bluuebunny/crossref_metadata_2025_split huggingface dataset:
A pilot study of oncology massage to treat chemotherapy-induced peripheral neuropathy (CIPN).
Authors: Lopez Gabriel , Eng Cathy , Overman Michael J. , Liu Wenli , Cohen Lorenzo , Ramirez David Luis , Beinhorn Curtiss M , Sumler Pamela A , Chen Minxing , Bruera Eduardo , Prinsloo Sarah , Li Yisheng 
Published: May 2019

e23067 Background: Short- and long-term toxicity of platinum compounds and taxanes includes development of CIPN. Although anti-neuropathic medications are available, there is increased interest by health care providers and patients (pts) regarding the role of complementary approaches for symptom control. Therefore, we explored the role of massage therapy for symptomatic relief of chronic CIPN. Methods: This pilot study evaluated the optimum treatment schedule and initial efficacy of two treatment schedules of a standardized Swedish massage technique to treat lower extremity (LE) CIPN. Inclusion criteria: LE neuropathy attributed to oxaliplatin, paclitaxel, or docetaxel, no other history of attributable causes (concurrent upper extremity neuropathy allowed); self-reported neuropathy score ≥3, 0-10 scale; ≥ 6 months since last chemotherapy treatment; age ≥ 18. Pts were randomized to one of four groups: 1) LE massage 3 times (3X) week for 4 weeks; LE massage 2X week for 6 weeks; 3) head/neck/shoulder (control) massage 3X week for 4 weeks; or 4) control massage 2X week for 6 weeks. Massage completion rate was examined and symptoms of CIPN measured with the Pain Quality Assessment Scale [PQAS (Range: 0-10); subscales of PQAS-SP (surface pain), PQAS-DP (deep pain), and PQAS-PP (paroxysmal pain)] at baseline and at 10 weeks. Results: 71 pts fulfilled inclusion criteria: 77.5% women; 57.7% (breast cancer), and 42.3% (GI cancer); mean age 60.3 y/o (range: 40-77). Average length of time since the end of chemotherapy was > 3 yrs. Mean massage completion rates (max = 12) were 8.9 (SD 4.2) for 3X week and 9.8 (4.0) for 2X week with no statistical differences. There were no statistically significant differences in PQAS scores at follow-up between site-specific massage groups (lower extremity vs controls). Pts who had massage 3X week reported statistically and clinically significantly improved PQAS scores versus those who had massage 2X week (change scores: PQAS-SP: -2.3 vs. -0.6, p = 0.001; PQAS-DP: -2.1 vs. -0.9, p = 0.008; PQAS-PP: -2.3 vs. -1.0, p = 0.025), with sustained improvement maintained in the 3X week group, but minimal change in the 2X week group. Conclusions: We observed sustained reduction in pts with long-term CIPN up to 6 weeks after treatment completion for the more intensive 3X week massage group, regardless of massage treatment site. A large-scale efficacy trial is warranted to validate the role of oncology massage therapy for CIPN. Clinical trial information: NCT02221700.
Percutaneous pericardiocentesis versus pericardial window: A retrospective subset analysis in a cancer population.
Authors: Hofeld Benjamin C , Widlansky Michael , Gitter Michael 
Published: May 2019

e23093 Background: Malignant pericardial effusions (PEs) must often, and for a multitude of reasons, be managed invasively. Options for intervention include percutaneous or surgical drainage. There is a paucity of data directly comparing efficacy of these interventions. This study compares efficacy of surgical pericardial window (PW) percutaneous pericardiocentesis (PP) in cancer subjects with PEs, with respect to mortality, readmission, and repeat procedure. Methods: We performed a 5 year, retrospective, single center study at a major academic center. 79 patients were selected using ICD codes for PP (n = 19) and PW (n = 59) and grouped by first procedure performed. Log Rank Regression of Kaplan-Meier Curves was performed for major adverse events, as defined by repeat procedure, readmission, or mortality during the surveillance period. Results: Log Rank Tests of readmission and mortality were not statistically significant (P = 0.54, 0.656 respectively). Single Variate Log Rank Test of repeat procedure favored PW (P = 0.008, event rates: PP 21.1% vs PW 3.4%. Multivariate Log Rank Test of and all 3 events was not statistically significant (P = 0.168). Fig 1: Kaplan-Meier Analysis of PP (0) vs PW (1) by any event (repeat procedure, readmission, or mortality). Event Rate = 89.5% PC, 89.5% PW. Conclusions: PW patients had a lower incidence of repeat procedures. There were no differences in readmission, mortality, or a composite of all 3 events. Future aims will identify risk factors associated with repeat procedures in PCs and PWs.
Defining cardiotoxicity of doxorubicin and trastuzumab.
Authors: Khan Abir , Amidi Omid , Hess Kenneth R. , Ewer Michael S. , Yusuf Wamique , Banchs Jose , Palaskas Nicolas 
Published: May 2019

