The Experts below are selected from a list of 1704 Experts worldwide ranked by ideXlab platform

Rafael G Amado - One of the best experts on this subject based on the ideXlab platform.

Johan Vansteenkiste - One of the best experts on this subject based on the ideXlab platform.

  • Darbepoetin alfa: impact on treatment for Chemotherapy-Induced Anemia and considerations in special populations.
    Oncology (Williston Park N.Y.), 2020
    Co-Authors: Johan Vansteenkiste, Gregory Rossi, Erik Poulsen, John Glaspy
    Abstract:

    Our objective was to evaluate the effects of darbepoetin alfa (Aranesp) on hemoglobin and transfusions in anemic patients with cancer undergoing Chemotherapy, and the impact of age, sex, baseline hemoglobin, Chemotherapy type, and tumor type. Patients were randomized to one of three darbepoetin alfa groups based on average weekly dose (< 1.5 microg/kg, 1.5 to 2.25 microg/kg, and > 2.25 microg/kg) or to placebo. Dose response was evaluated for change in hemoglobin, hemoglobin and hematopoietic responses, and red blood cell transfusion rates. Hazard ratios for the incidence of hemoglobin response and transfusions were calculated. Adverse events and antibody formation were assessed. Treatment effects were observedfor all hemoglobin end points and incidence of transfusion. The incidence of hematopoietic response among the darbepoetin alfa dose groups ranged from 46% (95% confidence interval [CI] = 33%-60%) to 74% (95% CI = 66%-81%) and increased with higher darbepoetin alfa dose. Patients receiving darbepoetin alfa were more likely to exhibit a hemoglobin response and less likely to require a transfusion, compared with placebo, irrespective of the patient characteristics examined. No increased risk of adverse events and no development of neutralizing antibodies were observed with darbepoetin alfa use. Darbepoetin alfa increased the likelihood of a hemoglobin response and decreased the need for transfusions in cancer patients with Chemotherapy-Induced Anemia.

  • Chemotherapy Induced Anemia the story of darbepoetin alfa
    Current Medical Research and Opinion, 2013
    Co-Authors: Johan Vansteenkiste, John A. Glaspy, Isabelle Wauters, Steven G Elliott, Michael Hedenus
    Abstract:

    AbstractBackground:Prior to the approval of the first erythropoiesis-stimulating agent (ESA) in the early 1990s, red blood cell transfusions were the primary means of treating severe Chemotherapy-Induced Anemia (CIA), with little recourse for those with more mild forms of the condition. The introduction of the ESAs allowed treatment of mild-to-moderate CIA in patients with cancer. It has been a decade since darbepoetin alfa (DA), a second-generation ESA with a longer half-life, became available to patients with CIA.Objective and methods:We present a review of studies on DA in CIA, from its development through to the present day. Medline was searched for randomized clinical trials on DA. Additional trials and meta-analyses on ESAs were incorporated into this review when relevant.Results:The first publications on DA generally focused on optimal dosing, efficacy and tolerability. In these, it was shown that DA is an effective and well tolerated treatment option to achieve hematopoietic response, regardless o...

  • flexible dosing with darbepoetin alfa for the treatment of Chemotherapy Induced Anemia
    Therapeutics and Clinical Risk Management, 2006
    Co-Authors: Isabelle Wauters, Johan Vansteenkiste
    Abstract:

