tbuckley/cabot-search huggingface dataset:
The Role of Cardiovascular Implantable Electronic Devices in the Detection and Treatment of Subclinical Atrial Fibrillation
Authors: Paul L. Hess, Jeff S. Healey, Christopher B. Granger, Stuart J. Connolly, Paul D. Ziegler, John H. Alexander, Peter R. Kowey, Christian T. Ruff, Greg Flaker, Jonathan L. Halperin, Robert G. Hart, Renato D. Lopes
Journal: JAMA Cardiology (2017)

Subclinical atrial fibrillation (AF) is associated with an increased risk for stroke.Subclinical AF is asymptomatic, short in duration, and usually detected with long-term, continuous monitoring. Most prior studies have explored its consequences using cardiovascular implantable electronic devices (CIEDs). Although current prevalence estimates are derived from study populations with prior CIEDs, 3 trials will assess the time to a first AF diagnosis among patients receiving a CIED for purposes of AF detection. Stroke risk estimates are currently limited to patients with a prior CIED and vary widely, ranging from a hazard ratio of 0.87 (95% CI, 0.58-1.31) to 9.40 (95% CI, 1.80-47.00). Stroke risk pathogenesis may include factors that are proximately causal, upstream risk activators, and risk markers. The treatment of subclinical AF may be a useful stroke prevention strategy; however, no direct evidence of benefit from oral anticoagulation exists in this population. Two ongoing trials will assess the risk and benefit of non-vitamin K oral anticoagulants among patients at high risk for stroke with a previously placed implantable CIED, but without a prior diagnosis of clinical AF. If clinical benefit is proven, then the cost-effectiveness of screening for and the treatment of subclinical AF will require additional study.At present, no evidence suggests that implanting a CIED to detect AF or initiating oral anticoagulation therapy among those in whom AF is detected is beneficial. Ongoing and future studies will identify people at high risk for developing subclinical AF and will evaluate the efficacy, safety, and economic value of oral anticoagulation therapy in this population.
Understanding of leukemic stem cells and their clinical implications
Authors: Xuefei Wang, Shile Huang, Ji-Long Chen
Journal: Molecular Cancer (2017)

Since leukemic stem cells (LSCs) or cancer stem cells (CSCs) were found in acute myeloid leukemia (AML) in 1997, extensive studies have been contributed to identification and characterization of such cell populations in various tissues. LSCs are now generally recognized as a heterogeneous cell population that possesses the capacities of self-renewal, proliferation and differentiation. It has been shown that LSCs are regulated by critical surface antigens, microenvironment, intrinsic signaling pathways, and novel molecules such as some ncRNAs. To date, significant progress has been made in understanding of LSCs, leading to the development of numerous LSCs-targeted therapies. Moreover, various novel therapeutic agents targeting LSCs are undergoing clinical trials. Here, we review current knowledge of LSCs, and discuss the potential therapies and their challenges that are being tested in clinical trials for evaluation of their effects on leukemias.
Migration of Donor Cells from the Yolk Sac to Fetal Tissues after In Utero Transplantation of Early to Mid-Gestation Canine Fetuses.
Authors: Andrea K. Vaags, Cathy Gartley, Yanzhen Zheng, Howard Dobson, Krista B. Halling, Warren D. Foltz, Alexander J. Dick, Stephen A. Kruth, Margaret R. Hough
Journal: Blood (2007)
Impact of circulating endothelial progenitor cells on the growth of viable tumor rim after treatment with a vascular disrupting agent.
Authors: Yuval Shaked, Alessia Ciarrocchi, Marcela Franco, Christina R. Lee, Shan Man, Alison Cheung, Daniel Hicklin, Stuart Foster, Robert Benezra, Robert S. Kerbel
Journal: Cancer Research (2006)