e23097 Background: Doxorubicin and trastuzumab have been described to cause clinical heart failure and asymptomatic declines in left ventricular ejection fraction (LVEF). Initial studies of doxorubicin in the 1970’s defined cardiotoxicity by the clinical syndrome of heart failure without imaging for LVEF determination. Trials with adjuvant trastuzumab used various LVEF cut-offs that were arbitrarily determined. This study aims to compare the predictive value of commonly used definitions of cardiotoxicity associated with chemotherapy for the development of clinical heart failure. Methods: A retrospective chart review was performed on an IRB approved cohort of 638 patients with breast cancer who received doxorubicin, trastuzumab, or both and who had baseline and follow up echocardiograms, collecting LVEF values for each echocardiogram. Clinical heart failure was determined by formal cardiology evaluations denoting clinical heart failure in patients. Four different definitions of cardiotoxicity were compared; American Society of Echocardiography (ASE), Cardiac Review and Evaluation Committee (CREC), Alexander et al, and Schwartz et al (Table). Results: Only 8 patients (1.25%) developed clinical heart failure. The sensitivity, specificity, positive predictive value, and negative predictive value of each definition of cardiotoxicity are listed in the table. Conclusions: Overall there is a low threshold for detection of clinical heart failure in breast cancer therapy. While the ASE definition has the highest combination of sensitivity, specificity, and positive predictive value, it has a sensitivity of only 62.5%. Thus, cardiologists and oncologists should collaborate to develop a definition of cardiotoxicity better correlated to clinical outcomes. [Table: see text]
Patient experience of an intervention combining nurse navigators and e-Health technologies for use of oral anticancer agents.
Authors: Ferrua Marie , YATIM FATIMA , Fourcade Aude , Lacaze Marilène Guillet , Minvielle Etienne , Mir Olivier 
Published: May 2019

e23149 Background: An intervention (named CAPRI) combining Nurse Navigators (NN) and a mobile application dedicated to patients treated with oral anticancer agents was implemented in 2016 at Gustave Roussy (Villejuif, France). NN provide regular telephone follow-ups to manage patients' symptoms and assess toxicities, adherence to treatment and supportive care needs. Patients can have access to a mobile application to record tracking data, contact NN via secure messaging, view therapy and side effect information or store documents. Methods: A questionnaire was addressed to patients after using for 5 months the CAPRI intervention in order to assess their experience with the device. In parallel, interviews were conducted with patients. To determine patient utilization of the mobile application, data were extracted over a 24-month period. Results: 148 patients completed the evaluation (response rate = 81%). 15 interviews were conducted. Patients' experience with CAPRI intervention is very positive: The open-ended comments on the questionnaires and interviews with patients highlighted the importance of listening, having a contact person who is easily reachable, available and empathetic. 83% of patients preferred contacting NN by phone rather than through the mobile application. Only 50% (n = 74) of patients reported having tried to connect to the mobile application and 38% reported monitoring data at least once. Conclusions: Patients' experience is highly positive about the intervention. However, the application is poorly used, patients seems to prefer human contact. In perspective, results from the randomized trial currently conducted will evaluate the impact of the intervention on clinical criteria.[Table: see text]
Improve: A community-based physical activity intervention to improve functional and health outcomes in older breast cancer survivors: Rationale, design, and methods.
Authors: Owusu Cynthia , Nock Nora , Hergenroeder Paul , Austin Kris , Bennett Beth , Cerne Stephen , Moore Halle C. F. , Petkac Jean , Schluchter Mark D. , SCHMITZ KATHRYN H. , Atkins Lindsay , Asagba Oghenerukeme , Wimbley Leonard , Berger Nathan A. 
Published: May 2019

