Digital Commons Network^™

Intervention For Cognitive Reserve Enhancement In Delaying The Onset Of Alzheimer's Symptomatic Expression (Increase), A Randomized Controlled Trial: Rationale, Study Design, And Protocol, Daniela C. Moga, Brooke F. Beech, Erin L. Abner, Frederick A. Schmitt, Riham H. El Khouli, Ashley I. Martinez, Lynne Eckmann, Mark Huffmyer, Rosmy George, Gregory A. Jicha

Pharmacy Practice and Science Faculty Publications

BACKGROUND: The course of Alzheimer's disease (AD) includes a 10-20-year preclinical period with progressive accumulation of amyloid β (Aβ) plaques and neurofibrillary tangles in the absence of symptomatic cognitive or functional decline. The duration of this preclinical stage in part depends on the rate of pathologic progression, which is offset by compensatory mechanisms, referred to as cognitive reserve (CR). Comorbid medical conditions, psychosocial stressors, and inappropriate medication use may lower CR, hastening the onset of symptomatic AD. Here, we describe a randomized controlled trial (RCT) designed to test the efficacy of a medication therapy management (MTM) intervention to reduce inappropriate …

Safety Of Paclitaxel-Coated Balloon Angioplasty For Femoropopliteal Peripheral Artery Disease, Kenneth Ouriel, Mark A. Adelman, Kenneth Rosenfield, Dierk Scheinert, Marianne Brodmann, Constantino Peña, Patrick Geraghty, Arthur Lee, Roseann White, Daniel G. Clair

2010-2019 OA Pubs

OBJECTIVES: The aim of this study was to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program.

BACKGROUND: A recent systematic review and meta-analysis of heterogenous trials and summary-level data identified increased long-term mortality in patients treated with paclitaxel-coated balloons and stents.

METHODS: We evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and …

Gantenerumab Reduces Amyloid-Β Plaques In Patients With Prodromal To Moderate Alzheimer's Disease: A Pet Substudy Interim Analysis, Gregory Klein, Paul Delmar, Nicola Voyle, Sunita Rehal, Carsten Hofmann, Danielle Abi-Saab, Mirjana Andjelkovic, Smiljana Ristic, Guoqiao Wang, Randall Bateman, Geoffrey A Kerchner, Monika Baudler, Paulo Fontoura, Rachelle Doody

Open Access Publications

BACKGROUND: We previously investigated low doses (105 or 225 mg) of gantenerumab, a fully human monoclonal antibody that binds and removes aggregated amyloid-β by Fc receptor-mediated phagocytosis, in the SCarlet RoAD (SR) and Marguerite RoAD (MR) phase 3 trials. Several lines of evidence suggested that higher doses may be necessary to achieve clinical efficacy. We therefore designed a positron emission tomography (PET) substudy to evaluate the effect of gantenerumab uptitrated to 1200 mg every 4 weeks on amyloid-β plaques as measured using florbetapir PET in patients with prodromal to moderate Alzheimer's disease (AD).

METHODS: A subset of patients enrolled in …

Mifepristone Treatment In Four Cases Of Primary Bilateral Macronodular Adrenal Hyperplasia (Bmah)., Pejman Cohan, Honey E East, Sandi-Jo Galati, Jennifer U Mercado, Precious J Lim, Michele Lamerson, James J Smith, Anne L Peters, Kevin C J Yuen

Neurology

CONTEXT: Primary bilateral macronodular adrenal hyperplasia (BMAH) is a rare form of adrenal Cushing syndrome conventionally treated with adrenalectomy. Medical treatment is often reserved for patients not eligible for surgery. However, to date there have been few studies about the efficacy of mifepristone for the treatment of BMAH associated with hypercortisolism.

OBJECTIVE: To describe a series of patients with hypercortisolism due to BMAH treated with mifepristone from multiple medical practices.

DESIGN: We retrospectively assessed four patients treated with mifepristone for hypercortisolism due to BMAH who had either failed unilateral adrenalectomy, declined surgery, or were poor surgical candidates.

