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Pegfilgrastim

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https://www.readbyqxmd.com/read/29671069/a-pharmacokinetics-and-pharmacodynamics-equivalence-trial-of-the-proposed-pegfilgrastim-biosimilar-myl-1401h-versus-reference-pegfilgrastim
#1
Cornelius F Waller, Renger G Tiessen, Tracey E Lawrence, Andrew Shaw, Mark Shiyao Liu, Rajiv Sharma, Mark Baczkowski, Mudgal A Kothekar, Catherine E Micales, Abhijit Barve, Gopinath M Ranganna, Eduardo J Pennella
PURPOSE: Pegfilgrastim is a long-acting granulocyte colony-stimulating factor indicated for prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy by promoting neutrophil recovery. METHODS: This phase 1, randomized, double-blind, three-way crossover trial in healthy volunteers evaluated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of the proposed biosimilar, comparing MYL-1401H, reference pegfilgrastim (Neulasta® , Amgen Inc, Thousand Oaks, CA, USA) sourced from the European Union, and reference pegfilgrastim sourced from the USA...
April 18, 2018: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/29651919/the-incidence-and-timing-of-leukocyte-overshoot-after-pegfilgrastim-administration
#2
Eiseki Usami, Michio Kimura, Mina Iwai, Makiko Go, Hiroki Asano, Shoya Takenaka, Shino Adachi, Tomoaki Yoshimura
Introduction Pegfilgrastim is a PEGylated formulation of filgrastim with a long half-life. It is highly convenient and less burdensome for patients. However, white blood cell count may temporarily increase after administration; in particular, a leukocyte overshoot may be observed. The present study retrospectively examined the incidence and timing of leukocyte overshoot after pegfilgrastim administration. Patients and methods Fifty-five patients (118 occasions of pegfilgrastim) were evaluated. Leukocyte overshoot was defined as white blood cell count ≥10,000/mm3 exceeding the reference value...
January 1, 2018: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/29590407/costs-associated-with-febrile-neutropenia-in-japanese-patients-with-primary-breast-cancer-post-hoc-analysis-of-a-randomized-clinical-trial
#3
Osamu Miyake, Kyoko Murata, Shiro Tanaka, Hiroshi Ishiguro, Masakazu Toi, Kazuo Tamura, Koji Kawakami
Background: Febrile neutropenia (FN), a decrease in blood neutrophils accompanied by fever, is a major adverse event (AE) associated with cancer chemotherapy. We aimed to estimate the direct medical costs associated with FN management in breast cancer patients within a clinical trial with pegfilgrastim, a pegylated form of recombinant granulocyte colony-stimulating factor (G-CSF). Methods: We obtained data from 346 Japanese breast cancer patients in a randomized, placebo-controlled clinical trial comparing FN incidence due to TC adjuvant chemotherapy (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) between pegfilgrastim-treated and placebo groups...
March 26, 2018: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/29573207/an-open-label-dose-ranging-study-of-rolontis-a-novel-long-acting-myeloid-growth-factor-in-breast-cancer
#4
Jeffrey L Vacirca, Arlene Chan, Klára Mezei, Clarence S Adoo, Zsuzsanna Pápai, Kimberly McGregor, Meena Okera, Zsolt Horváth, László Landherr, Jerzy Hanslik, Steven J Hager, Emad N Ibrahim, Makharadze Rostom, Gajanan Bhat, Mi Rim Choi, Guru Reddy, Karen L Tedesco, Richy Agajanian, István Láng, Lee S Schwartzberg
This randomized, open-label, active-controlled study investigated the safety and efficacy of three doses of Rolontis (eflapegrastim), a novel, long-acting myeloid growth factor, versus pegfilgrastim in breast cancer patients being treated with docetaxel and cyclophosphamide (TC). The primary efficacy endpoint was duration of severe neutropenia (DSN) during the first cycle of treatment. Patients who were candidates for adjuvant/neoadjuvant TC chemotherapy were eligible for participation. TC was administered on Day 1, followed by 45, 135, or 270 μg/kg Rolontis or 6 mg pegfilgrastim on Day 2...