TPS11629 Background: African-Americans (AA) and lower socioeconomic status (SES) older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. Promotion of healthy behaviors, such as physical activity (PA), is critical to addressing these health disparities. Here we describe the rationale, design and methods of a randomized controlled trial testing the effectiveness of a physical activity intervention among older BCS from diverse racial and SES backgrounds. Methods: The IMPROVE Study is a community-based randomized-controlled trial designed to recruit 320 BCS, 80 in each of four strata defined by race (AA vs. Non-Hispanic Whites [NHW]) and SES (low vs. high). Participants are aged ≥ 65 years, AA or NHW and are within five years from treatment completion for stage I-III breast cancer. Participants are recruited utilizing the Ohio Cancer Incidence and Surveillance System database or directly from three area hospitals in Cleveland, Ohio and randomized to one of two arms: a 52-week moderate intensity aerobic and resistance group training intervention (n = 160) versus attention-control (support group sessions), (n = 160). The first 20 weeks of the PA intervention includes 3x per week 60-minute supervised sessions. The last 32 weeks of the PA intervention are unsupervised. Each of the 60-minute supervised PA sessions include 30 minutes of moderate intensity aerobic activity at 50%-70% of HRmax (maximum heart rate) and 30 minutes of resistance training based on 1-RM (repetition maximum) for chest and leg press. The attention-control group attend a once per week 60-minute support group session for the first 20 weeks and have unsupervised group sessions during the last 32 weeks. Exit interviews are being conducted at 52 weeks. The primary outcome is change in Short Physical Performance Battery (SPPB) Scores at 20 weeks. Secondary outcomes include change in SPPB scores at 52 weeks, and change in body composition and biomarkers of breast cancer prognosis at 20 and 52 weeks. One hundred and seventy-four participants have been enrolled as of 02/07/2019. Discussion: This study includes three underserved populations, (older BCS in general, older AA BCS and older low SES BCS) in one study. Results may contribute to a better understanding of factors associated with recruitment, sustained participation and acceptability, and will inform physical activity programs that will optimally improve the functional and health outcomes for older women during breast cancer survivorship. Clinical trial information: CNCT02763228.
Randomized open-label study of M7824 versus pembrolizumab as first-line (1L) treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).
Authors: Ahn Myung-Ju , Barlesi Fabrice , Felip Enriqueta , Garon Edward B. , Martin Claudio Marcelo , Mok Tony S. K. , Vokes Everett E. , Ojalvo Laureen S. , Koenig Andre , Dussault Isabelle , Paz-Ares Luis G. 
Published: May 2019

TPS9114 Background: Transforming growth factor β (TGF- β) promotes tumor progression via immune- and non–immune-related processes. M7824 is an innovative first-in-class bifunctional fusion protein composed of 2 extracellular domains of TGF-βRII (a TGF-β “trap”) fused to a human IgG1 monoclonal antibody against PD-L1. Targeting these independent and complementary pathways may restore and enhance antitumor responses. An expansion cohort of the NCT02517398 study of patients with advanced NSCLC (n = 80) treated with M7824 in the second-line setting presented at ESMO 2018 showed an objective response rate of 86% in the subgroup with high PD-L1 tumor expression at the recommended phase 2 dose (1200 mg intravenously [IV] every 2 weeks [Q2W]). Observed data support the hypothesis that M7824 may be superior to other PD-(L)1 inhibitors, including pembrolizumab, for the treatment of NSCLC. Based on the promising antitumor activity and manageable safety profile, this study will evaluate M7824 treatment in patients with advanced NSCLC in the 1L setting. Methods: Here we present a global, randomized trial comparing M7824 vs pembrolizumab in the 1L treatment of patients with metastatic NSCLC with high PD-L1 expression levels. Patients in this study must have a histologically confirmed diagnosis of advanced NSCLC with high PD-L1 expression on tumor cells (defined as either ≥80% by the Dako 73-10 pharmDx kit or ≥50% by the Dako 22C3 pharmDx kit since both assays are expected to select a similar patient population at their respective cut-offs). ECOG performance status must be 0 or 1. Patients must not have received prior systemic treatment for advanced NSCLC. Patients with tumors with actionable mutations (for which targeted therapy is locally approved) are not eligible. Patients will receive 1200 mg Q2W or pembrolizumab 200 mg Q3W as an IV infusion until confirmed disease progression, unacceptable toxicity, or trial withdrawal. Dual primary endpoints are progression-free survival and best overall response; key secondary endpoints include overall survival, duration of response, and safety. Estimated enrollment is 300 patients. Clinical trial information: NCT03631706.
ATALANTE-1 randomized phase III trial, OSE 2101 versus standard treatment as second- or third-line in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients.
Authors: Felip Enriqueta , Giaccone Giuseppe , Dziadziuszko Rafal , Denis Fabrice , Moran Teresa , Debieuvre Didier , Cobo Manuel , Galetta Domenico , Vanel François Roger , Romano Giampiero , Madroszyk Anne , Chouaid Christos , Ferrand Francois-Regis , Hilgers Werner , Cappuzzo Federico , Masson Philippe , Peled Nir , Vasseur Berangere , Remon Jordi , Besse Benjamin 
Published: May 2019

