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Pegfilgrastim

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https://www.readbyqxmd.com/read/28549110/thoracic-aortitis-and-aortic-dissection-following-pegfilgrastim-administration
#1
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
#2
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
#3
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
#4
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...
May 8, 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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
https://www.readbyqxmd.com/read/28237422/determination-of-pegfilgrastim-aggregates-by-size-exclusion-high-performance-liquid-chromatography-on-a-methacrylate-based-column
#13
Majid Shahbazi, Elnaz Tamaskany Zahedy, Shiva Kiumarsi, Mojtaba Hadi Soltanabad, Saleh Shahbazi Azar, Hossein Amini
A size-exclusion high-performance liquid chromatographic method using a methacrylate-based column was developed, validated and implemented for the determination of pegfilgrastim aggregates. The samples were directly injected into a TSKgel G4000PWXL column (7.5 mm × 300 mm, 10 μm, <500 A°) with a mobile phase of 100 mM phosphate, pH 2.5. Detection was made at 215 nm and analyses were run at a flow-rate of 0.6 ml/min at 10 °C. Vortex-mixing of samples produced oligomers, however, very high molecular weight aggregates were formed at high temperatures...
March 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28223672/-influence-of-next-day-administration-of-pegfilgrastim-after-fec100-chemotherapy-in-japanese-with-breast-cancer-on-neutrophil-count
#14
Daichiro Fujiwara, Keiji Mashimo, Kayo Kimura, Akihiro Noda, Kazuo Taki, Hiroshi Yoshibayashi, Tomoya Takeda, Masanobu Tsubaki, Shozo Nishida, Katsuhiko Sakaguchi
Febrile neutropenia(FN)is one of the serious treatment-related toxicities after FEC100(5-fluorouracil 500mg/m2, epiru- bicin 100mg/m2, cyclophosphamide 500 mg/m2)chemotherapy for breast cancer. Granulocyte-colony stimulating factor(GCSF) is used as a support therapy for FN. Thus, we evaluated retrospectively the safety of administering pegfilgrastim the day after FEC100 chemotherapy in Japanese patients with breast cancer as compared with lenograstim. Grade 3 or 4 neutropenia was observed in 91.7% patients after pegfilgrastim administration and in 63...
February 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28152926/cancer-care-decision-support-for-wbc-growth-factors-gf-geographic-differences-in-utilization-and-provider-malleability
#15
Kenneth Sherman Wurtz, Anna DiMarco, Lourdes Feliciano, Dinah Faith Q Huff, Kevin B Knopf, William J Hrushesky, Michael Baum
128 Background: Growth factor use is the largest single category of drug expenditure for US cancer patients. Oncology Analytics is a decision support company that assists physicians in determining the appropriate use of GF based on the NCCN, ASCO, and ASH guidelines and the level one data that underlies these guidelines. We hypothesized that there would be geographic variation among GF preference and in the malleability of those practice patterns after OA entered a market. We determined the proportion of initial pegfilgrastim requests for preauthorization over other types of GF as well as the review outcomes and final drug of choice after OA intervention of inappropriate GF requests across three specific jurisdictions: Florida, Puerto Rico, Georgia and Texas...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28133212/-use-of-pegfilgrastim-in-adjuvant-and-neoadjuvant-chemotherapy-for-breast-cancer
#16
Noriko Abe, Tohru Ohtake, Sadahiko Abe, Keita Aoto, Maiko Okano, Kazunoshin Tachibana, Seiich Takenoshita
We assessed the incidence of febrile neutropenia(FN), infection, and relative dose intensity(RDI)with or without the use of pegfilgrastim in breast cancer patients receiving adjuvant or neoadjuvant chemotherapy. Twenty-five patients received 4 cycles of FEC(5-FU 500mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 100 mg/m2 q3w)followed by 4 cycles of docetaxel(75mg/m2 q3w). Ten patients were administered pegfilgrastim as primary prophylaxis throughout all cycles of chemotherapy, and 15 patients were not...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28133096/-primary-prophylactic-administration-of-pegfilgrastim-in-folfirinox-therapy-for-locally-advanced-pancreatic-carcinoma
#17
Riki Ninomiya, Akiko Nakazawa, Youichi Miyata, Tetsuya Mitsui, Masahiko Komagome, Akira Maki, Fumiaki Ozawa, Yoshifumi Beck
FOLFIRINOX therapy has a high response rate for pancreatic carcinoma, but has serious adverse effects. FOLFIRINOX therapy was administered to 11 patients with locally advanced pancreatic carcinoma at our hospital. We investigated the usefulness of primary prophylactic administration of pegfilgrastim(PegG). In the group receiving PegG, as well as with onset of neutropenia and thrombocytopenia, febrile neutropenia was reduced. Rates of anorexia and fatigue were also lower than in those who did not receive PegG...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28122890/efficacy-of-reduced-dose-of-pegfilgrastim-in-japanese-breast-cancer-patients-receiving-dose-dense-doxorubicin-and-cyclophosphamide-therapy
#18
Yoshio Mizuno, Hiromi Fuchikami, Naoko Takeda, Masaru Iwai, Kazuhiko Sato
BACKGROUND: This retrospective study aimed to evaluate the efficacy of a 3.6-mg dose of pegfilgrastim for primary prophylaxis in Japanese breast cancer patients receiving dose-dense chemotherapy. METHODS: Patients treated with adjuvant or neoadjuvant chemotherapy for early-stage breast cancer at the Tokyo-West Tokushukai Hospital were included in this analysis. Because 6 mg pegfilgrastim has not yet been approved for use in Japan, we compared the outcomes of a dose-dense doxorubicin and cyclophosphamide regimen plus 3...
January 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28107322/on-body-injector-an-administration-device-for-pegfilgrastim
#19
Linda J Mahler, Regina DiBlasi, Anielka Perez, Jeannie Gaspard, Dayna McCauley
Many chemotherapy regimens used today require the support of a granulocyte-colony-stimulating factor for the prevention of life-threatening neutropenia. In March 2015, a delivery method was introduced for Neulasta® (pegfilgrastim) through an on-body injector (Onpro®), which may eliminate the need for patients to return for injection after chemotherapy, increase workflow, and allow more patients to be seen. The purpose of this study was to monitor the implementation of the Onpro delivery system in an outpatient facility...
February 1, 2017: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/28105350/interstitial-pneumonia-following-administration-of-pegfilgrastim-during-carboplatin-and-etoposide-chemotherapy-for-small-cell-lung-cancer
#20
Masayuki Shirasawa, Yoshiro Nakahara, Hideyuki Niwa, Shinya Harada, Takahiro Ozawa, Seiichiro Kusuhara, Masashi Kasajima, Yasuhiro Hiyoshi, Jiichiro Sasaki, Noriyuki Masuda
Pegfilgrastim is a long-acting granulocyte colony-stimulating factor formulation that has been approved for the prevention of febrile neutropenia. We herein report a case of interstitial pneumonia following administration of pegfilgrastim. A 65-year-old man with stage IV small-cell lung cancer was treated with carboplatin and etoposide as third-line chemotherapy. Pegfilgrastim was administered during the second cycle of chemotherapy. On the day after the administration of pegfilgrastim, interstitial pneumonia developed...
December 2016: Molecular and Clinical Oncology
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