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https://www.readbyqxmd.com/read/28549110/thoracic-aortitis-and-aortic-dissection-following-pegfilgrastim-administration
#1
Yuki Sato, Shuichiro Kaji, Hiroyuki Ueda, Keisuke Tomii
The patient was a 67-year-old woman with a history of advanced lung adenocarcinoma. Eight days after pegfilgrastim administration, her computed tomography scan revealed thickened bilateral common carotid arteries and thoracic aorta, which led to the diagnosis of pegfilgrastim-associated aortitis. Thirty-six days after pegfilgrastim administration, asymptomatic Stanford type B aortic dissection was detected. Her serum biomarker analysis suggested that interleukin-6 might be involved in the pathogenesis. Physicians should be aware of these adverse effects of filgrastim...
May 26, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/28527129/efficacy-and-safety-of-plerixafor-for-the-mobilization-collection-of-peripheral-hematopoietic-stem-cells-for-autologous-transplantation-in-japanese-patients-with-multiple-myeloma
#2
Masaki Ri, Kosei Matsue, Kazutaka Sunami, Chihiro Shimazaki, Akio Hayashi, Yoshinori Sunaga, Toru Sasaki, Kenshi Suzuki
To evaluate the efficacy and safety of plerixafor for the mobilization/collection of peripheral hematopoietic stem cells (HSCs) for autologous transplantation in Japanese patients with multiple myeloma (MM). In a randomized study, patients received G-CSF (filgrastim, 400 µg/m(2)/day) for 4 days prior to the first dose of plerixafor. Starting on Day 4 evening and for up to 4 days, patients received either plerixafor (240 µg/kg/day) + G-CSF group (PG group) or G-CSF alone (G group). Daily apheresis started on Day 5 for up to 4 days, or until ≥6 × 10(6) CD34+ cells/kg were collected...
May 19, 2017: International Journal of Hematology
https://www.readbyqxmd.com/read/28485020/pegylated-granulocyte-colony-stimulating-factor-versus-non-pegylated-granulocyte-colony-stimulating-factor-for-peripheral-blood-stem-cell-mobilization-a-systematic-review-and-meta-analysis
#3
Jew W Kuan, Anselm T Su, Chooi F Leong
Granulocyte-colony stimulating factor (G-CSF) mobilizes and increases the amount of hematopoietic stem cells in peripheral blood, enabling its harvest by few apheresis procedures. The pegylated G-CSF has longer half-life and is given once only, which is more comfortable for patients, whereas the non-pegylated requires multiple daily injection because of its short half-life. We summarized results of randomized trials comparing the efficacy and safety of pegylated and non-pegylated G-CSF for peripheral blood stem cell mobilization...
May 9, 2017: Journal of Clinical Apheresis
https://www.readbyqxmd.com/read/28454057/application-of-2d-nmr-with-room-temperature-nmr-probes-for-the-assessment-of-the-higher-order-structure-of-filgrastim
#4
Robert G Brinson, Houman Ghasriani, Derek J Hodgson, Kristie M Adams, Ian McEwen, Darón I Freedberg, Kang Chen, David A Keire, Yves Aubin, John P Marino
The higher order structure (HOS) of biotherapeutics is a critical quality attribute that can be evaluated by nuclear magnetic resonance (NMR) spectroscopy at atomic resolution. NMR spectral mapping of HOS can be used to establish HOS consistency of a biologic across manufacturing changes or to compare a biosimilar to an innovator reference product. A previous inter-laboratory study performed using filgrastim drug products demonstrated that two-dimensional (2D)-NMR (1)H(N)-(15)N(H) heteronuclear correlation spectroscopy is a highly robust and precise method for mapping the HOS of biologic drugs at natural abundance using high sensitivity NMR 'cold probes...
