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Pegfilgrastim

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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
#1
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
#2
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)...
February 28, 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
#3
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...
February 22, 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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
https://www.readbyqxmd.com/read/28097385/two-phase-1-dose-escalation-studies-exploring-multiple-regimens-of-litronesib-ly2523355-an-eg5-inhibitor-in-patients-with-advanced-cancer
#11
Jeffrey R Infante, Amita Patnaik, Claire F Verschraegen, Anthony J Olszanski, Montaser Shaheen, Howard A Burris, Anthony W Tolcher, Kyriakos P Papadopoulos, Muralidhar Beeram, Scott M Hynes, Jennifer Leohr, Aimee Bence Lin, Lily Q Li, Anna McGlothlin, Daphne L Farrington, Eric H Westin, Roger B Cohen
PURPOSE: This first-in-human report examined the recommended Phase 2 dose and schedule of litronesib, a selective allosteric kinesin Eg5 inhibitor. METHODS: Two concurrent dose-escalation studies investigated litronesib across the dose range of 0.125-16 mg/m(2)/day, evaluating the following schedules of administration on a 21-day cycle: Days 1, 2, 3; Days 1, 5, 9; Days 1, 8; Days 1, 5; or Days 1, 4, with or without pegfilgrastim. Best overall response was defined per Response Evaluation Criteria in Solid Tumors (RECIST Version 1...
February 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28038931/safety-of-same-day-pegfilgrastim-administration-in-metastatic-castration-resistant-prostate-cancer-treated-with-cabazitaxel-with-or-without-carboplatin
#12
Mehmet Asim Bilen, Diana H Cauley, Bradley J Atkinson, Hsiang-Chun Chen, Diana H Kaya, Xuemei Wang, Raghu Vikram, Shi-Ming Tu, Paul G Corn, Jeri Kim
INTRODUCTION: Although myeloid growth factors are commonly used to treat metastatic castration-resistant prostate cancer (mCRPC), the optimal timing of administration has not been well studied. We assessed the effects of same-day pegfilgrastim, a neutrophil stimulator, after cabazitaxel treatment with or without carboplatin in patients with mCRPC. We also evaluated the frequency of urinary tract inflammation during treatment. PATIENTS AND METHODS: Between September 2010 and September 2014, 151 consecutive patients with mCRPC underwent cabazitaxel treatment with or without the addition of carboplatin at a single institution...
December 13, 2016: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28038865/a-phase-iii-randomized-double-blind-placebo-controlled-trial-of-pegfilgrastim-in-patients-receiving-first-line-folfox-bevacizumab-or-folfiri-bevacizumab-for-locally-advanced-or-metastatic-colorectal-cancer-final-results-of-the-pegfilgrastim-and-anti-vegf-evaluation
#13
Tamás Pinter, Zandra Klippel, Alvydas Cesas, Adina Croitoru, Jochen Decaestecker, Peter Gibbs, Yevhen Hotko, Jacek Jassem, Galina Kurteva, Jan Novotny, Seamus O'Reilly, Tomas Salek, Maureen Reiner, Phuong Khanh Morrow, Mi Rim Choi, Sadie Whittaker, Charles Blanke
BACKGROUND: Pegfilgrastim's role in reducing the risk of febrile neutropenia (FN) in patients with colorectal cancer (CRC) receiving chemotherapy plus bevacizumab was not previously evaluated in a prospective study. The present phase III, double-blind trial evaluated the efficacy of pegfilgrastim versus placebo in reducing the incidence of grade 3/4 FN in patients with advanced CRC receiving bevacizumab combined with first-line chemotherapy (FOLFOX [leucovorin, 5-fluorouracil, oxaliplatin] or FOLFIRI [leucovorin, 5-fluorouracil, irinotecan])...
September 7, 2016: Clinical Colorectal Cancer
https://www.readbyqxmd.com/read/27986205/costo-efectividad-del-uso-profil%C3%A3-ctico-del-factor-estimulante-de-colonias-de-granulocitos-en-adultos-con-leucemia-linfobl%C3%A3-stica-aguda-en-colombia
#14
Elkin Javier Casadiego Rincón, Jorge Augusto Díaz Rojas, Carlos Daniel Bermúdez, Víctor Prieto Martínez
OBJECTIVE: To assess the cost-effectiveness of prophylactic administration of Granulocyte Colony-Stimulating Factor (G-CSF) compared with no use of it, during the induction phase of chemotherapy in Adults with Acute Lymphoblastic Leukemia (ALL) in Colombia. METHODS: A decision tree with a time horizon of 30 days was built under colombian health system perspective including only direct costs. The costs of procedures and medications were taken from official sources and an institution of national reference of oncology services...
December 2016: Value in Health Regional Issues
https://www.readbyqxmd.com/read/27983764/bendamustine-lenalidomide-and-dexamethasone-brd-has-high-activity-as-2-nd-line-therapy-for-relapsed-and-refractory-multiple-myeloma-a-phase-ii-trial
#15
Ulrich J M Mey, Wolfram Brugger, Heike Schwarb, Stefanie Pederiva, Andreas Schwarzer, Tobias Dechow, Paul Jehner, Jacqueline Rauh, Christian J Taverna, Mathias Schmid, Martin Schmidt-Hieber, Steffen Doerfel, Natalie Fischer, Axel Ruefer, Carsten Ziske, Wolfgang Knauf, Richard Cathomas, Roger von Moos, Felicitas Hitz, Rafael Sauter, Elke Hiendlmeyer, Nathan Cantoni, Mario Bargetzi, Christoph Driessen
The combination of lenalidomide (Revlimid(®) , R) and dexamethasone (d) is a standard regimen for patients with relapsed/refractory multiple myeloma (rrMM). With this regimen, only a small fraction of patients will achieve high quality responses [≥ very good partial response (VGPR)]. The combination of bendamustine (B), lenalidomide and dexamethasone (BRd) has shown high efficacy in patients with advanced rrMM. However, dose-limiting haematotoxicity restricted its use in extensively pre-treated patient populations...
