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Filgrastim dose in obese women: Effect of Body Mass on Filgrastim Pharmacokinetics

FDA Safety Alerts for all medications.

William Murphy
Monday, April 30, 2018
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  • National Institutes of Health U. Email address.

  • The datasets used and analysed during the current study are available from the corresponding author on reasonable request. Conflict-of-interest disclosure: The authors declare no competing financial interests.

Key Points

Effect of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy. Read our disclaimer for details. November 1, Key Record Dates. White Blood Cells. G-CSF treatment of severe congenital neutropenia reverses neutropenia but does not correct the underlying functional deficiency of the neutrophil in defending against microorganisms.

  • Stem cell transplantation in patients with severe congenital neutropenia without evidence of leukemic transformation.

  • View large Download PPT. AnderliniPaolo N.

  • The statistical analyses of the data were performed in SPSS software version

  • Increased volume of blood processed on day 5 was associated with lower stem cell collection yield.

Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff filgrasyim the contact information provided by the sponsor. The results of this study using the diagram of trend of changes in ANC and platelet count and lymphocyte count as the main indicators of the effectiveness of drugs showed no significant differences between the two groups. Purification of a factor inducing differentiation in murine myelomonocytic leukemia cells. Adverse events among unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program. A clinical development plan including the study outline was also submitted to EMEA, which examined the documentation and gave advice about the present study design.

Google Scholar 2. The normal BMI category obese women filgraatim second largest group, at Elsevier; Complication of rapidly progressive glomerulonephritis in severe congenital neutropenia treated with long-term granulocyte colony-stimulating factor filgrastim. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Leukocytosis in obese individuals: possible link in patients with unexplained persistent neutrophilia.

Usual Adult Dose for Neutropenia Associated with Chemotherapy

Actual Study Start Date filgrastim dose in obese women. Peiman HemattiPeiman Hematti. View Metrics. The purpose of this study is to determine whether obese breast cancer patients who receive pegfilgrastim are at increased risk of developing febrile neutropenia. Older donors were at less risk of grade 2 to 4 pain and toxicities in the pericollection period, but they were more likely to have persistent pain and toxicities at 2 days after collection.

Comparison of autologous peripheral blood stem cell dosing by ideal vs actual body weight. Upper CL. A total of about tablespoons of blood will be drawn for this study. Normal Overall. Secondary Outcome Measures : Alpha and beta half-life of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Maximum concentration Cmax of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Time to maximum concentration Tmax of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ] Volume of distribution Vds and Vdss of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ].

Curr Opin Allergy Clin Immunol. SugrueMichele W. Cite Icon Cite. Footnote 8. J Biol Chem.

  • Comparison of autologous peripheral blood stem cell dosing by ideal vs actual body weight.

  • Google Scholar. KambleRammurti T.

  • Conflict-of-interest disclosure: The authors declare no competing financial interests.

  • These data suggest that higher BMI predicts a better HSC mobilization filgrastik to G-CSF and identify a dose threshold above which there is no appreciable increase in progenitor cell yield in obese and severely obese healthy unrelated donors. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy.

  • Close Key Points.

  • Polyethylene glycol-conjugated pharmaceutical proteins. Michele W.

In the third course, ANC decreased to on the 7th day of the injection. Donors in the obese and morbidly obese groups were older median age, 35 years dilgrastim with donors with normal BMI median age, 28 years. The most important of these complications is the progress of MDS to AML, although it is still unclear whether G-CSF is the cause of this progression or if the increased survival of congenital patients by G-CSF creates an opportunity for this transformation to take place because of the inherent tendency of MDS to progress towards the congenital neutropenic disease called AML [ 2122 ]. Br J Haematol. Gardner SN. Listing a study does not mean it has been evaluated by the U.

PulsipherMichael A. Adjusted for donor race, age, sex, year of obese women, and baseline MNC counts. The sites, where the injections are to be performed, are planned obesr follows:. A reduction in the hematologic component and its increase after GCF injection was the prominent pattern of data variations in each course. The PEGylation of drugs improves their clinical value; for instance, it increases their solubility [ 26 ], protects them against enzyme degradation [ 27 ], decreases their renal clearance [ 28 ], causes physical and thermal stability [ 29 ], and increases the antigenicity and toxicity half-life [ 30 ].

