E. , Nishimura S. , Nakamura Y. , Nishiyama K. , Esaki T. , Ohno S. 
Published: August 2020

e11584 Background: In woman with breast cancer, sentinel lymph node (SLN) biopsy (SLNB) provides staging information and a favorable effect on quality of life if the SLN does not have metastasis. While many reports already showed safety and reliability about SLNB for breast cancer patients in Western countries, few reports have published from Asian countries. Our purpose of this study is to prove the technical success, accuracy and safety of this method for Asian population. Methods: We did feasibility study of 183 patients from 2000 to 2002. After that, we evaluated detection rate, positive rate, axillary relapse rate in 1,000 consecutive patients who underwent sentinel lymph node biopsy for breast cancer at a single institute in Japan from 2002 to August 2008. In this series, both radioactive agent (technetium) and vital blue die (indigocarmine) were used to investigate the SLNs. Results: We could accurately predict SLNs in 994 (99.4%) of the 1,000 patients. The proportion of technical success was high regardless of surgeon's experience. Intraoperative frozen section histology showed that positive SLNs were found in 176 (17.7%) patients (13 micrometastasis and 163 macrometastasis). Defenitive histology found metastasis in 24 cases who defined as negative by the frozen section examination. 15 of 24 (62.5%) cases underwent delayed axillary lymph node dissection (ALND) after definitive histology. The histological concordance between frozen section and permanent sections of SLNs was 97.6%. Finally, 796 patients were followed up without ALND. With a median follow-up time of 3.5 years (0.5–5.2), axillary lymph node recurrence were occurred in 5 patients (5 of 796, 0.6%). The relapse time since SLNB ranged from 16 to 33 months. There were not any patients with allergic reactions. Conclusions: This is the report about observation study including more than 1,000 patients from Asian country. SLNB is seemed to be a safe and acceptably accurate method for Asian early breast cancer patients. No significant financial relationships to disclose.
A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: Results of NSABP Protocol C-08
Authors: Wolmark N. , Yothers G. , O'Connell M. J. , Sharif S. , Atkins J. N. , Seay T. E. , Feherenbacher L. , O'Reilly S. , Allegra C. J. 
Published: August 2020

LBA4 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. No significant financial relationships to disclose.
Implementation of a High-Risk Breast Clinic for Comprehensive Care of Women With Elevated Breast Cancer Risk Identified by Risk Assessment Models in the Community
Authors: Laws Alison , Mulvey Therese M. 
Published: August 2020

INTRODUCTION: Many radiology centers perform risk assessment at time of screening mammography. The Massachusetts General Hospital North Shore Cancer Center (MGHNS) developed a nurse practitioner (NP)–led high-risk breast clinic (HRBC) to provide comprehensive care for patients with elevated breast cancer risk by a validated tool. PATIENTS AND METHODS: Patient and administrative data from the MGHNS HRBC was collected to evaluate clinical and implementation outcomes. We compared patients from the HRBC with those identified as having ≥ 20% lifetime risk at 5 community imaging centers. RESULTS: From March 2018 to February 2019, 318 patients were seen in the HRBC; 264 (83%) had ≥ 20% lifetime risk, 13 (4%) had prior atypia/lobular carcinoma in situ, 9 (3%) had ≥ 1.7% 5-year risk, and 32 (10%) had no indication of elevated risk. Genetic testing was recommended for 159 patients (50%); 33 (21%) completed testing with 1 mutation identified. Chemoprevention was discussed with 99 patients (31%); 9 (9%) initiated treatment. Screening magnetic resonance imaging (MRI) was recommended for 284 patients (89%); 184 (65%) had MRI performed with 2 mammographically occult cancers identified. During this time period, 215,112 patients had risk assessment performed at time of breast imaging; of these, 1,170 were found to have ≥ 20% lifetime risk. Compared with those identified as high risk in the community, patients seen in the HRBC were more likely to be white (94.3% v 85.4%; P < .001) and have a family history of ovarian cancer (16.4% v 9.4%; P < .001). CONCLUSION: We demonstrate the feasibility of an NP-led HRBC. Follow-through of recommendations by patients was highest for screening MRI; use of genetic testing and chemoprevention was lower than anticipated. In our community, uptake of the HRBC by referring providers remains a barrier, with only a minority of identified high-risk patients assessed in our clinic.
Probing Floquet modes in a time periodic system with time defects using Faraday instability
Authors: d'Hardemare Guillaume , Eddi Antonin , Fort Emmanuel 
Published: August 2020

