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https://www.readbyqxmd.com/read/28990128/a-single-center-retrospective-analysis-to-compare-the-efficacy-and-safety-of-filgrastim-sndz-to-filgrastim-for-prophylaxis-of-chemotherapy-induced-neutropenia-and-for-neutrophil-recovery-following-autologous-stem-cell-transplantation
#1
Julia Zecchini, Kendra Yum, Amir Steinberg, Cardinale Smith, Sara Kim
Filgrastim-sndz (Zarxio®) was approved by the FDA in March 2015 as a biosimilar product of its reference product, filgrastim (Neupogen®) for all five indications. The NCCN Clinical Practice Guidelines has incorporated filgrastim-sndz into its recommendations as a category 1 recommendation for use in settings of febrile neutropenia, myelosuppressive chemotherapy administration, and post-hematopoietic stem cell transplant (HSCT). As a cost-saving initiative, our institution switched from filgrastim to filgrastim-sndz for all indications starting in March 2016...
October 8, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28944145/rare-case-of-ameloblastoma-with-pulmonary-metastases
#2
Ivan Valkadinov, Nikolay Conev, Dian Dzhenkov, Ivan Donev
Ameloblastoma is a rare low-grade odontogenic tumor of epithelial origin. The World Health Organization (WHO) has defined malignant ameloblastoma (MA) as a histologically benign-appearing ameloblastoma that has metastasized. Treatment of the primary ameloblastoma usually consists of radical excision of the tumor and adjuvant radiotherapy. Chemotherapy should be used to treat metastases due to its indolent clinical course. Presented here is the case of a 43-year-old woman who was admitted to a hospital in 2006 with a large mass involving the neck and left mandible...
August 2017: Intractable & Rare Diseases Research
https://www.readbyqxmd.com/read/28939926/a-systematic-literature-review-of-the-efficacy-effectiveness-and-safety-of-filgrastim
#3
REVIEW
David C Dale, Jeffrey Crawford, Zandra Klippel, Maureen Reiner, Timothy Osslund, Ellen Fan, Phuong Khanh Morrow, Kim Allcott, Gary H Lyman
PURPOSE: Filgrastim (NEUPOGEN(®)) is the originator recombinant human granulocyte colony-stimulating factor widely used for preventing neutropenia-related infections and mobilizing hematopoietic stem cells. This report presents findings of a systematic literature review and meta-analysis of efficacy and safety of originator filgrastim to update previous reports. METHODS: A literature search of electronic databases, congress abstracts, and bibliographies of recent reviews was conducted to identify English-language reports of clinical trials and observational studies evaluating filgrastim in its US-approved indications up to February 2015...
September 22, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28935847/cd56bright-nk-regulatory-cells-in-filgrastim-primed-donor-blood-or-marrow-products-regulate-chronic-gvhd-cbmtg-randomized-0601-study-results
#4
Amina Kariminia, Sabine Ivison, Bernard Ng, Jacob Rozmus, Susanna Sung, Avani Varshney, Mahmoud Aljurf, Silvy Lachance, Irwin Walker, Cindy Toze, Jeff Lipton, Stephanie J Lee, Jeff Szer, Richard Doocey, Ian Lewis, Clayton Smith, Naeen Chaudhri, Megan K Levings, Raewyn Broady, Gerald Devins, David Szwajcer, Ronan Foley, Sara Mostafavi, Steven Pavletic, Donna A Wall, Stephen Couban, Tony Panzarella, Kirk R Schultz
Randomized trials have conclusively shown higher rates of chronic graft-versus-host disease with filgrastim-stimulated apheresis peripheral blood as a donor source than unstimulated bone marrow. The Canadian Blood and Marrow Transplant Group conducted a phase 3 study of adults who received either filgrastim-stimulated apheresis peripheral blood or filgrastim-stimulated bone marrow from human leukocyte antigen-identical sibling donors. Because all donors received the identical filgrastim dosing schedule, this study allowed for a controlled evaluation of the impact of stem cell source on development of chronic graft-versus-host disease...