TPS9121 Background: New treatment strategies are needed for advanced NSCLC patients who progress on treatment with immune checkpoint inhibitors (ICI). Tedopi (OSE2101) is a neoepitope vaccine restricted to HLA-A2 positive patients (45%) targeting five tumor-associated antigens frequently expressed in lung cancer cells, ACE, HER2, MAGE2, MAGE3 and P53. Previously, in a phase II trial (Barve et al. JCO 2008), Tedopi showed a median overall survival (OS) of 17.3 months with a manageable safety profile in advanced NSCLC patients. ATALANTE-1 (NCT02654587) is a randomized, open-label, phase 3 study comparing the efficacy and safety of TEDOPI with standard of care (SoC) treatment in HLA-A2 positive patients with advanced NSCLC, as second- or third-line therapy. Methods: Patients with advanced NSCLC without EGFR-sensitizing mutations or ALK rearrangements; progressive disease to platinum-based chemotherapy (ChT) with sequential or concurrent ICI; HLA-A2 positivity (blood test); ECOG PS 0-1; with treated and asymptomatic brain metastases,, are randomized 2:1 to receive 5mg Tedopi subcutaneously Q3W for 6 cycles, then Q8W for the reminder of the year and finally Q12W, or SoC treatment with: docetaxel 75 mg/m2 Q3W or pemetrexed 500 mg/m2 Q3W (in non-squamous and pemetrexed-naïve patients). Treatment continues until progression, intolerable toxicity or consent withdrawal, in both arms. Patients are stratified by histology, best response to first line, and line rank of ICI. Tumor assessment is performed every 6 weeks (RECIST 1.1). Primary endpoint is OS. Secondary end points are PFS, ORR, DCR, and duration of response, quality of life and safety. This is a superiority study with a hazard ratio of 0.7, two-sided alpha 5% and power 80%, after 278 events are observed. An independent analysis (1year OS rate) is planned in the first 84 patients treated with Tedopi. Last trial review by the DMC in June 18 suggested that the trial continues as planned. Translational research will be performed evaluating pharmacodynamic markers of efficacy such as immunogenicity response against Tedopi vaccine neoantigens, as well as parameters in liquid and tissue biopsies. End January 19, 87 patients (51 Tedopi, 36 Soc) have been enrolled. Clinical trial information: NCT02654587.
Insecurities of Expulsion
Authors: Hundle Anneeth Kaur 
Published: May 2019

Abstract
This article examines citizenship formations and political practices in relation to racialized and gendered postcolonial insecurities for the “Asian community” in contemporary Uganda. After disaggregating the notion of Asian community, it examines (1) how formalistic, liberal, and legal-juridical conceptions of citizenship and political practice are ineffective analytics in the context of Africanization efforts and racialized expulsion in Uganda; and (2) the tendency to erase people of South Asian descent from the study of normative state-society relations and political engagement via civil society in mainstream scholarship. It argues for a productive synthesis of Indian and African postcolonial theories of democratic agency and political practice by analyzing the possibilities and limitations of Partha Chatterjee's notion of “political society” relative to local community governance and the cultural politics of informal citizenship practices in contemporary Uganda. Contemporary citizenship formations are richly textured practices that can be both democratic and antidemocratic in nature, often characterized by disavowal of liberal, legal-juridical forms of citizenship. Finally, by closely examining domains of gender-based activism and coalition building within and across racialized communities, this essay explores the possibilities for popular politics and democratic, inclusionary multiracial and gendered citizenship in the post-Asian-expulsion context of Uganda.
BetweenQasbasand Cities
Authors: Orsini Francesca 
Published: May 2019