Abstract
Time crystals are systems whose properties are periodically modulated in time. Among these, Floquet time crystals exhibit momentum gaps in their band structures, analogous to energy gaps in spatial crystals. Recently, time defects with a

-shift in the time modulation have been introduced theoretically as temporal analogues of spatial topological defects associated with localized edge modes. Here we perform experiments in a time periodic system using Faraday instability, a parametric excitation of a liquid bath by vertical shaking. Although time defects also trigger an exponentially decaying wave, we show that the analogy does not hold due to temporal causality and lack of energy conservation. However, these time defects provide an original way to explore momentum gaps and reveal their overdamped modes.
No QTc Prolongation in Girls and Women with Turner Syndrome
Authors: Noordman Iris D , Duijnhouwer Anthonie L , Coert Misty , Bos Melanie , Kempers Marlies , Timmers Henri J L M , Fejzic Zina , van der Velden Janiëlle A E M , Kapusta Livia 
Published: August 2020

Abstract

Context
Turner syndrome (TS) is a genetic condition that is reported to be associated with a prolonged rate-corrected QT (QTc) interval.

Objectives
To evaluate the prevalence of QTc prolongation in patients with TS, to compare their QTc intervals with healthy controls, and to investigate whether QTc prolongation is associated with a monosomy 45,X karyotype.

Method
Girls (n = 101) and women (n = 251) with TS visiting our center from 2004–2018 were included in this cross-sectional study. QT intervals of 12-leaded electrocardiograms were measured manually, using Bazett’s and Hodges formulas to correct for heart rate. A QTc interval of &gt;450 ms for girls and &gt;460 ms for women was considered prolonged. Corrected QT (QTc) intervals of patients with TS were compared to the QTc intervals of healthy girls and women from the same age groups derived from the literature.

Results
In total, 5% of the population with TS had a prolonged QTc interval using Bazett’s formula and 0% using Hodges formula. Mean QTc intervals of these patients were not prolonged compared with the QTc interval of healthy individuals from the literature. Girls showed shorter mean QTc intervals compared with women. We found no association between monosomy 45,X and prolongation of the QTc interval.

Conclusions
This study shows that the QTc interval in girls and women with TS is not prolonged compared with the general population derived from the literature, using both Bazett’s and Hodges formulas. Furthermore, girls show shorter QTc intervals compared with women, and a monosomy 45,X karyotype is not associated with QTc prolongation.
Arterial Stiffness Is Associated with Clinical Outcome and Cardiorenal Injury in Lateralized Primary Aldosteronism
Authors: Chan Chieh-Kai , Yang Wei-Shiung , Lin Yen-Hung , Huang Kuo-How , Lu Ching-Chu , Hu Ya-Hui , Wu Vin-Cent , Chueh Jeff S , Chu Tzong-Shinn , Chen Yung-Ming 
Published: August 2020

Abstract

Context
The association between arterial stiffness and clinical outcome in lateralized primary aldosteronism (PA) patients after adrenalectomy has not been clearly identified.

Objective
We hypothesized that arterial stiffness estimated by brachial-ankle pulse wave velocity (baPWV) before adrenalectomy was associated with the clinical outcomes and cardiorenal injury in lateralized PA patients after adrenalectomy.

Design and Patients
We designed a retrospective observational cohort study. We collected lateralized PA patients who had undergone adrenalectomy between 2013 and 2016 from the Taiwan Primary Aldosteronism Investigation database. The primary outcome was achieving complete clinical success at 1 year after adrenalectomy. The secondary outcome was estimated glomerular filtration rate declining over 20% and improved left ventricular mass index.

