Response Assessment to Erythropoietin-Zeta (Epo-Alpha Biosimilar) Therapy in Low-Risk Myelodysplastic Syndromes

Author:

Vetro CalogeroORCID,Di Giacomo Valeria,Mannina DonatoORCID,Magrin Silvana,Mulè Antonio,Mitra Maria Enza,Siragusa Sergio,Duminuco AndreaORCID,Garibaldi Bruno,Vadalà Maria Cristina Emanuela,Di Raimondo Francesco,Palumbo Giuseppe A.ORCID

Abstract

Background. This prospective observational study aimed to verify the efficacy of erythropoietin zeta in the treatment of patients with low-risk myelodysplastic syndrome. Methods. Patients with low/int-1 IPSS risk and serum erythropoietin level below 500 U/L were enrolled. Treatment consisted of erythropoietin zeta 40,000 U subcutaneously once a week. The primary endpoint was the erythroid response. According to Simon’s two-stage statistical design, 36 patients were recruited. The median age was 75 years (range 56–83 years), male/female ratio was 1.1/1, median baseline serum erythropoietin was 57.9 U/L (range 9.4–475 U/L). 53% of patients had low-risk disease, while the remaining had Int-1 risk. Results. After 8 weeks, a significant response (rise in Hb levels of at least 1.5 g/dL) was achieved in 18 patients (50%) out of 36. However, 17 patients did not improve; 8/17 patients pursued the 40,000 U weekly schedule of erythropoietin zeta, and 4/8 (50%) of them reached the erythroid response after 16 weeks. Nine patients underwent dosage doubling (40,000 U twice per week), and 5/9 (55%) of them achieved the erythroid response. Conclusion. Compared with data from the literature, this prospective study revealed that EPO-zeta is a safe and effective therapeutic option in low-risk MDS patients.

Publisher

MDPI AG

Subject

General Medicine

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