March 23, 2018: Cancer Medicine
https://www.readbyqxmd.com/read/29561198/reply-re-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
#5
Ali McBride, Kim Campbell, Mohan Bikkina, Karen MacDonald, Ivo Abraham, Sanjeev Balu
No abstract text is available yet for this article.
March 21, 2018: Journal of Medical Economics
https://www.readbyqxmd.com/read/29549536/predictive-factors-in-patients-eligible-for-pegfilgrastim-prophylaxis-focusing-on-rdi-using-ordered-logistic-regression-analysis
#6
Yuko Kanbayashi, Takeshi Ishikawa, Motohiro Kanazawa, Yuki Nakajima, Rumi Kawano, Yusuke Tabuchi, Tomoko Yoshioka, Norihiko Ihara, Toyoshi Hosokawa, Koichi Takayama, Keisuke Shikata, Tetsuya Taguchi
Although pegfilgrastim prophylaxis is expected to maintain the relative dose intensity (RDI) of chemotherapy and improve safety, information is limited. However, the optimal selection of patients eligible for pegfilgrastim prophylaxis is an important issue from a medical economics viewpoint. Therefore, this retrospective study identified factors that could predict these eligible patients to maintain the RDI. The participants included 166 cancer patients undergoing pegfilgrastim prophylaxis combined with chemotherapy in our outpatient chemotherapy center between March 2015 and April 2017...
March 16, 2018: Medical Oncology
https://www.readbyqxmd.com/read/29547012/re-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
Mark Bensink, Christine Edwards, Charles Bowers, Jon Campbell
No abstract text is available yet for this article.
March 16, 2018: Journal of Medical Economics
https://www.readbyqxmd.com/read/29496254/amrubicin-and-carboplatin-with-pegfilgrastim-in-patients-with-extensive-stage-small-cell-lung-cancer-a-phase-ii-trial-of-the-sarah-cannon-oncology-research-consortium
#8
David R Spigel, John D Hainsworth, Dianna L Shipley, Tarek M Mekhail, John D Zubkus, David M Waterhouse, Davey B Daniel, Howard A Burris, F Anthony Greco
PURPOSE: First-line treatment for patients with extensive-stage small cell lung cancer (SCLC) includes treatment with platinum-based combination chemotherapy. Amrubicin is a synthetic anthracycline with single-agent activity in relapsed/refractory SCLC. In an attempt to improve treatment efficacy, we evaluated amrubicin/carboplatin as first-line therapy for extensive-stage SCLC. PATIENTS AND METHODS: In this multicenter phase II trial, patients received amrubicin (30 mg/m2 daily on Days 1, 2, and 3) and carboplatin (AUC = 5 on Day 1); cycles were repeated every 21 days for 4 cycles...
March 2018: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/29434148/pseudogout-attack-after-pegfilgrastim-administration-in-anaplastic-large-cell-lymphoma
#9
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/29398647/pegylated-filgrastim-versus-filgrastim-for-stem-cell-mobilization-in-multiple-myeloma-after-novel-agent-induction
#10
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/29361623/-effect-of-pegfilgrastim-primary-prophylactic-administration-on-relative-dose-intensity-rdi-in-postoperative-adjuvant-chemotherapy-tc-therapy-for-breast-cancer-a-single-center-retrospective-study
#11
Yukiko Nagashima, Hikari Chijimatsu, Kei Furuya, Junya Kondo, Yoshinari Maeda, Hideaki Somura, Norikazu Takemoto, Noboru Yahara, Toshihiro Abe, Hiroto Hayashi, Hidefumi Kubo, Shigeru Yamamoto, Hiroaki Nagano
This study assessed the effect of pegfilgrastim in patients with early stage breast cancer who were receiving docetaxel and cyclophosphamide(TC)therapy(75mg/m / 2 docetaxel plus 600 mg/m2 cyclophosphamide). In total, 17 patients who were to receive 4 planned cycles of TC therapy every 3 weeks were included in this study. Of the 17 patients, 10 who received pegfilgrastim after January 2016 formed the Peg-G group and 7 who did not receive pegfilgrastim until December 2015 formed the control group. We observed a high successful execution rate and relative dose intensity(RDI)with docetaxel in both groups...