Background

Factors associated with granulocyte colony-stimulating factor-induced peripheral blood stem cell yield in healthy donors. Sign In or Create an Account. Sign In.

Obesity has been associated with persistent leukocytosis, elevated circulating progenitor cells, and enhanced stem cell mobilization. Both study treatments were administered according to a cross-over design in 2 subsequent periods separated by wash-out periods of at least 28 days. These symptoms included the incidence of grade 2 to 4 or grade 3 to 4 skeletal pain and the highest toxicity level across selected body symptoms at 24 hours after the first G-CSF dose and peak toxicity between days 1 to 5 of G-CSF administration and 2 days and 1 week postcollection. Whether this dosing strategy would also reduce pain and acute toxicities should be further studied.

Hillard M. These data suggest that higher BMI predicts a better HSC mobilization response to G-CSF and identify a dose threshold above which there is no appreciable increase in progenitor cell yield in obese and severely obese healthy unrelated donors. New Journal Content Alert. Storage requirements: Store refrigerated at 2C to 8C and do not freeze; protect from light. MurthyHemant S.

Stepwise logistic regression was performed on grade 2 to 4 pain and grade 2 to 4 toxicities at various time points, in the same manner as described. Comparison of autologous peripheral blood stem cell dosing by ideal vs actual body weight. Jean A. New Journal Content Alert. Normal

Filgrastim dose in obese women BredesonChristopher Bredeson. Overweight Talk with your doctor and family members or friends about deciding to join a study. Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen for a total of 24 hours. Author notes The full-text version of this article contains a data supplement. The prevalence of obesity has increased in the United States over the past few decades. Actual Study Start Date :.

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Race and ethnicity influences collection of granulocyte colony-stimulating factor-mobilized peripheral blood progenitor cells from unrelated donors, a Center for International Blood and Marrow Transplant Research analysis. Cancer Res. Raquel SchearsRaquel Schears. SavaniBipin N. A randomized multicenter comparison of bone marrow and peripheral blood in recipients of matched sibling allogeneic transplants for myeloid malignancies.

Received : 22 September Jack W. Evaluation of pegylation reaction and purification of monopegylated recombinant human granulocyte colony stimulating factor; The randomization blocks were pockets given by the corresponding researcher.

If receiving treatment with PGL, the patient should receive the drug every day after chemotherapy for at least six days, but if receiving PDL, only one shot of the drug is required in filgrasrim course of chemotherapy. Older donors were at less risk of grade 2 to 4 pain and toxicities in the pericollection period, but they were more likely to have persistent pain and toxicities at 2 days after collection. LazarusHillard M. Five patients had unbearable side effects that resulted in the discontinuation of the drug; one of these patients developed renal insufficiency with a dose of micrograms per kilogram, and four others developed the following side effects with a dose of at least 30 micrograms: Fever, diarrhea, nausea and dehydration. Therapy for neutropenia in hairy cell leukemia with recombinant human granulocyte colony-stimulating factor.

I accept the Terms and Privacy Policy. Obesity is associated with a state of chronic low-grade inflammation resulting from chronic activation of the innate immune system. Prediction of hematopoietic stem cell yield after mobilization with granulocyte-colony-stimulating factor in healthy unrelated donors. Drug Information available for: Filgrastim. View large Download slide. Monthly Newsletter.

  • Search all BMC articles Search.

  • Table 4. Wingard; Weighty choices: selecting optimal G-CSF doses for stem cell mobilization to optimize yield.

  • The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.

  • ConferDennis L. Table 5.

  • Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body.

Peripheral blood stem cell yield in normal donors mobilised with granulocyte colony-stimulating factor G-CSF : impact of age, sex, donor weight and type of G-CSF used. Although a cost analysis was not performed in this study, limiting the doses of G-CSF in obese and severely obese donors will reduce direct costs of stem cell mobilization. Multivariate analysis of grade 2 to 4 skeletal pain between days 1 and day 5 of G-CSF administration. YaredJean A.

Save this study. PBSC collection yield relies on effective mobilization of hematopoietic precursors from the bone marrow. One other factor that was independently associated with an increase in toxicities and pain in the pericollection period was a higher baseline MNC count. Ratio of means.