    Anemia is frequent in cancer patients with Chemotherapy, and has an important negative effect on health-related quality of life (QoL). Darbepoetin alfa belongs to a new class of erythropoietic proteins with a unique molecular structure and interesting properties compared with classic recombinant human erythropoietin. Darbepoetin alfa is effective for Chemotherapy-Induced Anemia when administered once weekly at a dose of 2.25 μg/kg, as shown in two large phase III placebo-controlled trials in patients with solid tumors and hematological malignancies. Furthermore, it was safe and well tolerated. More recently attention has been focused on optimizing Darbepoetin alfa therapy. Front-loaded dosing was explored to accelerate the hemoglobin (Hb) response and effect on QoL, but this idea could not be confirmed in a large phase III study. Based on the prolonged half-life of Darbepoetin alfa, administration every 3 weeks was appealing. In a large phase III trial, noninferiority of administration of 500 μg every 3 weeks compared with the weekly dosing could be confirmed, both in terms of reduction of red blood cell transfusion, Hb parameters, and QoL. This schedule is very convenient for patients and caregivers as it allows synchronization of erythropoietic therapy and common Chemotherapy schedules. Questions for future study are the optimal iron supplementation strategy and the effect of Darbepoetin alfa on outcome. This article reviews the clinical development of Darbepoetin alfa with emphasis on recent data.

  • Randomized, Double-Blind, Active-Controlled Trial of Every-3-Week Darbepoetin Alfa for the Treatment of Chemotherapy-Induced Anemia
    Journal of the National Cancer Institute, 2006
    Co-Authors: Jean-luc Canon, Johan Vansteenkiste, G. Rossi, Gyorgy Bodoky, M. Victoria Mateos, Laurent Bastit, Irene Ferreira, Rafael G Amado
    Abstract:

    Background: In the United States, darbepoetin alfa (Aranesp) is often used to treat patients with Chemotherapy-Induced Anemia using weekly or every-2-week administration schedules. In Europe, darbepoetin alfa is used either weekly or in every-3-week dosing. The every-3-week schedule can be synchronized with many Chemotherapy regimens, resulting in fewer visits and reducing burden to patients, but the safety and effi cacy of this regimen have not been clear. Methods: A randomized, double-blind, double-dummy, active-controlled phase 3 trial was performed in 110 European centers. Eligible patients (age ≥ 18 years) were anemic (hemoglobin level

  • randomized double blind active controlled trial of every 3 week darbepoetin alfa for the treatment of Chemotherapy Induced Anemia
    Journal of the National Cancer Institute, 2006
    Co-Authors: Jean-luc Canon, Johan Vansteenkiste, G. Rossi, Gyorgy Bodoky, Laurent Bastit, Irene Ferreira, Victoria M Mateos, Rafael G Amado
    Abstract:

    Background: In the United States, darbepoetin alfa (Aranesp) is often used to treat patients with Chemotherapy-Induced Anemia using weekly or every-2-week administration schedules. In Europe, darbepoetin alfa is used either weekly or in every-3-week dosing. The every-3-week schedule can be synchronized with many Chemotherapy regimens, resulting in fewer visits and reducing burden to patients, but the safety and effi cacy of this regimen have not been clear. Methods: A randomized, double-blind, double-dummy, active-controlled phase 3 trial was performed in 110 European centers. Eligible patients (age ≥ 18 years) were anemic (hemoglobin level <11 g/dL), had a nonmyeloid malignancy, and were to receive at least 12 weeks of Chemotherapy. Patients were randomly assigned 1:1 to darbepoetin alfa treatment every 3 weeks (500- μ g dose) or weekly (2.25- μ g/kg) for 15 weeks. We compared red blood cell transfusion incidence among the two arms from week 5 to the end of the treatment phase using a noninferiority study design. Noninferiority was determined if the upper limit of the 95% confi dence interval (CI) for the difference in blood transfusions between groups, calculated using Kaplan – Meier methods, did not exceed 12.5%, a margin based on previous placebo-controlled studies. Results: A total of 705 patients were randomly assigned, and 672 remained in the study at week 5. Fewer patients in the every3-week arm than in the weekly arm received blood transfusions from week 5 to the end of the treatment phase (unadjusted Kaplan – Meier estimates = 23% versus 30%, difference = − 6.8%; 95% CI = − 13.6 to 0.1). Percentages of patients achieving the target hemoglobin level ( ≥ 11 g/dL, consistent with evidence-based practice guidelines) were 84% (every 3 weeks) and 77% (weekly). The frequency of cardiovascular/thromboembolic adverse events was 8% in both groups, and safety was comparable. Conclusions: Patients with Chemotherapy-Induced Anemia can safely and effectively be treated with 500 μ g of darbepoetin alfa every 3 weeks. [J Natl Cancer Inst 2006;98:273 – 84]

Michael Hedenus - One of the best experts on this subject based on the ideXlab platform.

