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https://www.readbyqxmd.com/read/29227817/comparing-granulocyte-colony-stimulating-factor-filgrastim-and-pegfilgrastim-to-its-biosimilars-in-terms-of-efficacy-and-safety-a-meta-analysis-of-randomised-clinical-trials-in-breast-cancer-patients
#1
Edoardo Botteri, Andriy Krendyukov, Giuseppe Curigliano
BACKGROUND: Granulocyte colony-stimulating factors (G-CSFs) are widely used to prevent neutropenia in cancer patients undergoing myelosuppressive chemotherapy. Several biosimilar medicines of G-CSF are now available, with their development involving a step-wise series of comparisons to demonstrate similarity to reference biologics. Randomised clinical trials (RCTs) are considered confirmatory, and for G-CSF biosimilars, patients with breast cancer (BC) undergoing myelosuppressive chemotherapy are the most sensitive population in which to confirm similarity...
December 8, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29214415/a-multi-center-pragmatic-randomized-feasibility-trial-comparing-standard-of-care-schedules-of-filgrastim-administration-for-primary-febrile-neutropenia-prophylaxis-in-early-stage-breast-cancer
#2
Mohammed F K Ibrahim, John Hilton, Sasha Mazzarello, Dean Fergusson, Brian Hutton, Andrew Robinson, Nadia Califaretti, Tina Hsu, Stan Gertler, Mihaela Mates, Carol Stober, Lisa Vandermeer, Ranjeeta Mallick, Mark Clemons
INTRODUCTION: The most effective duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer (EBC) patients is unknown. Despite significant differences in cost and toxicity, no prospective trial has been performed to optimize practice. We assessed the feasibility of using a novel pragmatic trial model to compare the most commonly used schedules of filgrastim. METHODS: Early breast cancer patients receiving chemotherapy were randomized to 5, 7, or 10 days of filgrastim as primary FN prophylaxis...
December 6, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29201667/the-effects-of-adjuvant-therapies-on-embryo-transfer-success
#3
Rachael Shirlow, Martin Healey, Michelle Volovsky, Vivien MacLachlan, Beverley Vollenhoven
Background: Many adjuvant therapies are employed during IVF treatment in an attempt to improve outcomes. The objective of our study was to evaluate the impact of thirteen adjuvants (Intralipid, steroids, melatonin, coenzyme Q10, Filgrastim, testosterone, DHEA, growth hormone, antibiotics, hCG infusion, aspirin, enoxaparin/heparin and dopamine agonists) on the success of embryo transfers. Methods: This is a retrospective cohort study of all embryo transfers between January 2010 and April 2015 from a multi-site IVF clinic...
October 2017: Journal of Reproduction & Infertility
https://www.readbyqxmd.com/read/29189615/multi-modal-treatment-of-rhinocerebral-mucormycosis-in-a-pediatric-patient-with-relapsed-pre-b-acute-lymphoblastic-leukemia
#4
Zephyr D Dworsky, John S Bradley, Matthew T Brigger, Alice L Pong, Dennis John Kuo
A 17-year-old female developed invasive rhinocerebral mucormycosis during intensive re-induction chemotherapy for relapsed pre-B acute lymphoblastic leukemia. Due to the high case fatality rate for invasive mucormycosis in profoundly immunosuppressed patients, an aggressive treatment regimen was pursued. In addition to the standard of care treatments with intravenous amphotericin and aggressive surgical debridements, she received intraventricular amphotericin to the brain via an Ommaya reservoir, hyperbaric oxygen treatments, filgrastim, intravenous immunoglobulin and anti-fungal in vitro synergy testing to allow for more targeted antifungal therapy with the addition of micafungin...
November 16, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/29187137/evaluation-of-filgrastim-therapy-in-kidney-transplant-recipients
#5
Teresa Poon, Christina M Guerra
CONTEXT: Neutropenia is associated with a high risk of serious infections in kidney transplant recipients. There are no sufficient studies of using granulocyte colony-stimulating factors, such as filgrastim, in renal transplant recipients to establish a clear, specified role of this off-label indication. Using filgrastim in these patients may increase the risk of rejection by overstimulating the immune system. OBJECTIVE: To evaluate the use of filgrastim in adult kidney transplant recipients presenting with neutropenia...