Proc Amer Assoc Cancer Res, Volume 47, 2006

5710 

Unlike most antiangiogenic drugs, vascular disrupting agents (VDAs) can cause an acute shutdown in tumor blood flow, leading to a subsequent rapid cytotoxic-like process of extensive tumor necrosis. However, the impact of this therapeutic effect is compromised by a remaining viable tumor rim, from which the tumors can rapidly re-grow, a process accompanied by robust angiogenesis. This suggests that the use of a VDA with an antiangiogenic agent e.g., anti-VEGFR-2 antibodies, could be a very effective combination vascular targeting treatment, for which there is some evidence. The basis for rapid and robust angiogenesis at the viable tumor rim after VDA treatment is unclear. We hypothesized that in addition to exploiting the vasculature of the surrounding normal tissue, angiogenesis at the viable rim after VDA treatment must be facilitated by a compensatory host process. We present evidence that the immediate influence of bone marrow derived endothelial progenitor cells (CEPs) homing to the rim, may indeed represent such a contributory mechanism. Thus we found the following: i) administration of a VDA (CA4P or Oxi-4503) to normal (non tumor bearing) mice leads to a marked (3 fold) increase in CEP levels in peripheral blood within 4 hours - in contrast to antiangiogenic agents such as anti-VEGFR-2 antibody (e.g. DC101), which suppress CEPs levels; ii) the CEPs ‘home’ to the viable tumor rim after VDA treatment in two distinct tumor models (human melanoma xenograft and Lewis lung mouse carcinoma); iii) administration of DC101 24 hours prior to the VDA prevents the spike in CEPs which leads to virtually complete obliteration of the viable tumor rim; iv) administration of Oxi-4503 to Id mutant tumor-bearing mice, which cannot mobilize CEPs, leads to a powerful anti-tumor effect, compared to wild type control mice. Overall, our results suggest a compelling role for CEPs in the response to VDAs, and hence, a strategy to maximize the therapeutic potential of both VDAs and antiangiogenic drugs.
Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia
Authors: Steven Fishbane, Geoffrey A. Block, Lisa Loram, John Neylan, Pablo E. Pergola, Katrin Uhlig, Glenn M. Chertow
Journal: Journal of the American Society of Nephrology (2017)

Iron deficiency anemia is common and consequential in nondialysis-dependent CKD (NDD-CKD). Efficacy and tolerability of conventional oral iron supplements are mixed; intravenous iron administration associates with finite but important risks. We conducted a randomized double-blind clinical trial in adults with NDD-CKD and iron deficiency anemia to compare the safety and efficacy of oral ferric citrate (n=117) and placebo (n=115). The primary end point was the proportion of patients who achieved a ≥1.0 g/dl increase in hemoglobin at any time during a 16-week randomized period. Patients who completed the 16-week period could also participate in an 8-week open-label extension period. Significantly more patients randomized to ferric citrate achieved the primary end point (61 [52.1%] versus 22 [19.1%] with placebo; P<0.001). All secondary end points reached statistical significance in the ferric citrate group, including the mean relative change in hemoglobin (0.84 g/dl; 95% confidence interval, 0.58 to 1.10 g/dl; P<0.001) and the proportion of patients who achieved a sustained increase in hemoglobin (≥0.75 g/dl over any 4-week period during the randomized trial; 57 [48.7%] versus 17 [14.8%] with placebo; P<0.001). Rates of serious adverse events were similar in the ferric citrate (12.0%) and placebo groups (11.2%). Gastrointestinal disorders were the most common adverse events, with diarrhea reported in 24 (20.5%) and 19 (16.4%) and constipation in 22 (18.8%) and 15 (12.9%) patients treated with ferric citrate and placebo, respectively. Overall, in patients with NDD-CKD, we found oral ferric citrate to be a safe and efficacious treatment for iron deficiency anemia.
New Vaccines against Epidemic Infectious Diseases
Authors: John-Arne Røttingen, Dimitrios Gouglas, Mark Feinberg, Stanley Plotkin, Krishnaswamy V. Raghavan, Andrew Witty, Ruxandra Draghia-Akli, Paul Stoffels, Peter Piot
Journal: New England Journal of Medicine (2017)

The newly formed international Coalition for Epidemic Preparedness Innovations aims to stimulate, finance, and coordinate the development of vaccines against epidemic infectious diseases, especially in cases in which market incentives alone are insufficient.
Efficacy and Safety of Epoetin beta 30 000 IU Once Weekly in Anemic Patients with Non-Myeloid Malignancies Receiving Chemotherapy.
Authors: Gandhi Damaj, Reda Garidi, Philippe Rodon, Dominique Bordessoule, Dominique Spaeth, Paola Fiorentini, Loïc Bergougnoux
Journal: Blood (2005)
Genomic Characterization Of Newly Established Two Distinct Patient-Driven Multiple Myeloma Cell Lines (SNU_MM1393_BM and SNU_MM1393_SC) From a Single Patient
Authors: Youngil Koh, Kwang-Sung Ahn, Chansu Lee, Woo June Jung, Hyun Jung Lee, Dong Soon Lee, Hyo Jung Kim, Hwi-Joong Yoon, Sung-Soo Yoon
Journal: Blood (2013)
Nonstructural protein 5B promotes degradation of the NORE1A tumor suppressor to facilitate hepatitis C virus replication
Authors: Payal Arora, Amartya Basu, M. Lee Schmidt, Geoffrey J. Clark, Howard Donninger, Daniel B. Nichols, Diego F. Calvisi, Neerja Kaushik‐Basu
Journal: Hepatology (2017)