RESULTS: Mifepristone induced …

Cognitive Decline Over Time In Patients With Systolic Heart Failure: Insights From Warcef., Tetz C Lee, Min Qian, Yutong Liu, Susan Graham, Douglas L Mann, Koki Nakanishi, John R Teerlink, Gregory Y H Lip, Ronald S. Freudenberger Md, Ralph L Sacco, Jay P Mohr, Arthur J Labovitz, Piotr Ponikowski, Dirk J Lok, Kenji Matsumoto, Conrado Estol, Stefan D Anker, Patrick M Pullicino, Richard Buchsbaum, Bruce Levin, John L P Thompson, Shunichi Homma, Marco R Di Tullio

Department of Medicine

OBJECTIVES: This study sought to characterize cognitive decline (CD) over time and its predictors in patients with systolic heart failure (HF).

BACKGROUND: Despite the high prevalence of CD and its impact on mortality, predictors of CD in HF have not been established.

METHODS: This study investigated CD in the WARCEF (Warfarin versus Aspirin in Reduced Ejection Fraction) trial, which performed yearly Mini-Mental State Examinations (MMSE) (higher scores indicate better cognitive function; e.g., normal score: 24 or higher). A longitudinal time-varying analysis was performed among pertinent covariates, including baseline MMSE and MMSE scores during follow-up, analyzed both as a continuous variable …

Associations Of Race And Ethnicity With Risk Of Developing Invasive Breast Cancer After Lobular Carcinoma In Situ, Vanessa Dania, Ying Liu, Foluso Ademuyiwa, Jason D Weber, Graham A Colditz

Open Access Publications

BACKGROUND: Lobular carcinoma in situ (LCIS) of the breast is a risk factor of developing invasive breast cancer. We evaluated the racial differences in the risks of subsequent invasive breast cancer following LCIS.

METHODS: We utilized data from the Surveillance, Epidemiology, and End Results registries to identify 18,835 women diagnosed with LCIS from 1990 to 2015. Cox proportional hazards regression was used to estimate race/ethnicity-associated hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) of subsequent invasive breast cancer.

RESULTS: During a median follow-up of 90 months, 1567 patients developed invasive breast cancer. The 10-year incidence was 7.9% for Asians, …

Validation Of A 5-Item Tool To Measure Patient Assessment Of Clinician Compassion In The Emergency Department, Praveen Sabapathi, Michael B Roberts, Brian M Fuller, Michael A Puskarich, Christopher W Jones, J Hope Kilgannon, Valerie Braz, Christina Creel-Bulos, Nathaniel Scott, Kristina L Tester, Anthony Mazzarelli, Stephen Trzeciak, Brian W Roberts

Open Access Publications

BACKGROUND: To test if the 5-item compassion measure (a tool previously validated in the outpatient setting to measure patient assessment of clinician compassion) is a valid and reliable tool to quantify a distinct construct (i.e. clinical compassion) among patients evaluated in the emergency department (ED).

METHODS: Cross-sectional study conducted in three academic emergency departments in the U.S. between November 2018 and April 2019. We enrolled adult patients who were evaluated in the EDs of the participating institutions and administered the 5-item compassion measure after completion of care in the ED. Validity testing was performed using confirmatory factor analysis. Cronbach's alpha …

Immune Globulin Subcutaneous, Human - Klhw 20% For Primary Humoral Immunodeficiency: An Open-Label, Phase Iii Study, John W Sleasman, William R Lumry, Iftikhar Hussain, H James Wedner, James B Harris, Kecia L Courtney, Elsa Mondou, Jiang Lin, Mark R Stein

2010-2019 OA Pubs

No abstract provided.