Obese PBSCs were collected by apheresis over obeze or 2 days. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan. Obesity is associated with a state of chronic low-grade inflammation resulting from chronic activation of the innate immune system. Yared, Michael A.

FDA Safety Alerts for all medications. Donor response after 5 d of G-CSF administration. Substances pegfilgrastim Polyethylene Glycols Filgrastim. Dennis L. Jean A.

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Hematologic Neoplasms Neutropenia Neoplasms Agranulocytosis. Dennis Filgrsstim. Solh, Thomas Spitzer, Jean Medical conditions related to obesity and diabetes. Pain and toxicities were assessed at baseline, during G-CSF administration, and postcollection. Previous studies evaluating the impact of BMI on PBSC yield in related and unrelated donors were mostly single-center studies limited by small numbers of donors. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Grade 3 to 4 pain and toxicities were infrequently experienced in all BMI groups, but obese and severely obese donors had a slightly higher percentage of reported grade 3 to 4 skeletal pain and toxicities on days 1 to 5 of G-CSF administration.

Siddhartha GangulySiddhartha Ganguly. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Obese and severely wo,en donors were more likely to experience grade 2 pain and toxicities compared with normal and overweight donors between days 1 and 5 of G-CSF administration and 2 days after donation. Federal Government. One other factor that was independently associated with an increase in toxicities and pain in the pericollection period was a higher baseline MNC count. Previous Article Next Article.

MeSH terms

Pintip ChitphakdithaiPintip Chitphakdithai. Article Navigation. Paolo N. Donor and procedure characteristics, including donor sex, age at donation, race, weight at baseline, use of a central line, volume of whole blood processed, collection year, baseline white blood cell WBC count, platelet, neutrophil, and mononuclear cell MNC values, and G-CSF dosage were described. Process Biochem.

Mona PapariMona Papari. Elsevier; Multivariate analysis of factors influencing peripheral blood collection yield in unrelated donors. PulsipherMichael A.

Actual Study Start Date :. PulsipherMichael A. Previous Article Filgrastim dose in obese women Article. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. One other factor that was independently associated with an increase in toxicities and pain in the pericollection period was a higher baseline MNC count.

Key Points

Several studies have proven the efficacy of PDG as a drug. PBSC collection yield relies on effective mobilization of hematopoietic precursors from the bone marrow. YaredJean A. Competing interests The authors have no conflicts of interest.

  • Paolo N. The baseline demographic and collection characteristics are summarized in Table 1.

  • Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program. We found significantly higher collection yields in obese and severely obese donors compared with normal and overweight donors.

  • An interim analysis was achieved after reaching one-third of the sample size. Various cytogenetic abnormalities have been associated with these malignancies; for example, CSF3R mutation the G-CSF receptorELA2 gene mutation, rascogenic activity, chromosome 7 monosomy, and chromosomal changes.

To evaluate whether a G-CSF dose threshold exists above which donors may experience a significant increase in acute pain and toxicities from mobilization, the impact of different Womn dosing subgroups was analyzed for each BMI category Table 5. BMI group. Donor demographic and laboratory predictors of allogeneic peripheral blood stem cell mobilization in an ethnically diverse population. Uses : -Patients acutely exposed to myelosuppressive doses of radiation hematopoietic syndrome of acute radiation syndrome -To increase survival in patients acutely exposed to myelosuppressive doses of radiation. Study Description. Richard F.

Switzer, Dennis L. A mechanistic, predictive model of dose-response curves for cell cycle phase-specific and -nonspecific drugs. There is wide interindividual variation in mobilization response to G-CSF, oobese in healthy volunteer donors. The study design was chosen according to the internationally recognised guideline for pharmacokinetics studies and in accordance with the EMEA guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor G-CSFwhich is annexed to the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Severe congenital neutropenia: trends in diagnosis and therapy. These patients also often do not show good treatment outcomes even after hematopoietic stem-cell transplantation [ 32324 ]. Study design: Single and multiple escalating dose, double-blind, randomised, two-way cross-over, pharmacodynamic and pharmacokinetic bioequivalence study.

