INTENSIVE CHEMOTHERAPY FOR POOR-PROGNOSIS MYELODYSPLASIA (MDS) AND SECONDARY ACUTE MYELOID-LEUKEMIA (SAML) FOLLOWING MDS OF MORE THAN 6 MONTHS DURATION - A PILOT-STUDY BY THE LEUKEMIA COOPERATIVE GROUP OF THE -ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-IN-CANCER (EORTC-LCG)

We conducted a prospective, multicenter pilot study of remission induc tion therapy in patients with poor prognosis MDS and AML evolving from a preceding phase of MDS. Fifty evaluable patients from 15 institutio ns were treated with one or two remission-induction courses consisting of i.v. idarubicin 12 mg/m(2)/day on days 1, 2, and 3 combined with a continuous i.v. infusion of cytarabine of 200 mg/m(2)/day on days 1 t o 7. Of the 27 complete remitters (54%), 23 received a consolidation c ourse which was identical to the remission-induction course except for the idarubicin 12 mg/m(2) which was given on day 1 only. Fifteen pati ents received maintenance therapy consisting of six courses of cytarab ine 10 mg/m(2), s.c. twice daily, for 14 days. Two complete remitters were allografted and five patients received an ABMT. The median surviv al of all 50 treated patients was 14 months. The median duration of di sease-free survival was 11 months with two patients in CR more than 2 years after entering CR. Twenty-four of the 27 remitters have relapsed . Four patients died during remission-induction therapy, but no patien t died as a result of persisting hypoplasia. No fatal complications oc curred during the consolidation and maintenance courses. Age and stage of disease had no significant impact on CR rate nor on remission dura tion. The CR rate was significantly (P = 0.03) higher in patients with only normal metaphases compared to patients with cytogenetic abnormal ities. The DFS at 2 years was 33 vs 8%, respectively, for patients wit hout or with cytogenetic abnormalities (P = 0.02). This study shows th at patients below the age of 60 years with poor risk features are cand idates for treatment with combination chemotherapy. A complete remissi on rate of more than 50% may be expected. Maintaining remission after remission-induction chemotherapy Is a difficult issue. Patients not el igible for allogeneic BMT may be treated with intensive post-remission chemotherapy or autologous BMT.