tbuckley/cabot-search huggingface dataset:
Abortive Plasma Cell Differentiation with Loss of Mature B-Cell Phenotype in a Subset of Patients with De Novo Diffuse Large B-Cell Lymphoma and Transformed Follicular Lymphoma: Relevance of cMYC Rearrangements.
Authors: Matthew J. Cullen, Sharon L. Barrans, Stephen J. Richards, Andy C. Rawstron, Sheila J.M. O’Connor, Reuben M. Tooze, Roger G. Owen, Andrew Jack
Journal: Blood (2006)
P2.01-089 Predictive Value of AEG-1 Expression on Tumor Response by Liquid Biopsy in NSCLC Patients Treated with Chemotherapy
Authors: Ying-Yin Chen, Chung-Yu Chen, Kuan-Yu Chen, Chao-Chi Ho, Jin-Yuan Shih, Chong-Jen Yu, Pan-Chyr Yang
Journal: Journal of Thoracic Oncology (2017)
Purified MHC-Matched Hematopoietic Stem Cell Transplantation Following Total Lymphoid Irradiation and Anti-Thymocyte Globulin (TLI+ATG) Blocks EAE Pathogenesis.
Authors: Li-Fen Lee, Matthew Burge, Peggy Ho, Raymond Sobel, Judith Shizuru
Journal: Blood (2007)
Gene Expression Profile Analysis According to Recurrent Gene Copy Number Abnormalities Defines a Diffuse Large B-Cell Lymphoma Subgroup Characterized by 9p21 Locus Deletion, Ribosome Machinery Deregulation and Poor Prognosis. A GELA Study
Authors: Fabrice Jardin, Jean-Philippe Jais, Thierry Jo Molina, Francoise Parmentier, Jean-Michel Picquenot, Philippe Ruminy, Herve Tilly, Christian Bastard, Gilles Andre Salles, Bertrand Coiffier, Corinne Haioun, Karen Leroy
Journal: Blood (2008)
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Refractory or Relapsed Lymphoid Malignancies.
Authors: Wyndham H. Wilson, Anil Tulpule, Alexandra M. Levine, Kieron Dunleavy, Andrew P. Krivoshik, Anne E. Hagey, Margaret Shovlin, Melanie A. Gloria, Renee Greco, Hao Xiong, Yi-Lin Chiu, Steven W. Elmore, Owen A. O’Connor
Journal: Blood (2007)
P3.02b-019 TTF-1 Expression as a Predictor of Response to EGFR-TKIs in Patients with Lung Adenocarcinoma
Authors: Kostas Syrigos, Evangelos Sarris, Ilias Kotteas, Georgios Fotopoulos, Ioannis Vamvakaris, Rodoula Trigidou, Dimitra Grapsa
Journal: Journal of Thoracic Oncology (2017)
PAX5 Wild-Type without IKZF1 (Ikaros) Deletion Is Associated with Prolonged Disease-Free Survival and Low Rate of Cumulative Incidence of Relapse in Adult BCR-ABL1-Positive Acute Lymphoblastic Leukemia (ALL): On Behalf of GIMEMA AL Working Party.
Authors: Ilaria Iacobucci, Cristina Papayannidis, Francesca Paoloni, Annalisa Lonetti, Markus Muschen, Marco Vignetti, Daniela Cilloni, Simona Soverini, Francesca Messa, Stefania Paolini, Sabina Chiaretti, Viviana Guadagnuolo, Paola Fazi, Antonella Vitale, Giovanna Meloni, Marco Gobbi, Michele Malagola, Giuseppe Saglio, Fabrizio Pane, Michele Baccarani, Robin Foà, Giovanni Martinelli
Journal: Blood (2009)
In the Aftermath of the National Children’s Study
Authors: Terence Dwyer, Per Magnus, Jørn Olsen
Journal: JAMA Pediatrics (2017)

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The new generation of combined hormone contraceptives and risk of gynecologic cancers.
