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Pegfilgrastim

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https://www.readbyqxmd.com/read/28958157/risk-of-chemotherapy-induced-febrile-neutropenia-by-day-of-pegfilgrastim-prophylaxis-in-us-clinical-practice-from-2010-2015
#1
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...
September 28, 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-2010-2015
#2
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...
September 28, 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
#3
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
#4
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
#5
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
#6
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/28868219/appraisal-of-biochemical-classes-of-radioprotectors-evidence-current-status-and-guidelines-for-future-development
#7
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
#8
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
#9
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/28795868/management-and-cost-analysis-of-cancer-patients-treated-with-g-csf-a-cohort-study-based-on-the-french-national-healthcare-insurance-database
#10
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
#11
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
#12
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
https://www.readbyqxmd.com/read/28782407/evaluation-of-pegfilgrastim-use-at-an-academic-medical-center
#13
Kathy Tang, Alison Duffy, Steven Gilmore
Purpose Pegfilgrastim is indicated to reduce the risk of febrile neutropenia. As a cost-savings initiative, Pegfilgrastim Process Guidelines were developed and implemented at a large, academic teaching institution to improve appropriate use of pegfilgrastim and to decrease costs of outpatient infusion center administration by deferring doses to home self-administration for eligible patients. Methods A retrospective medical record review was conducted post-implementation of the Pegfilgrastim Process Guideline to evaluate the use of pegfilgrastim and to assess the safety and efficacy of transferring pegfilgrastim orders from outpatient infusion center to home administration for eligible patients...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28768977/the-first-case-of-pseudomonas-aeruginosa-bacteremic-pneumonia-in-a-cancer-patient-receiving-pegfilgrastim
#14
Fujiko Morita, Yuji Hirai, Kiyozumi Suzuki, Yuki Uehara, Kazunori Mitsuhashi, Masahito Takahashi, Sumio Watanabe, Toshio Naito
A single dose of pegfilgrastim or the daily administration of colony-stimulating factors can be used to prevent febrile neutropenia. This may delay the detection of rapidly progressive infections among cancer patients undergoing chemotherapy. We report a case of Pseudomonas aeruginosa bacteremic pneumonia that occurred in a patient receiving pegfilgrastim.
2017: Internal Medicine
https://www.readbyqxmd.com/read/28752433/a-phase-i-study-to-determine-safety-pharmacokinetics-and-pharmacodynamics-of-anf-rho%C3%A2-a-novel-pegylated-granulocyte-colony-stimulating-factor-in-healthy-volunteers
#15
Hemant Misra, John Berryman, Ronald Jubin, Abraham Abuchowski
Patients receiving pegfilgrastim (Neulasta®) for the treatment of neutropenia can experience bone pain following the injections required to achieve effective neutrophil levels. The safety, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of ANF-RHO™, a novel pegylated granulocyte colony stimulating factor, were assessed in a randomized, controlled, double-blind Phase 1 clinical study in healthy volunteers. Subjects received a single subcutaneous dose of ANF-RHO over a range of 6 doses (5-50 μg/kg), placebo (saline), or the recommended clinical dose of pegfilgrastim administered at the labeled fixed 6 mg dosage (equivalent to 80-100 μg/kg)...
July 28, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28722494/cost-efficiency-analyses-for-the-us-of-biosimilar-filgrastim-sndz-reference-filgrastim-pegfilgrastim-and-pegfilgrastim-with-on-body-injector-in-the-prophylaxis-of-chemotherapy-induced-febrile-neutropenia
#16
Ali McBride, Kim Campbell, Mohan Bikkina, Karen MacDonald, Ivo Abraham, Sanjeev Balu
AIMS: Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. The aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio EP2006) with reference to filgrastim (Neupogen), pegfilgrastim (Neulasta), and a pegfilgrastim injection device (Neulasta Onpro; hereafter pegfilgrastim-injector) for CIN/FN prophylaxis...