Cabozantinib Versus Sunitinib For Untreated Patients With Advanced Renal Cell Carcinoma Of Intermediate Or Poor Risk: Subgroup Analysis Of The Alliance A031203 Cabosun Trial, Daniel J George, Colin Hessel, Susan Halabi, M Dror Michaelson, Olwen Hahn, Meghara Walsh, Joel Picus, Eric J Small, Shaker Dakhil, Darren R Feldman, Milan Mangeshkar, Christian Scheffold, Michael J Morris, Toni K Choueiri

Open Access Publications

Cabozantinib treatment prolonged progression-free survival (PFS) and improved objective response rate (ORR) compared with sunitinib in patients with advanced renal cell carcinoma (RCC) of intermediate or poor risk by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria in the phase II CABOSUN trial (NCT01835158). In the trial, 157 patients were randomized 1:1 to receive cabozantinib or sunitinib, stratified by IMDC risk group and presence of bone metastases. Here, PFS and ORR, both determined by independent radiology committee (IRC), were analyzed by subgroups of baseline characteristics. Cabozantinib treatment was generally associated with improved PFS and ORR versus sunitinib across subgroups, …

Post-Acquisition Processing Confounds In Brain Volumetric Quantification Of White Matter Hyperintensities, Ahmed A. Bahrani, Omar M. Al-Janabi, Erin L. Abner, Shoshana H. Bardach, Richard J. Kryscio, Donna M. Wilcock, Charles D. Smith, Gregory A. Jicha

Neurology Faculty Publications

BACKGROUND: Disparate research sites using identical or near-identical magnetic resonance imaging (MRI) acquisition techniques often produce results that demonstrate significant variability regarding volumetric quantification of white matter hyperintensities (WMH) in the aging population. The sources of such variability have not previously been fully explored.

NEW METHOD: 3D FLAIR sequences from a group of randomly selected aged subjects were analyzed to identify sources-of-variability in post-acquisition processing that can be problematic when comparing WMH volumetric data across disparate sites. The methods developed focused on standardizing post-acquisition protocol processing methods to develop a protocol with less than 0.5% inter-rater variance.

RESULTS: A series …

Development And Psychometric Properties Of A Prostate Cancer Knowledge Scale For African American Men, Otis L. Owens, Abbas S. Tavakoli, Theda Rose, Nikki R. Wooten

Faculty Publications

African American men have the highest prostate cancer-related mortality nationally. In response to this disparity, targeted interventions are emerging to enhance African American men's prostate cancer (PrCA) knowledge to ensure they are equipped to make informed decisions about PrCA screening with health-care providers. African American men's PrCA knowledge has been measured inconsistently over time with limited psychometric evidence. The factor structure of this construct in African American men is relatively unknown. This study describes the development and psychometric evaluation of an 18-item Prostate Cancer Knowledge Scale among 352 African American men. Exploratory factor analysis (EFA) was conducted using weighted least …

Development And Psychometric Properties Of A Prostate Cancer Knowledge Scale For African American Men, Otis L. Owens, Abbas Tavakoli Drph, Theda Rose, Nikki R. Wooten

Faculty Publications

African American men have the highest prostate cancer-related mortality nationally. In response to this disparity, targeted interventions are emerging to enhance African American men's prostate cancer (PrCA) knowledge to ensure they are equipped to make informed decisions about PrCA screening with health-care providers. African American men's PrCA knowledge has been measured inconsistently over time with limited psychometric evidence. The factor structure of this construct in African American men is relatively unknown. This study describes the development and psychometric evaluation of an 18-item Prostate Cancer Knowledge Scale among 352 African American men. Exploratory factor analysis (EFA) was conducted using weighted least …

30-Day Emergency Department Revisit Rates Among Older Adults With Documented Dementia, Tyler Kent, Adriane Lesser, Juhi Israni, Ula Hwang, Christopher Carpenter, Kelly J Ko

Open Access Publications

OBJECTIVES: Published literature on national emergency department (ED) revisit rates among older adults with dementia is sparse, despite anecdotal evidence of higher ED utilization. Thus we evaluated the odds ratio (OR) of 30-day ED revisits among older adults with dementia using a nationally representative sample.

