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Filgrastim

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https://www.readbyqxmd.com/read/29446445/lenograstim-5-%C3%A2%C2%B5g-kg-is-not-superior-to-biosimilar-filgrastim-10-%C3%A2%C2%B5g-kg-in-lymphoma-patients-undergoing-peripheral-blood-stem-cell-mobilization-after-chemotherapy-preliminary-results-from-a-prospective-randomized-study
#1
Francesco Marchesi, Michele Vacca, Diana Giannarelli, Francesco Ipsevich, Annino Pandolfi, Svitlana Gumenyuk, Daniela Renzi, Francesca Palombi, Francesco Pisani, Atelda Romano, Antonio Spadea, Elena Papa, Marco Canfora, Luca Pierelli, Andrea Mengarelli
BACKGROUND: Randomized trials comparing chemomobilization efficiency between lenograstim and biosimilar filgrastim are lacking. Our previous retrospective study suggested that lenograstim could be more effective than biosimilar filgrastim when used at the same conventional dosage (5 µg/kg) only in lymphoma patients undergoing peripheral blood stem cell mobilization. We planned a prospective randomized study comparing lenograstim 5 µg/kg with biosimilar filgrastim 10 µg/kg to verify the hypothesis of lenograstim superiority even at half the dosage (stress test)...
February 15, 2018: Transfusion
https://www.readbyqxmd.com/read/29434148/pseudogout-attack-after-pegfilgrastim-administration-in-anaplastic-large-cell-lymphoma
#2
Mayumi Hatayama, Katsuya Ikuta, Masatomo Ishioh, Takeshi Saito, Yasumichi Toki, Masayo Yamamoto, Motohiro Shindo, Yoshihiro Torimoto, Toshikatsu Okumura
A 67-year-old man with relapsed anaplastic large cell lymphoma received salvage chemotherapy, and pegfilgrastim was used to prevent febrile neutropenia. On day 18 of chemotherapy, he developed a pseudogout attack. Although the first symptoms improved, another pseudogout attack occurred when he received the second course of chemotherapy and pegfilgrastim. Filgrastim was then used for the third course of chemotherapy, and a pseudogout attack did not occur. The serum granulocyte-stimulating factor (G-CSF) level was extremely elevated only when pegfilgrastim was used, suggesting a relationship between pseudogout and G-CSF...
February 9, 2018: Internal Medicine
https://www.readbyqxmd.com/read/29430414/pattern-and-impact-of-drugs-targeted-toward-toxicity-amelioration-in-patients-receiving-cancer-chemotherapy
#3
Shruti Singh, Prashant Kumar Singh
Background: Drug therapy today is remarkably safe and efficacious. Still, some drugs - particularly anticancer drugs - are fraught with numerous adverse drug reactions (ADRs), severely jeopardizing quality of life of cancer patients. Fortunately, most of these ADRs are preventable provided adequate prophylactic drugs are administered along with chemotherapy. Aims: The aim of this study is to assess the pattern and impact of cytoprotective prophylactic drugs on anticancer ADRs in patients receiving cancer chemotherapy...
January 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/29411131/filgrastim-use-in-patients-receiving-chemotherapy-for-early-stage-breast-cancer-a-survey-of-physicians-and-patients
#4
John Hilton, Lisa Vandermeer, Marta Sienkiewicz, Sasha Mazzarello, Brian Hutton, Carol Stober, Dean Fergusson, Phillip Blanchette, Anil A Joy, A Brianne Bota, Mark Clemons
PURPOSE: Despite its widespread use as primary febrile neutropenia (FN) prophylaxis during chemotherapy for early-stage breast cancer, the optimal duration of daily filgrastim is unknown. Using the minimum effective duration may improve patient comfort and acceptability while reducing costs. Yet, suboptimal dosing may also negatively impact patient care. A survey was performed to obtain information regarding current practices for granulocyte colony-stimulating factor (G-CSF) use. METHODS: Canadian oncologists involved in the treatment of breast cancer patients, as well as patients who had received neo/adjuvant chemotherapy for breast cancer, were surveyed...