April 4, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28453180/a-novel-homozygous-vps45-p-p468l-mutation-leading-to-severe-congenital-neutropenia-with-myelofibrosis
#5
Rikin K Shah, Mary Munson, Klaas J Wierenga, Hanumantha R Pokala, Peter E Newburger, David Crawford
VPS45-associated severe congenital neutropenia (SCN) is a rare disorder characterized by life-threating infections, neutropenia, neutrophil and platelet dysfunction, poor response to filgrastim, and myelofibrosis with extramedullary hematopoiesis. We present a patient with SCN due to a homozygous c.1403C>T (p.P468L) mutation in VPS45, critical regulator of SNARE-dependent membrane fusion. Structural modeling indicates that P468, like the T224 and E238 residues affected by previously reported mutations, cluster in a VPS45 "hinge" region, indicating its critical role in membrane fusion and VPS45-associated SCN...
April 28, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28439700/filgrastim-alone-versus-pegylated-filgrastim-alone-for-autologous-peripheral-blood-stem-cells-mobilization-in-newly-diagnosed-multiple-myeloma-patients
#6
Barbara Skopec, Matevz Skerget, Darja Zontar, Vesna Zadnik, Samo Zver
BACKGROUND: Autologous hematopoietic stem cell transplantation (aHSCT) is the recommended standard upfront treatment for transplant eligible myeloma patients. Considering possible complications related to chemotherapy-cytokine mobilization, cytokine-alone mobilization is often used. We compared mobilization with filgrastim alone to pegfilgrastim alone in newly diagnosed myeloma patients after induction treatment with bortezomib and dexamethasone. The comparison was made between peripheral blood stem cell (PBSC) yields, number of apheresis, hematopoietic stem cell subsets, and time to neutrophil and platelet engraftment after aHSCT...
April 24, 2017: Wiener Klinische Wochenschrift
https://www.readbyqxmd.com/read/28438855/the-effectiveness-of-febrile-neutropenia-prophylaxis-with-lipegfilgrastim-in-routine-clinical-practice
#7
REVIEW
Lubos Holubec, Jiri Polivka, Lenka Lisnerova, Tereza Kubikova, Martin Safanda
Febrile neutropenia (FN) is a common and potentially fatal complication of anticancer treatment, particularly in patients receiving myelosuppressive chemotherapy. It has been shown that prophylaxis with granulocyte colony-stimulating factor (G-CSF), especially its pegylated forms, significantly reduces the incidence of FN, the likelihood of chemotherapy dose intensity reduction and, also, the number of hospitalizations due to FN. This review discusses currently published results from clinical trials dealing with FN prophylaxis in routine clinical practice in patients with solid tumors and myeloproliferative malignancies with a focus on lipegfilgrastim, which is the newest modification of the original molecule filgrastim...
May 2017: In Vivo
https://www.readbyqxmd.com/read/28362168/impact-of-abbreviated-filgrastim-schedule-on-survival-and-hematopoietic-recovery-after-irradiation-in-four-mouse-strains-with-different-radiosensitivity
#8
Merriline Satyamitra, Vidya P Kumar, Shukla Biswas, Lynnette Cary, Leonora Dickson, Srinivasan Venkataraman, Sanchita P Ghosh
Filgrastim (Neupogen(®), granulocyte-colony stimulating factor) is among the few countermeasures recommended for management of patients in the event of lethal total-body irradiation. Despite the plethora of studies using filgrastim as a radiation countermeasure, relatively little is known about the optimal dose schedule of filgrastim to mitigate radiation lethality. We evaluated the efficacy of filgrastim in improving 30-day survival of CD2F1 mice irradiated with a lethal dose (LD70/30) in the AFRRI cobalt-60 facility...
March 31, 2017: Radiation Research
https://www.readbyqxmd.com/read/28353170/impact-of-guidance-on-the-prescription-patterns-of-g-csfs-for-the-prevention-of-febrile-neutropenia-following-anticancer-chemotherapy-a-population-based-utilization-study-in-the-lazio-region
#9
Francesco Trotta, Flavia Mayer, Alessandra Mecozzi, Laura Amato, Antonio Addis
BACKGROUND: Current guidelines recommend prophylaxis with granulocyte colony-stimulating factors (G-CSFs) for patients with cancer who are at greater risk of febrile neutropenia (FN) while receiving chemotherapy. G-CSF biosimilars are available and represent a savings opportunity; however, their uptake has thus far been low. OBJECTIVE: Our objective was to evaluate prescribing patterns for G-CSFs in the prevention of chemotherapy-related FN and to evaluate the impact of regional guidance on G-CSF prescription...