Hepatitis C virus (HCV) infection is a common risk factor for the development of liver cancer. The molecular mechanisms underlying this effect are only partially understood. Here, we show that the HCV protein, nonstructural protein (NS) 5B, directly binds to the tumor suppressor, NORE1A (RASSF5), and promotes its proteosomal degradation. In addition, we show that NORE1A colocalizes to sites of HCV viral replication and suppresses the replication process. Thus, NORE1A has antiviral activity, which is specifically antagonized by NS5B. Moreover, the suppression of NORE1A protein levels correlated almost perfectly with elevation of Ras activity in primary human samples. Therefore, NORE1A inactivation by NS5B may be essential for maximal HCV replication and may make a major contribution to HCV‐induced liver cancer by shifting Ras signaling away from prosenescent/proapoptotic signaling pathways. Conclusion : HCV uses NS5B to specifically suppress NORE1A, facilitating viral replication and elevated Ras signaling. (H epatology 2017;65:1462‐1477).
The Novel Leukemia Stem Cell Marker GPR56 Discriminates Leukemic Subclones with Divergent Stem Cell Properties in Human Acute Myeloid Leukemia
Authors: Caroline Pabst, Anne Bergeron, Vincent-Philippe Lavallée, Jonathan Yeh, Patrick Gendron, Jana Krosl, Geneviève Boucher, Sébastien Lemieux, Josee Hébert, Guy Sauvageau, Frédéric Barabé
Journal: Blood (2015)
Imaging Locally Advanced, Recurrent, and Metastatic Prostate Cancer
Authors: Maria L. Lindenberg, Baris Turkbey, Esther Mena, Peter L. Choyke
Journal: JAMA Oncology (2017)

<h3>Importance</h3> Prostate cancer is the second leading cause of cancer deaths in US men. The course of prostate cancer is highly variable, and timely and accurate detection of clinically significant cancer is critical in positively affecting outcomes. <h3>Observations</h3> Molecular imaging methods and magnetic resonance imaging (MRI) are the most promising new developments for prostate tumor visualization. While the benefits of MRI are many, positron emission tomography (PET) radiotracers are still available only as research tools. <h3>Conclusions and Relevance</h3> The current research-based evidence on PET imaging has demonstrated encouraging potential in the initial diagnosis and detection of recurrence and metastases of prostate cancer.
RELATIONSHIP BETWEEN TIDAL VOLUME AND MORTALITY IN MECHANICALLY VENTILATED CHILDREN: A SYSTEMATIC REVIEW AND META-ANALYSIS OF OBSERVATIONAL STUDIES
Authors: Pauline de Jager, J. G. M. Burgerhof, M. J. I. J. Albers, D. G. Markhorst, Martin C.J. Kneyber, Groningen Res Inst Asthma Copd
Journal: Intensive Care Medicine (2011)
Momelotinib Therapy in Myelofibrosis: 6-Years Follow-up Data on Safety, Efficacy and the Impact of Mutations on Overall and Relapse-Free Survival
Authors: Ayalew Tefferi, Daniela Barraco, Terra L. Lasho, Kebede H. Begna, Aref Al-Kali, William J. Hogan, Mark R Litzow, Curtis A. Hanson, Rhett P. Ketterling, Naseema Gangat, Animesh Pardanani
Journal: Blood (2016)
Noninvasive Imaging of Myocardial Inflammation in Myocarditis using <sup>68</sup>Ga-tagged Mannosylated Human Serum Albumin Positron Emission Tomography
Authors: Seung-Pyo Lee, Hyung-Jun Im, Shinae Kang, Seock-Jin Chung, Ye Seul Cho, Hyejeong Kang, Ho Seon Park, Do-Won Hwang, Jun-Bean Park, Jin-Chul Paeng, Gi-Jeong Cheon, Yun-Sang Lee, Jae Min Jeong, Yong-Jin Kim
Journal: Theranostics (2017)