February 6, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/29410296/low-cd34-cell-doses-are-associated-with-increased-cost-and-worse-outcome-following-of-tandem-autologous-stem-cell-transplantation-in-patients-with-relapsed-or-refractory-germ-cell-tumors
#5
Mustafa A Hyder, W Scott Goebel, Kirsten D Ervin, Jennifer E Schwartz, Michael J Robertson, Teresa C Thakrar, Costantine Albany, Sherif S Farag
Tandem autologous stem cell transplantation (ASCT) improves long-term survival of platinum-refractory germ cell tumors (GCT) patients. Studies, predominantly in lymphoma, showed that CD34+ cell doses > 5.0 x 106/kg/single transplant lead to decreased resource utilization. As most GCT patients have received prior cisplatin-based treatment, collecting >10x106 CD34+ cells/kg is challenging. We analyzed the effect of CD34+ cell dose on resource utilization and outcome of in 131 GCT patients, median age 29...
February 2, 2018: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/29403286/biosimilar-filgrastim-vs-filgrastim-a-multicenter-nationwide-observational-bioequivalence-study-in-patients-with-chemotherapy-induced-neutropenia
#6
Alper Sevinç, Metin Özkan, Ahmet Özet, Faysal Dane, Berna Öksüzoğlu, Abdurrahman Işıkdoğan, Feyyaz Özdemir, Doğan Uncu, Mahmut Gümüş, Türkkan Evrensel, Arzu Yaren, Oğuz Kara, Salim Başol Tekin
Background: We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia. Patients and methods: This multicenter, observational study was conducted at 14 centers. The study included 337 patients experiencing neutropenia under chemotherapy. Patients were given either filgrastim 30 MIU or 48 MIU (Neupogen®) or biosimilar filgrastim 30 MIU (Leucostim®). Data regarding age, chemotherapeutic agents used, number of chemotherapy courses, previous diagnosis of neutropenia, neutrophil count of patients after treatment, medications used for the treatment of neutropenia, and duration of neutropenia were collected...
2018: OncoTargets and Therapy
https://www.readbyqxmd.com/read/29401143/false-positive-18f-fdg-pet-ct-due-to-filgrastim-that-induced-extramedullary-liver-hematopoiesis-in-a-burkitt-lymphoma
#7
Anna Margherita Maffione, Lucia Rampin, Paolini Rossella, Sara Pecori, Patrick M Colletti, Domenico Rubello
We report a case of Burkitt lymphoma with largely extranodal disease localizations at staging. Chemotherapy was given, thus obtaining a complete metabolic response in all previous disease sites as shown at a control PET, however associated to the appearance of new focal uptake areas in the liver; these findings were confirmed at US and MRI. Chemotherapy determined also neutropenia that was treated by filgrastim, followed by a prompt and important medullary response. Liver biopsy revealed extramedullary hematopoiesis, probably filgrastim induced...
February 3, 2018: Clinical Nuclear Medicine
https://www.readbyqxmd.com/read/29398647/pegylated-filgrastim-versus-filgrastim-for-stem-cell-mobilization-in-multiple-myeloma-after-novel-agent-induction
#8
Muhammad Bilal Abid, Sanjay De Mel, Muhammad Abbas Abid, Eng Soo Yap, Sathish Kumar Gopalakrishnan, Yunxin Chen, Yi Ching Yuen, Hung Chew Wong, Adeline Lin, Li Mei Poon, Liang Piu Koh, Wee Joo Chng, Lip Kun Tan
BACKGROUND: The current standard of care for transplant-eligible myeloma patients is novel agent-based induction, followed by high-dose chemotherapy and autologous stem cell rescue. Chemo-mobilization of peripheral blood CD34+ stem cells (PBSCs) with pegylated filgrastim (pegfilgrastim), a sustained-duration formulation of filgrastim, has been used as an alternative to filgrastim in several studies involving heterogeneous cohorts of lymphoma and multiple myeloma (MM) patients and shown to be equivalent in PBSC yield and cost-effectiveness...
January 5, 2018: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29398477/clinical-safety-and-efficacy-of-filgrastim-biosimilar-2-in-japanese-patients-in-a-post-marketing-surveillance-study
#9
Kazuo Tamura, Kazue Hashimoto, Kiyohiro Nishikawa
We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5...
