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Anaemic Patients With MDS Benefit From Erythropoietin, Myeloid Growth Factor Hormones

WASHINGTON, DC -- September 17, 2009 -- Patients with myelodysplastic syndromes (MDS) and anaemia may benefit from treatment with an erythropoietin (EPO)-based regimen plus supportive care without added complications as compared with those receiving supportive care alone, according to a study published in the September 17 issue of Blood.

The phase 3 prospective, randomised trial, conducted by research teams of the Eastern Cooperative Oncology Group, was designed to evaluate the efficacy and safety of EPO with or without granulocyte colony-stimulating factor (G-CSF) and supportive care (SC) with red blood cell transfusions for patients with early-stage MDS (n = 53), in comparison with supportive care alone (n = 57).

For the study, the researchers followed MDS treatment and dosing guidelines recommended by the National Comprehensive Cancer Network, which include managing anemia with erythropoiesis-stimulating agents (ESAs) such as EPO.

"EPO is a recommended treatment for MDS, but the combination with G-CSF and supportive care required comparative studies in this patient population," said lead author Peter Greenberg, MD, Stanford University Cancer Center, Palo Alto, California. "Our goal was to manage anaemia while not increasing the risk of transformation to leukaemia, and we undertook this study to understand if this combination might be successfully utilised in these patients."

After the first course of therapy, 36% of patients in the EPO arm responded to treatment, compared with only 9.6% in the SC alone arm. After subsequent courses, 47% responded in the EPO arm.

Researchers then followed both patient groups for a median of 5.8 years to determine their long-term response to treatment. Responders to EPO experienced increased survival in comparison to the non-responders (5.5 vs 2.3 years) and significantly improved physical, emotional, and functional well-being, reduced fatigue, and improved overall quality of life.

The research team otherwise found no statistically significant differences in overall survival of patients between the EPO and SC arms (3.1 vs 2.6 years) or the incidence of transformation to AML (7.5% vs 10.5% of patients, respectively), suggesting long-term safety of the EPO treatment regimen.

The study results also indicated that the combination of EPO plus G-CSF was beneficial for patients who either did not respond initially to EPO or who experienced a delayed response.

Furthermore, higher doses of EPO seemed to prove valuable for a proportion of patients who initially failed to respond. Importantly, the outcomes suggested long-term tolerance to the treatment combination, with a low overall incidence of adverse events. The researchers found no significant treatment-related increase in incidence of either cardiovascular or thrombotic events or transformation to AML in the patients who received EPO alone or with G-CSF, as compared with those in the SC arm.

"We believe the data suggest that the negative effects of cytokines, like ESAs, demonstrated in some studies of other diseases may relate to biologic and clinical features or the specific treatments associated with the differing disorders studied," said Dr. Greenberg. "Findings from this study demonstrate the relative safety and efficacy of EPO plus G-CSF for treating anemic lower-risk MDS patients and may be considered as part of future treatment recommendations for the use of this class of therapies."

SOURCE: American Society of Hematology

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