December 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/29340092/first-line-dose-dense-chemotherapy-with-docetaxel-cisplatin-folinic-acid-and-5-fluorouracil-dcf-plus-panitumumab-in-patients-with-locally-advanced-or-metastatic-cancer-of-the-stomach-or-gastroesophageal-junction-final-results-and-biomarker-analysis-from-an
#12
Gianluca Tomasello, Nicola Valeri, Michele Ghidini, Elizabeth C Smyth, Wanda Liguigli, Laura Toppo, Rodolfo Mattioli, Alessandra Curti, Jens C Hahne, Federica M Negri, Stefano Panni, Margherita Ratti, Silvia Lazzarelli, Fabiana Gerevini, Chiara Colombi, Andrea Panni, Massimo Rovatti, Leonardo Treccani, Mario Martinotti, Rodolfo Passalacqua
Background: Survival for patients with advanced gastroesophageal cancer (AGC) using standard treatment regimens is poor. EGFR overexpression is common in AGC and associated with poor prognosis. We hypothesized that increasing the dose intensity of chemotherapy and adding panitumumab could improve efficacy. Methods: HER2 negative, PS 0-1 patients, received up to 4 cycles of panitumumab 6 mg/kg d 1, docetaxel 60 mg/m2 d 1, cisplatin 50 mg/m2 d 1, l-folinic acid 100 mg/m2 d 1-2, followed by 5-FU 400 mg/m2 bolus d 1-2, and then 600 mg/m2 as a 22 h c...
December 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/29318653/pharmacokinetic-pharmacodynamic-modelling-of-neutrophil-response-to-g-csf-in-healthy-subjects-and-patients-with-chemotherapy-induced-neutropenia
#13
Murad Melhem, Isabelle Delor, Juan Jose Pérez-Ruixo, John Harrold, Andrew Chow, Liviawati Wu, Philippe Jacqmin
AIM: The objective of the present 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 treated with filgrastim and pegfilgrastim. METHODS: Data were extracted from 10 phase I-III 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/29233743/a-phase-ii-trial-of-rituximab-combined-with-pegfilgrastim-in-patients-with-indolent-b-cell-non-hodgkin-lymphoma
#14
Pallawi Torka, Priyank Patel, Wei Tan, Gregory Wilding, Seema A Bhat, Myron S Czuczman, Kelvin P Lee, George Deeb, Vishala Neppalli, Cory Mavis, Paul Wallace, Francisco J Hernandez-Ilizaliturri
BACKGROUND: To explore the role of augmenting neutrophil function in B-cell lymphoma, we conducted a phase II study evaluating the safety and clinical efficacy of pegfilgrastim and rituximab in low-grade CD20+ B-cell non-Hodgkin lymphoma (B-NHL). PATIENTS AND METHODS: Twenty patients with indolent B-NHL were treated with rituximab (375 mg/m2 ) every other week for 4 doses, followed by every 2 months for 4 additional doses. Pegfilgrastim was administered subcutaneously 3 days before each dose of rituximab...
January 2018: Clinical Lymphoma, Myeloma & Leukemia
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
#15
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...
January 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29212975/-diffuse-large-b-cell-lymphoma-complicated-with-drug-induced-vasculitis-during-administration-of-pegfilgrastim
#16
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
#17
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
#18
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
#19
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
#20
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...
December 2017: Journal of Oncology Practice
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