March 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/27928760/cost-effectiveness-analysis-of-prophylaxis-treatment-strategies-to-reduce-the-incidence-of-febrile-neutropenia-in-patients-with-early-stage-breast-cancer-or-non-hodgkin-lymphoma
#16
Kelly Fust, Xiaoyan Li, Michael Maschio, Guillermo Villa, Anju Parthan, Richard Barron, Milton C Weinstein, Luc Somers, Caroline Hoefkens, Gary H Lyman
OBJECTIVE: The objective of this study was to evaluate the cost effectiveness of no prophylaxis, primary prophylaxis (PP), or secondary prophylaxis (SP) with granulocyte colony-stimulating factors (G-CSFs), i.e., pegfilgrastim, lipegfilgrastim, filgrastim (6- and 11-day), or lenograstim (6- and 11-day), to reduce the incidence of febrile neutropenia (FN) in patients with stage II breast cancer receiving TC (docetaxel, cyclophosphamide) and in patients with non-Hodgkin lymphoma (NHL) receiving R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) over a lifetime horizon from a Belgian payer perspective...
April 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/27904448/mobilization-with-cyclophosphamide-reduces-the-number-of-lymphocyte-subpopulations-in-the-leukapheresis-product-and-delays-their-reconstitution-after-autologous-hematopoietic-stem-cell-transplantation-in-patients-with-multiple-myeloma
#17
Matevz Skerget, Barbara Skopec, Darja Zontar, Peter Cernelc
BACKGROUND: Autologous hematopoietic stem cell transplantation is considered the standard of care for younger patients with multiple myeloma. Several mobilization regimens are currently used, most commonly growth factors alone or in combination with chemotherapy. The aim of our study was to investigate the differences in lymphocyte subpopulation counts between three different mobilization regimens on collection day, in the leukapheresis product and on day 15 after autologous hematopoietic stem cell transplantation...
December 1, 2016: Radiology and Oncology
https://www.readbyqxmd.com/read/27822615/g-csf-use-in-patients-receiving-first-line-chemotherapy-for-non-hodgkin-s-lymphoma-nhl-and-granulocyte-colony%C3%A2-stimulating-factors-g-csf-as-observed-in-clinical-practice-in-italy
#18
MULTICENTER STUDY
Umberto Vitolo, Francesco Angrili, Lucy DeCosta, Sally Wetten, Massimo Federico
Treatment of non-Hodgkin lymphoma (NHL) requires chemotherapy regimens with significant risk of febrile neutropenia (FN). For patients at ≥20% FN risk, guidelines recommend primary prophylaxis (PP) with granulocyte-colony stimulating factor (G-CSF). This study assessed whether G-CSF use in NHL was in line with recommendations in routine practice. This was a retrospective, observational study of adult NHL patients receiving first-line (R)CHOP-like chemotherapy and G-CSF support between June 2010 and 2012, in Italy...
December 2016: Medical Oncology
https://www.readbyqxmd.com/read/27819161/performance-of-the-pegfilgrastim-on-body-injector-as-studied-with-placebo-buffer-in-healthy-volunteers
#19
Rajeshree S Joshi, Ogo I Egbuna, Alex S Cairns, Michael J Friedman, Bassam Abosaleem, Maureen T Reiner, Phuong Khanh Morrow
OBJECTIVE: The pegfilgrastim on-body injector (OBI) is a single-use, disposable, battery-powered injector that is designed to automatically deliver a single subcutaneous dose of pegfilgrastim beginning approximately 27 hours after activation and continuing over approximately 45 minutes. In this open-label study, we assessed performance of the OBI delivering placebo buffer in healthy volunteers. RESEARCH DESIGN AND METHODS: Healthy men and women aged 18-55 years, with a body mass index of 18-35 kg/m(2), were enrolled...
February 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/27783280/optimal-primary-febrile-neutropenia-prophylaxis-for-patients-receiving-docetaxel-cyclophosphamide-chemotherapy-for-breast-cancer-a-systematic-review
#20
REVIEW
Ricardo Fernandes, Sasha Mazzarello, Carol Stober, Lisa Vandermeer, Shaan Dudani, Mohamed F K Ibrahim, Habeeb Majeed, Kirstin Perdrizet, Risa Shorr, Brian Hutton, Dean Fergusson, Mark Clemons
BACKGROUND: Due to the high rate of febrile neutropenia (FN) with docetaxel-cyclophosphamide (DC) chemotherapy, primary FN prophylaxis is recommended. However, the optimal choice of prophylaxis [i.e., granulocyte-colony stimulating factors (G-CSF) or antibiotics] is unknown. A systematic review was performed to address this knowledge gap. METHODS: Embase, Ovid Medline, Pubmed, the Cochrane database of systematic reviews, and Cochrane register of controlled trials were searched from 1946 to April 2016 for studies evaluating primary prophylactic FN treatments in breast cancer patients receiving DC chemotherapy...
October 25, 2016: Breast Cancer Research and Treatment
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