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Pegfilgrastim

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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/29212975/-diffuse-large-b-cell-lymphoma-complicated-with-drug-induced-vasculitis-during-administration-of-pegfilgrastim
#2
Yuta Ito, Kentaro Noda, Keisuke Aiba, Shingo Yano, Tsunehiro Fujii
A 59-year-old female with diffuse large B-cell lymphoma was treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) regimen. In addition, we administered pegfilgrastim for treating chemotherapy-induced febrile neutropenia. She complained of fever and neck and chest pain a few days after pegfilgrastim administration during the third and fourth courses of R-CHOP. Radiological imaging revealed an inflammation of large vessels, which led to the diagnosis of drug-associated vasculitis...
2017: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/29166733/-comparative-study-on-the-efficacy-and-safety-between-pegfilgrastim-peg-rhg-csf-and-recombinant-human-granulocyte-colony-stimulating-factor-in-promoting-hematopoietic-recovery-after-allogeneic-hematopoietic-stem-cell-transplantation-after-hematological-malignancy
#3
F Yang, X D Sun, L Yuan, J C Zhang, J W Hu, N Liu, X Lou, Y F Su, Z Y Yu, J L Chen, Y H Li, L D Hu, H Chen, M Jiang
Objective: To observe the efficacy and safety between Pegfilgrastim (PEG-rhG-CSF) and Recombinant human granulocyte colony stimulating factor (rhG-CSF) in hematological malignancy after allogeneic hematopoietic stem cell transplantation (allo-HSCT) . Methods: 157 patients after allo-HSCT were enrolled in this study from June 2015 to November 2016. Two agents of G-CSF were used to stimulate hematopoietic recovery after transplantation. There were 65 cases in PEG-rhG-CSF and 92 cases in rhG-CSF groups. Patients in PEG-rhG-CSF group were given a single subcutaneous dose of 6 mg on the first day and +8 d, while cases in rhG-CSF group were given in dose of 5 μg·kg(-1)·d(-1) by subcutaneous injection from +1 d continuing to neutrophils more than 1...
October 14, 2017: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
https://www.readbyqxmd.com/read/29152672/effectiveness-of-biosimilar-filgrastim-vs-original-granulocyte-colony-stimulating-factors-in-febrile-neutropenia-prevention-in-breast-cancer-patients
#4
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/29147854/nolan-a-randomized-phase-2-study-to-estimate-the-effect-of-prophylactic-naproxen-or-loratadine-vs-no-prophylactic-treatment-on-bone-pain-in-patients-with-early-stage-breast-cancer-receiving-chemotherapy-and-pegfilgrastim
#5
Jeffrey J Kirshner, Maxwell C McDonald, Flavio Kruter, Andrew S Guinigundo, Linda Vanni, Cathy L Maxwell, Maureen Reiner, Terry E Upchurch, Jacob Garcia, Phuong Khanh Morrow
PURPOSE: Mild-to-moderate bone pain is a commonly reported adverse event (AE) associated with pegfilgrastim. We evaluated the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on pegfilgrastim-associated bone pain. METHODS: In this open-label study (NCT01712009), women ≥ 18 years of age with newly diagnosed stage I-III breast cancer and an ECOG performance status ≤ 2 who were planning ≥ 4 cycles of adjuvant or neoadjuvant chemotherapy with pegfilgrastim support starting in cycle 1 were randomized 1:1:1 to receive naproxen, loratadine, or no treatment to prevent pegfilgrastim-associated bone pain...
November 16, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/29136390/assurance-of-myeloid-growth-factor-administration-in-an-infusion-center-pilot-quality-improvement-initiative
#6
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/29103159/model-based-optimization-of-g-csf-treatment-during-cytotoxic-chemotherapy
#7
Sibylle Schirm, Christoph Engel, Sibylle Loibl, Markus Loeffler, Markus Scholz
PURPOSE: Although G-CSF is widely used to prevent or ameliorate leukopenia during cytotoxic chemotherapies, its optimal use is still under debate and depends on many therapy parameters such as dosing and timing of cytotoxic drugs and G-CSF, G-CSF pharmaceuticals used and individual risk factors of patients. METHODS: We integrate available biological knowledge and clinical data regarding cell kinetics of bone marrow granulopoiesis, the cytotoxic effects of chemotherapy and pharmacokinetics and pharmacodynamics of G-CSF applications (filgrastim or pegfilgrastim) into a comprehensive model...
