[AML-6 and AML-7 studies on the treatment of acute myelocytic leukemia. Cyclic alternating chemotherapy during remission, and induction of remission and survival of elderly patients].

Twenty-five institutions are participating in the AML-6-trial designed to improve remission incidence and to delay the time of relapse. Therefore, an intensive cyclic therapy is employed early after achievement of remission using either the same drugs of the induction regimen or rotating combinations of alternative drugs, e.g. AMSA, 5-AZA and HD-araC. So far, 266 patients entered the trial. The overall C.R. rate is 71%. 58 patients are randomized to 'maintenance' arm I, 54 to arm II, 79/112 patients are still being studied. Toxicity was in 7% and 3% respectively a reason to interrupt the study during induction or 'maintenance'. Since the intensity of modern protocols for remission induction of AML presents a major problem in elderly patients due to toxicity, and since most studies indicate low remission rates with an increasing death rate in this age group, the AML-7-study was initiated to prospectively compare survival and quality of life of two different therapeutic strategies: immediate intensive remission induction versus supportive care, 'wait and see' policy, and palliative cytoreduction with hydroxyurea and ara C when necessary. During the first 8 months after activating this study, 27 patients entered, 13 were randomized to branch I, and 14 to branch II.