Uses : -Patients undergoing autologous peripheral blood progenitor cell collection and therapy -Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Talk with your doctor and family members or friends about deciding to join a study. Federal Government. Normal

The first patient received PDL in ij courses of chemotherapy. The prevalence of obesity has increased in the United States over the past few decades. BMC Cancer 21, She recovered after three days of antibiotic therapy in the hospital. Hypercholesterolemia-induced expression of adhesion molecules and the release of proinflammatory cytokines lead to leukocyte recruitment and chronic mild leukocytosis.

Toxicity was defined as fever in the absence of signs of infection, fatigue, skin rash, local reactions, nausea, vomiting, anorexia, dizziness, syncope, and insomnia. Donor response obese women 5 d of G-CSF administration. The most important of these complications is the progress of MDS to AML, although it is still unclear whether G-CSF is the cause of this progression or if the increased survival of congenital patients by G-CSF creates an opportunity for this transformation to take place because of the inherent tendency of MDS to progress towards the congenital neutropenic disease called AML [ 2122 ]. Multiple linear regression was used to model log collection yield as a function of the primary variables of interest BMI group and G-CSF dosage as well as donor characteristics. G-CSF has several effects on the granulocytic cell line; not only does it stimulate the growth and differentiation of myeloid precursors, it also enhances the activity of adult neutrophils [ 16 ]. The half-life of PDL is 12 times longer than the half-life of non-conjunctive drugs.

Usual Adult Dose for Bone Marrow Transplantation

You can also search for this author in PubMed Google Scholar. Cite this article Najafi, S. A high-fat diet increases interleukin-3 and granulocyte colony-stimulating factor production by bone marrow cells and triggers bone marrow hyperplasia and neutrophilia in Wistar rats.

A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim filgrastiim patients receiving myelosuppressive chemotherapy. Normal Eur J Cancer. The changes in the hematologic parameters during the eight courses of chemotherapy were compared between the two groups using the GEE analysis as well. Niemeyer C, Kratz C. Sachiko SeoSachiko Seo. Received : 22 September

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Information from the National Library of Medicine Obese women to participate in a study is an important personal decision. Obesity has been associated with persistent leukocytosis, elevated circulating progenitor cells, and enhanced stem cell mobilization. However, they may have a lower threshold for febrile neutropenia and require more antibiotics after chemotherapy. There were several limitations to this study. These patients will be in the hospital already and will not need to make additional trips back to have blood drawn.

  • MurthyHemant S.

  • Previous studies in unrelated donors have identified higher BMI as a risk factor in developing toxicities with apheresis.

  • A clinical development plan including the study outline was also submitted to EMEA, which examined the documentation and gave advice about the present study design.

  • Hematologic effects of recombinant human granulocyte colony-stimulating factor in patients with malignancy.

J Clin Oncol. Footnote 8 Table 1 The demographic and clinical characteristics of the patients in the two study groups Full size table. Considering the non-inferiority margin of 0. Pharmaceutical Sci Technol Today. Prediction of hematopoietic stem cell yield after mobilization with granulocyte-colony-stimulating factor in healthy unrelated donors. Race and ethnicity influences collection of granulocyte colony-stimulating factor-mobilized peripheral blood progenitor cells from unrelated donors, a Center for International Blood and Marrow Transplant Research analysis. Correspondence: Bronwen E.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Obesity is associated with a state of chronic low-grade inflammation resulting from chronic activation of the innate immune system. Descriptive statistics were used to present the frequency of the demographic and clinical characteristics in the two groups. J Clin Oncol. Raquel SchearsRaquel Schears.

Acute toxicities of unrelated bone marrow versus peripheral blood stem cell donation: results of a prospective trial from the National Marrow Donor Program. Michele W. Jack W.

Close Key Points. Rammurti T. Increased spleen size has been reported as a side effect in most patients. Increased serum levels of granulocyte colony-stimulating factor in patients with severe congenital neutropenia;

  • Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs.

  • Donors in the obese and morbidly obese groups were older median age, 35 years compared with donors with normal BMI median age, 28 years. Obesity has been associated with persistent leukocytosis, elevated circulating progenitor cells, and enhanced stem cell mobilization.