November 4, 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/29072395/pegfilgrastim-versus-filgrastim-for-primary-prophylaxis-of-febrile-neutropenia-in-patients-with-non-hodgkin%C3%A2-s-lymphoma-a-cost-effectiveness-study
#8
Ramin Ravangard, Najme Bordbar, Khosro Keshavarz, Mehdi Dehghani
Aim: One method to deal with febrile neutropenia is the use of granulocyte colony stimulating factors (G-CSFs). Pegfilgrastim or Filgrastim injection can lead to a reduction in febrile neutropenia and severe neutropenia in patients receiving chemotherapy. This study aimed to compare the cost-effectiveness of using Pegfilgrastim, 3-day Filgrastim and 1-day Filgrastim medication strategies for the primary prophylaxis of febrile neutropenia in patients with relapsed non-Hodgkin’s lymphoma after salvage chemotherapy who referred to two referral centers affiliated to Iran, Shiraz University of Medical Sciences in 2014...
October 26, 2017: Asian Pacific Journal of Cancer Prevention: APJCP
https://www.readbyqxmd.com/read/28958157/risk-of-chemotherapy-induced-febrile-neutropenia-by-day-of-pegfilgrastim-prophylaxis-in-us-clinical-practice-from-2010-to-2015
#9
Derek Weycker, Mark Bensink, Alexander Lonshteyn, Robin Doroff, David Chandler
OBJECTIVE: Pegfilgrastim prophylaxis (PP) is recommended 1-3 days following administration of chemotherapy during the cycle. Some patients, however, receive PP before or after the recommended timing. While evidence suggests that risk of febrile neutropenia (FN) may be lower when PP is administered per recommendation, such evidence is based on older data. We undertook a new study to compare FN risk between patients who received PP on the last day of chemotherapy ("day 0") or 4-5 days following chemotherapy ("days 4-5"), versus 1-3 days following chemotherapy ("days 1-3"), using recent data from US clinical practice...
October 16, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28958156/risk-of-chemotherapy-induced-febrile-neutropenia-with-early-discontinuation-of-pegfilgrastim-prophylaxis-based-on-real-world-data-from-2010-to-2015
#10
Derek Weycker, Mark Bensink, Hongsheng Wu, Robin Doroff, David Chandler
OBJECTIVE: Evidence suggests that not all cancer chemotherapy patients who receive first-cycle pegfilgrastim prophylaxis (PP) continue to receive it in later cycles, and that these patients may be subsequently at higher risk of febrile neutropenia (FN). Available evidence, however, may not be reflective of current clinical practice. We undertook an evaluation to estimate the odds of FN, beginning with second chemotherapy cycle, among patients who received PP in that cycle and all previous cycles versus those who received PP in all previous cycles only, using recent real-world data...
October 16, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28955224/cost-utility-analysis-of-lipegfilgrastim-compared-to-pegfilgrastim-for-the-prophylaxis-of-chemotherapy-induced-neutropenia-in-patients-with-stage-ii-iv-breast-cancer
#11
Esse I H Akpo, Irshaad R Jansen, Edith Maes, Steven Simoens
Background: Lipegfilgrastim (Lonquex®) has demonstrated to be non-inferior to pegfilgrastim (Neulasta®) in reducing the duration of severe neutropenia (SN) in patients with stage II-IV breast cancer. Compared to pegfilgrastim, lipegfilgrastim also demonstrated statistically significant lower time to ANC recovery in cycles 1-3, lower incidence of SN in cycle 2 and lower depth of absolute neutrophil count (ANC) nadir in cycles 2 and 3. The aim of this study was to quantify the cost utility of lipegfilgrastim compared to pegfilgrastim in stage II-IV breast cancer patients, taking the perspective of the Belgian payer over a lifetime horizon...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28929372/clinical-equivalence-with-g-csf-biosimilars-methodologic-approach-in-a-neo-adjuvant-setting-in-non-metastatic-breast-cancer
#12
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/28898593/biosimilars-implications-for-clinical-practice
#13
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/28879595/preemptive-plerixafor-injection-added-to-pegfilgrastim-after-chemotherapy-in-non-hodgkin-lymphoma-patients-mobilizing-poorly
#14
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...