  • Chemotherapy Induced Anemia the story of darbepoetin alfa
    Current Medical Research and Opinion, 2013
    Co-Authors: Johan Vansteenkiste, John A. Glaspy, Isabelle Wauters, Steven G Elliott, Michael Hedenus
    Abstract:

    AbstractBackground:Prior to the approval of the first erythropoiesis-stimulating agent (ESA) in the early 1990s, red blood cell transfusions were the primary means of treating severe Chemotherapy-Induced Anemia (CIA), with little recourse for those with more mild forms of the condition. The introduction of the ESAs allowed treatment of mild-to-moderate CIA in patients with cancer. It has been a decade since darbepoetin alfa (DA), a second-generation ESA with a longer half-life, became available to patients with CIA.Objective and methods:We present a review of studies on DA in CIA, from its development through to the present day. Medline was searched for randomized clinical trials on DA. Additional trials and meta-analyses on ESAs were incorporated into this review when relevant.Results:The first publications on DA generally focused on optimal dosing, efficacy and tolerability. In these, it was shown that DA is an effective and well tolerated treatment option to achieve hematopoietic response, regardless o...

  • A randomized, controlled trial comparing darbepoetin alfa correction/maintenance dosing with weekly dosing for treating Chemotherapy-Induced Anemia.
    Current Medical Research and Opinion, 2007
    Co-Authors: Dusan Kotasek, Michael Hedenus, Jean-luc Canon, G. Rossi, M. Victoria Mateos, Kerry Taylor
    Abstract:

    ABSTRACTObjective: To evaluate if a darbepoetin alfa correction/maintenance dosing regimen is non-inferior to a weekly regimen with respect to red blood cell trans­fusion requirements in patients with Chemotherapy-Induced Anemia (CIA).Research design and methods: In this randomized, active-controlled, double-blind phase 3 trial, CIA patients were randomized 1 : 1 to receive darbepoetin alfa in either a correction/maintenance schedule (4.5 μg/kg weekly for 4 weeks followed by 4.5 μg/kg every 3 weeks (Q3W)) or a weekly schedule (2.25 μg/kg weekly). The primary endpoint was the transfusion incidence during weeks 1–16. Non-inferiority was to be concluded if the upper limit of the 95% confidence interval (CI) of the difference in transfusion incidence between treatment groups was below 12.5%. Hematologic responses and safety profiles were also compared.Results: Transfusion incidence (95% CI) during weeks 1–16 was 37% (32–42) and 38% (32–43) in the weekly and correction/maintenance groups, respectively. The dif...

  • darbepoetin alfa for the treatment of Chemotherapy Induced Anemia disease progression and survival analysis from four randomized double blind placebo controlled trials
    Journal of Clinical Oncology, 2005
    Co-Authors: Michael Hedenus, Johan Vansteenkiste, Dusan Kotasek, Matthew Austin, Rafael G Amado
    Abstract:

    Darbepoetin alfa for the treatment of Chemotherapy-Induced Anemia: disease progression and survival analysis from four randomized, double-blind, placebo-controlled trials

Kerry Taylor - One of the best experts on this subject based on the ideXlab platform.