August 4, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28699225/intensive-consolidation-with-g-csf-support-tolerability-safety-reduced-hospitalization-and-efficacy-in-acute-myeloid-leukemia-patients-%C3%A2-60-years
#17
MULTICENTER STUDY
Wolfgang R Sperr, Susanne Herndlhofer, Karoline Gleixner, Michael Girschikofsky, Ansgar Weltermann, Sigrid Machherndl-Spandl, Thamer Sliwa, Rainer Poehnl, Veronika Buxhofer-Ausch, Karin Strecker, Gregor Hoermann, Paul Knoebl, Ulrich Jaeger, Klaus Geissler, Michael Kundi, Peter Valent
The aim of this study was to evaluate the efficacy and feasibility of intensified consolidation therapy employing fludarabine and ARA-C in cycle 1 and intermediate-dose ARA-C (IDAC) in cycles 2 through 4, in elderly acute myeloid leukemia (AML) patients and to analyze the effects of pegfilgrastim on the duration of neutropenia, overall toxicity, and hospitalization-time during consolidation in these patients. Thirty nine elderly patients with de novo AML (median age 69.9 years) who achieved complete remission (CR) after induction-chemotherapy were analyzed...
October 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28637287/pooled-analysis-of-two-randomized-double-blind-trials-comparing-proposed-biosimilar-la-ep2006-with-reference-pegfilgrastim-in-breast-cancer
#18
K Blackwell, P Gascon, C M Jones, A Nixon, A Krendyukov, R Nakov, Y Li, N Harbeck
Background: Following the functional and physicochemical characterization of a proposed biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar safety and efficacy to the reference product in a sensitive patient population. Patients and methods: LA-EP2006 is a proposed biosimilar that has been developed for pegfilgrastim, a long-acting form of granulocyte colony-stimulating factor for the prevention of neutropenia. The current analysis reports data pooled from two independent, multinational, prospective, randomized, controlled, double-blind phase III studies of similar design comparing the safety and efficacy of reference pegfilgrastim with LA-EP2006 in patients with breast cancer receiving myelotoxic (neo)adjuvant TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy and requiring granulocyte colony-stimulating factor...
September 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28619479/a-demonstration-of-analytical-similarity-comparing-a-proposed-biosimilar-pegfilgrastim-and-reference-pegfilgrastim
#19
Stephen Brokx, Louise Scrocchi, Nirmesh Shah, Jason Dowd
BACKGROUND: Recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) is used primarily to reduce incidence and duration of severe neutropenia and its associated complications in cancer patients that have received a chemotherapy regimen. The pegylated form of filgrastim, "pegfilgrastim", is a long-acting form that requires only a once-per-cycle administration for the management of chemotherapy-induced neutropenia. Apobiologix, a division of ApoPharma USA, Inc., and Intas Pharmaceuticals Limited have co-developed a proposed pegfilgrastim biosimilar to US-licensed pegfilgrastim...
June 12, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28614980/meta-analysis-and-indirect-treatment-comparison-of-lipegfilgrastim-with-pegfilgrastim-and-filgrastim-for-the-reduction-of-chemotherapy-induced-neutropenia-related-events
#20
T Christopher Bond, Erika Szabo, Susan Gabriel, Jean Klastersky, Omar Tomey, Udo Mueller, Lee Schwartzberg, Boxiong Tang
Background Granulocyte colony-stimulating factors are effective at reducing the risk and duration of neutropenia. The current meta-analysis compared the neutropenia-related efficacy and safety of lipegfilgrastim to those of pegfilgrastim and filgrastim. Methods Embase was searched for trials examining the efficacy/safety of lipegfilgrastim, pegfilgrastim, or filgrastim. Outcomes included febrile neutropenia, severe neutropenia, duration of severe neutropenia, time to recovery of absolute neutrophil count, and incidence of bone pain...
January 1, 2017: Journal of Oncology Pharmacy Practice
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