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Pegfilgrastim

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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
#1
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
#2
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...
August 21, 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
#3
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
#4
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
#5
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
#6
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
#7
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. Our 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 filgrastim (Neupogen(®)), pegfilgrastim (Neulasta(®)), and pegfilgrastim injection device (Neulasta Onpro(®); hereafter pegfilgrastim-injector) for CIN/FN prophylaxis...
July 19, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28699225/intensive-consolidation-with-g-csf-support-tolerability-safety-reduced-hospitalization-and-efficacy-in-aml-patients-%C3%A2-60-years
#8
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 hospitalisation-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...
July 11, 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
#9
K Blackwell, P Gascon, C M Jones, A Nixon, A Krendyukov, R Nakov, Y Li, N Harbeck
NCT01735175, NCT01516736.
June 16, 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
#10
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
#11
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
https://www.readbyqxmd.com/read/28614905/long-term-follow-up-of-chemoimmunotherapy-with-rituximab-oxaliplatin-cytosine-arabinoside-dexamethasone-road-in-patients-with-relapsed-cd20-b-cell-non-hodgkin-lymphoma-results-of-a-study-of-the-mayo-clinic-cancer-center-research-consortium-mccrc-mc0485-now
#12
Thomas E Witzig, Patrick B Johnston, Betsy R LaPlant, Paul J Kurtin, Levi D Pederson, Dennis F Moore, Nassim H Nabbout, Daniel A Nikcevich, Kendrith M Rowland, Axel Grothey
Patients with relapsed aggressive non-Hodgkin lymphoma (NHL) are often treated with platinum-based chemoimmunotherapy regimens in preparation for autologous stem cell transplant. We sought to reduce toxicity and maintain efficacy by using oxaliplatin with rituximab, cytarabine and dexamethasone (ROAD) in a phase II clinical trial in patients who had relapsed after one prior regimen. ROAD was delivered q21 days and consisted of rituximab 375 mg/m(2) IV weekly x 4 doses (cycle 1 only); dexamethasone 40 mg PO/IV d2 - 5; oxaliplatin 130 mg/m(2) IV day 2; cytarabine 2000 mg/m(2) IV × two doses on days 2 to 3; and pegfilgrastim 6 mg SC on day 4...
June 14, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28600210/accelerated-versus-standard-epirubicin-followed-by-cyclophosphamide-methotrexate-and-fluorouracil-or-capecitabine-as-adjuvant-therapy-for-breast-cancer-in-the-randomised-uk-tact2-trial-cruk-05-19-a-multicentre-phase-3-open-label-randomised-controlled-trial
#13
David Cameron, James P Morden, Peter Canney, Galina Velikova, Robert Coleman, John Bartlett, Rajiv Agrawal, Jane Banerji, Gianfilippo Bertelli, David Bloomfield, A Murray Brunt, Helena Earl, Paul Ellis, Claire Gaunt, Alexa Gillman, Nicholas Hearfield, Robert Laing, Nicholas Murray, Niki Couper, Robert C Stein, Mark Verrill, Andrew Wardley, Peter Barrett-Lee, Judith M Bliss
BACKGROUND: Adjuvant chemotherapy for early breast cancer has improved outcomes but causes toxicity. The UK TACT2 trial used a 2×2 factorial design to test two hypotheses: whether use of accelerated epirubicin would improve time to tumour recurrence (TTR); and whether use of oral capecitabine instead of cyclophosphamide would be non-inferior in terms of patients' outcomes and would improve toxicity, quality of life, or both. METHODS: In this multicentre, phase 3, randomised, controlled trial, we enrolled patients aged 18 years or older from 129 UK centres who had histologically confirmed node-positive or high-risk node-negative operable breast cancer, had undergone complete excision, and were due to receive adjuvant chemotherapy...
July 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28597691/safety-and-efficacy-of-pegfilgrastim-when-given-less-than-14-days-before-the-next-chemotherapy-cycle-retrospective-review-of-every-14-day-chemotherapy-regimen-containing-5-fu-continuous-infusion
#14
Kofi N Donkor, Julie H Selim, Ariani Waworuntu, Kelsey Lewis
BACKGROUND: Pegfilgrastim should not be given <14 days from the next chemotherapy because of concerns for cytopenias. Some clinicians are prescribing pegfilgrastim to be given <14 days in patients receiving 5-fluorouracil continuous infusion (5-FUCI) regimens. OBJECTIVE: To determine the effectiveness and safety of pegfilgrastim administered <14 days from the next chemotherapy in patients receiving 5-FUCI administered >46 hours. METHODS: Single-institution retrospective cohort study of patients who received 5-FUCI administered >46 hours from June 2013 to December 2015...
June 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28549110/thoracic-aortitis-and-aortic-dissection-following-pegfilgrastim-administration
#15
Yuki Sato, Shuichiro Kaji, Hiroyuki Ueda, Keisuke Tomii
The patient was a 67-year-old woman with a history of advanced lung adenocarcinoma. Eight days after pegfilgrastim administration, her computed tomography scan revealed thickened bilateral common carotid arteries and thoracic aorta, which led to the diagnosis of pegfilgrastim-associated aortitis. Thirty-six days after pegfilgrastim administration, asymptomatic Stanford type B aortic dissection was detected. Her serum biomarker analysis suggested that interleukin-6 might be involved in the pathogenesis. Physicians should be aware of these adverse effects of filgrastim...