April 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28300458/peripheral-blood-stem-cell-mobilization-with-a-single-dose-of-peg-filgrastim-in-patients-with-multiple-myeloma-previously-treated-with-radiotherapy
#10
Alfonso T Anguita-Compagnon, Maria T Dibarrart, Laura Paredes, Daniel Araos, Marcela Vargas, Alejandro Majlis
No abstract text is available yet for this article.
March 16, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28278727/biosimilars-of-filgrastim-in-autologous-stem-cell-transplantation-certain-differences-for-myeloma-patients-only
#11
Christophe Nicol, Chloé Henry, Marie-Anne Couturier, Pascal Delépine, Céline Tripogney, Caroline Buors, Gaëlle Guillerm, Christian Berthou, Adrian Tempescul, Jean-Christophe Ianotto
No abstract text is available yet for this article.
February 7, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28254831/false-homozygous-hla-genotyping-results-due-to-copy-number-neutral-loss-of-heterozygosity-in-acquired-aplastic-anaemia
#12
Bert Heyrman, Ann De Becker, Sonja Verheyden, Christian Demanet
The aim of this case report is to draw attention on possible false human leucocyte antigen (HLA) genotyping in acquired aplastic anaemia prior to allogeneic haematopoietic stem cell transplantation. In acquired aplastic anaemia loss of heterozygosity (LOH) of chromosome 6p is known to occur in around 12%. We report false HLA genotyping results due to LOH and a coinciding steep rise in neutrophils following filgrastim stimulation in a patient with very severe aplastic anaemia. At diagnosis we obtained heterozygous results on peripheral blood...
March 2, 2017: BMJ Case Reports
https://www.readbyqxmd.com/read/28254519/assessment-of-the-structure-of-pegylated-recombinant-protein-therapeutics-by-the-nmr-fingerprint-assay
#13
Derek J Hodgson, Yves Aubin
A number of recombinant protein therapeutic products, such as filgrastim (methionyl granulocyte colony stimulating factor [Met-GCSF] used to boost the immune system in chemotherapy treated cancer patients), and interferon alpha-2 (used for the treatment of various viral infections), have been chemically modified with the addition of a polyethylene glycol (PEG) chain. This modification prolongs residency of the drug in the body and reduces metabolic degradation, which allows less frequent administration of the products...
February 16, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28238900/safety-and-biosimilarity-of-ior-%C3%A2-leukocim-compared-to-neupogen-%C3%A2-based-on-toxicity-pharmacodynamic-and-pharmacokinetic-studies-in-the-sprague-dawley-rat
#14
Albert Licollari, Katherine Riddle, Simon R Taylor, Nuris Ledon, Gordon T Bolger
This study examined the safety, pharmacodynamic and pharmacokinetic similarity of the human recombinant filgrastim products ior(®)LeukoCIM and Neupogen(®) following a 28-day repeated subcutaneous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period. Safety profiling was based on clinical observations, clinical pathology, and pathology findings for control rats dosed with vehicle and rats dosed either with 15, 75, and 150 μg/kg of ior(®)LeukoCIM or with 150 μg/kg of Neupogen(®)...
February 24, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28194031/hematopoietic-stem-cell-remobilization-with-vinorelbine-and-filgrastim-in-aml
#15
V Blum, A D Heini, U Novak, B M Taleghani, G M Baerlocher, K Leibundgut, K Seipel, Y Banz, M Bargetzi, T Pabst
No abstract text is available yet for this article.