September 21, 2017: Haematologica
https://www.readbyqxmd.com/read/28929372/clinical-equivalence-with-g-csf-biosimilars-methodologic-approach-in-a-neo-adjuvant-setting-in-non-metastatic-breast-cancer
#5
REVIEW
A Krendyukov, M Schiestl, N Höbel, M Aapro
Biosimilars are biological medicines that have been shown to be similar to a reference biological medicine that has already been approved for use. Development of biosimilars is based on a "totality of evidence" approach that involves a series of steps by which biosimilars must demonstrate similarity to a reference product in all aspects of the drug and eliminate any remaining uncertainties. Clinical studies are then considered confirmatory and are performed to show that there are no clinically meaningful differences compared with the reference product in a sensitive patient population...
September 20, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28922288/addition-of-filgrastim-neupogen-for-clozapine-rechallenge-in-the-case-of-parkinson-disease-patient
#6
Joseph Friedman, Edith Yeboah, Matthew Hermenau
No abstract text is available yet for this article.
September 2017: Clinical Neuropharmacology
https://www.readbyqxmd.com/read/28912408/-results-of-a-drug-use-survey-of-filgrastim-biosimilar-1-filgrastim-bs-syringe-for-inj-mochida-and-f
#7
Tsukasa Teshima, Nao Takigawa, Yuki Makita, Chinatsu Kushiya
With the aim of evaluating the safety and efficacy of filgrastim biosimilar 1(Filgrastim BS syringe for Inj. "MOCHIDA"and "F"), we conducted a drug use results survey of this product for its indications, including mobilization of hematopoietic stem cells into peripheral blood and chemotherapy-induced neutropenia. Of the 518 cases enrolled between August 2013 and July 2015, 495 were selected to be subjects of our safety and efficacy evaluations. 37 cases (7.47%)experienced side effects, which were mainly lower back pain(19, 3...
September 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28898593/biosimilars-implications-for-clinical-practice
#8
Robert M Rifkin, Susan R Peck
In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The patents of several widely used biologic cancer therapies (including trastuzumab, rituximab, bevacizumab, cetuximab, and pegfilgrastim) are recently expired or due to expire in the near future, so the introduction of biosimilars into the oncology treatment armamentarium is imminent...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28898589/science-of-biosimilars
#9
R Donald Harvey
Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference products. These differences may affect biosimilars through posttranslational modifications that can occur in specific cellular production lines, and these modifications have potential effects on protein structure, function, clinical pharmacology, and immunogenicity...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28879595/preemptive-plerixafor-injection-added-to-pegfilgrastim-after-chemotherapy-in-non-hodgkin-lymphoma-patients-mobilizing-poorly
#10
A Partanen, J Valtola, A Ropponen, K Vasala, K Penttilä, L Ågren, M Pyörälä, T Nousiainen, T Selander, P Mäntymaa, J Pelkonen, V Varmavuo, E Jantunen
Filgrastim is usually combined with chemotherapy to mobilize hematopoietic progenitor cells in non-Hodgkin lymphoma (NHL) patients. Limited information is available on the efficacy of a preemptive plerixafor (PLER) injection in poor mobilizers after chemotherapy and pegfilgrastim. In this prospective study, 72 patients with NHL received chemotherapy plus pegfilgrastim, and 25 hard-to-mobilize patients received also PLER. The usefulness and efficacy of our previously developed algorithm for PLER use in pegfilgrastim-containing mobilization regimen were evaluated as well as the graft cellular composition, hematological recovery, and outcome after autologous stem cell transplantation (auto-SCT) according to the PLER use...
September 7, 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28871421/biosimilar-uptake-by-british-local-formularies-a-cross-sectional-study
#11
Saja Alnahar, Rachel A Elliott, Murray D Smith
Background Biological medicines are starting to lose their patent protection, so similar, inexact copies (biosimilars) are being developed and licensed. The high acquisition costs of biologics for healthcare providers could be reduced by switching to biosimilars, thus alleviating budgetary pressures and increasing patient access. Therefore, the acceptance of biosimilars by prescribers in Great Britain (GB; England, Scotland, Wales) needs to be described and understood. Objective To determine uptake of the first wave of biosimilars (somatropin, epoetin, filgrastim) by local formularies (lists of preferred medicines for prescribing in local healthcare settings)...