DESIGN: We assessed the frequency of claims associated with a 30-day ED revisit among Medicare beneficiaries with and without a dementia diagnosis before or at index ED visit. We used a logistic regression model controlling for dementia, age, sex, race, region, Medicaid status, transfer to a skilled nursing facility after ED, primary care physician use …

Integrated Proteogenomic Characterization Of Clear Cell Renal Cell Carcinoma, David J Clark, Yize Li, Yige Wu, Matthew A Wyczalkowski, Sunantha Sethuraman, Song Cao, Feng Chen, James J Hsieh, Li Ding, Et Al

Open Access Publications

To elucidate the deregulated functional modules that drive clear cell renal cell carcinoma (ccRCC), we performed comprehensive genomic, epigenomic, transcriptomic, proteomic, and phosphoproteomic characterization of treatment-naive ccRCC and paired normal adjacent tissue samples. Genomic analyses identified a distinct molecular subgroup associated with genomic instability. Integration of proteogenomic measurements uniquely identified protein dysregulation of cellular mechanisms impacted by genomic alterations, including oxidative phosphorylation-related metabolism, protein translation processes, and phospho-signaling modules. To assess the degree of immune infiltration in individual tumors, we identified microenvironment cell signatures that delineated four immune-based ccRCC subtypes characterized by distinct cellular pathways. This study reports a large-scale …

Gilteritinib Or Chemotherapy For Relapsed Or Refractory Flt3-Mutated Aml, Alexander E. Perl, Giovanni Martinelli, Jorge E. Cortes, Andreas Neubauer, Ellin Berman, Stefania Paolini, Pau Montesinos, Maria R. Baer, Richard A. Larson, Celalettin Ustun, Francesco Fabbiano, Harry P. Erba, Antonio Di Stasi, Robert Stuart, Rebecca Olin, Margaret Kasner, Fabio Ciceri, Wen-Chien Chou, Nikolai Podoltsev, Christian Recher, Hisayuki Yokoyama, Naoko Hosono, Sung-Soo Yoon, Je-Hwan Lee, Timothy Pardee, Amir T. Fathi, Chaofeng Liu, Nahla Hasabou, Xuan Liu, Erkut Bahceci, Mark J. Levis

Department of Medical Oncology Faculty Papers

BACKGROUND: Patients with relapsed or refractory acute myeloid leukemia (AML) with mutations in the FMS-like tyrosine kinase 3 gene (FLT3) infrequently have a response to salvage chemotherapy. Gilteritinib is an oral, potent, selective FLT3 inhibitor with single-agent activity in relapsed or refractory FLT3-mutated AML.

METHODS: In a phase 3 trial, we randomly assigned adults with relapsed or refractory FLT3-mutated AML in a 2:1 ratio to receive either gilteritinib (at a dose of 120 mg per day) or salvage chemotherapy. The two primary end points were overall survival and the percentage of patients who had complete remission …

Co-Prescription Network Reveals Social Dynamics Of Opioid Doctor Shopping, Brea L. Perry, Kai Cheng Yang, Patrick Kaminski, Meltem Odabas, Jaehyuk Park, Michelle M. Martel, Carrie B. Oser, Patricia R. Freeman, Yong-Yeol Ahn, Jeffery C. Talbert

Psychology Faculty Publications

This paper examines network prominence in a co-prescription network as an indicator of opioid doctor shopping (i.e., fraudulent solicitation of opioids from multiple prescribers). Using longitudinal data from a large commercially insured population, we construct a network where a tie between patients is weighted by the number of shared opioid prescribers. Given prior research suggesting that doctor shopping may be a social process, we hypothesize that active doctor shoppers will occupy central structural positions in this network. We show that network prominence, operationalized using PageRank, is associated with more opioid prescriptions, higher predicted risk for dangerous morphine dosage, opioid overdose, …

Case 22-2019: A 65-Year-Old Woman With Myopathy., Marinos C. Dalakas

Department of Neurology Faculty Papers

No abstract provided.