Authors: R. Haque, G. Inzhakova, J. M. Shi, J. Chung, F. Niu, C. T. Cheetham
Journal: Journal of Clinical Oncology (2011)

1571 Background: While older studies suggest that certain contraceptive medications can increase the risk of breast and cervical cancers and protect against ovarian and endometrial cancer, little is known about cancer risks associated with the new generation of combined hormone contraception (CHCs) drugs. The new CHCs utilize the same types of hormones (estrogen and progestin), but contain lower levels of estrogen at 15-35 mcg/day compared to 150 mcg/day in the older CHCs. The objective of this study was to examine the association of specific new CHCs (OrthoEvra, NuvaRing, and Yasmin) on the risk of breast, endometrial, cervical and ovarian cancers. Methods: Data for this population-based study came from a large health plan based in California that serves over 3.2 million diverse members. The cohort included 164,000 women aged 18-55 years at baseline (n==82,000 CHC users and n==82,000 age matched nonusers). We followed women until the date of cancer incidence, health plan disenrollment, death, or 12/31/2008. We compared incidence rates of various cancers among CHC-users and non-users. Cox proportional hazards models were used to determine the association between CHC use and cancer risk adjusted for ethnicity, income, sexually transmitted infections, history of hormone replacement treatment, Charlson comorbidity, outpatient utilization, and number of mammograms. Results: The cohort was followed a maximum of 8 years. Cancer incidence rates were similar in both groups for all anatomic sites. Overall, CHC-users had a slightly increased risk of each type of cancer; however, the confidence intervals were wide and included the null. Conclusions:Our results provide reassurance that the new generation of CHCs do not elevate cancer risk; however, these preliminary data need to be evaluated in cohorts with longer follow-up. Hazard ratios for cancer risks for CHC users versus nonusers. Cancer site Cases (N) Adjusted HR 95% CI Breast 296 1.17 1.00-1.38 Endometrial 49 1.48 0.96-2.28 Cervical 27 1.53 0.85-2.76 Ovarian 32 1.38 0.82-2.33
OA13.03 Long-Term Overall Survival for Patients with Malignant Pleural Mesothelioma on Pembrolizumab Enrolled in KEYNOTE-028
Authors: Evan Alley, Juanita Lopez, Armando Santoro, Anne Morosky, Sanatan Saraf, Bilal Piperdi, Jan H.M. Schellens
Journal: Journal of Thoracic Oncology (2017)
Phase III Prospective Randomized Trial of EPO with or without G-CSF Versus Supportive Therapy Alone in the Treatment of Myelodysplastic Syndromes (MDS): Results of the ECOG- CLSG Trial(E1996).
Authors: Kenneth B. Miller, Haesook T. Kim, Peter Greenberg, Richard van der Jagt, John M. Bennett, Martin S. Tallman, Elisabeth Paietta, Gordon Dewald, Jessie G. Houston, Mary Thomas, Jacob Rowe
Journal: Blood (2004)
P1.04-025 The Impact of Emergency Presentation on Survival of Lung Cancer Patients
Authors: Marko Jakopovic, Dzubur Fedza, Lela Bitar, Ivona Markelić, Fran Seiwerth, Ana Hecimovic, Branka Čučević, Ivica Mazuranic, Gzim Redzepi, Andrea Vukic Dugic, Mateja Jankovic, Miroslav Samarzija
Journal: Journal of Thoracic Oncology (2017)
Long Term Efficacy and Tolerance of Pegylated Interferon Alpha Therapy for Patients with High Risk Essential Thrombocythemia: An Observational Study of the French Intergroup of Myeloproliferative Disorders (FIM)
Authors: Lydia Roy, Jean Christophe Ianotto, Joelle Guilhot, Christian Récher, Laurence Legros, Dana Ranta, Emmanuel Raffoux, Pascale Cony Makhoul, Emmanuel Gyan, Benoit de Renzis, Françoise Boyer, Thierry Muron, Franck Emmanuel Nicolini, Kamel Laribi, Jean-Jacques Kiladjian, Stephane Giraudier
Journal: Blood (2014)
Receptor Activator of Nuclear Factor kB (RANK) Is Upregulated in Chronic Myeloid Leukemia Patients Taking Imatinib Mesylate: Can This Be Considered a Drug-Mediated Immune Activation Effect?.
