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Myelodysplastic syndromes darbepoetin

U Platzbecker, A Symeonidis, E N Oliva, J S Goede, M Delforge, J Mayer, B Slama, S Badre, E Gasal, B Mehta, J Franklin
The use of darbepoetin alfa to treat anemia in patients with lower-risk myelodysplastic syndromes (MDS) was evaluated in a phase 3 trial. Eligible patients had low/intermediate-1 risk MDS, hemoglobin ⩽10 g/dl, low transfusion burden and serum erythropoietin (EPO) ⩽500 mU/ml. Patients were randomized 2:1 to receive 24 weeks of subcutaneous darbepoetin alfa 500 μg or placebo every 3 weeks (Q3W), followed by 48 weeks of open-label darbepoetin alfa. A total of 147 patients were randomized, with median hemoglobin of 9...
June 19, 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
Tomoko Hata
Genetic analysis of myelodysplastic syndrome (MDS) using next-generation sequencing yields medcially important information, showing gene mutations in 90% of MDS cases. The World Health Organization (WHO) classification was revised in 2016 to incorporate SF3B1 gene mutations, frequently seen in MDS with ringed sideroblasts, into the diagnostic criteria. Unlike the poor prognosis seen in cases with ASXL1, EZH2, RUNX1 and in particular, TP53 MDS-related mutations, SF3B1 gene mutations show a favorable prognosis...
2017: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
Sophie Park, Pierre Fenaux, Peter Greenberg, Bhakti Mehta, Fiona Callaghan, Christopher Kim, Dianne Tomita, Hairong Xu
We conducted a systematic review and meta-analysis to estimate the efficacy of darbepoetin alpha (DA) for treatment of myelodysplastic syndrome (MDS)-related anaemia. Eligible studies were prospective, interventional, and reported World Health Organization, French-American-British, or International Prognostic Scoring System (IPSS) criteria. Outcomes included erythroid response rate (primary); haemoglobin response; change in haemoglobin, transfusion status, and quality-of-life (QoL); and safety. Ten studies (N = 647) were analysed...
September 2016: British Journal of Haematology
Jonathan Li, Stephen E Orlin, Karen E Revere, John H Kempen
A 79-year-old female with a 2-month history of newly diagnosed myelodysplastic syndrome for which she received blood transfusion with darbepoetin alfa presented with bilateral anterior uveitis 1 day after her fourth transfusion. On exam, visual acuity was 20/20 in both eyes with biomicroscopy notable for conjunctival injection and anterior chamber cell and flare consistent with anterior uveitis. She had no systemic symptoms, no history of eye trauma, and no known infections. This case, along with prior reports in the literature, suggests that anterior uveitis may be an idiosyncratic complication of darbepoetin alfa therapy...
December 2015: Journal of Ophthalmic Inflammation and Infection
Jun Ho Jang, Hironori Harada, Hirohiko Shibayama, Ryutaro Shimazaki, Hyeoung-Joon Kim, Kenichi Sawada, Kinuko Mitani
Darbepoetin alfa (DA) is a standard treatment for anemia in lower-risk MDS. However, to date there has been no comparative study to investigate the initial dosage. We, thus, conducted a randomized controlled trial to elucidate the optimal initial dosage of DA. International Prognostic Scoring System low or intermediate-1 risk MDS patients with hemoglobin levels ≤9.0 g/dL, serum erythropoietin levels ≤500 mIU/mL, and red blood cell transfusion dependency were enrolled. Patients were randomized to receive DA either at 60, 120, or 240 μg/week for 16 weeks followed by continuous administration with dose adjustment up to 48 weeks...
October 2015: International Journal of Hematology
Vu H Duong, Maria R Baer, Franklin Hendrick, Sheila R Weiss, Masayo Sato, Amer M Zeidan, Steven D Gore, Amy J Davidoff
INTRODUCTION: Erythropoiesis-stimulating agents (ESAs) reduce red blood cell (RBC) transfusions in approximately 40% of patients with myelodysplastic syndrome (MDS) in clinical trials. We studied the association of timing of ESA initiation, agent (epoetin alfa, darbepoetin) and number of weeks of ESA use with response in MDS patients in routine practice. METHODS: Patients diagnosed with MDS from 2001 to 2005 were identified in the Surveillance Epidemiology and End Results-Medicare linked database...
June 2015: Leukemia Research
Charlotte K Brierley, David P Steensma
Thrombocytopenia in patients with myelodysplastic syndromes (MDS) is a frequent cause of haemorrhage-related morbidity and mortality, and is associated with increased risk of leukaemic transformation and reduced overall survival. In addition, thrombocytopenia in MDS limits the tolerability and therapeutic efficacy of disease-modifying therapies, such as azacitidine or lenalidomide. The recombinant human erythropoietin (rHuEPO) erythropoiesis-stimulating agents, epoetin and darbepoetin, are an established component of anaemia management in lower-risk MDS...
