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Pegfilgrastim

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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
#1
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
#2
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
#3
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
#4
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
#5
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-research-consortium-mccrc-mc0485-now-known-as
#6
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/m2 IV weekly x 4 doses (cycle 1 only); dexamethasone 40 mg PO/IV d2 - 5; oxaliplatin 130 mg/m2 IV d2; cytarabine 2000 mg/m2 IV x two doses on days 2 - 3; and pegfilgrastim 6 mg SC on d4...
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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...
April 28, 2017: Future Oncology
https://www.readbyqxmd.com/read/28439700/filgrastim-alone-versus-pegylated-filgrastim-alone-for-autologous-peripheral-blood-stem-cells-mobilization-in-newly-diagnosed-multiple-myeloma-patients
#15
Barbara Skopec, Matevz Skerget, Darja Zontar, Vesna Zadnik, Samo Zver
BACKGROUND: Autologous hematopoietic stem cell transplantation (aHSCT) is the recommended standard upfront treatment for transplant eligible myeloma patients. Considering possible complications related to chemotherapy-cytokine mobilization, cytokine-alone mobilization is often used. We compared mobilization with filgrastim alone to pegfilgrastim alone in newly diagnosed myeloma patients after induction treatment with bortezomib and dexamethasone. The comparison was made between peripheral blood stem cell (PBSC) yields, number of apheresis, hematopoietic stem cell subsets, and time to neutrophil and platelet engraftment after aHSCT...
April 24, 2017: Wiener Klinische Wochenschrift
https://www.readbyqxmd.com/read/28423916/pegfilgrastim-induced-bone-pain-a-review-on-incidence-risk-factors-and-evidence-based-management
#16
Donald C Moore, Annie E Pellegrino
OBJECTIVE: To review the incidence, risk factors, and management of pegfilgrastim-induced bone pain (PIBP). DATA SOURCES: PubMed was searched from 1980 to March 31, 2017, using the terms pegfilgrastim and bone pain. STUDY SELECTION AND DATA EXTRACTION: English-language, human studies and reviews assessing the incidence, risk factors, and management of PIBP were incorporated. DATA SYNTHESIS: A total of 3 randomized, prospective studies and 2 retrospective studies evaluated pharmacological management of PIBP...
April 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28413791/safety-and-tolerability-of-peg-grafeel-%C3%A2-a-pegfilgrastim-for-the-prophylactic-treatment-of-chemotherapy-induced-neutropenia-and-febrile-neutropenia-a-prospective-observational-postmarketing-surveillance-study-in-india
#17
Vineet Talwar, Sharanabasappa S Nirni, Krishna Mohan Mallavarapu, Anupama Ramkumar, Nitu Sinha
BACKGROUND: A granulocyte colony-stimulating factor, pegfilgrastim, is efficacious though expensive for prophylactic treatment of chemotherapy-induced neutropenia and febrile neutropenia. Biologics available and accessible today, having acceptable safety-efficacy profiles, require postapproval studies for better understanding of such drugs in clinical settings. AIM: This postmarketing surveillance study evaluated the safety of prophylactic Peg-grafeel(™) (pegfilgrastim) in cancer patients with chemotherapy-induced neutropenia...
January 2017: South Asian Journal of Cancer
https://www.readbyqxmd.com/read/28353170/impact-of-guidance-on-the-prescription-patterns-of-g-csfs-for-the-prevention-of-febrile-neutropenia-following-anticancer-chemotherapy-a-population-based-utilization-study-in-the-lazio-region
#18
Francesco Trotta, Flavia Mayer, Alessandra Mecozzi, Laura Amato, Antonio Addis
BACKGROUND: Current guidelines recommend prophylaxis with granulocyte colony-stimulating factors (G-CSFs) for patients with cancer who are at greater risk of febrile neutropenia (FN) while receiving chemotherapy. G-CSF biosimilars are available and represent a savings opportunity; however, their uptake has thus far been low. OBJECTIVE: Our objective was to evaluate prescribing patterns for G-CSFs in the prevention of chemotherapy-related FN and to evaluate the impact of regional guidance on G-CSF prescription...
April 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28281183/a-phase-1b-dose-expansion-study-of-the-pan-class-i-pi3k-inhibitor-buparlisib-bkm120-plus-carboplatin-and-paclitaxel-in-pten-deficient-tumors-and-with-dose-intensified-carboplatin-and-paclitaxel
#19
Lillian M Smyth, Kelsey R Monson, Komal Jhaveri, Alexander Drilon, Bob T Li, Wassim Abida, Gopa Iyer, John F Gerecitano, Mrinal Gounder, James J Harding, Martin H Voss, Vicky Makker, Alan L Ho, Pedram Razavi, Alexia Iasonos, Philip Bialer, Mario E Lacouture, Jerrold B Teitcher, Joseph P Erinjeri, Nora Katabi, Matthew G Fury, David M Hyman
Purpose We previously reported the phase I dose escalation study of buparlisib, a pan-class 1A PI3K inhibitor, combined with platinum/taxane-based chemotherapy in patients with advanced solid tumors. The combination was well tolerated and promising preliminary efficacy was observed in PTEN deficient tumors. This phase I dose expansion study now evaluates buparlisib plus high dose carboplatin and paclitaxel in unselected patients with advanced solid tumors and buparlisib plus standard dose carboplatin and paclitaxel in patients with PTEN deficient tumors (ClinicalTrials...
March 9, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28245148/prior-authorization-for-medications-in-a-breast-oncology-practice-navigation-of-a-complex-process
#20
Ankit Agarwal, Rachel A Freedman, Felicia Goicuria, Catherine Rhinehart, Kathleen Murphy, Eileen Kelly, Erin Mullaney, Myra St Amand, Phuong Nguyen, Nancy U Lin
INTRODUCTION: The cost and burden associated with prior authorization (PA) for specialty medications are concerns for oncologists, but the impact of the PA process on care delivery has not been well described. We examined PA processes and approval patterns within a high-volume breast oncology clinic at a major academic cancer center. METHODS: We met with institutional staff to create a PA workflow and process map. We then abstracted pharmacy and medical records for all patients with breast cancer (N = 279) treated at our institution who required a PA between May and November 2015 (324 prescriptions)...
April 2017: Journal of Oncology Practice
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