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High‐dose (40,000 IU twice/week) alpha recombinant human erythropoietin as single agent in low/intermediate risk myelodysplastic syndromes: A retrospective investigation on 133 patients treated in a single institution
Author(s) -
Azzarà Antonio,
Carulli Giovanni,
Galimberti Sara,
Baratè Claudia,
Fazzi Rita,
Cervetti Giulia,
Petrini Mario
Publication year - 2011
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.22111
Subject(s) - medicine , gastroenterology , myelodysplastic syndromes , erythropoietin , anemia , basal (medicine) , retrospective cohort study , surgery , bone marrow , insulin
We investigated the efficacy of alpha recombinant human erythropoietin (α‐rHuEPO) administered as single agent to 133 patients affected by myelodysplastic syndromes referring to our Institution in the last 10 years. WPSS score was “very low” in 67%, “low” in 19%, “intermediate” in 14%. The starting schedule was: 40,000 IU bi‐weekly, with reduction or suspension, when necessary, in responsive patients. According to new IWG criteria, response rate (RR) was 75%, 66%, 59% after 8, 16, 24 weeks, respectively. Comparing “very low” and “low/intermediate” risk, RR was 81% vs. 43% ( P < 0.001); 70% vs. 45% ( P = 0.040); 63% vs. 42% ( P = NS) after 8, 16, 24 weeks. RR was significantly influenced by transfusion dependence ( P = 0.039) and basal serum EPO level ( P < 0.001). Mean Hb value was 94 ± 11 g/l before therapy; 114 ± 19 after 8 weeks ( P < 0.001); 116 ± 18 after 16 weeks ( P < 0.001); 114 ± 17 after 24 weeks ( P < 0.001). Reduction or suspension of therapy significantly affected Hb level after 4 ( P < 0.001) and 8 weeks ( P < 0.01). Conversely, restart of full dosage significantly enhanced again Hb level after 4 ( P < 0.01) and 8 weeks ( P < 0.001). 65% patients are alive (mean survival: 74 weeks). Seventy percent are alive in the “very low risk” group and 38% in “low/intermediate risk” group ( P < 0.001). Overall mean follow‐up was 69 weeks (range, 8–376): it was 80 weeks in responsive patients (max 376) and 38 weeks in patients who progressively became unresponsive (max 168) ( P < 0.01). Median response was 36 weeks, with 33% of patients still responding after one year. Treatment was well tolerated. Am. J. Hematol. 86:762–767, 2011. © 2011 Wiley‐Liss, Inc.