February 2, 2018: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
https://www.readbyqxmd.com/read/29392707/quantitative-relationship-between-auec-of-absolute-neutrophil-count-and-duration-of-severe-neutropenia-for-g-csf-in-breast-cancer-patients
#10
Liang Li, Lian Ma, Sarah J Schrieber, Nam Atiqur Rahman, Albert Deisseroth, Ann T Farrell, Yaning Wang, Vikram Sinha, Anshu Marathe
The aim of the study was to evaluate the quantitative relationship between duration of severe neutropenia (DSN, the efficacy endpoint) and area under effect curve of absolute neutrophil counts (ANC-AUEC, the pharmacodynamic endpoint), based on data from filgrastim products, a human granulocyte colony-stimulating factor (G-CSF). Clinical data from filgrastim product comparator and test arms of two randomized, parallel-group, phase III studies in breast cancer patients treated with myelosuppressive chemotherapy were utilized...
February 2, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29340124/the-use-of-filgrastim-in-patients-with-hodgkin-lymphoma-receiving-abvd
#11
Adam F Binder, Sonia Rai, Amir Steinberg
Background: There is conflicting data about the increased risk of pulmonary toxicity when granulocyte-stimulating factor (G-CSF) is given in combination with bleomycin. No clear consensus for management of patients with Hodgkin lymphoma (HL) who require G-CSF support exists. Our objective was to evaluate whether there is an increase in pulmonary toxicity in patients who receive bleomycin and G-CSF during treatment for HL. Materials and Methods: We conducted a single-center retrospective analysis of patients with Hodgkin Lymphoma from January 2003 until July 2015...
October 1, 2017: International Journal of Hematology-oncology and Stem Cell Research
https://www.readbyqxmd.com/read/29330390/freezing-the-graft-is-not-necessary-for-autotransplants-for-plasma-cell-myeloma-and-lymphomas
#12
Amado Kardduss-Urueta, Robert Peter Gale, César H Gutierrez-Aguirre, Miguel Angel Herrera-Rojas, Iván Murrieta-Álvarez, Rosendo Perez-Fontalvo, Guillermo J Ruiz-Delgado, Giovanni Ruiz-Rojas, Gregorio Jaimovich, Leonardo Feldman, Nancy Labastida-Mercado, Alicia Endara, Martín Castro, Samantha Galindo-Becerra, María Angélica Cardona-Molina, David Gomez-Almaguer, Guillermo J Ruiz-Argüelles
We studied rates of granulocyte and platelets recovery in 359 consecutive subjects receiving blood cell infusions in the context of autotransplants for plasma cell myeloma (N = 216) and lymphomas (N = 143). Blood cells were mobilised with filgrastim given for 4-5 days and collected after a median of 2 (range, 1-2) apheresis. Apheresis products were stored at 4° C for a median of 3 days (range, 2-6 days). Most subjects received carmustine, etoposide, cytarabine and melphalan (BEAM), cyclophosphamide, carmustine and etoposide (CBV) or high-dose melphalan...
January 12, 2018: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/29327204/neuroprotective-effects-of-filgrastim-in-rotenone-induced-parkinson-s-disease-in-rats-insights-into-its-anti-inflammatory-neurotrophic-and-antiapoptotic-effects
#13
Mariama S Azmy, Esther T Menze, Reem N El-Naga, Mariane G Tadros
All current treatments of Parkinson's disease (PD) focus on enhancing the dopaminergic effects and providing symptomatic relief; however, they cannot delay the disease progression. Filgrastim, a recombinant methionyl granulocyte colony-stimulating factor, demonstrated neuroprotection in many neurodegenerative and neurological diseases. This study aimed to assess the neuroprotective effects of filgrastim in rotenone-induced rat model of PD and investigate the potential underlying mechanisms of filgrastim actions...
January 11, 2018: Molecular Neurobiology
https://www.readbyqxmd.com/read/29318653/pharmacokinetic-pharmacodynamic-modelling-of-neutrophil-response-to-g-csf-in-healthy-subjects-and-patients-with-chemotherapy-induced-neutropenia
#14
Murad Melhem, Isabelle Delor, Juan Jose Pérez-Ruixo, John Harrold, Andrew Chow, Liviawati Wu, Philippe Jacqmin
AIM: The objective of this study was to use pharmacokinetic-pharmacodynamic modelling to characterize the effects of chemotherapy on the granulopoietic system and to predict the absolute neutrophil counts (ANCs) for patients with chemotherapy-induced neutropenia (CIN) treated with filgrastim and pegfilgrastim. METHODS: Data were extracted from 10 phase 1-3 studies conducted in 110 healthy adults and 618 adult and 52 paediatric patients on chemotherapy following administration of filgrastim or pegfilgrastim...
