Darbepoetin alpha for the treatment of anaemia in low‐intermediate risk myelodysplastic syndromes

Musto, Pellegrino; Lanza, Francesco; Balleari, Enrico; Grossi, Alberto; Falcone, Antonietta; Sanpaolo, Grazia; Bodenizza, Carlo; Scalzulli, Potito Rosario; Sala, Antonio La; Campioni, Diana; Ghio, Riccardo; Cascavilla, Nicola; Carella, Angelo Michele

doi:10.1111/j.1365-2141.2004.05288.x

Cited by 86 publications

(76 citation statements)

References 25 publications

(32 reference statements)

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“…There were too few studies for meaningful stratified analyses in any category except for study duration. The study with the longest duration (Ͼ20 weeks) of darbepoetin use [25] had a higher Hb response rate (55.8%) than the study [24] with the shortest duration (12 weeks) of darbepoetin use (40.0%). None of the darbepoetin studies reported use of concomitant iron.…”

Section: Efficacy Of Esps In Mdsmentioning

confidence: 87%

“…The most frequently reported significant predictor was baseline serum erythropoietin level, with low levels predicting response to exogenous ESPs ( [24,25,31,32]. Low pretrial transfusion needs were also predictive of ESP response, in three studies [24,31,32].…”

Section: Efficacy Of Esps In Mdsmentioning

confidence: 98%

“…For the three darbepoetin single-arm studies [23][24][25], efficacy results are displayed in Table 2. The average Hb response rate was 48.1% (95% CI, 25.2%-70.9%).…”

Section: Efficacy Of Esps In Mdsmentioning

confidence: 99%

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Efficacy and Safety of Erythropoiesis-Stimulating Proteins in Myelodysplastic Syndrome: A Systematic Review and Meta-Analysis

Ross¹,

Allen

Probst³

et al. 2007

The Oncologist

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Disclosure: S.D.R., C.A.P., S.M.C., B.S., and G.R. are employees of United BioSource Corporation (UBC) performing contract work for Amgen. I.E.A. received financial compensation from UBC for statistical consulting and reviewing the manuscript. No potential conflicts of interest were reported by the planners, reviewers, or staff managers of this article. LEARNING OBJECTIVESAfter completing this course, the reader will be able to:1. Provide the current best estimates of hemoglobin response with erythropoiesis-stimulating proteins in anemia of MDS.2. Specify prognostic factors for response that are potentially useful.3. Describe the gaps in the existing evidence base regarding these agents in MDS.Access and take the CME test online and receive 1 AMA PRA Category 1 Credit ™ at CME.TheOncologist.com CME CME ABSTRACT Objective. The objective was to assess the efficacy and safety of erythropoiesis-stimulating proteins (ESPs) in anemia of myelodysplastic syndrome (MDS).Method. A systematic review and meta-analysis was conducted covering English-language studies published from 1980 to December 2005.Results. Fifty-nine studies qualified: five controlled trials (n ‫؍‬ 354), all epoetin versus control (EvC); 51 epoetin single-arm studies (n ‫؍‬ 1,650); and three darbepoetin single-arm studies (n ‫؍‬ 102). In the EvC studies, epoetin patients demonstrated a significant advantage over controls in terms of hemoglobin (Hb) response (odds ratio, 5.2; 95% confidence interval, 2.5-10.8). Hb response was 48.1% in single-arm darbepoetin studies, 32.1% in epoetin single-arm studies, and 27.3% in EvC studies. Major Hb response averaged 38.8% in darbepoetin studies, 24.5% in epoetin single-arm studies, and 11.4% in EvC studies. Stratified analyses suggest that lower baseline erythropoietin levels, longer treatment durations, and concurrent iron may be associated with greater Hb response to ESPs. None of the analyzable predictors of Hb response (gender, baseline Hb, ESP type, and ESP duration) were significant in meta-regression analyses. In the few studies with quality-of-life measures, ESP groups attained a pre-post change (Functional Assessment of Cancer Therapy -Fatigue) that exceeded minimum clinically important differences. Selected adverse event rates did not differ between the epoetin and darbepoetin groups.Conclusion. Published studies suggest that ESPs are efficacious in anemia of MDS. Hb response appears higher in darbepoetin patients than in epoetin patients, and safety appears comparable, but darbepoetin data are sparse, and there are as yet no direct comparison studies.