  • Various studies have been conducted on the side effects of G-CSF.

  • Google Scholar. Leukocytosis and ischemic vascular disease morbidity and mortality: is it time to intervene?

Localization of the G-CSF gene on chromosome 17 proximal to the breakpoint in the t 15;17 in acute promyelocytic leukemia. In the PDL group, the mean values of WBC, Plt, and ANC in the first half of the treatment were, andand in the second half, they were, andrespectively. Lehrnbecher T. Pharmacodynamics, pharmacokinetics and safety of BK injectable formulation 0. Nirali N.

Drug Information available for: Filgrastim. Previous wojen in unrelated donors have identified higher BMI as a risk factor in developing toxicities with apheresis. In addition, older donors were at a higher risk for grade 2 to 4 toxicities at 1 week after collection. The prevalence of obesity has increased in the United States over the past few decades. Study Type :. In the prior study, hypercholesterolemia was also associated with higher hematopoietic progenitor cell yields in patients receiving cyclophosphamide and G-CSF for mobilization before autologous transplantation. However, differences were noted in the severity of pain and toxicities at both the pericollection and early postdonation recovery periods.

Drug Saf. The variation in repeated measurements of the outcome was compared between the two groups using Generalized Estimating Equation GEE analysis. Competing interests The authors have no conflicts of interest. Actual Study Completion Date :.

  • Hillard M. Normal

  • Optimizing dose and scheduling of filgrastim granulocyte colony-stimulating factor for mobilization and collection of peripheral blood progenitor cells in normal volunteers. Uses : -Patients with SCN -Chronic administration to reduce the incidence of sequelae of neutropenia e.

  • The study is aimed at investigating the pharmacodynamic equivalence and the pharmacokinetic bioequivalence of the new BK injectable formulation of filgrastim 0.

  • Google Scholar. Multivariate analysis of factors influencing peripheral blood collection yield in unrelated donors.

Donor demographic and laboratory predictors of allogeneic peripheral blood stem cell mobilization in an ethnically diverse xose. Contacts and Locations. The views expressed in this article do not reflect the official policy or position of the National Institutes of Health, the Department of the Navy, the Department of Defense, the Health Resources and Services Administration, or any other agency of the US Government. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Normal The total filfrastim of blood processed by the apheresis procedure was targeted to be between 12 and 24 L, determined by donor body weight. Hematologic Neoplasms Neutropenia Neoplasms Agranulocytosis. Saurabh ChhabraSaurabh Chhabra. National Institutes of Health U. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan. A randomized multicenter comparison of bone marrow and peripheral blood in recipients of matched sibling allogeneic transplants for myeloid malignancies.

Medically reviewed by Drugs. Talk with your doctor and family members or friends about deciding to join a study. Correspondence: Bronwen E.

The total volume of blood processed by the apheresis procedure was targeted to be between 12 and 24 Filgrastim dose in obese women, wpmen by donor body weight. Obesity is associated with a state of chronic low-grade inflammation resulting from chronic activation of the innate immune system. PBSCs were collected by apheresis over 1 or 2 days. View Metrics. FDA Safety Alerts for all medications. Stem cell mobilization by G-CSF in solid and hematological malignancies: single daily dose is better than split dose in obese patients. Overweight

Michele Obese women. Patients in this study will womn blood draws once before they take Neupogen and 6 times after they take the Neuopen for a total of 24 hours. Email address. The purpose of this study is to determine whether obese breast cancer patients who receive pegfilgrastim are at increased risk of developing febrile neutropenia. Select one or more newsletters to continue. Hematologic Neoplasms Neutropenia Neoplasms Agranulocytosis. Wingard; Weighty choices: selecting optimal G-CSF doses for stem cell mobilization to optimize yield.

The within- and between-groups variations in blood count were analyzed at baseline and on days 7 and 15 in each course of chemotherapy Table 3. YaredJean A. Recombinant human granulocyte colony-stimulating factor: effects on normal and leukemic myeloid cells. Correspondence: Bronwen E.

  • Close Modal. Process Biochem.

  • G-CSF dosing for analysis of pain and toxicities was based on days 1 to 4, because pain and toxicities on day 5 were evaluated before day 5 G-CSF administration.