May 2015: British Journal of Haematology
David J Seastone, Aaron T Gerds
The myelodysplastic syndromes are characterized by refractory cytopenias that lead to symptomatic anemia, bleeding, and increased risk for infections. For almost two decades, the use of darbepoetin and other erythropoietin stimulating agents to treat symptomatic anemia in lower-risk myelodysplastic syndromes has been a standard of care. This practice is supported by numerous Phase I/II studies and one Phase III study demonstrating the benefit of using erythropoietin stimulating agents alone, or in combination with granulocyte colony stimulating factor, for treatment of symptomatic anemia with the goal of decreasing red blood cell transfusion requirements...
April 2015: Expert Review of Hematology
C Kelaidi, O Beyne-Rauzy, T Braun, R Sapena, P Cougoul, L Adès, F Pillard, C Lamberto, C Lambert, J C Charniot, A Guerci, B Choufi, A Stamatoullas, B Slama, B De Renzis, S Ame, G Damaj, F Boyer, M P Chaury, L Legros, S Cheze, A Testu, E Gyan, M C Béné, C Rose, F Dreyfus, P Fenaux
Darbepoetin (DAR), with or without granulocyte colony-stimulating factor (G-CSF), has proved effective in treating anemia in patients with lower-risk myelodysplastic syndrome (MDS), but its effects on quality of life (QoL) and exercise functioning are less well established. In this phase II study (no. NCT00443339), lower-risk MDS patients with anemia and endogenous erythropoietin (EPO) level <500 IU/L received DAR 500 μg once every 2 weeks for 12 weeks, with G-CSF added at week 12 in non-responders...
May 2013: Annals of Hematology
David P Steensma
Hematopoietic growth factors (HGFs) continue to be the most widely prescribed class of medications for patients with myelodysplastic syndromes (MDS), despite the advent of disease-modifying therapies for MDS (eg, azacitidine, decitabine, and lenalidomide) and the current absence of an MDS-specific US Food and Drug Administration (FDA)-approved indication for any of the HGFs. Erythropoiesis-stimulating agents (ESAs: epoetin alfa, darbepoetin alfa), myeloid growth factors (MGFs: filgrastim, pegfilgrastim, sargramostim), and the newest group of HGFs, thrombopoiesis-stimulating agents (TSAs: romiplostim, eltrombopag), can increase peripheral blood counts in some patients, and may ameliorate some of the signs and symptoms of MDS-associated bone marrow failure...
October 2011: Seminars in Oncology
Valeria Santini
Myelodysplastic syndromes (MDS) are heterogeneous clonal diseases characterized by cytopenias resulting from ineffective hemopoiesis. Anemia affects the vast majority of patients with MDS and contributes substantially to their symptoms. For more than 20 years, recombinant human erythropoietin has been available for clinical use, and it has been employed in an attempt to relieve MDS-related anemia. Erythropoietin-alpha, erythropoietin-beta, and more recently darbepoetin have been found to increase hemoglobin levels and abolish transfusion dependence in 19%-68% of MDS cases...
2011: Oncologist
Herman Nilsson-Ehle, Gunnar Birgegård, Jan Samuelsson, Petar Antunovic, Jan Astermark, Hege Garelius, Lena M Engström, Lars Kjeldsen, Lars Nilsson, Anna Olsson, Mette Skov-Holm, Jonas Wallvik, Nina Gulbrandsen, Eva Hellström-Lindberg
OBJECTIVE: Anaemia in low-risk myelodysplastic syndromes (MDS) is associated with reduced quality of life (QoL). Response to treatment with erythropoietin ± granulocyte colony-stimulating factor (G-CSF) is associated with improved QoL, but whether transfusion therapy with higher haemoglobin (Hb) target levels has similar effects is unknown. The objective for this prospective phase II Nordic multicentre trial was to assess QoL, response rate and physical function in elderly anaemic MDS patients treated to a target Hb level of >120 g/L...
September 2011: European Journal of Haematology
A Villegas, B Arrizabalaga, C Fernández-Lago, M Castro, J R Mayans, J R González-Porras, R F Duarte, A F Remacha, E Luño, J A Gasquet
BACKGROUND: Current guidelines support the use of erythropoiesis-stimulating agents for the treatment of anemia associated with low-risk myelodysplastic syndromes (MDS). DESIGN AND METHODS: Single-arm, open-label, multi-center, phase 2 trial that evaluated the efficacy and safety of darbepoetin alfa (DA) in patients with low or intermediate-risk MDS, hemoglobin <100 g/L, erythropoietin (EPO) levels <500 IU/L and transfusion requirements <2 units/month over the preceding 2 months...
May 2011: Current Medical Research and Opinion
J Douglas Rizzo, Melissa Brouwers, Patricia Hurley, Jerome Seidenfeld, Murat O Arcasoy, Jerry L Spivak, Charles L Bennett, Julia Bohlius, Darren Evanchuk, Matthew J Goode, Ann A Jakubowski, David H Regan, Mark R Somerfield
PURPOSE: To update American Society of Clinical Oncology/American Society of Hematology recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer. METHODS: An Update Committee reviewed data published between January 2007 and January 2010. MEDLINE and the Cochrane Library were searched. RESULTS: The literature search yielded one new individual patient data analysis and four literature-based meta-analyses, two systematic reviews, and 13 publications reporting new results from randomized controlled trials not included in prior or new reviews...