The diagnosis of myocarditis traditionally relies on invasive endomyocardial biopsy but none of the imaging studies so far are specific for infiltration of the inflammatory cells itself.We synthesized 68 Ga-2-(p-isothiocyanatobenzyl)-1,4,7-triazacyclononane-1,4,7-triacetic acid (NOTA) mannosylated human serum albumin (MSA) by conjugating human serum albumin with mannose, followed by conjugation with NOTA and labeling it with 68 Ga.The efficacy of 68 Ga-NOTA-MSA positron emission tomography (PET) for imaging myocardial inflammation was tested in a rat myocarditis model.A significant number of mannose receptor-positive inflammatory cells infiltrated the myocardium in both human and rat myocarditis tissue. 68Ga-NOTA-MSA uptake was upregulated in organs of macrophage accumulation, such as liver, spleen, bone marrow and myocardium (0.32 (0.31~0.33) for normal versus 1.02 (0.86~1.06) for myocarditis (median (range), SUV); n=4~6 per group, p-value=0.01). 68Ga-NOTA-MSA uptake in the left ventricle was upregulated in myocarditis compared with normal rats (2.29 (1.42~3.40)for normal versus 4.18 (3.43~6.15)for myocarditis (median (range), average standard uptake value ratio against paraspinal muscle); n=6 per group, p-value<0.01),which was downregulated in rats with cyclosporine-A treated myocarditis (3.69 (2.59~3.86)for myocarditis versus 2.28 (1.76~2.60)for cyclosporine-A treated myocarditis; n=6 per group, p-value<0.01).The specificity of the tracer was verified by administration of excess non-labeled MSA. 68Ga-NOTA-MSA uptake was significantly enhanced earlier in the evolution of myocarditis before any signs of inflammation could be seen on echocardiography.These results demonstrate the potential utility of visualizing infiltration of mannose receptor-positive macrophages with 68 Ga-NOTA-MSA PET in the early diagnosis of as well as in the monitoring of treatment response of myocarditis.
Targeting Antiapoptotic Bcl-2 Family Members with AT-101 in Pre-Clinical Models of Aggressive Lymphoma in Combination with Cyclophosphamide (C) and Rituximab (R) Produces a Marked Improvement in Therapeutic Efficacy.
Authors: L. Paoluzzi, M. Gonen, L. Toner, E. Smith, D. Yang, J. Holmund, M. Sorensen, Owen O’Connor
Journal: Blood (2005)
Evaluation of the Cytogenetic Aberration Pattern in AL Amyloidosis Compared to Monoclonal Gammopathies Not Requiring Treatment: Translocation t(11;14) Is More Frequent in AL Amyloidosis.
Authors: Tilmann Bochtler, Stefan O. Schonland, Anna Jauch, Christiane Heiss, Axel Benner, Friedrich W. Cremer, Dirk Hose, Marion Moos, Claus R. Bartram, Anthony D. Ho, Hartmut Goldschmidt, Ute Hegenbart
Journal: Blood (2007)
Clostridium Difficile Infection in Haematology Patients Significantly Increases Length of Stay; A Case Control Study
Authors: Louise Imlay-Gillespie, Caroline Dix, Ashley McEwan, Kelly Wong, Melanie Figtree, Christopher Arthur, Luke Coyle, Keith Fay, Matthew Greenwood, Naomi Mackinlay, Stephen Mulligan, William Stevenson, Christopher M Ward, Ian H. Kerridge
Journal: Blood (2015)
Evidence for Involvement of Clonally Expanded CD8+ T Cells in Anti-Cancer Immune Responses in CLL Patients Following Nonmyeloablative Conditioning and Hematopoietic Cell Transplantation (HCT).
Authors: Tania Kollgaard, Soren L. Petersen, Sine Reker Hadrup, Tania N. Masmas, Tina Seremet, Mads H. Andersen, Hans O. Madsen, Lars Vindelov, Per Thor Straten
Journal: Blood (2005)
Functional Polymorphisms in Oxidant Metabolism and DNA Repair Pathways and Risk of Leukemia and Transient Myeloproliferative Disorder in Children with Down Syndrome
Authors: Melissa S Rayburg, Mi-Ok Kim, Todd Alonzo, Robert Gerbing, Gretchen A Radloff, Stella M Davies, Alan Gamis, John Perentesis
Journal: Blood (2008)
Expression of the Human Concentrative Nucleotide Transporter (hCNT1) Gene Correlates with Clinical Response in Patients Affected by Waldenstrom’s Macroglobulinemia (WM), Undergoing a Combination Treatment with Cladribine (2-CdA) and Rituximab.
Authors: Daniele Laszlo, Cristina Rabascio, Giovanna Andreola, Luca Saronni, Liliana Calabrese, Luigi Rigacci, Alberto Fabbri, Antonello Pinto, Ferdinando Frigeri, Atto Billio, Graziella Pinotti, Simona Sammassimo, Giovanni Martinelli
Journal: Blood (2007)
Aid is a key regulator of myeloid/erythroid differentiation and DNA methylation in hematopoietic stem/progenitor cells
Authors: Hiroyoshi Kunimoto, Anna Sophia McKenney, Cem Meydan, Kaitlyn Shank, Abbas Nazir, Franck Rapaport, Benjamin Durham, Francine E. Garrett-Bakelman, Elodie Pronier, Alan H. Shih, Ari Melnick, Jayanta Chaudhuri, Ross L. Levine
Journal: Blood (2017)
Secondary Prophylaxis in a Cohort of Adolescent and Adult Italian Hemophiliacs.
Authors: Annarita Tagliaferri, Gianna Franca Rivolta, Antonio Coppola, Cristina Santoro, Gina Rossetti, Alfredo Dragani, Giulio Feola, Ezio Zanon, Pier Giorgio Iannaccaro, Paolo Radossi, Massimo Franchini
Journal: Blood (2007)
A novel protective role for activating transcription factor 3 in the cardiac response to metabolic stress
Authors: Alessandra Ghigo, Giacomo Frati, Sebastiano Sciarretta
Journal: Cardiovascular Research (2016)

