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Annals of Oncology Advance Access published online on September 15, 2005
Annals of Oncology, doi:10.1093/annonc/mdi400
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© 2005 European Society for Medical Oncology
Received April 19, 2005
Revised June 26, 2005
Accepted July 21, 2005

Original article

Darbepoetin alfa for the treatment of anemic patients with low- and intermediate-1-risk myelodysplastic syndromes

R. Stasi 1*, E. Abruzzese 2, G. Lanzetta 3, E. Terzoli 4, and S. Amadori 2

1 Department of Medical Sciences, Regina Apostolorum Hospital, Albano Laziale, Italy
2 Department of Hematology, University of Rome ‘Tor Vergata’, S. Eugenio Hospital, Rome, Italy
3 Department of Oncology, INI, Grottaferrata, Italy
4 Department of Complementary Oncology, IFO - Regina Elena Institute, Rome, Italy

* To whom correspondence should be addressed.
R. Stasi, E-mail: roberto.stasi{at}uniroma2.it


  Abstract

Background: The hematological and quality of life (QoL) changes associated with darbepoetin alfa (DA) therapy were assessed in anemic patients with previously untreated low- and intermediate-1-risk myelodysplastic syndrome (MDS).

Patients and methods: Fifty-three patients received DA administered subcutaneously once a week for 24 weeks. Treatment was initiated at 150 µg fixed dose and was doubled if after the first 12 weeks there was no or suboptimal erythroid response.

Results: The final response rate was 24/53 (45%), with 21 major and three minor responses. Most of the responses (21/24; 87.5%) were obtained at the dose of 150 µg. With a median follow-up of 9.4 months, 17 patients maintain their response. Treatment was well tolerated with no relevant side-effects. MDS progression was observed in one case. Increases in hemoglobin levels were positively correlated with improved QoL scores using both the linear analog scale assessment (energy level, r = 0.429, P = 0.036; daily activities, r = 0.653, P < 0.001; overall well-being, r = 0.457, P = 0.024) and the Functional Assessment of Cancer Therapy-Anemia questionnaire (r = 0.247, P = 0.025). In multivariate analysis, only low levels (<200 IU/l) of endogenous erythropoietin predicted response to DA therapy.

Conclusions: DA is an active, safe and well tolerated treatment for anemia in a substantial proportion of patients with low- and intermediate-1-risk MDS, and has a positive impact on the patients' QoL.

Keywords: anemia; darbepoetin alfa; erythropoietin; myelodysplastic syndrome; predictive factors.
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