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Section: Efficacy Of Esps In Mdsmentioning

confidence: 87%

Section: Efficacy Of Esps In Mdsmentioning

confidence: 98%

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Efficacy and Safety of Erythropoiesis-Stimulating Proteins in Myelodysplastic Syndrome: A Systematic Review and Meta-Analysis

Ross¹,

Allen

Probst³

et al. 2007

The Oncologist

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“…Although increased erythroid responses have been noted with the addition of GCSF to EPO as well as with increased EPO doses (Greenberg et al, 2009b), a meta-analysis of data using these regimens demonstrated higher responses with the drug combination mainly in patients with relatively lower dose EPO monotherapy (Mundle et al, 2009). Darbepoetin (a longer acting version of EPO) has demonstrated similar and perhaps improved efficacy at doses of 150-300 lg sc every 1-2 weeks (Musto et al, 2005;Stasi et al, 2005;Mannone et al, 2006;Gotlib et al, 2008).…”

Section: Management Of Lower Risk Diseasementioning

confidence: 99%

Current therapeutic approaches for patients with myelodysplastic syndromes

Greenberg

2010

Br J Haematol

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SummaryThe myelodysplastic syndromes (MDS) are a heterogeneous spectrum of disorders requiring selective therapy based on patients' specific clinical features, predominantly their prognostic subgroups, age and performance status. Guidelines for management of patients with MDS have been generated by a number of national panels. This review focuses on evidencebased data supporting therapeutic approaches, which have also been recommended by the US National Comprehensive Cancer Network MDS Panel, with discussion of accessibility of recommended drugs in the US and in other countries. For lower risk disease (International Prognostic Scoring System Low and Intermediate-1) therapy is aimed at haematological improvement whereas for higher risk disease (Intermediate-2 and High) treatment focuses on altering disease natural history. Recent information regarding additional clinical and biological features has provided useful parameters for assessing disease prognosis that aid risk-based management decisions. The rationale for use of low versus high intensity therapies with these agents, including allogeneic haematopoietic stem cell transplantation, is discussed in detail.

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“…17,18 The phase II study reported a response rate of 60%, with few additional responses when G-CSF was added. Further studies are needed to explore the long-term activity of darbepoetin as well as the optimal dosing schedules.…”

Section: Hemopoietic Growth Factorsmentioning

confidence: 99%

Update on Supportive Care and New Therapies: Immunomodulatory Drugs, Growth Factors and Epigenetic-Acting Agents

Hellström‐Lindberg¹

2005

Hematology

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Patients with "low-risk" myelodysplastic syndrome (MDS) are mostly treated with approaches aiming to reduce the negative consequences of ineffective hematopoiesis. Transfusion therapy should be tailored to allow adequate oxygenation and optimal quality of life, and may lead to the need for iron chelation therapy. Growth factors (erythropoietin and granulocyte colony-stimulating factor [G-CSF]) may induce long-lasting improvement of hemoglobin levels and does not increase the risk for leukemic transformation. Growth factors should be offered to defined subgroups of patients. Immunosuppression with antithymoglobulin or cyclosporine A may be an alternative for younger patients with refractory anemia (RA). The new immunomodulating compound lenalidomide, CC5013, is very active in the 5q-syndrome and is under evaluation for other low-risk MDS subtypes. "High-risk" MDS is associated with poor survival and high risk for leukemic transformation. The DNA hypomethylating compounds azacytidine and decitabine may offer improved long-term outcomes in this group of patients, although there has so far been no effect on survival rates. The efficacy of farnesyl transferase inhibitors has been evaluated in a series of phase II trials. The overall response rate was low, but the majority of responses were CRs. Finally, a number of new drugs directed to various biological and genetic targets are entering clinical trials.

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Darbepoetin alpha for the treatment of anaemia in low‐intermediate risk myelodysplastic syndromes

Cited by 86 publications

References 25 publications

Efficacy and Safety of Erythropoiesis-Stimulating Proteins in Myelodysplastic Syndrome: A Systematic Review and Meta-Analysis

Efficacy and Safety of Erythropoiesis-Stimulating Proteins in Myelodysplastic Syndrome: A Systematic Review and Meta-Analysis

Current therapeutic approaches for patients with myelodysplastic syndromes

Update on Supportive Care and New Therapies: Immunomodulatory Drugs, Growth Factors and Epigenetic-Acting Agents

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