This editorial refers to ‘ATF3 expression in cardiomyocytes preserves homeostasis in the heart and controls peripheral glucose tolerance’ by R. Kalfon et al ., pp. 134–146. 

Type 2 diabetes mellitus (T2D) can promote the development of a specific form of cardiomyopathy independent of coronary artery disease and hypertension. This is the so-called diabetic cardiomyopathy, which represents a major cause of heart failure in Western countries.1 Unfortunately, the molecular mechanisms underlying the pathogenesis of diabetic cardiomyopathy still need to be elucidated. Similarly, the molecular and metabolic pathways mediating the cardiac response to diabetes-associated metabolic derangements are still elusive.1 The article by Kalfon et al. 2 significantly extends our current knowledge regarding the signalling pathways that are modulated in the heart in response to diabetes. They identified activating transcription factor 3 (ATF3) as a critical sensor of the metabolic stress associated with T2D in cardiomyocytes. ATF3 was found to protect the heart against T2D-induced cardiac remodelling and dysfunction, also controlling peripheral insulin sensitivity. 

ATF3 is an immediate early transcription factor of the basic leucine zipper (bZIP) superfamily, whose expression is generally low in physiological conditions. However, it is up-regulated by multiple stressors, including those that are involved in T2D cardiomyopathy, such as metabolic, oxidative, and endoplasmic reticulum stress, as well as inflammation.3 ATF3 functions by binding to the cyclic AMP response element (CRE) and, in turn, modulates the expression of multiple target genes including pro-inflammatory cytokines and …
Prospective evaluation of the aetiology of acute otitis media with spontaneous tympanic membrane perforation
Authors: P. Marchisio, S. Esposito, M. Picca, E. Baggi, L. Terranova, A. Orenti, E. Biganzoli, N. Principi, P. Gallia, E. Mazzucchi, J. Onorato, A. Russo, A.M. Vaccarino
Journal: Clinical Microbiology and Infection (2017)
Hodgkin's Disease and HIV Infection (HD-HIV): Prognostic Factors In 596 Patients (pts) within the European Group for the Study of HIV and Tumours (GECAT)
Authors: Michele Spina, Josep-Maria Ribera, Jean Gabarre, Christoph Wyen, Silvia Montoto, Ulrich Jaeger, Renato Talamini, Alessandro Re, Pilar Miralles, Umberto Tirelli
Journal: Blood (2010)
Dasatinib Therapy Affects Bone Homeostasis in Patients with Chronic Myelogenous Leukemia in Chronic Phase Independently of Molecular Response
Authors: Daniela Hoehn, L. Jeffrey Medeiros, Naveen Pemmaraju, Anthony Sireci, Govind Bhagat, Jorge E. Cortes, Carlos E. Bueso-Ramos
Journal: Blood (2012)
Safety Trial of NK Cell Enhanced Donor Lymphocyte Infusions from a 3-5/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation
Authors: David A. Rizzieri, Robert Storms, Daniel Nikcevich, Bercedis Peterson, Debashish Misra, Christine Apple, Megan Baker, Cristina Gasparetto, Mitchell Horwitz, John Chute, Ashley Morris, Nelson J. Chao
Journal: Blood (2008)