Authors: Francesco Albano, Luisa Anelli, Antonella Zagaria, Maria Guastadisegni, Alessandra Pannunzio, Vincenzo Liso, Mariano Rocchi, Giorgina Specchia
Journal: Blood (2006)
P3.02c-051 A Pre-Treatment Serum Test Based on Complement and IL-10 Pathways Identifies Patients Benefiting from the Addition of Bavituximab to Docetaxel
Authors: David Gerber, Joanna Roder, Nikoletta Kallinteris, Leora Horn, Gyorgy Losonczy, Ronald Natale, Min Tang, Heinrich Roder, Joseph Shan, Rachel Sanborn
Journal: Journal of Thoracic Oncology (2017)
P3.02c-071 Spatially Selective Depletion of Regulatory T Cells with near Infrared Photoimmunotherapy for Syngeneic Lewis Lung Carcinoma
Authors: Kazuhide Sato, Noriko Sato, Biying Xu, Peter Choyke, Yoshinori Hasegawa, Hisataka Kobayashi
Journal: Journal of Thoracic Oncology (2017)
P3.07-004 Nivolumab for Non-Small Cell Lung Cancer (NSCLC): An Economic Model for Risk Sharing Based on Real-Life Data
Authors: Elizabeth Dudnik, Daniel Goldstein, Laila Roisman, Ariel Hammerman, Sari Greenberg-Dotan, Jair Bar, Mor Moskovitz, Sameh Daher, Sivan Shamai, Ekaterina Hanovich, Yelena Shechtman, Mahmoud Abu-Amna, Alona Zer, Mira Wollner, Ofer Merimsky, Arnold Cyjon, Nir Peled
Journal: Journal of Thoracic Oncology (2017)
P2.03a-023 Induction-Maintenance Treatment Sequence in Non-Squamous Non-Small Cell Lung Cancer (neNSCLC): Pemetrexed vs Vinorelbine-Based Induction
Authors: Xabier Mielgo Rubio, Ruth Martínez-Cabañes, Clara Olier-Garate, Jorge Silva-Ruiz, María García-Ferrón, Susana Hernando, Juan Carlos Cámara-Vicario, Alicia Hurtado-Nuño, Cristina Aguayo-Zamora, Diana Moreno-Muñoz, Elia Pérez-Fernández, Carlos Jara-Sánchez
Journal: Journal of Thoracic Oncology (2017)
Phase I trial of bevacizumab combined with concurrent chemoradiation for squamous cell carcinoma of the head and neck: Preliminary outcome results.
Authors: P. M. Harari, D. Khuntia, A. M. Traynor, T. Hoang, D. T. Yang, G. K. Hartig, T. M. McCulloch, R. Jeraj, M. J. Nyflot, P. A. Wiederholt, L. R. Gentry
Journal: Journal of Clinical Oncology (2011)

5518 Background: A Phase I trial has been completed to examine the safety and feasibility of combining bevacizumab (bev) with radiation and cisplatin in patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). We assessed the capacity of bev monotherapy to induce tumor response as measured by functional imaging and biomarker evaluation. We report preliminary clinical outcome as well as correlative imaging and biomarker results. Methods: All patients underwent experimental imaging [FLT-PET (proliferation), CuATSM-PET (hypoxia), DCE-CT scans (flow/perfusion)] and biomarker evaluation prior to bev monotherapy. At three weeks, repeat tumor biopsy and imaging/serum studies were performed. Comprehensive H&N chemoradiation (CRT) was then delivered to 70 Gy in 33 fractions with concurrent weekly cisplatin at 30 mg/m2 and Q3 week bev (wks 1, 4, 7) with dose escalation from 5 to 10 to 15 mg/kg. Results: Between 2007-2010, ten LA-HNSCC pts were enrolled. All had stage IV HNSCC and remain alive (9 NED) with a mean survival of 22.4 months. There have been two recurrences at 15 and 16 months respectively. Nine patients experienced grade 3 toxicity (dysphagia-9, mucositis-7, tumor pain-3, weight loss-4, nausea/vomiting-2), with two cases of grade 4 lymphopenia. No significant bleeding was observed. Tumor proliferation (FLT) following bev monotherapy and at mid-course showed significant reduction (p<0.05). Tumor hypoxia (Cu-ATSM) showed minimal change following bev alone, but showed reduction during CRT. AQUA histology confirmed reduction in VEGFR2 expression from tumor biopsies following bev therapy. Conclusions: The incorporation of bev with comprehensive CRT for LA-HNSCC appears safe and feasible. Several patients manifested tumor regression following administration of bev alone. Three patients experienced pronounced tumor pain early in the treatment course. Experimental imaging and biomarker evaluation demonstrated clear changes following bev alone and during CRT. These findings may afford opportunities to forecast clinical outcome for individual patients and thereby tailor therapy approaches in future clinical trials.