  • Hematopoietic growth factors in prophylaxis and therapy of infections complications in children with neutropenia. Most patients should take some kind of GCSF during dose-dense treatments.

  • Obesity was associated with higher levels of self-reported donation-related pain and toxicities in the pericollection and early postdonation recovery periods.

  • To evaluate whether a G-CSF dose threshold exists above which donors may experience a significant increase in acute pain and toxicities from mobilization, the impact of different G-CSF dosing subgroups was analyzed for each BMI category Table 5.

A reduction in the hematologic component and its increase after GCF injection was womdn prominent pattern of data variations in each course. Touw Filgrastim dose in obese women, Bontenbal M. Other factors considered in this analysis were donor race, donor sex, volume of blood processed, baseline neutrophils, and preapheresis WBC, platelet, and neutrophil counts. References 1. Adverse events among unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program.

Stepwise logistic regression was performed on grade 2 to 4 pain and grade 2 to 4 obes obese women various time points, in the same manner as described. The severity of skeletal pain was defined as the maximum grade of pain among these sites. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Rammurti T. Hypercholesterolemia-induced expression of adhesion molecules and the release of proinflammatory cytokines lead to leukocyte recruitment and chronic mild leukocytosis. For general information, Learn About Clinical Studies. Study Description.

Purpose: Common breast cancer chemotherapy regimens are associated with a risk of febrile neutropenia, so filgrastim dose in obese women colony-stimulating factors are incorporated for high-risk patients. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Obesity has been associated with persistent leukocytosis, elevated circulating progenitor cells, and enhanced stem cell mobilization. FDA Resources. Although a cost analysis was not performed in this study, limiting the doses of G-CSF in obese and severely obese donors will reduce direct costs of stem cell mobilization.

Paolo N. About this article. Filgrastim Obese Non-obese Pharmacokinetics. Bipin N. Toxicity was defined as fever in the absence of signs of infection, fatigue, skin rash, local reactions, nausea, vomiting, anorexia, dizziness, syncope, and insomnia. J Clin Oncol.

Google Scholar Donors in the obese and morbidly obese women groups were older median age, 35 years compared with donors with normal BMI median age, 28 years. Competing interests The authors have no conflicts of interest. Purification and characterization of human granulocyte colony-stimulating factor G-CSF. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Wingard; Weighty choices: selecting optimal G-CSF doses for stem cell mobilization to optimize yield.

  • Nirali N.

  • Christopher BredesonChristopher Bredeson. In the prior study, hypercholesterolemia was also associated with higher hematopoietic progenitor cell yields in patients receiving cyclophosphamide and G-CSF for mobilization before autologous transplantation.

  • Google Scholar 2.

  • Donor demographic and laboratory predictors of allogeneic peripheral blood stem cell mobilization in an ethnically diverse population.

Wingard; Filgrastim dose in obese women choices: selecting optimal G-CSF doses for stem cell mobilization to optimize yield. Last Update Posted : September 9, Both study treatments were administered according to a cross-over design in 2 subsequent periods separated by wash-out periods of at least 28 days. Adverse events among unrelated donors of peripheral blood stem cells: results of a prospective trial from the National Marrow Donor Program. September 4, Key Record Dates.

Confer, Bronwen E. Cite Icon Cite. Sign In. Filgrastim utilizes weight-based dosing; however, its sustained-release formulation utilizes fixed dosing. Donor demographic and laboratory predictors of allogeneic peripheral blood stem cell mobilization in an ethnically diverse population. Warning You have reached the maximum number of saved studies

There were several limitations to this study. In addition, older donors were at a higher risk for grade 2 to 4 toxicities at 1 week after collection. Outcome Measures. Keywords: Breast cancer; febrile neutropenia; obesity; pegfilgrastim.

LoganBrent R. Last Update Posted : December 17, Michele W. There ih limited data on the effect of donor body mass index BMI on obese women blood stem cell PBSC mobilization response to granulocyte colony-stimulating factor G-CSFespecially in unrelated donors. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. These symptoms included the incidence of grade 2 to 4 or grade 3 to 4 skeletal pain and the highest toxicity level across selected body symptoms at 24 hours after the first G-CSF dose and peak toxicity between days 1 to 5 of G-CSF administration and 2 days and 1 week postcollection. SeesJennifer A.

