RECOMBINANT INTERFERON ALPHA-2A, THYMOPENTIN AND LOW-DOSES OF CYTOSINE-ARABINOSIDE FOR THE TREATMENT OF MYELODYSPLASTIC SYNDROMES - A PILOT-STUDY

Eighteen patients (pts) with myelodysplastic syndrome (MDS) were treat ed with thymopentin (TP) (50 mg subcutaneously for 5 days) and recombi nant interferon alpha 2a (rIFN alpha 2a) (3 MU/ m(2) subcutaneously on the sixth day); the courses were delivered every week. Moreover those pts with greater than or equal to 10% blasts in the bone marrow were additionally treated with low dose cytosine arabinoside (LDARAc) (20 m g standard dose, subcutaneously, twice a day for seven days every four weeks). Sixteen pts were finally assessable for response. Seven pts ( 44%) were classified as good responders, 5 (31%) had a PR; the overall response rate (GR + PR) was 75%. Two pts (12.5%) showed stable diseas e and the 2 remaining (12.5%) had progressive disease. Six pts with an initial moderate anemia never required supportive care before and dur ing the therapy; in contrast to 10 pts who were transfusion-dependent. After six months of therapy 2 pts decreased their transfusional needs by 50% (1 of them did not receive any transfusion over the following six months of therapy); 2 pts needed no packed red cell infusions and 1 pt decreased his transfusional support by 75%. Five pts kept an unch anged supportive care load. The overall median survival was 12.5 month s. Therapy was generally well tolerated with acceptable compliance; th e most frequently recorded side effects were neutropenia and thrombocy topenia grade 2-3 among the group receiving LDARAc. However no life-th reatening infectious episodes or bleeding were observed. TP, rIFN alph a 2a and LDARAc can be safely administered on an outpatient basis to M DS pts and appears to have significant activity. Recruitment of a larg er number of pts and longer observation is warranted and Randomized tr ials are also needed in order to evaluate the impact on the time to AM L evolution.