Долгосрочные результаты лечения острых миелоидных лейкозов у взрослых в многоцентровом клиническом исследовании ОМЛ 06.06

SUMMARY The purpose of this trial was to evaluate the role of high doses Ara-C consolidation, maintenance chemotherapy, bone marrow transplantation (BMT) by assessing the long-term results of adult patients (pts) with acute myeloid leukemia (AML) according to AML-06.06 treatment protocol. During the period 2006-2009, 216 AML pts (except M3 and secondary AML) were included in this study. 143 of them were randomized in 2 groups. Chemotherapy consisted of conventional dose Ara-C + daunorubicin as the first induction course «7+3», High dose Ara-C + Mitoxantrone (HAM) as the second induction/consolidation course, HAM as the third course was applied if no complete remission (CR) after the first course has been achieved or High dose Ara-C (HiDAC) as the third course if CR was obtained after the first course, the fourth and the fifth courses with HiDAC, and two randomized arms of maintenance: «5+2» (AraC + Mercaptopurine) versus stop chemotherapy (randomization was performed before the treatment start). BMT was performed after 3, or 4, or 5 consolidation courses (26 AlloBMT, 10 AutoBMT). CR was obtained in 155 pts (72 %). If CR was obtained during the first 60 days of treatment then 5-year leukemia-free survival (LFS) was 38 %, if later — 18 % (p = 0,0244). OS was similar. 5-year LFS in cytogenetic low and intermediate risk groups was 37 %, and in high risk groups — 8 % (p = 0,0044). In cytogenetic low risk group 5-year overall survival was 100 % in inv(16) pts and 20 % in t(8;21) pts (p = 0736). If lactate dehydrogenase (LDH) activity was 1500 U/l and higher, 5-year LFS was 8 %, if lower — 23 %, p = 0,0011). 5-year LFS in AutoBMT pts was 40 %, in AlloBMT pts — 32 %, in chemotherapy pts — 25 % (p = 0,4464). Relapse probability was 83 % in no-maintenance randomization group and 50 % — in maintenance group (p = 0,0667).