September 4, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28870106/expanded-access-to-cancer-treatments-from-conversion-to-neutropenia-prophylaxis-with-biosimilar-filgrastim-sndz
#12
Ali McBride, Sanjeev Balu, Kim Campbell, Mohan Bikkina, Karen MacDonald, Ivo Abraham
AIM: Biosimilar medicines offer significant cost-savings potential over their reference products, which can be re-allocated to provide access to other cancer treatments on a budget-neutral basis. METHODS: Simulation study using cost data for the USA under consideration of several prophylaxis patterns. RESULTS: Potential savings from conversion from reference filgrastim to biosimilar filgrastim-sndz are significant. These savings expand budget-neutral access to novel immunotherapies (obinutuzumab; pembrolizumab) or supportive care (filgrastim-sndz)...
September 5, 2017: Future Oncology
https://www.readbyqxmd.com/read/28842778/refining-the-role-of-pegfilgrastim-a-long-acting-g-csf-for-prevention-of-chemotherapy-induced-febrile-neutropenia-consensus-guidance-recommendations
#13
REVIEW
Matti Aapro, Ralph Boccia, Robert Leonard, Carlos Camps, Mario Campone, Sylvain Choquet, Marco Danova, John Glaspy, Iwona Hus, Hartmut Link, Thamer Sliwa, Hans Tesch, Vicente Valero
PURPOSE: Chemotherapy-induced febrile neutropenia (FN) causes treatment delays and interruptions and can have fatal consequences. Current guidelines provide recommendations on granulocyte colony-stimulating factors (G-CSF) for prevention of FN, but guidance is unclear regarding use of short- vs long-acting G-CSF (e.g., filgrastim vs pegfilgrastim/lipegfilgrastim, respectively). An international panel of experts convened to develop guidance on appropriate use of pegfilgrastim for prevention of chemotherapy-induced FN...
August 25, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28817190/a-phase-1-and-2-study-of-filanesib-alone-and-in-combination-with-low-dose-dexamethasone-in-relapsed-refractory-multiple-myeloma
#14
Jatin J Shah, Jonathan L Kaufman, Jeffrey A Zonder, Adam D Cohen, William I Bensinger, Brandi W Hilder, Selena A Rush, Duncan H Walker, Brian J Tunquist, Kevin S Litwiler, Mieke Ptaszynski, Robert Z Orlowski, Sagar Lonial
BACKGROUND: Filanesib (ARRY-520) is a highly selective inhibitor of kinesin spindle protein, which has demonstrated preclinical antimyeloma activity. METHODS: This open-label Phase 1/2 study determined the maximum tolerated dose of Filanesib administered on Days 1 and 2 of 14-Day Cycles in patients with multiple myeloma (MM) and included expansion cohorts with and without dexamethasone (40 mg/week). Patients in the dose-escalation (N = 31) and Phase 2 single-agent (N = 32) cohorts had received prior bortezomib as well as prior thalidomide and/or lenalidomide...
August 17, 2017: Cancer
https://www.readbyqxmd.com/read/28806028/treatment-of-peritonsillar-abscess-in-immunosuppressed-patients
#15
Jed H Assam, William C Spanos
Peritonsillar abscess (PTA) is a common pathology in otolaryngology emergency. The treatment of PTA is usually bedside drainage or surgical removal of the tonsils (Quincy tonsillectomy) in combination with antibiotic treatment. However, patients with immune suppression might have a more difficult treatment course. Such difficulties may be further magnified within older patients. This case report will describe successful multi-modality treatment of two separate incidents of PTA developing in the context of immunosuppression...
July 2017: South Dakota Medicine: the Journal of the South Dakota State Medical Association
https://www.readbyqxmd.com/read/28804626/efficacy-and-safety-of-biosimilar-filgrastim-in-primary-and-secondary-prevention-of-febrile-neutropenia
#16
Leszek Kraj, Joanna Krawczyk-Lipiec, Joanna Górniewska, Grzegorz Orlik
Neutropenia and febrile neutropenia (FN) are among the most common side effects/complications of chemotherapy. The aim of the present study was to evaluate the practice of the use of biosimilar filgrastim in the primary and secondary prevention of FN, and assess its efficacy and safety. A multi-center, non-interventional epidemiological study of 170 cancer patients aged 23-82 years was conducted. Data were collected via a questionnaire completed based on medical documentation and patient examination over five chemotherapy visits...