  • The statistical analyst was also not informed about the assignment of the patients to the groups.

  • Donor body mass index is an important factor that affects peripheral blood progenitor cell yield in healthy donors after mobilization with granulocyte-colony-stimulating factor. These patients will be in the hospital already and will not need to make additional trips back to have blood drawn.

  • To evaluate whether a G-CSF dose threshold exists above which donors may experience a significant increase in acute pain and toxicities from mobilization, the impact of different G-CSF dosing subgroups was analyzed for each BMI category Table 5. MA and VK contributed to data collection, and managing the project.

Table 4 A comparison of very common side effects between the two groups Full size table. View large Download slide. Batch release: Amgen Europe B. Effect of Body Mass on Filgrastim Pharmacokinetics.

Filggastim Filgrastim dose in obese women. Table 2. Funding A grant from Pooyesh Darou Company funded the original research. Process Biochem. Kinetics of mammary tumor cell growth and implications for therapy. The severity of skeletal pain was defined as the maximum grade of pain among these sites. Donor body mass index is an important factor that affects peripheral blood progenitor cell yield in healthy donors after mobilization with granulocyte-colony-stimulating factor.

Eligibility Criteria. Healthy Male Subjects. Close Key Points.

Jack W. Oxford University Press; The sites, where the injections are to be performed, are planned as follows: st injection: upper part obese women the upper arm, posterior surface nd injection: upper part of the thigh rd injection: abdomen with the exception of the umbilical area th injection: upper part of the contra-lateral upper arm, posterior surface th injection: upper part of the contra-lateral thigh th injection: abdomen with the exception of the umbilical area th injection: upper part of the same upper arm, posterior surface as for the 1st injection. Pharmacokinetics of glycosylated recombinant human granulocyte colony-stimulating factor lenograstim in healthy male volunteers. For general information, Learn About Clinical Studies.

John R. Multiple linear regression was used to model log collection yield as a function of the primary variables of interest BMI group and G-CSF dosage as well as donor characteristics. Galen E. For general information, Learn About Clinical Studies.

Melhem M. A copy of the signed informed consent form will be retained by the filgraztim institution. Abstract Purpose: Common breast cancer chemotherapy regimens are associated with a risk of febrile neutropenia, so prophylactic colony-stimulating factors are incorporated for high-risk patients. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Bipin N.

National Library of Medicine U. Donor skeletal pain and toxicities. Previous studies evaluating the impact of BMI on PBSC yield in related and unrelated donors were mostly single-center studies limited by small numbers of donors. Study Description. Upper CL. MurthyHemant S.

  • Peiman HemattiPeiman Hematti. Complication of rapidly progressive glomerulonephritis in severe congenital neutropenia treated with long-term granulocyte colony-stimulating factor filgrastim.

  • Secondary outcomes included donor symptoms associated with PBSC mobilization and collection.

  • Klinische Padiatrie. Donor response after 5 d of G-CSF administration.

  • SolhMelhem M. Federal Government.

  • In conclusion, we have demonstrated that in unrelated donors, there is a correlation between higher BMI and apheresis yields, consistent with previously published findings. Leukocytosis and ischemic vascular disease morbidity and mortality: is it time to intervene?

In addition, our results suggest that the higher PBSC collection yield observed in obese donors is not solely due to a relatively higher average daily G-CSF dose but also may be influenced by some intrinsic factor associated with obesity. Blood Adv ; 4 4 : — Outcome measurements were achieved at baseline and on days 7 and 15 in each course of chemotherapy. In another study randomly comparing multiple doses of PDL with filgrastim in breast cancer patients, a PDL dose of micrograms per kilogram of weight had good efficacy and a favorable side effect profile [ 24 ]. One week after donation, most pain and toxicities had abated, and there were no differences noted based on BMI.

PBSC collection yield relies on effective mobilization of hematopoietic precursors from the bone marrow. John R. Previous studies evaluating the impact of BMI on PBSC yield in related and unrelated donors were mostly single-center studies limited by small numbers of donors. Close Key Points. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

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