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Treatment of anemia in myelodysplastic syndromes with amifostine In vitro testing of response



Treatment of anemia in myelodysplastic syndromes with amifostine In vitro testing of response



Blood 96(11 Part 2): 259b, November 16



Amifostine (AMF) promotes in vitro growth and survival of hematopoietic progenitor cells. In a pilot study we evaluated the efficacy of AMF in the treatment of anemia in patients (pts) with myelodysplastic syndromes (MDS). The eligibility criteria for entrance in the study were: primary low risk MDS (RA, RARS and RAEB with <10% blasts in the bone marrow), Hb levels <9g/dl and no clinically significant organ disease. Two different doses of AMF, 300mg/m2 (group A) or 400mg/m2 (group B) were studied. AMF was given, iv, 3 times weekly for 3 weeks followed by 2 weeks off therapy. Pts were evaluated after 2 cycles of treatment. Partially or non-responding (NR) pts of group A received 400mg/m2 AMF and were reevaluated. An increase of Hb values above 2g/dl and a 100% decrease in transfusion requirements for at least 6 weeks was defined as complete response (CR) while an increase of Hb values of 1-2g/dl and a 50% decrease of transfusion requirements was considered as partial response (PR). Group A included 12 pts (4 RA, 2 RARS and 6 RAEB), 9M/3F, with a median age of 78 years while group B included 16 pts (12 RA, 3 RARS and 1 RAEB), 10M/6F, with a median age of 68 years. In group A 2/12 pts (16.6%) achieved CR and 2/12 PR, while in group B only 2 pts (12.5%) achieved PR. 10/12 pts of group A (2 PR and 8 NR) received 400mg/m2 AMF and only 1 NR had a PR. No side effects were observed at 300mg/m2 AMF while 11/26 (42.3%) experienced nausea and vomiting or fatigue or hypotension during infusion at 400mg/m2 AMF. In pts of group A bone marrow progenitor assays were performed in methylcellulose short-term cultures before and after the first course of treatment. BFU-Es were increased in 5/12 pts and this increase preceded the rise in Hb levels in two of them. In group B clonogenic assay was performed in 10/16 pts before any treatment to predict a subset of pts who might respond to treatment with AMF. In vitro results after pretreatment with 500 muM AMF for 15 min confirmed response in 2 MDS pts (1 with PR, 1 with 100% increase of reticulocyte count with no hematological response). No response in vitro was observed in 100% of 8 NR pts. We conclude that 300mg/m2 of AMF is an adequate initial treatment for MDS pts with no side effects and the clonogenic assay before any treatment has a strong predicting value for response to treatment.

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Accession: 035980948

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