Chronic Obstructive Pulmonary Disease: Thoracic Ct Texture Analysis And Machine Learning To Predict Pulmonary Ventilation, Andrew Westcott, Dante P I Capaldi, David G Mccormack, Aaron D Ward, Aaron Fenster, Grace Parraga

Medical Biophysics Publications

Background Fixed airflow limitation and ventilation heterogeneity are common in chronic obstructive pulmonary disease (COPD). Conventional noncontrast CT provides airway and parenchymal measurements but cannot be used to directly determine lung function. Purpose To develop, train, and test a CT texture analysis and machine-learning algorithm to predict lung ventilation heterogeneity in participants with COPD. Materials and Methods In this prospective study (

Adjuvant Chemotherapy And Survival Among Patients 70 Years Of Age And Younger With Node-Negative Breast Cancer And The 21-Gene Recurrence Score Of 26-30, Seho Park, Yunan Han, Ying Liu, Adetunji T Toriola, Lindsay L Peterson, Graham A Colditz, Seung Il Kim, Young Up Cho, Byeong-Woo Park, Yikyung Park

Open Access Publications

BACKGROUND: The benefits of chemotherapy in node-negative, hormone receptor-positive, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients with the 21-gene recurrence score (RS) of 18-30, particularly those with RS 26-30, are not known.

METHODS: Using the Surveillance, Epidemiology, and End Results (SEER) data, we retrospectively identified 29,137 breast cancer patients with the 21-gene RS of 18-30 diagnosed between 2004 and 2015. Mortality risks according to the RS and chemotherapy use were compared by the Kaplan-Meier method and Cox's proportional hazards model.

RESULTS: Among the breast cancer patients with the RS 18-30, 21% of them had RS 26-30. …

Development Of A Non-Invasive Device For Swallow Screening In Patients At Risk Of Oropharyngeal Dysphagia: Results From A Prospective Exploratory Study, Catriona M. Steele, Rajat Mukherjee, Juha M. Kortelainen, Harri Pölönen, Michael Jedwab, Susan L. Brady, Kayla Brinkman Theimer, Susan Langmore, Luis F. Riquelme, Nancy B. Swigert, Philip M. Bath, Larry B. Goldstein, Richard L. Hughes, Dana Leifer, Kennedy R. Lees, Atte Meretoja, Natalia Muehlemann

Neurology Faculty Publications

Oropharyngeal dysphagia is prevalent in several at-risk populations, including post-stroke patients, patients in intensive care and the elderly. Dysphagia contributes to longer hospital stays and poor outcomes, including pneumonia. Early identification of dysphagia is recommended as part of the evaluation of at-risk patients, but available bedside screening tools perform inconsistently. In this study, we developed algorithms to detect swallowing impairment using a novel accelerometer-based dysphagia detection system (DDS). A sample of 344 individuals was enrolled across seven sites in the United States. Dual-axis accelerometry signals were collected prospectively with simultaneous videofluoroscopy (VFSS) during swallows of liquid barium stimuli in thin, …

The Effects Of Long-Term Benzodiazepine Use And Withdrawal In The Elderly, Lydia Suchecki, Hannah Granger, Jamie Kellner, Mary Ellen Hethcox

Pharmacy and Wellness Review

Benzodiazepines remain a commonly prescribed medication in the United States, and the high usage of this drug class is especially a concern in the elderly population for several reasons. First, elderly patients metabolize drugs differently, leading to varying responses. Age-related changes also have a significant impact on the effects of benzodiazepines. Second, elderly patients are more likely to be taking multiple centrally-acting drugs, which can further exacerbate negative effects. In regard to long-term benzodiazepine use, elderly patients experience an increased risk of cognitive impairment, motor vehicle accidents, decline in physical performance, falls and subsequent fractures, and sleep disturbances. Withdrawal is …

The Gut-Microbiome In Gulf War Veterans: A Preliminary Report, Patricia A. Janulewicz, Ratanesh K. Seth, Jeffrey M. Carlson, Joy Ajama, Emily Quinn, Timothy Heeren, Nancy Klimas, Steven M. Lasley, Ronnie Horner, Kimberly Sullivan, Saurabh Chatterjee

Faculty Publications

Gulf War Illness (GWI) is a chronic multi-symptom disorder affecting the central nervous system (CNS), immune and gastrointestinal (GI) systems of Gulf War veterans (GWV). We assessed the relationships between GWI, GI symptoms, gut microbiome and inflammatory markers in GWV from the Boston Gulf War Illness Consortium (GWIC). Three groups of GWIC veterans were recruited in this pilot study; GWV without GWI and no gastrointestinal symptoms (controls), GWV with GWI and no gastrointestinal symptoms (GWI-GI), GWV with GWI who reported gastrointestinal symptoms (GW+GI). Here we report on a subset of the first thirteen stool samples analyzed. Results showed significantly different …