November 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28868219/appraisal-of-biochemical-classes-of-radioprotectors-evidence-current-status-and-guidelines-for-future-development
#15
REVIEW
Krishnanand Mishra, Ghazi Alsbeih
The search for efficient radioprotective agents to protect from radiation-induced toxicity, due to planned or accidental radiation exposure, is still ongoing worldwide. Despite decades of research and development of widely different biochemical classes of natural and derivative compounds, a safe and effective radioprotector is largely unmet. In this comprehensive review, we evaluated the evidence for the radioprotective performance of classical thiols, vitamins, minerals, dietary antioxidants, phytochemicals, botanical and bacterial preparations, DNA-binding agents, cytokines, and chelators including adaptogens...
October 2017: 3 Biotech
https://www.readbyqxmd.com/read/28860445/-efficacy-of-gc-therapy-for-the-patient-of-itnbc-with-resistance-to-tac-therapy
#16
Mai Yamada, Makoto Kubo, Masaya Kai, Hidetaka Yamamoto, Masafumi Nakamura
We report a case of TNBC treated effectively with a platinum-based regimen after developing resistance to anthracycline and taxane-based neoadjuvant chemotherapy(NAC). A 59-year-old woman with a right breast mass and high fever visited our clinic and was diagnosed as having inflammatory triple negative breast cancer(iTNBC). She was treated with NAC of docetaxel, doxorubicin, and cyclophosphamide(TAC)using pegfilgrastim. After 5 courses of TAC, the therapy failed and the disease progressed. Thus, a combination regimen of gemcitabine and carboplatin(GC)was administered...
August 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
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
#17
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...
November 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
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
#18
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/28795609/comparison-of-treatment-patterns-and-economic-outcomes-among-metastatic-pancreatic-cancer-patients-initiated-on-nab-paclitaxel-plus-gemcitabine-versus-folfirinox
#19
COMPARATIVE STUDY
Ali McBride, Machaon Bonafede, Qian Cai, Nicole Princic, Oth Tran, Corey Pelletier, Monika Parisi, Manish Patel
BACKGROUND: The economic burden of metastatic pancreatic cancer (mPC) is substantial while treatment options are limited. Little is known about the treatment patterns and healthcare costs among mPC patients who initiated first-line gemcitabine plus nanoparticle albumin-bound paclitaxel (nab-P + G) and FOLFIRINOX. METHODS: The MarketScan® claims databases were used to identify adults with ≥2 claims for pancreatic cancer, 1 claim for a secondary malignancy, completed ≥1 cycle of nab-P + G or FOLFIRINOX during 4/1/2013 and 3/31/2015, and had continuous plan enrollment for ≥6 months pre- and 3 months after the first-line treatment...
October 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28791509/feasibility-of-dose-dense-epirubicin-and-cyclophosphamide-with-subcutaneous-pegfilgrastim-3-6%C3%A2-mg-support-a-single-center-prospective-study-in-japan
#20
Sachi Morita, Toyone Kikumori, Nobuyuki Tsunoda, Takahiro Inaishi, Yayoi Adachi, Akiko Ota, Masahiro Shibata, Ayumu Matsuoka, Kenichi Nakanishi, Dai Takeuchi, Takefumi Mizutani, Tomoya Shimokata, Hironori Hayashi, Osamu Maeda, Yuichi Ando
BACKGROUND: Dose-dense chemotherapy consisting of a combination of epirubicin and cyclophosphamide (EC) improves the survival of patients with breast cancer. Although pegfilgrastim was used at a subcutaneous dose of 6.0 mg in a pivotal study of dose-dense EC treatment, pegfilgrastim at a dose of 3.6 mg has been approved in Japan. We have assessed the feasibility of dose-dense EC treatment supported with a 3.6 mg dose of pegfilgrastim by evaluating the relative dose intensity (RDI) and safety of the treatment, together with measuring the pegfilgrastim concentrations remaining on the day of starting the next cycle of chemotherapy...
August 8, 2017: International Journal of Clinical Oncology
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