  • randomized double blind placebo controlled trial of every 3 week darbepoetin alfa 300 micrograms for treatment of Chemotherapy Induced Anemia
    Current Medical Research and Opinion, 2009
    Co-Authors: Enrique Hernandez, Dianne Tomita, Peter Ganly, Veena Charu, Joseph Dibenedetto, Tom Lillie, Kerry Taylor
    Abstract:

    ABSTRACTObjective: Darbepoetin alfa is effective in treating Chemotherapy-Induced Anemia (CIA). Administration of subcutaneous darbepoetin alfa every 3 weeks (Q3W) could simplify treatment through synchronization with common Q3W Chemotherapy regimens. We report results from a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of fixed-dose Q3W darbepoetin alfa in patients with a wide variety of tumor types who experienced CIA.Research design and methods: Patients aged ≥ 18 years with Anemia (hemoglobin <11 g/dL) being treated for nonmyeloid malignancy were randomized 1:1 to receive darbepoetin alfa 300 μg (n = 193) or placebo (n = 193) subcutaneously Q3W from weeks 1 to 13 in this 16-week study. Doses could be adjusted per prespecified rules.Main outcome measures: The primary endpoint was the proportion of patients who received ≥1 red blood cell (RBC) transfusion between week 5 and the end of the treatment period (EOTP). The study also analyzed the ...

  • A randomized, controlled trial comparing darbepoetin alfa correction/maintenance dosing with weekly dosing for treating Chemotherapy-Induced Anemia.
    Current Medical Research and Opinion, 2007
    Co-Authors: Dusan Kotasek, Michael Hedenus, Jean-luc Canon, G. Rossi, M. Victoria Mateos, Kerry Taylor
    Abstract:

    ABSTRACTObjective: To evaluate if a darbepoetin alfa correction/maintenance dosing regimen is non-inferior to a weekly regimen with respect to red blood cell trans­fusion requirements in patients with Chemotherapy-Induced Anemia (CIA).Research design and methods: In this randomized, active-controlled, double-blind phase 3 trial, CIA patients were randomized 1 : 1 to receive darbepoetin alfa in either a correction/maintenance schedule (4.5 μg/kg weekly for 4 weeks followed by 4.5 μg/kg every 3 weeks (Q3W)) or a weekly schedule (2.25 μg/kg weekly). The primary endpoint was the transfusion incidence during weeks 1–16. Non-inferiority was to be concluded if the upper limit of the 95% confidence interval (CI) of the difference in transfusion incidence between treatment groups was below 12.5%. Hematologic responses and safety profiles were also compared.Results: Transfusion incidence (95% CI) during weeks 1–16 was 37% (32–42) and 38% (32–43) in the weekly and correction/maintenance groups, respectively. The dif...

Jean-luc Canon - One of the best experts on this subject based on the ideXlab platform.

  • Practice guidelines on the use of erythropoiesis-stimulating agents in the treatment of Chemotherapy-Induced Anemia
    2010
    Co-Authors: Luc Dirix, Yves Beguin, Ahmad Awada, D. Bron, Jean-luc Canon, Jacques De Grève, Yves Humblet, Marc Peeters, Simon Van Belle, Jan Vansteenkiste
    Abstract:

    On July 1st 2009, a panel of experts met with the goal to provide a joint medical opinion on the use of erythropoiesis-stimulating agents (ESAs) in Chemotherapy-Induced Anemia (CIA), as well as a joint proposal for revised reimbursement criteria in Belgium. The goal is to provide a clear and workable guidance on the use of ESAs in their registered indication:Chemotherapy Induced Anemia in cancer patients. An overview of participating experts can be found in Table 1

  • A randomized, controlled trial comparing darbepoetin alfa correction/maintenance dosing with weekly dosing for treating Chemotherapy-Induced Anemia.
    Current Medical Research and Opinion, 2007
    Co-Authors: Dusan Kotasek, Michael Hedenus, Jean-luc Canon, G. Rossi, M. Victoria Mateos, Kerry Taylor
    Abstract:

    ABSTRACTObjective: To evaluate if a darbepoetin alfa correction/maintenance dosing regimen is non-inferior to a weekly regimen with respect to red blood cell trans­fusion requirements in patients with Chemotherapy-Induced Anemia (CIA).Research design and methods: In this randomized, active-controlled, double-blind phase 3 trial, CIA patients were randomized 1 : 1 to receive darbepoetin alfa in either a correction/maintenance schedule (4.5 μg/kg weekly for 4 weeks followed by 4.5 μg/kg every 3 weeks (Q3W)) or a weekly schedule (2.25 μg/kg weekly). The primary endpoint was the transfusion incidence during weeks 1–16. Non-inferiority was to be concluded if the upper limit of the 95% confidence interval (CI) of the difference in transfusion incidence between treatment groups was below 12.5%. Hematologic responses and safety profiles were also compared.Results: Transfusion incidence (95% CI) during weeks 1–16 was 37% (32–42) and 38% (32–43) in the weekly and correction/maintenance groups, respectively. The dif...