S26 Feasibility and patient tolerability of transcutaneous electrical stimulation in obstructive sleep apnoea
Authors: KI Reed, MF Pengo, S Xiao, C Ratneswaran, N Shah, T Chen, A Douiri, N Hart, Y Luo, GF Rafferty, GP Rossi, A Williams, MI Polkey, J Moxham, J Steier
Journal: Thorax (2016)

<h3>Introduction</h3> Transcutaneous electrical stimulation (TES) provides neuromuscular tone to the pharyngeal dilator muscles of the upper airway (UA) while asleep, but feasibility of this method to treat obstructive sleep apnoea (OSA) throughout the whole night has not been tested. <h3>Patients and methods</h3> We conducted a phase two double-blind, sham-controlled, randomised controlled trial using TES of the UA muscles in 36 patients with confirmed OSA to assess patients’ device acceptance and the side effect profile. Patients were studied using polysomnography during randomly assigned nights of sham-stimulation and active treatment following titration of the current while awake. Assessment of patients’ device acceptance and experience of side effects was measured using a visual analogue scale (0–10 points) where high scores indicated better outcomes. <h3>Results</h3> We included 36 patients (age mean 50.8 (SD 11.2) years, male/female 30/6, body mass index median 29.6 (IQR 26.9–34.9) kg/m<sup>2</sup>, Epworth Sleepiness Scale 10.5 (4.6) points, oxygen desaturation index median 25.7 (16.0–49.1)/hour, apnoea-hypopnoea index median 28.1 (19.0–57.0)/hour). None of the patients reported skin discomfort, unpleasant tongue sensations or morning headache. There was no difference in patients’ perceived sleep quality. There was a 59% reduction in mouth dryness after active treatment compared to sham-stimulation. There were no severe adverse events (Table). <h3>Conclusion</h3> TES of the UA dilator muscles in OSA can be delivered throughout the night with few side effects and does not lead to arousal from sleep, if appropriately titrated.
P3.02a-015 Ceritinib as First-Line Therapy in Patients with ALK-Rearranged Non-Small Cell Lung Cancer: ASCEND-1 Subgroup Analysis
Authors: Daniel Shao-Weng Tan, Enriqueta Felip, Laura Qm Chow, Sunil Sharma, Patrick Urban, Isabelle Malet, Santosh Sutradhar, Siyu Li, Alice Shaw
Journal: Journal of Thoracic Oncology (2017)
Genomic analysis of circulating cell-free DNA (cfDNA) to investigate mechanisms of resistance to enzalutamide (ENZ) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts).
Authors: Arun Azad, Alexander Wyatt, Stanislav Volik, Anne Haegert, Stephane Le Bihan, Robert H Bell, Shawn A Anderson, Brian McConeghy, Robert Shukin, Martin Edwin Gleave, Colin Collins, Kim N. Chi
Journal: Journal of Clinical Oncology (2015)

157 Background: Factors driving clinical resistance to ENZ are poorly understood. Genomic analysis of cfDNA is a promising and minimally invasive approach for investigating mechanisms of therapeutic resistance in mCRPC. Methods: Baseline plasma samples were collected from 53 mCRPC pts commencing ENZ. In 31 of these pts, 12-week and treatment cessation samples were also obtained. DNA was extracted and subjected to array Comparative Genomic Hybridization (aCGH) for chromosome copy number (CN) analysis and androgen receptor (AR) gene sequencing (MiSeq) for mutation analysis. Endpoints were i) PSA50 or PSA30 response rates (RR) (PSA decline ≥ 50% or 30% for ≥ 3 weeks); and ii) radiographic/clinical progression-free survival (PFS). Results: CN changes on baseline aCGH included 8p loss (26%), 8q gain (32%), MYC gain (28%), CCND1 gain/amplification (amp) (11%), MET gain (13%), RB1 loss (21%) and AR gain/amp (30%). Correlation of clinical and genomic data showed multiple links between AR CN status and outcomes on ENZ. Firstly, compared to no AR gain/amp, pts with pre-treatment AR gain/amp had lower PSA50 (41% vs. 19%, P=0.12; Χ 2 ) and PSA30 RR (54% vs. 25%, P=0.051; Χ 2 ) and shorter median PFS (4.6 vs. 2.3 months, P&lt;0.001; log-rank). Secondly, on multivariate analysis, pre-treatment AR gain/amp (HR 3.42, P=0.002) together with prior abiraterone (HR 4.72, P=0.001) was confirmed as an independent prognostic factor for PFS. Thirdly, in pts with serial plasma samples, 16% (5/31) had a change in AR CN status from baseline with 3 pts converting from no AR gain to AR gain and 2 pts from AR gain to AR amp. Of note, median PFS in these 5 pts was only 2.8 months. Finally, AR gain/amp at baseline or emergence of AR gain/amp on-treatment was associated with decreased median PFS compared with no AR CN increase at any timepoint (2.3 months vs. 6.5 months, P&lt;0.001; log-rank). Conclusions: Detection of AR gain/amp in pre- or on-treatment cfDNA samples correlated with adverse outcomes on ENZ. These data indicate that AR gain/amp may be a biomarker of primary and acquired resistance to ENZ in mCRPC pts. Updated data including AR gene sequencing will be presented.