Multiple Sclerosis Outcomes After Cancer Immunotherapy, Catherine R. Garcia, Rani Jayswal, Val R. Adams, Lowell B. Anthony, John L. Villano

Markey Cancer Center Faculty Publications

INTRODUCTION: Neurological immune-related adverse events are a rare but potentially deadly complication after immune checkpoint inhibitor (ICI) treatment. As multiple sclerosis (MS) is an immune-mediated disease, it is unknown how ICI treatment may affect outcomes.

METHODS: We analyzed the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database for pembrolizumab, atezolizumab, nivolumab, ipilimumab, avelumab, and durvalumab 2 years prior their FDA approval until December 31, 2017, to include all cases with confirmed diagnosis/relapse of MS. We also included cases reported in the literature and a patient from our institution.

RESULTS: We identified 14 cases of MS …

The Diagnostic Yield Of Malignancy Comparing Cytology, Fish, And Molecular Analysis Of Cell Free Cytology Brush Supernatant In Patients With Biliary Strictures Undergoing Endoscopic Retrograde Cholangiography (Erc): A Prospective Study, Vladimir M Kushnir, Daniel K Mullady, Koushik Das, Gabriel Lang, Thomas G Hollander, Faris M Murad, Sara A Jackson, Nicole A Toney, Sydney D Finkelstein, Steven A Edmundowicz

Open Access Publications

BACKGROUND: Routine cytology of biliary stricture brushings obtained during endoscopic retrograde cholangiopancreatography (ERCP) has suboptimal sensitivity for malignancy. We compared the individual and combined ability of cytology, fluorescence in situ hybridization (FISH) analysis and PCR-based mutation profiling (MP) to detect malignancy in standard biliary brushings.

METHODS: We performed a prospective study of patients undergoing ERCP using histology or 1 year follow-up to determine patient outcomes. MP was performed on free-DNA from biliary brushing specimens using normally discarded supernatant fluid. MP examined KRAS point mutations and tumor suppressor gene associated loss of heterozygosity mutations at 10 genomic loci. FISH examined chromosome …

Pulmonary Coccidioidomycosis Diagnosed By Endobronchial Ultrasound With Fine Needle Aspiration Biopsy Of A Paratracheal Pulmonary Nodule, Aibek E. Mirrakhimov, Oleh Hnatiuk, Tiffany Grant, David R. Martin, Ali I. Saeed

Pathology Research and Scholarship

occidioidomycosis is a fungal infection which is prevalent in the southwestern region of the United States.¹ Clinical presentation of pulmonary coccidioidomycosis is nonspecific, and the disease can manifest as subclinical infection, upper respiratory viral-like illness, and rarely severe respiratory failure requiring intensive care admission. Radiologically the disease can present with pulmonary infiltrates, nodules or cavitary lesions which can mimic other infectious, autoimmune, and neoplastic disorders.² The diagnosis is typically made using serologic testing.³ The most commonly performed serologic methods are enzyme-linked immunoassay (EIA), qualitative immunodiffusion testing for immunoglobulin M and G antibodies and quantitative complement fixation.^{3 …}

Quantifying Balance Control After Spinal Cord Injury: Reliability And Validity Of The Mini-Bestest, Katherine Chan, Janelle Unger, Jae Woung Lee, Gillian Johnston, Marissa Constand, Kei Masani, Kristin E Musselman

Physical Therapy Publications

Context/Objective: Incomplete spinal cord injury (iSCI) causes deficits in balance control. The Mini-Balance Evaluation Systems Test (mini-BESTest) is a comprehensive measure; however, further testing of its psychometric properties among the iSCI population is needed. We evaluated the mini-BESTest’s test-retest reliability, and concurrent and convergent validity among individuals living with iSCI for more than one year.

Design: Cross-sectional study.

Setting: Rehabilitation hospital.

Participants: Twenty-one individuals with chronic motor iSCI (14 females, mean age 56.8 ± 14.0 years).

Interventions: None.