Blood Flow Is Increased in Wounds and Peri-Wound Area by Laser Speckle Contrast Imaging and Infrared Thermography in Adults with Sickle Cell Leg Ulcers
Authors: Kara M Delaney, Alexander Gorbach, Nitin Malik, Jordan Maivelett, Yuen Yi Hon, Dihua Xu, Enrico M. Novelli, Sophia Lanzkron, James G. Taylor, Gregory J. Kato, Caterina P. Minniti
Journal: Blood (2012)
Efficacy of PRT060318, a Novel Highly Specific SYK Inhibitor, in Acute Lymphoblastic Leukemia (ALL)
Authors: Stefan KÖhrer, Greg Coffey, Ekaterina Kim, Nathalie Y Rosin, Uma Sinha, Anjali Pandey, Medhat Shehata, Ulrich Jäger, Susan M. O'Brien, William G. Wierda, Zeev Estrov, Deborah Thomas, Hagop M Kantarjian, Jan A. Burger
Journal: Blood (2012)
Prediction of Survival in Patients with Non-Hodgkin’s Lymphoma: Role of Tumor Necrosis Factor Ligand-Receptor and Extracellular Protein Kinase A.
Authors: Chul Won Choi, Soo-Young Yoon, Hwa Jung Sung, In Keun Choi, Seok Jin Kim, Sang Cheul Oh, Jae Hong Seo, Byung Soo Kim, Sang Won Shin, Yeul Hong Kim, Jun Suk Kim
Journal: Blood (2005)
Bone Marrow Mixed Chimerism Is a Risk Factor for Relapse After T-Cell Depleted Allogeneic Stem Cell Transplant
Authors: Amanda L Olson, Juliet N Barker, Hugo Castro-Malaspina, Sean Devlin, Sergio A Giralt, Jenna D Goldberg, Rachel Lehrman, Molly Maloy, Richard J. O'Reilly, Miguel-Angel Perales, Esperanza B. Papadopoulos, Ann A Jakubowski
Journal: Blood (2012)
U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab
Authors: Maitreyee Hazarika, Meredith K. Chuk, Marc R. Theoret, Sirisha Mushti, Kun He, Shawna L. Weis, Alexander H. Putman, Whitney S. Helms, Xianhua Cao, Hongshan Li, Hong Zhao, Liang Zhao, Joel Welch, Laurie Graham, Meredith Libeg, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research (2017)

Abstract On December 22, 2014, the FDA granted accelerated approval to nivolumab (OPDIVO; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received 3 mg/kg of nivolumab intravenously every 2 weeks with at least 6-month follow-up in an ongoing, randomized, open-label, active-controlled clinical trial. The ORR as assessed by a blinded independent review committee per RECIST v1.1 was 31.7% (95% confidence interval, 23.5–40.8). Ongoing responses were observed in 87% of responding patients, ranging from 2.6+ to 10+ months. In 13 patients, the response duration was 6 months or longer. The risks of nivolumab, including clinically significant immune-mediated adverse reactions (imARs), were assessed in 268 patients who received at least one dose of nivolumab. The FDA review considered whether the ORR and durations of responses were reasonably likely to predict clinical benefit, the adequacy of the safety database, and systematic approaches to the identification, description, and patient management for imARs in product labeling. Clin Cancer Res; 23(14); 3484–8. ©2017 AACR.
Pharmacokinetic Evaluation of Von Willebrand Factor/Factor VIII Concentrate (Humate-P®) Prior to Elective Surgery in Patients with Von Willebrand Disease.
Authors: Jorge Di Paola, Joan Gill, Jonathan Bernstein, Cindy Leissinger, Margaret Ragni, Rinah Shopnik, Leonard Valentino, Carl Friedman, Sigurd Knaub
Journal: Blood (2006)