January 9, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29317553/safety-profile-of-biosimilar-filgrastim-zarzio-zarxio-a-combined-analysis-of-phase-iii-studies
#15
Nadia Harbeck, Pere Gascón, Andriy Krendyukov, Nadja Hoebel, Sreekanth Gattu, Kimberly Blackwell
BACKGROUND: Evaluation of adverse events (AEs) in pivotal registration trials and ongoing postmarketing surveillance is important for all biologics, including biosimilars. A combined analysis of two pivotal registration studies was performed to strengthen evidence on safety for biosimilar filgrastim EP2006 in patients with breast cancer receiving myelosuppressive chemotherapy, a sensitive clinical setting to confirm biosimilarity of filgrastim. MATERIALS AND METHODS: Data were combined from two phase III studies of biosimilar filgrastim EP2006...
January 9, 2018: Oncologist
https://www.readbyqxmd.com/read/29285951/seifem-2017-from-real-life-to-an-agreement-on-the-use-of-granulocyte-transfusions-and-colony-stimulating-factors-for-prophylaxis-and-treatment-of-infectious-complications-in-patients-with-hematologic-malignant-disorders
#16
Alessandro Busca, Simone Cesaro, Luciana Teofili, Mario Delia, Chiara Cattaneo, Marianna Criscuolo, Francesco Marchesi, Nicola Stefano Fracchiolla, Caterina Giovanna Valentini, Francesca Farina, Roberta Di Blasi, Lucia Prezioso, Angelica Spolzino, Anna Candoni, Maria Ilaria Del Principe, Luisa Verga, Annamaria Nosari, Franco Aversa, Livio Pagano
The rapid spread of severe infections mainly due to resistant pathogens, justifies the search for therapies aiming to restore immune functions severely compromised in patients with hematologic malignancies. Areas covered: The present review summarizes the current knowledge on the role of granulocyte transfusions and colony-stimulating factors as treatment strategy for hematologic patients with serious infectious complications. In addition, a survey among 21 hematologic centers, to evaluate the clinical practice for the use of G-CSF originator and biosimilars was performed...
January 3, 2018: Expert Review of Hematology
https://www.readbyqxmd.com/read/29284143/long-term-safety-of-short-term-administration-of-filgrastim-rhg-csf-and-leukophresis-procedure-in-healthy-children-application-of-peripheral-blood-stem-cell-collection-in-pediatric-donors
#17
Maryam Behfar, Sara Faghihi-Kashani, Ashraf Sadat Hosseini, Ardeshir Ghavamzadeh, Amir Ali Hamidieh
INTRODUCTION: Administration of Filgrastim (rhG-CSF) (Neupogen®) in healthy donors to mobilize hematopoietic stem cells (HSC) is a widespread practice in adults. Application of peripheral blood stem cell (PBSC) collection in normal pediatric donors is scarce due to ethical issues. Hence, there are insufficient data on the long-term impact of PBSC procedure in healthy children. This retrospective study aimed to evaluate the early and late adverse effects of PBSC donation in pediatric donors...
December 25, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/29246820/mobilization-of-hematopoietic-progenitor-cells-with-standard-or-reduced-dose-filgrastim-after-vinorelbine-in-multiple-myeloma-patients-a-randomized-prospective-single-center-phase-ii-study
#18
Panagiotis Samaras, Markus F Rütti, Burkhardt Seifert, Helga Bachmann, Urs Schanz, Maya Eisenring, Christoph Renner, Antonia Maria Müller, Adrian Schmidt, Axel Mischo, Ivo Fuchs, Mario Bargetzi, Markus G Manz, Roger Stupp, Ulf Petrausch, Frank Stenner-Liewen
Vinorelbine combined with filgrastim (r-metHuG-CSF) at a dose of 10 µg/kg of body weight (BW) per day is a reliable and well tolerated regimen for mobilization of hematopoietic progenitor cells (HPC) in patients with multiple myeloma. This prospective randomized phase 2 study was initiated to assess the feasibility of a reduced filgrastim dosage. Vinorelbine was combined with either standard dosed filgrastim (10 µg/kg body weight (BW) per day) or reduced dosed filgrastim (5 µg/kg BW per day). Leukapheresis sessions were planned to start at day 8 and were continued until the predefined target amount of 4 x 106 HPC/kg BW was collected...
December 12, 2017: Biology of Blood and Marrow Transplantation
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
#19
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
#20
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
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