February 13, 2017: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/28182150/evaluation-of-a-biosimilar-granulocyte-colony-stimulating-factor-filgrastim-xm02-for-peripheral-blood-stem-cell-mobilization-and-transplantation-a-single-center-experience-in-japan
#16
Hideaki Yoshimura, Masaaki Hotta, Takahisa Nakanishi, Shinya Fujita, Aya Nakaya, Atsushi Satake, Tomoki Ito, Kazuyoshi Ishii, Shosaku Nomura
BACKGROUND: Biosimilar granulocyte colony-stimulating factor (G-CSF) has recently been introduced into clinical practice. G-CSFs are used to mobilize CD34(+) cells and accelerate engraftment after transplantation. However, in Asia, particularly in Japan, data for peripheral blood stem cell (PBSC) mobilization by this biosimilar G-CSF are currently lacking. Therefore, the clinical efficacy and safety of biosimilar G-CSF for hematopoietic stem cell transplantation needs to be evaluated in a Japanese context...
2017: Journal of Blood Medicine
https://www.readbyqxmd.com/read/28164135/role-of-cd8-regulatory-t-cells-versus-tc1-and-tc17-cells-in-the-development-of-human-graft-versus-host-disease
#17
Adriana Gutiérrez-Hoya, Rubén López-Santiago, Jorge Vela-Ojeda, Laura Montiel-Cervantes, Octavio Rodríguez-Cortés, Víctor Rosales-García, Vladimir Paredes-Cervantes, Raúl Flores-Mejía, Daniela Sandoval-Borrego, Martha Moreno-Lafont
CD8(+) T cells that secrete proinflammatory cytokines play a central role in exacerbation of inflammation; however, a new subpopulation of CD8 regulatory T cells has recently been characterized. This study analyzes the prominent role of these different subpopulations in the development of graft-versus-host disease (GVHD). Samples from 8 healthy donors mobilized with Filgrastim® (G-CSF) and 18 patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) were evaluated by flow cytometry. Mobilization induced an increase in Tc1 (p < 0...
2017: Journal of Immunology Research
https://www.readbyqxmd.com/read/28152926/cancer-care-decision-support-for-wbc-growth-factors-gf-geographic-differences-in-utilization-and-provider-malleability
#18
Kenneth Sherman Wurtz, Anna DiMarco, Lourdes Feliciano, Dinah Faith Q Huff, Kevin B Knopf, William J Hrushesky, Michael Baum
128 Background: Growth factor use is the largest single category of drug expenditure for US cancer patients. Oncology Analytics is a decision support company that assists physicians in determining the appropriate use of GF based on the NCCN, ASCO, and ASH guidelines and the level one data that underlies these guidelines. We hypothesized that there would be geographic variation among GF preference and in the malleability of those practice patterns after OA entered a market. We determined the proportion of initial pegfilgrastim requests for preauthorization over other types of GF as well as the review outcomes and final drug of choice after OA intervention of inappropriate GF requests across three specific jurisdictions: Florida, Puerto Rico, Georgia and Texas...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28111718/over-and-under-prophylaxis-for-chemotherapy-induced-febrile-neutropenia-relative-to-evidence-based-guidelines-is-associated-with-differences-in-outcomes-findings-from-the-monitor-gcsf-study
#19
Carsten Bokemeyer, Pere Gascón, Matti Aapro, Heinz Ludwig, Mario Boccadoro, Kris Denhaerynck, Michael Gorray, Andriy Krendyukov, Ivo Abraham, Karen MacDonald
PURPOSE: In the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC guidelines, but 17.4% were prophylacted below and 26.0% above guideline recommendations. METHODS: MONITOR-GCSF is a prospective, observational study of 1447 evaluable patients from 140 cancers centers in 12 European countries treated with myelosuppressive chemotherapy for up to 6 cycles receiving biosimilar GCSF prophylaxis...
June 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28090158/zarxio-filgrastim-sndz-the-first-biosimilar-approved-by-the-fda
#20
Mina Awad, Pavit Singh, Olga Hilas
Zarxio (filgrastim-sndz), a biosimilar for the treatment of severe chronic neutropenia.
January 2017: P & T: a Peer-reviewed Journal for Formulary Management
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