To date, clinical trials have provided a reasonable composite picture of the safety and efficacy of HGF in MDS and AA. In AA, future studies should aim to better characterize the additional benefit derived from the use of rHuG-CSF with immunosuppressive therapy and to define further the risk associated with rHuG-CSF and the later development of clonal hematologic disorders. In MDS, quality-of-life and pharmacoeconomic comparisons between rHuEPO therapy and red blood cell transfusions will assist physician and patient decision making regarding individual treatment options and will shape the debate regarding health care resource allocation for these diseases (166).

Novel longer-acting recombinant cytokines such as darbepoetin alfa and pegfilgras-tim have shown comparable safety and efficacy in studies of cancer patients with anemia owing to chronic disease or multicycle chemotherapy. Currently, phase 1-2 trials of darbepoetin alfa in MDS are evaluating whether less frequent dosing of this potent erythropoietin can add to the convenience of therapy of these chronic anemias. The recent establishment of consensus response criteria by the International Working Group will permit better interpretation of the results of trials of these cytokines and other agents in MDS (167).

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