Identification of a Novel Splice Donor Mutation In the Thrombopoietin Gene In a Philippine Family with Hereditary Thrombocythemia
Authors: Jason Gotlib, Bing Zhang, Carol D. Jones, Jonathan Riess, Wendy B. Wong, Erin F. Simonds, Matthew B. Hale, Parveen Abidi, Janell McClung, Garry P. Nolan, Stephen T. Oh, James L. Zehnder
Journal: Blood (2010)
Abstract B23: Crucial deubiquitinases in cancer cell survival
Authors: Lorna Kategaya, Trinna Cuellar, Ben Haley, Jinfeng Liu, Andy Tran, Yi Cao, David Stokoe, Mark McCleland, Beth Blackwood, Sharon Yee, Joy Drobnick, Jake Drummond, James Ernst, Michael Kwok, Cuong Ly, Richard Pastor, Paola Di Lello, Chudi Ndubaku, Robert Blake, Vickie Tsui, Jeremy Murray, Till Maurer, Ingrid Wertz
Journal: Clinical Cancer Research (2017)

Abstract Deubiquitinases (DUBs) are enzymes that proteolytically cleave ubiquitin from substrates. Substrates include oncogenes, tumor suppressors and polyubiquitinated proteins marked for degradation by the proteasome. Ubiquitin specific peptidase-7 (USP7) deubiquitinates MDM2 (an oncogene). MDM2 is a ligase that ubiquitinates p53 (a tumor suppressor protein), targeting it for proteosomal degradation. As such, USP7 is a promising cancer target because its inhibition stabilizes p53 and thereby promotes apoptosis and cell cycle arrest, processes that are often deregulated in tumors (Nicholson and Suresh Kumar, 2011). We found that USP7 was selectively druggable following a fragment-based lead discovery effort to obtain USP7 antagonists. Cellular and xenograft studies confirm that inhibiting USP7 activity stabilized p53 levels and p53-downstream target, p21. Additionally, normal primary and p53-null cells were less sensitive than the corresponding p53-WT cancer cells to USP7 inhibition. To investigate whether other DUBs are involved in cancer cell survival, we carried out a drop-out CRISPR screen using a pooled DUB library in HCT116 and A549 cells. Out of the approximately 100 DUBs targeted, nine, including USP7, were found to affect cell viability. These hits were validated using siRNA-mediated knockdown in cancer cell lines (A549, HCT116, MCF7). Three DUBs that robustly decreased cell proliferation were further tested in normal cells (Human Mammary Epithelial Cells and Human Bronchial Epithelial Cells). DUB protein expression levels and activity were also determined. In general, DUB expression levels, activity and knockdown efficiency were higher in cancer cells compared to normal cells. Collectively, our studies support the hypothesis that USP7 inhibition may be an efficacious strategy to promote cancer cell death. Furthermore, there are other DUBs that should be considered as novel cancer targets. Citation Format: Lorna Kategaya, Trinna Cuellar, Ben Haley, Jinfeng Liu, Andy Tran, Yi Cao, David Stokoe, Mark McCleland, Beth Blackwood, Sharon Yee, Joy Drobnick, Jake Drummond, James Ernst, Michael Kwok, Cuong Ly, Richard Pastor, Paola Di Lello, Chudi Ndubaku, Robert Blake, Vickie Tsui, Jeremy Murray, Till Maurer, Ingrid Wertz. Crucial deubiquitinases in cancer cell survival. [abstract]. In: Proceedings of the AACR Precision Medicine Series: Targeting the Vulnerabilities of Cancer; May 16-19, 2016; Miami, FL. Philadelphia (PA): AACR; Clin Cancer Res 2017;23(1_Suppl):Abstract nr B23.