Results
We enrolled 221 patients with lateralized PA (50.7% men; mean age, 51.9 years), of whom 101 patients (45.7%) achieved complete clinical success at the 1-year follow-up assessment after adrenalectomy. Lower baPWV before adrenalectomy (odds ratio = 0.998; 95% confidence interval, 0.996-0.999; P = 0.003) correlated with higher likelihood of complete clinical success by multivariate logistic regression analysis. Multifactorial adjusted generalized additive model demonstrated that preoperative baPWV&lt;1600 cm/sec was significantly associated with complete cure of hypertension. In addition, higher preoperative baPWV was associated with renal function decline and less left ventricular mass regression after adrenalectomy in lateralized PA patients during the follow-up period.

Conclusions
Our study demonstrated that the preoperative severe arterial stiffness was associated with absent complete clinical success in lateralized PA patients after adrenalectomy, and this effect may contribute to cardiorenal injury, which at least partially explains kidney function deterioration and lessened regression of heart mass.
WELLNESS RIGHT FROM THE START
Authors: Faigenbaum Avery D. , Bruno Laura E. 
Published: August 2020

Apply It!Summary
•Health and fitness professionals can protect young children from disease and other risks while making sure they reach their fullest potential by recognizing the effect of daily physical activity, positive childhood experiences, and family lifestyle habits on wellness.
•By encouraging imaginative play with lots of expressive movement, young children can improve physical skills and other dimensions of wellness as they explore their environment, socialize with friends, learn from each other, create new games, and cope with challenges.
Wellness is not merely the absence of disease but rather a state of physical, emotional, social, intellectual, environmental, and spiritual well-being that optimizes development and provides an opportunity for young children to reach their fullest potential. Because early childhood is a time of rapid growth and a critical period for developing healthy behaviors, girls and boys should participate daily in developmentally appropriate physical activities that support all dimensions of wellness. The first responder program illustrates creative ways to meet the needs and interests of young children through imaginative firefighter play. Because emerging technologies are changing the way today’s youth play, socialize, and think, concerted efforts are needed to protect a young child from disease and other risks while providing opportunities that influence overall wellness throughout the growing years.
ENHANCING WELLNESS DURING YOUNG ADULTHOOD
Authors: Sforzo Gary A. , Diggin David 
Published: August 2020

Apply It!
•Guiding young adult clients to adopt an active lifestyle has a positive effect on developing well-being.
•Identifying a client’s barriers to physical activity, and healthy living in general, is critical to long-term wellness.
•Barriers can be discovered during initial intake/screening or subsequent conversations.
•Personalizing habit-forming strategies can help clients to overcome barriers.
•Using technology, social media, games, challenges, and rewards create external motivators to jump start or motivate a client’s wellness behaviors.
•When a client is resistant to healthy behavior change, or is having trouble adhering to wellness programming, consider referring to a qualified health and wellness coach.
An assessment of the autism neuroimaging literature for the prospects of re-executability
Authors: Hodge Steven M. , Haselgrove Christian , Honor Leah , Kennedy David N. , Frazier Jean A. 
Published: August 2020

Background: The degree of reproducibility of the neuroimaging literature in psychiatric application areas has been called into question and the issues that relate to this reproducibility are extremely complex. Some of these complexities have to do with the underlying biology of the disorders that we study and others arise due to the technology we apply to the analysis of the data we collect. Ultimately, the observations we make get communicated to the rest of the community through publications in the scientific literature. Methods: We sought to perform a ‘re-executability survey’ to evaluate the recent neuroimaging literature with an eye toward seeing if our publication practices are helping or hindering the overall quest for a more reproducible understanding of brain development and aging. The topic areas examined include availability of the data, the precision of the imaging method description and the reporting of the statistical analytic approach, and the availability of the complete results. We applied the survey to 50 publications in the autism neuroimaging literature that were published between September 16, 2017 to October 1, 2018. Results: The results of the survey indicate that for the literature examined, data that is not already part of a public repository is rarely available, software tools are usually named but versions and operating system are not, it is expected that reasonably skilled analysts could approximately perform the analyses described, and the complete results of the studies are rarely available. Conclusions: We have identified that there is ample room for improvement in research publication practices. We hope exposing these issues in the retrospective literature can provide guidance and motivation for improving this aspect of our reporting practices in the future.