December 2017: Progress in Transplantation
https://www.readbyqxmd.com/read/29181696/comparison-of-clinical-remission-and-survival-between-clag-and-flag-induction-chemotherapy-in-patients-with-refractory-or-relapsed-acute-myeloid-leukemia-a-prospective-cohort-study
#6
Y Bao, J Zhao, Z-Z Li
PURPOSE: To compare the clinical remission and survival between CLAG and FLAG induction chemotherapy in treating patients with refractory or relapsed acute myeloid leukemia (R/R AML). METHODS: 103 R/R AML patients were consecutively enrolled in this prospective cohort study. 55 patients were treated by CLAG induction chemotherapy as follows: 5 mg/m2/day cladribine (days 1-5); 2 g/m2/day cytarabine (days 1-5) and 300 μg/day filgrastim (days 0-5). While 48 patients were treated by FLAG: 30 mg/m2/day fludarabine (days 1-5), 2 g/m2/day cytarabine (days 1-5), and 300 μg/day filgrastim (days 0-5)...
November 27, 2017: Clinical & Translational Oncology
https://www.readbyqxmd.com/read/29172983/a-comparison-of-brand-and-biosimilar-granulocyte-colony-stimulating-factors-for-prophylaxis-of-chemotherapy-induced-febrile-neutropenia
#7
Andrea G Douglas, Phil Schwab, Daniel Lane, Kenneth Kennedy, S Lane Slabaugh, Andy Bowe
BACKGROUND: Filgrastim-sndz, a granulocyte-colony stimulating factor (G-CSF), was introduced as a biosimilar to filgrastim in 2015, but real-world comparative effectiveness for filgrastim versus filgrastim-sndz has not been reported to date. OBJECTIVES: To (a) compare the incidence of febrile neutropenia for patients taking filgrastim versus those taking filgrastim-sndz and (b) compare the incidence of a potential serious adverse event for filgrastim versus filgrastim-sndz...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29172979/pharmacovigilance-of-biologics-in-a-multisource-environment
#8
Sreedhar Sagi, Hillel P Cohen, Gillian R Woollett
It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29172978/application-of-the-fda-biosimilar-extrapolation-framework-to-make-off-label-determinations
#9
Edward Li, Ernesto Lobaina
BACKGROUND: The FDA's extrapolation framework allows for a biosimilar to obtain licensure for indications that were not explicitly studied in the context of a clinical trial by extending conclusions from studies in 1 population to make inferences in other populations. Within routine clinical care, drugs and biologics are routinely used for medically accepted off-label indications. The appropriateness of these products for off-label indications are typically curated by compendia and guidelines, which have established processes and criteria for reviewing and evaluating the evidence to make such determinations...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29172977/conversion-from-filgrastim-to-tbo-filgrastim-experience-of-a-large-health-care-system
#10
Foluso Agboola, Prabashni Reddy
BACKGROUND: In 2008, tbo-filgrastim was approved as a biosimilar in Europe and then approved in the United States by the FDA in 2012 as a biologic product with 1 similar indication to filgrastim. Because tbo-filgrastim was less expensive than filgrastim, and clinical information and expert opinion supported similarity, the Pharmacy & Therapeutics Committee of a large health care system approved tbo-filgrastim as the preferred granulocyte-colony stimulating factor (G-CSF) product in March 2014...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29171913/monitor-gcsf-dlbcl-subanalysis-treatment-patterns-outcomes-with-biosimilar-filgrastim-for-chemotherapy-induced-febrile-neutropenia-prophylaxis
#11
Pere Gascón, Andriy Krendyukov, Nadja Höbel, Matti Aapro
MONITOR-GCSF DLBCL subanalysis: treatment patterns/outcomes with biosimilar filgrastim for chemotherapy-induced/febrile neutropenia prophylaxis OBJECTIVE: Prospective data on the use of granulocyte-colony stimulating factor (G-CSF) in non-Hodgkin's lymphoma and its aggressive subtypes, including diffuse large B-cell lymphoma (DLBCL) are limited. MONITOR-GCSF is a pan-European, multicenter, prospective, observational study aiming to describe treatment patterns and clinical outcomes in patients receiving biosimilar filgrastim in the prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) METHODS: This analysis describes patient characteristics, treatment patterns, and outcomes for 245 patients with stage 3 or 4 DLBCL receiving ≤6 chemotherapy cycles as part of MONITOR-GCSF study, including patients aged ≥65 years and ≥70 years...