Adhesion Receptor Expression by Acute Myeloid Leukemia (AML) Bone Marrow Derived or Circulating Blasts and AML Stem Cells: The Key to Overcoming Chemoresistance.
Authors: Pamela S. Becker, Sylvia Chien, Mikhail Roshal, Brent Wood, Elihu Estey, Thalia Papayannopoulou, Xin Zhao, Soumit Basu, Mark McGrath, Kenneth Kopecky, Frederick R Appelbaum
Journal: Blood (2009)
Interleukin-6, Hepcidin, and Other Biomarkers in Anemia of Chronic Disease (ACD) and Chemotherapy-Induced Anemia (CIA): Potential Therapeutic Targets.
Authors: Saroj Vadhan-Raj, Xiao Zhou, Carlos E. Bueso-Ramos, Shreyaskumar Patel, Robert S Benjamin, Martin Ngyuen
Journal: Blood (2012)
MA11.07 Improved Small Cell Lung Cancer (SCLC) Response Rates with Veliparib and Temozolomide: Results from a Phase II Trial
Authors: Lauren Averett Byers, Lee Krug, Saiama Waqar, Afshin Dowlati, Christine Hann, Alberto Chiappori, Taofeek Owonikoko, Kaitlin Woo, Yevgeniya Bensman, Brenda Hurtado, Robert Cardnell, Lixia Diao, Youhong Fan, Junya Fujimoto, Jaime Rodriguez-Canales, Lihong Long, Erik Sulman, Ignacio Wistuba, Jing Wang, William Travis, Alice Chen, Charles Rudin, Mark Kris, Martin Fleisher, John Heymach, M Catherine Pietanza
Journal: Journal of Thoracic Oncology (2017)
Abstract 11473: Dabigatran Treatment Simulation in Patients Undergoing Maintenance Hemodialysis
Authors: Karl-Heinz Liesenfeld, Andreas Clemens, Joerg Kreuzer, Martina Brueckmann, Azhar Ahmad, Friedrich Schulze
Journal: Circulation (2015)

Background: Patients undergoing maintenance hemodialysis (HD) with atrial fibrillation (AF) are at increased risk of ischemic stroke and bleeds. At present, vitamin K antagonists, e.g. warfarin, are predominantly used for anticoagulation in this patient population. In such patients, limited data are available on the use of non-vitamin K oral anticoagulants. Dabigatran etexilate (DE) is mainly (85%) renally eliminated, thus its half-life is prolonged in renal impairment. It has been established that 4-hour HD can remove up to 60% of dabigatran from the plasma. The aim of the presented study is to evaluate the dose-exposure relationship for DE in HD patients considering different dosages and HD modalities by pharmacokinetic modeling. The resulting data could inform DE dose selection in future clinical trials. Method: We compared modeled DE exposure at once- and twice-daily doses of 75 mg, 110 mg, 150 mg in HD patients from pre- and post-dialysis dosing, with values simulated from AF patients in the RE-LY ® trial, based on a previously characterized pharmacometric model. Furthermore, variations in non-renal clearance, and several dialysis settings were simulated. Exposure (area under the curve, AUC) was compared to those from typical clinical HD settings. Results: Twice-daily DE doses showed a 1.5- to 3.3-fold increase in AUC of dabigatran compared with a typical RE-LY ® patient. A once-daily dose of 75 mg given after dialysis or 110 mg given before dialysis achieved an AUC comparable (-13.3 and +4.4%, respectively) to typical RE-LY ® patients. Of the patient and dialysis variables, non-renal clearance had the highest impact on exposure (≤ 31% change). Duration of dialysis, dialysate and blood flow rate changed exposure by ≤14%. Conclusion: Twice-daily dosing of all DE doses tested in this simulation resulted in exposures clearly above what can be seen in typical RE-LY ® patients and thus might not be recommendable, although this is based on modeling only and the clinical impact is unknown. In patients undergoing maintenance HD, DE 75 mg once daily (given after dialysis) or 110 mg once daily (given before dialysis), resulted in exposure comparable to that simulated in typical RE-LY ® patients.