November 20, 2010: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
J Douglas Rizzo, Melissa Brouwers, Patricia Hurley, Jerome Seidenfeld, Murat O Arcasoy, Jerry L Spivak, Charles L Bennett, Julia Bohlius, Darren Evanchuk, Matthew J Goode, Ann A Jakubowski, David H Regan, Mark R Somerfield
PURPOSE: To update American Society of Hematology/American Society of Clinical Oncology recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer. METHODS: An Update Committee reviewed data published between January 2007 and January 2010. MEDLINE and the Cochrane Library were searched. RESULTS: The literature search yielded one new individual patient data analysis and four literature-based meta-analyses, two systematic reviews, and 13 publications reporting new results from randomized controlled trials not included in prior or new reviews...
November 18, 2010: Blood
Esther N Oliva, Francesco Nobile, Giuliana Alimena, Giorgina Specchia, Marco Danova, Bianca Rovati, Francesca Ronco, Stefana Impera, Antonio Risitano, Caterina Alati, Massimo Breccia, Ida Carmosino, Iolanda Vincelli, Roberto Latagliata
To evaluate efficacy, safety, changes in biological features, and quality of life (QoL) in low-risk anemic patients with MDS treated with darbepoetin alfa (DPO), 41 patients received DPO 150 microg weekly for 24 weeks. The dose was increased to 300 microg weekly in non-responsive patients. During treatment, 10/17 (59%) transfusion-dependent (TD) and 13/23 (56%) transfusion-free (TF) patients responded. In TF patients, Hb increased from 9.2 +/- 0.9 g/dL to 10.3 +/- 1.4 g/dL by 24 weeks (p = 0.004). The mean response duration was 22 weeks (95% CI: 19...
June 2010: Leukemia & Lymphoma
Florence Reibel, Camille Debord, Samir Bouhadiba, Pascal Chaïbi, Chrystele Bilhou-Nabera, Magali Le Garff, Isabelle Gouin-Thibault, Virginie Siguret
We report two cases of myelodysplastic syndrome (MDS) with del(5q) isolated cytogenetic abnormality in elderly patients: AREB-1 in Patient 1, "5q syndrome" in Patient 2. A first line of treatment including hematopoietic growth factors (darbepoetin alone or associated with G-CSF) failed after several months and a treatment with lenalidomide was initiated in both cases. The treatment was poorly tolerated (myelosuppression) in Patient 1 without an improvement of the quality of life; a progression of the disease was observed with an increase of the bone marrow blastosis and a new acquired karyotypic abnormality (t13;17), leading to the prescription of 5-azacytidine...
March 2010: Annales de Biologie Clinique
C Kelaidi, P Fenaux
IMPORTANCE OF THE FIELD: Anemia is the leading clinical manifestation in myelodysplastic syndromes (MDS), significantly altering quality of life. Darbepoetin alfa has recently been added to the armentarium of erythropoiesis stimulating agents (ESAs) for the treatment of anemia in MDS. AREAS COVERED IN THIS REVIEW: We review here the efficacy and safety data on the use of darbepoetin alfa in the management of anemia in MDS patients. Published reports covering the period from 2005 till today were reviewed, as well as updated guidelines on the use of ESAs...
April 2010: Expert Opinion on Biological Therapy
Beth L Nordstrom, Weixiu Luo, Kathy Fraeman, Joanna L Whyte, Robert J Nordyke
BACKGROUND: Prior to 2007, the erythropoiesis-stimulating agents (ESAs) epoetin alfa and darbepoetin alfa were indicated for use in chemotherapyinduced anemia to achieve target hemoglobin (Hb) levels of approximately 12 grams per deciliter (gm per dL), and treatment was to be withheld if Hb exceeded 13 gm per dL. In March 2007, the FDA changed the labeling of the ESAs to add boxed warnings, updated in November 2007, to include the following key points: (a) ESAs should be used only to treat anemia that occurs in patients with cancer while they are undergoing chemotherapy; (b) treatment with ESAs should be stopped when chemotherapy ends; and (c) dosing ESAs to an Hb target of 12 gm per dL or greater has resulted in more rapid cancer progression or shortened overall survival in patients with breast, head and neck, lymphoid, cervical, and non-small cell lung malignancies...
November 2008: Journal of Managed Care Pharmacy: JMCP
Jason Gotlib, Philip Lavori, Sylvia Quesada, Richard S Stein, Shahin Shahnia, Peter L Greenberg
This Phase II study evaluated darbepoetin alfa (DA) in 24 patients with predominantly low or intermediate-1 risk myelodysplastic syndrome (MDS). Intra-patient dose escalation of DA was undertaken in three 6-week dose cohorts until a major erythroid response was achieved: 4.5 mcg/kg/week, 9 mcg/kg/week, and 9 mcg/kg/week plus granulocyte-colony stimulating factor (G-CSF) 2.5 mcg/kg twice weekly. Patients with refractory anemia with ringed sideroblasts (RARS) commenced DA at 9 mcg/kg/week. The weight-based dosing regimen translated into a median starting DA dose of 390 mcg/week...
January 2009: American Journal of Hematology
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