November 24, 2017: European Journal of Haematology
https://www.readbyqxmd.com/read/29162397/biosimilar-filgrastim-leucostim%C3%A2-have-similar-efficacy-in-steady-state-hematopoietic-progenitor-cell-mobilization-compared-to-original-filgrastim-neupogen%C3%A2-and-lenograstim-granocyte%C3%A2-a-retrospective-multicenter-study
#12
Ömür Kayıkçı, Emre Tekgündüz, Ali Hakan Kaya, Hakan Göker, Alma Aslan, Dicle İskender, Sinem Namdaroglu, Aysegul Tetik, Şerife Koçubaba, Fevzi Altuntaş
Biosimilar filgrastim (Leucostim(®)) was shown to be similar in terms of efficacy and safety in hematopoietic progenitor cell mobilization (HPCM) compared to originator filgrastim (Neupogen(®)) and lenograstim (Granocyte(®)) in healthy donors and chemomobilization settings. Here we report our retrospective experience with Leucostim(®) (n: 43) compared to Neupogen(®) (n: 71) and Granocyte(®) (n: 32) in steady-state mobilization of patients presenting with Hodgkin lymphoma, non-Hodgkin lymphoma and multiple myeloma...
November 10, 2017: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/29153313/what-is-the-role-of-biosimilar-g-csf-agents-in-hematopoietic-stem-cell-mobilization-at-present
#13
REVIEW
Serdal Korkmaz, Fevzi Altuntas
Mobilization of hematopoietic stem cells, which has largely replaced bone marrow harvesting as a source of hematopoietic stem cells, using recombinant agents such as filgrastim or lenograstim has become a standard procedure in both patients and healthy donors prior to peripheral blood stem cell collection for autologous and allogeneic stem cell transplantation. Published literature data suggest that mobilization with recombinant granulocyte-colony stimulating factor (G-CSF) is safe and mobilization outcomes are satisfactory...
November 8, 2017: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/29152672/effectiveness-of-biosimilar-filgrastim-vs-original-granulocyte-colony-stimulating-factors-in-febrile-neutropenia-prevention-in-breast-cancer-patients
#14
Isabel Puértolas, Alberto Frutos Pérez-Surio, María Aránzazu Alcácera, Raquel Andrés, María Del Tránsito Salvador
PURPOSE: The purpose of this study is to describe the effectiveness of biosimilar filgrastim and original granulocyte colony-stimulating factors (G-CSFs), lenograstim and pegfilgrastim, in febrile neutropenia (FN) prevention in breast cancer patients receiving docetaxel/doxorubicin/cyclophosphamide (TAC) as adjuvant/neoadjuvant treatment and to analyze their treatment patterns. METHODS: A pharmacoepidemiology cohort study was developed in a university hospital (with 23 healthcare centers) with retrospective data collection (2012-2014)...
November 19, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29144113/-can-we-transfer-the-mechanisms-of-the-generics-market-to-biosimilars
#15
Ch O Jacke, F Wild
Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period...
December 15, 2016: Versicherungsmedizin
https://www.readbyqxmd.com/read/29136390/assurance-of-myeloid-growth-factor-administration-in-an-infusion-center-pilot-quality-improvement-initiative
#16
Pamela Maree Ramirez, Barry Peterson, Christine Holtshopple, Kristina Borja, Vincent Torres, Lucille Valdivia-Peppers, Julio Harriague, Melanie D Joe
PURPOSE: Four incident reports involving missed doses of myeloid growth factors (MGFs) triggered the need for an outcome-driven initiative. From March 1, 2015, to February 29, 2016, at University of California Irvine Health Chao Infusion Center, 116 of 3,300 MGF doses were missed (3.52%), including pegfilgrastim, filgrastim, and sargramostim. We hypothesized that with the application of Lean Six Sigma methodology, we would achieve our primary objective of reducing the number of missed MGF doses to < 0...