August 2017: Biomedical Reports
https://www.readbyqxmd.com/read/28801752/biosimilar-g-csf-versus-filgrastim-and-lenograstim-in-healthy-unrelated-volunteer-hematopoietic-stem-cell-donors
#17
Roiya Farhan, Elżbieta Urbanowska, Hanna Zborowska, Małgorzata Król, Maria Król, Tigran Torosian, Iwona Piotrowska, Krzysztof Bogusz, Kamila Skwierawska, Wiesław Wiktor-Jędrzejczak, Emilian Snarski
The World Marrow Donor Organization recommends original granulocyte-colony stimulating factor (G-CSF) for the mobilization of stem cells in healthy unrelated hematopoietic stem cell donors. We report the comparison of a biosimilar G-CSF (Zarzio) with two original G-CSFs (filgrastim and lenograstim) in mobilization in unrelated donors. We included data of 313 consecutive donors who were mobilized during the period from October 2014 to March 2016 at the Medical University of Warsaw. The primary endpoints of this study were the efficiency of CD34+ cell mobilization to the circulation and results of the first apheresis...
August 11, 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28797783/results-of-a-prospective-randomized-open-label-noninferiority-study-of-tbo-filgrastim-granix-versus-filgrastim-neupogen-in-combination-with-plerixafor-for-autologous-stem-cell-mobilization-in-patients-with-multiple-myeloma-and-non-hodgkin-lymphoma
#18
Pavan Kumar Bhamidipati, Mark A Fiala, Brenda J Grossman, John F DiPersio, Keith Stockerl-Goldstein, Feng Gao, Geoffrey L Uy, Peter Westervelt, Mark A Schroeder, Amanda F Cashen, Camille N Abboud, Ravi Vij
Autologous hematopoietic stem cell transplantation (auto-HSCT) improves survival in patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Traditionally, filgrastim (Neupogen; recombinant G-CSF) has been used in as a single agent or in combination with plerixafor for stem cell mobilization for auto-HSCT. In Europe, a biosimilar recombinant G-CSF (Tevagrastim) has been approved for various indications similar to those of reference filgrastim, including stem cell mobilization for auto-HSCT; however, in the United States, tbo-filgrastim (Granix) is registered under the original biological application and is not approved for stem cell mobilization...
August 7, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28795868/management-and-cost-analysis-of-cancer-patients-treated-with-g-csf-a-cohort-study-based-on-the-french-national-healthcare-insurance-database
#19
Patrick Tilleul, William Jacot, Corinne Emery, Antoine Lafuma, Julie Gourmelen
OBJECTIVES: To describe the management and costs associated with G-CSF therapy in cancer patients in France. METHODS: We analyzed a representative random population sample from the French national healthcare insurance database, focusing on 1,612 patients with hematological or solid malignancies who were reimbursed in 2013 or 2014 for at least one G-CSF treatment dispensed in a retail pharmacy. Patient characteristics and treatment costs were analyzed according to the type of cancer...
August 10, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28769538/cytokine-kinetics-in-febrile-neutropenic-children-insights-on-the-usefulness-as-sepsis-biomarkers-influence-of-filgrastim-and-behavior-of-the-il-23-il-17-pathway
#20
Orlei Ribeiro de Araujo, Reinaldo Salomão, Milena Karina Coló Brunialti, Dafne Cardoso Bourguignon da Silva, Andreza Almeida Senerchia, Fabianne Altruda de Moraes Costa Carlesse, Antonio Sergio Petrilli
BACKGROUND: The study aimed to describe the kinetics of various cytokines from day 1 to day 14 of the onset of fever in neutropenic children and to evaluate their performances as discriminators of sepsis in the first 24 hours of fever, the possible influence of filgrastim, and the functioning of the IL-23/IL-17 axis. METHODS: IL-1β, TNF-α, IL-10, IL-12/23p40, IL-21, IL-6, IL-8, IL-17, G-CSF, and GM-CSF were measured in plasma on days 1, 2, 3, 5, and 14 from the onset of fever in 35 patients...
2017: Mediators of Inflammation
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