HIGH-DOSE CYTOSINE-ARABINOSIDE AND DAUNORUBICIN POSTREMISSION THERAPYIN ADULTS WITH DE-NOVO ACUTE MYELOID-LEUKEMIA - LONG-TERM FOLLOW-UP OF A PROSPECTIVE MULTICENTER TRIAL

A total of 149 consecutive de novo AML patients aged 50 years or less (median age = 37 years) were enrolled in this prospective multicenter trial initiated in May 1985. All patients received the same induction and early consolidation therapy with daunorubicin (DNR), cytosine arab inoside (Ara-C), and etoposide (DAV). High-dose Ara-C/DNR therapy incl uded Ara-C at 3 g/m(2), in 12 doses (HD-Ara-C/DNR I) and eight doses ( HD-Ara-C/DNR II), followed by DNR 30 mg/m(2) for 3 days. A complete re mission (CR) was achieved in 104 (70%) patients; 61 complete responder s received at least one cycle with HD-Ara-C/DNR. If those patients who were transplanted in first CR (n = 26), were not considered, the medi an relapse-free-survival (MRFS) of the remaining 78 patients was 15 mo nths, with a probability of relapse-free survival (RFS) at 116 months of 30% (95% CI, 20-40%) after a median follow-up of 95 months. The MRF S of the HD-Ara-C/DNR consolidated patients was 25 months, with a prob ability of RFS at 116 months of 37% (95% CI, 24-50%). If all patients who were transplanted (n = 44) were not considered, the median surviva l time (MST) was 18 months with a probability of being alive at 118 mo nths of 24% (95% CI, 16-33%). MST of the HD-Ara-C/DNR consolidated pat ients was 58 months with a survival probability of 46% (95% CI, 31-60% ) at 118 months. Prognostic factor analysis did not reveal any signifi cant influence of age, sex, FAB subtype, white blood cell count, hemog lobin level, thrombocyte count, LDH, or response to the first inductio n course on RFS of the HD-Ara-C/DNR consolidated patients. In summary, HD-Ara-C/DNR consolidation can improve the long-term outcome of a sub group of de novo AML patients. Further improvement of the outcome seem s to depend on the identification of patients with an inferior outcome under that strategy who might benefit from alternative treatment stra tegies.