AbstractThe cultural memory of Awadh is almost exclusively identified with Urdu poetry and courtesan culture, and already in the colonial period it came to stand as the epitome of the “last phase of Oriental culture” (‘Abdul Halim Sharar). But if instead of taking a retrospective, nostalgic view we approach literary culture in Awadh prospectively and multilingually and broaden our lens to consider not just the capitals, Faizabad and Lucknow, but also the qasbas (small towns), the small rural courts, the nearby growing city of Banaras, and the colonial capital of Calcutta, a different set of literary dynamics and shifts comes into view. The prevalent image of Awadh as identified with Urdu and Lucknow is not wrong, of course, but it does obscure the other stories, trajectories, and languages. This essay considers some of them. A multilingual and prospective approach helps us consider the circulation of literary tastes across the colonial divide and recognize the production of forgetfulness and ignorance that accompanied modern narratives of languages and literary histories, both colonial and Indian, and that made a host of texts “homeless” (Mohamad Tavakoli-Targhi).
Gridlock Politics
Authors: Barak On 
Published: May 2019

Abstract
Anwar Sadat's “open door” policy involved the forceful promotion of an American-inspired car society. This essay traces the development of Egypt's motorscape by recounting the first eight decades of automobility in Egypt. Focusing on the 1970s, it suggests that the increasing number of vehicles on the road and consequent congestion were the result, and apparently also the driving force, of politics at every level: from class and gender to geopolitics. In particular, the adoption of the car during the infitah was informed by a discourse of demographic and urban crisis that it was meant to solve yet actually aggravated. Contrasting the private car to the public bus—and stressing zahma, population control, and regulation of sexuality—brought to the fore gendered aspects of automobility and especially sexual harassment rather than issues such as energy efficiency, traffic accidents, and environmental pollution, which would describe the car as the more dangerous vehicle. This contextualization helped neutralize the immoral connotations cars carried over from the prerevolutionary era. Against this background, Egypt's motorscape was partitioned into public and private, dangerous and safe, humiliating and respectable, in a way that made the bus stand for all the former connotations and the car for all the latter.
Developmental origins for semilunar valve stenosis identified in mice harboring congenital heart disease-associated GATA4 mutation
Authors: LaHaye Stephanie , Majumdar Uddalak , Yasuhara Jun , Koenig Sara N. , Matos-Nieves Adrianna , Kumar Rahul , Garg Vidu 
Published: May 2019

ABSTRACT
Congenital heart defects affect ∼2% of live births and often involve malformations of the semilunar (aortic and pulmonic) valves. We previously reported a highly penetrant GATA4 p.Gly296Ser mutation in familial, congenital atrial septal defects and pulmonic valve stenosis and showed that mice harboring the orthologous G295S disease-causing mutation display not only atrial septal defects, but also semilunar valve stenosis. Here, we aimed to characterize the role of Gata4 in semilunar valve development and stenosis using the Gata4G295Ski/wt mouse model. GATA4 is highly expressed in developing valve endothelial and interstitial cells. Echocardiographic examination of Gata4G295Ski/wt mice at 2 months and 1 year of age identified functional semilunar valve stenosis predominantly affecting the aortic valve with distal leaflet thickening and severe extracellular matrix (ECM) disorganization. Examination of the aortic valve at earlier postnatal timepoints demonstrated similar ECM abnormalities consistent with congenital disease. Analysis at embryonic timepoints showed a reduction in aortic valve cushion volume at embryonic day (E)13.5, predominantly affecting the non-coronary cusp (NCC). Although total cusp volume recovered by E15.5, the NCC cusp remained statistically smaller. As endothelial to mesenchymal transition (EMT)-derived cells contribute significantly to the NCC, we performed proximal outflow tract cushion explant assays and found EMT deficits in Gata4G295Ski/wt embryos along with deficits in cell proliferation. RNA-seq analysis of E15.5 outflow tracts of mutant embryos suggested a disease state and identified changes in genes involved in ECM and cell migration as well as dysregulation of Wnt signaling. By utilizing a mouse model harboring a human disease-causing mutation, we demonstrate a novel role for GATA4 in congenital semilunar valve stenosis.
This article has an associated First Person interview with the joint first authors of the paper.