November 14, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/29130518/automated-red-blood-cell-exchange-in-preparation-for-filgrastim-mobilization-of-autologous-peripheral-blood-hematopoietic-progenitor-cells-in-a-patient-with-sickle-cell-anemia
#17
Yong Zhao, Jeffrey A Bailey, Jeanne Linden, Patricia St Pierre, Jan Cerny, Michelle Vauthrin, Mindy Greene, Robert Weinstein
Increasing survival of patients with sickle cell anemia (SCA) well into adulthood results in a rising likelihood of developing hematological malignancy. High-dose chemotherapy with autologous hematopoietic progenitor cell (HPC) rescue is standard of care for several hematological malignancies, but the risk of severe or life-threatening vaso-occlusive phenomena during filgrastim mobilization of HPC for collection poses a potential barrier to this approach. We report the use of automated red cell exchange in preparation for filgrastim mobilization in a patient with homozygous SCA...
November 11, 2017: Journal of Clinical Apheresis
https://www.readbyqxmd.com/read/29126867/allogeneic-hematopoietic-cell-transplantation-for-richter-syndrome-a-single-center-experience
#18
Mohamed A Kharfan-Dabaja, Ambuj Kumar, Facundo E Stingo, Farhad Khimani, Mohammad Hussaini, Ernesto Ayala, Taiga Nishihori, Bijal Shah, Frederick L Locke, Javier Pinilla-Ibarz, Julio C Chavez
BACKGROUND: Recent studies have shown dismal outcomes when chronic lymphocytic leukemia progresses to Richter syndrome after patients receive ibrutinib, with a median overall survival ranging from 2.6 to 3.5 months. Published data on efficacy of allogeneic hematopoietic cell transplantation in Richter syndrome are limited to single-center case series and registry data. PATIENTS AND METHODS: We evaluated the efficacy of allogeneic transplantation in 10 patients, median age of 63 (range, 50-74) years, allografted at a median of 5 (range, 4-25) months from diagnosis of Richter syndrome...
October 12, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29107446/characterisation-of-the-site-specific-monopegylated-rhg-csf-analogue-pegteograstim
#19
Jeungwoon Hong, Byoungju Lee, Kwanyub Kang, Seung-Hoon Lee, Jaehwan Ryu, Gangsoo Jung, Jaetaek Oh, Eui-Cheol Jo, Chan-Wha Kim
We describe the characterisation of a novel monoPEGylated recombinant human granulocyte colony-stimulating factor analogue, pegteograstim (Neulapeg), prepared by site-specific 20 kDa maleimide-PEG conjugation. An additional cysteine was inserted between Gly136 and Ala137 of filgrastim (methionyl human granulocyte colony-stimulating factor) for site-specific PEGylation, and Cys18 of filgrastim was replaced with Ser18 to prevent unwanted PEGylation. Pegteograstim was produced by Escherichia coli and purified by cation exchange chromatography, and its structural, physicochemical, biological and immunological properties were investigated...
October 26, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29107342/sweet-syndrome-in-patients-with-and-without-malignancy-a-retrospective-analysis-of-83-patients-from-a-tertiary-academic-referral-center
#20
Caroline A Nelson, Megan H Noe, Christine M McMahon, Asha Gowda, Benedict Wu, Hovik J Ashchyan, Alexander E Perl, William D James, Robert G Micheletti, Misha Rosenbach
BACKGROUND: Sweet syndrome is a neutrophilic dermatosis that may be categorized into classic, malignancy-associated, and drug-induced subtypes. Few studies have systematically analyzed this rare disorder. OBJECTIVE: To describe the clinicopathologic characteristics and treatment of Sweet syndrome and identify characteristics associated with concurrent malignancy. METHODS: We retrospectively reviewed patients with Sweet syndrome at the University of Pennsylvania from 2005 to 2015...
October 26, 2017: Journal of the American Academy of Dermatology
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