This study was designed to test the efficacy of rHuEPO in inducing an increase of at least 2 gr/dl over baseline hemoglobin levels in patients affected by solid tumors, with or without bone marrow invasion. The treatment plan consisted of the administration of rHuEPO 150 U/kg of body weight 3 times/week for 6 weeks. In responding patients, a maintenance schedule of 150 U/kg/week was given for a further 6 weeks. Twenty patients with hemoglobin levels of between 8 and 10 gr/dl were treated, 10 of whom (50%) had bone marrow infiltration. There was a significant difference between median baseline serum EPO levels in patients with and without bone marrow invasion (123.5 vs 40 mU/ml, p=0.002). A response was achieved in 10 of the 20 cases (50%), the median duration being 14 weeks (range 3-34+). Three of the 10 patients with bone marrow involvement responded to treatment, as opposed to 7 without bone marrow invasion (30% vs 70%; p=0.179). The treatment was well tolerated and did not give rise to any severe side effects, These data suggest that the rHuEPO 150 U/kg 3 times/wk controls chronic anemia in 50% of patients affected by solid tumors. Good efficacy of rHuEPO treatment was observed in patients without bone marrow infiltration.

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