May 26, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/28548643/condensed-versus-standard-schedule-of-high-dose-cytarabine-consolidation-therapy-with-pegfilgrastim-growth-factor-support-in-acute-myeloid-leukemia
#16
S Jaramillo, A Benner, J Krauter, H Martin, T Kindler, M Bentz, H R Salih, G Held, C-H Köhne, K Götze, M Lübbert, A Kündgen, P Brossart, M Wattad, H Salwender, B Hertenstein, D Nachbaur, G Wulf, H-A Horst, H Kirchen, W Fiedler, A Raghavachar, G Russ, S Kremers, E Koller, V Runde, G Heil, D Weber, G Göhring, K Döhner, A Ganser, H Döhner, R F Schlenk
The aim of this cohort study was to compare a condensed schedule of consolidation therapy with high-dose cytarabine on days 1, 2 and 3 (HDAC-123) with the HDAC schedule given on days 1, 3 and 5 (HDAC-135) as well as to evaluate the prophylactic use of pegfilgrastim after chemotherapy in younger patients with acute myeloid leukemia in first complete remission. One hundred and seventy-six patients were treated with HDAC-135 and 392 patients with HDAC-123 with prophylactic pegfilgrastim at days 10 and 8, respectively, in the AMLSG 07-04 and the German AML Intergroup protocol...
May 26, 2017: Blood Cancer Journal
https://www.readbyqxmd.com/read/28485020/pegylated-granulocyte-colony-stimulating-factor-versus-non-pegylated-granulocyte-colony-stimulating-factor-for-peripheral-blood-stem-cell-mobilization-a-systematic-review-and-meta-analysis
#17
Jew W Kuan, Anselm T Su, Chooi F Leong
Granulocyte-colony stimulating factor (G-CSF) mobilizes and increases the amount of hematopoietic stem cells in peripheral blood, enabling its harvest by few apheresis procedures. The pegylated G-CSF has longer half-life and is given once only, which is more comfortable for patients, whereas the non-pegylated requires multiple daily injection because of its short half-life. We summarized results of randomized trials comparing the efficacy and safety of pegylated and non-pegylated G-CSF for peripheral blood stem cell mobilization...
May 9, 2017: Journal of Clinical Apheresis
https://www.readbyqxmd.com/read/28484882/the-effectiveness-and-safety-of-same-day-versus-next-day-administration-of-long-acting-granulocyte-colony-stimulating-factors-for-the-prophylaxis-of-chemotherapy-induced-neutropenia-a-systematic-review
#18
REVIEW
Gary H Lyman, Kim Allcott, Jacob Garcia, Scott Stryker, Yanli Li, Maureen T Reiner, Derek Weycker
PURPOSE: Granulocyte colony-stimulating factors (G-CSF) are commonly used in clinical practice to prevent febrile neutropenia (FN). US and EU prescribing information and treatment guidelines from the NCCN, ASCO, and EORTC specify that pegfilgrastim, a long-acting (LA) G-CSF, should be administered at least 24 h after myelosuppressive chemotherapy. Nevertheless, many patients receive LA G-CSFs on the same day as chemotherapy. This systematic literature review evaluated the relative merits of same-day versus next-day dosing of LA G-CSFs...
August 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28459941/german-adjuvant-intergroup-node-positive-study-gain-a-phase-iii-trial-comparing-two-dose-dense-regimens-iddepc-vs-ddec-pwx-in-high-risk-early-breast-cancer-patients
#19
V Moebus, G von Minckwitz, C Jackisch, H-J Lück, A Schneeweiss, H Tesch, D Elling, N Harbeck, B Conrad, T Fehm, J Huober, V Müller, I Bauerfeind, A du Bois, S Loibl, V Nekljudova, M Untch, C Thomssen
Background: Dose-dense (dd) regimens are one of the preferred options for the adjuvant treatment of breast cancer patients with intermediate to high risk. The GAIN trial aimed at optimizing intense dose-dense (idd) strategies by evaluating drug combinations and the addition of capecitabine. Patients and Methods: Women (aged 18 and biologically <65 years) with histologically involved axillary lymph nodes were randomly assigned to receive three courses each of epirubicin (E) 150mg/m 2 , paclitaxel (P) 225mg/m 2 and cyclophosphamide (C) 2500mg/m 2 (reduced to 2000mg/m 2 after recruitment of 1200 patients) q2w intravenously (i...
April 28, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28453299/proposed-biosimilar-pegfilgrastim-la-ep2006-compared-with-reference-pegfilgrastim-in-asian-patients-with-breast-cancer-an-exploratory-comparison-from-two-phase-iii-trials
#20
Nadia Harbeck, Pere Gascon, Clyde M Jones, Allen Nixon, Andriy Krendyukov, Roumen Nakov, Yuhan Li, Kimberly Blackwell
AIM: This is a pooled subgroup analysis of Asian patients enrolled in two Phase III confirmatory studies comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer. PATIENTS & METHODS: Women were randomized to LA-EP2006 (n = 90) or reference (n = 84) pegfilgrastim (Neulasta(®), Amgen, Inc., CA, USA) for ≤6 cycles of TAC chemotherapy. Primary end point was duration of severe neutropenia during Cycle 1 (number of consecutive days with absolute neutrophil count <0...
July 2017: Future Oncology
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