Document Detail


High response rate and improved exercise capacity and quality of life with a new regimen of darbepoetin alfa with or without filgrastim in lower-risk myelodysplastic syndromes: a phase II study by the GFM.
MedLine Citation:
PMID:  23358617     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. Physical performance was assessed with the 6-min walking test and, for fit patients, maximal oxygen consumption (VO2max). QoL was evaluated using SF-36 and FACT-An tests. In 99 patients, erythroid response rate according to IWG 2006 criteria was 48 and 56 % at 12 and 24 weeks, respectively. Addition of G-CSF rescued 22 % of non-responders. In 48 % of the responders, interval between darbepoetin injections could be increased for maintenance treatment. Serum EPO level was the only independent predictive factor of response at 12 weeks, and its most discriminant cutoff value was 100 IU/L. QoL and VO2max showed improvement over time in responders, compared with non-responders. With a median follow-up of 52 months, median response duration was not reached, and 3-year cumulative incidence of acute myeloid leukemia and overall survival (OS) was 14.5 and 70 %, respectively. Baseline transfusion dependence, International Prognostic Score System (IPSS), and Revised IPSS accurately predicted OS from treatment onset. Tolerance of darbepoetin was good. In conclusion, this regimen of darbepoetin every 2 weeks yielded high response rates and prolonged response duration. Objective improvement in exercise testing and in patient-reported QoL confirms the clinical relevance of anemia correction with erythropoiesis-stimulating agents.
Authors:
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
Related Documents :
12757547 - Traceability of inbred and crossbred cinta senese pigs by evaluating the oxidative stress.
22353227 - Faster pulmonary oxygen uptake kinetics in children vs adults due to enhancements in ox...
8088087 - The bioenergetic and gas exchange basis of exercise testing.
17913377 - Factors associated with resilience in healthy adults.
17325117 - Physical activity preferences and perceived barriers to activity among persons with sev...
8149387 - Relationship between exercise tolerance, hemodynamics at rest and during exercise and e...
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study     Date:  2013-01-29
Journal Detail:
Title:  Annals of hematology     Volume:  92     ISSN:  1432-0584     ISO Abbreviation:  Ann. Hematol.     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-04-08     Completed Date:  2013-05-28     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  9107334     Medline TA:  Ann Hematol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  621-31     Citation Subset:  IM    
Affiliation:
GFM Service d'Hématogie Clinique, Hôpital Avicenne, Assistance Publique des Hôpitaux de Paris, Université Paris 13, 125 rue de Stalingrad, Bobigny, France.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00443339
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Aged
Anemia / complications,  drug therapy,  mortality,  physiopathology
Erythropoietin / administration & dosage,  adverse effects,  analogs & derivatives*
Exercise / physiology
Exercise Tolerance / drug effects*
Female
Granulocyte Colony-Stimulating Factor / administration & dosage*,  adverse effects
Hematinics / administration & dosage,  adverse effects
Humans
Male
Myelodysplastic Syndromes / complications,  drug therapy*,  mortality,  physiopathology
Quality of Life*
Recombinant Proteins / administration & dosage,  adverse effects
Risk
Survival Analysis
Treatment Outcome
Chemical
Reg. No./Substance:
0/Hematinics; 0/Recombinant Proteins; 11096-26-7/Erythropoietin; 121181-53-1/Filgrastim; 143011-72-7/Granulocyte Colony-Stimulating Factor; 15UQ94PT4P/darbepoetin alfa
Comments/Corrections
Erratum In:
Ann Hematol. 2013 May;92(5):633
Note: Lambert, Christine [corrected to Lamberto, C]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Autologous stem cell transplantation with busulfan, cyclophosphamide, and etoposide as an intensifyi...
Next Document:  Burnout Syndrome: population-based study on public servants.