  • Randomized, Double-Blind, Active-Controlled Trial of Every-3-Week Darbepoetin Alfa for the Treatment of Chemotherapy-Induced Anemia
    Journal of the National Cancer Institute, 2006
    Co-Authors: Jean-luc Canon, Johan Vansteenkiste, G. Rossi, Gyorgy Bodoky, M. Victoria Mateos, Laurent Bastit, Irene Ferreira, Rafael G Amado
    Abstract:

    Background: In the United States, darbepoetin alfa (Aranesp) is often used to treat patients with Chemotherapy-Induced Anemia using weekly or every-2-week administration schedules. In Europe, darbepoetin alfa is used either weekly or in every-3-week dosing. The every-3-week schedule can be synchronized with many Chemotherapy regimens, resulting in fewer visits and reducing burden to patients, but the safety and effi cacy of this regimen have not been clear. Methods: A randomized, double-blind, double-dummy, active-controlled phase 3 trial was performed in 110 European centers. Eligible patients (age ≥ 18 years) were anemic (hemoglobin level

  • randomized double blind active controlled trial of every 3 week darbepoetin alfa for the treatment of Chemotherapy Induced Anemia
    Journal of the National Cancer Institute, 2006
    Co-Authors: Jean-luc Canon, Johan Vansteenkiste, G. Rossi, Gyorgy Bodoky, Laurent Bastit, Irene Ferreira, Victoria M Mateos, Rafael G Amado
    Abstract:

    Background: In the United States, darbepoetin alfa (Aranesp) is often used to treat patients with Chemotherapy-Induced Anemia using weekly or every-2-week administration schedules. In Europe, darbepoetin alfa is used either weekly or in every-3-week dosing. The every-3-week schedule can be synchronized with many Chemotherapy regimens, resulting in fewer visits and reducing burden to patients, but the safety and effi cacy of this regimen have not been clear. Methods: A randomized, double-blind, double-dummy, active-controlled phase 3 trial was performed in 110 European centers. Eligible patients (age ≥ 18 years) were anemic (hemoglobin level <11 g/dL), had a nonmyeloid malignancy, and were to receive at least 12 weeks of Chemotherapy. Patients were randomly assigned 1:1 to darbepoetin alfa treatment every 3 weeks (500- μ g dose) or weekly (2.25- μ g/kg) for 15 weeks. We compared red blood cell transfusion incidence among the two arms from week 5 to the end of the treatment phase using a noninferiority study design. Noninferiority was determined if the upper limit of the 95% confi dence interval (CI) for the difference in blood transfusions between groups, calculated using Kaplan – Meier methods, did not exceed 12.5%, a margin based on previous placebo-controlled studies. Results: A total of 705 patients were randomly assigned, and 672 remained in the study at week 5. Fewer patients in the every3-week arm than in the weekly arm received blood transfusions from week 5 to the end of the treatment phase (unadjusted Kaplan – Meier estimates = 23% versus 30%, difference = − 6.8%; 95% CI = − 13.6 to 0.1). Percentages of patients achieving the target hemoglobin level ( ≥ 11 g/dL, consistent with evidence-based practice guidelines) were 84% (every 3 weeks) and 77% (weekly). The frequency of cardiovascular/thromboembolic adverse events was 8% in both groups, and safety was comparable. Conclusions: Patients with Chemotherapy-Induced Anemia can safely and effectively be treated with 500 μ g of darbepoetin alfa every 3 weeks. [J Natl Cancer Inst 2006;98:273 – 84]