Outcome Measures: Participants completed the mini-BESTest at two sessions spaced two weeks apart. At the second session, participants …

Phase I, Open-Label, Dose-Escalation Study Of The Safety, Pharmacokinetics, Pharmacodynamics, And Efficacy Of Gsk2879552 In Relapsed/Refractory Sclc, Todd M Bauer, Benjamin Besse, Alex Martinez-Marti, Jose Manuel Trigo, Victor Moreno, Pilar Garrido, Geraldine Ferron-Brady, Yuehui Wu, Jennifer Park, Therese Collingwood, Ryan G Kruger, Helai P Mohammad, Marc S Ballas, Arindam Dhar, Ramaswamy Govindan

Open Access Publications

INTRODUCTION: This first-time-in-humans study assessed the safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of GSK2879552 in patients with relapsed or refractory SCLC.

METHODS: This phase I, multicenter, open-label study (NCT02034123) enrolled patients (≥18 years old) with relapsed or refractory SCLC (after ≥1 platinum-containing chemotherapy or refusal of standard therapy). Part 1 was a dose-escalation study; Part 2 was a dose-expansion study. Dose escalations were based on safety, PK, and PD. The primary end point (Part 1) was to determine the safety, tolerability, and recommended dose and regimen of GSK2879552. Secondary end points were to characterize PK and PD parameters …

Socioemotional Selectivity And Psychological Health In Amyotrophic Lateral Sclerosis Patients And Caregivers: A Longitudinal, Dyadic Analysis, Suzanne C. Segerstrom, Edward J. Kasarskis, David W. Fardo, Philip M. Westgate

Psychology Faculty Publications

Objective: Socioemotional selectivity theory predicts that as the end of life approaches, goals and resources that provide immediate, hedonic reward become more important than those that provide delayed rewards. This study tested whether these goal domains differentially affected psychological health in the context of marital dyads in which one partner had been diagnosed with amyotrophic lateral sclerosis (ALS), a life-limiting disease.

Design: ALS patients (N = 102) being treated in three multidisciplinary clinics and their spouses (N = 100) reported their loneliness, financial worry and psychological health every 3 months for up to 18 months.

Main …

Noninvasive Detection Of Graft Injury After Heart Transplant Using Donor-Derived Cell-Free Dna: A Prospective Multicenter Study, Kiran K Khush, Jignesh Patel, Sean Pinney, Andrew Kao, Rami Alharethi, Eugene Depasquale, Gregory Ewald, Peter Berman, Manreet Kanwar, David Hiller, James P Yee, Robert N Woodward, Shelley Hall, Jon Kobashigawa

2020-Current year OA Pubs

Standardized donor-derived cell-free DNA (dd-cfDNA) testing has been introduced into clinical use to monitor kidney transplant recipients for rejection. This report describes the performance of this dd-cfDNA assay to detect allograft rejection in samples from heart transplant (HT) recipients undergoing surveillance monitoring across the United States. Venous blood was longitudinally sampled from 740 HT recipients from 26 centers and in a single-center cohort of 33 patients at high risk for antibody-mediated rejection (AMR). Plasma dd-cfDNA was quantified by using targeted amplification and sequencing of a single nucleotide polymorphism panel. The dd-cfDNA levels were correlated to paired events of biopsy-based diagnosis …

Race And Risk Of Subsequent Aggressive Breast Cancer Following Ductal Carcinoma In Situ, Ying Liu, Robert West, Jason D Weber, Graham A Colditz

Open Access Publications

BACKGROUND: General populations of black women have a higher risk of developing breast cancer negative for both estrogen receptor (ER) and progesterone receptor (PR) in comparison with white counterparts. Racial differences remain unknown in the risk of developing aggressive invasive breast cancer (IBC) that is characterized by negativity for both ER and PR (ER-PR-) or higher 21-gene recurrence scores after ductal carcinoma in situ (DCIS).

METHODS: This study identified 163,892 women (10.5% black, 9.8% Asian, and 8.6% Hispanic) with incident DCIS between 1990 and 2015 from the Surveillance, Epidemiology, and End Results data sets. Cox proportional hazards regression was used …