Russian Interregional Register of hematopoietic stem cell transplantation was established in 2000. 11 transplant centres from 7 Russian cities are including in Register now. In this analysis we applied transplant activity survey data from 01.01.1996 to 31.12.2006. A total 1118 transplants (846 – autologous and 272 – allogeneic) were carried during this period.

AIM:To comparatively analyze the toxicity of 4 treatment protocols in patients with acute myeloid leukemia (AML), which were used in the Russian multicenter center in 1992 to 2009.MATERIALS AND METHODS:The information obtained in 4 Russian multicenter studies conducted in 33 hematology departments of 26 cities and towns of the Russian Federation in 1992 to 2009 was analyzed. Randomization was made in 243 patients with AML (median age 38 years) in 1992-1995, 396 patients (median age 39 years) in 1995-1999, 392 patients (median age 39 years) in 2001-2006, and 137 patients (median age 40 years) in 2006-2009. The analysis excluded patients with acute promyelocytic leukemias who were recruited in the AML-92 and AML-95 studies. These patients' statutory forms adequately filled in were 60-70% therefore toxicity was analyzed on the basis of the data of 631 patients.RESULTS:The baseline clinical and laboratory parameters in the patients enrolled in the studies in different years slightly differ in the count of leukocytes at the onset of the disease and in the level of lactate dehydrogenase (LDH): the recent studies revealed a larger number of high-risk group patients (leukocytes more than 30 10(9)(/l; LDH more than 500 units) possibly due to the later diagnosis of AML. During the studies, the number of complete remissions remained as before (55%) after the first course and increased from 65 to 78% after the second course using cytosine arabinoside in high doses. Despite treatment intensification, mortality in the induction period remained as before (19-21%). Remission mortality decreased from 18 to 10-13%. The long-term results of using the aggressive therapy did not differ from those obtained during the standard treatment protocols. The duration of leucopenia after standard induction courses during the all studies remained equal (17-19 days); the exclusion was a HAM course as the second induction course after which the duration of neutropenia was much more than that of the standard course (17 and 10 days, respectively). During the study years, there was an increase in platelet transfusion volumes (from 20 to 53 doses during the first course and from 7 to 28 doses during the second course) and a reduction in the percentage of severe hemorrhagic complications. The incidence of pneumonias remained at the same level (40-50%) during the induction courses and that of septic complications and necrotic enteropathy considerably decreased from 40-46 to 17-19%. The incidence of invasive aspergillosis during the current programs from AML treatment was 10% (two induction courses), that of invasive candidiasis was 4.7% (two induction courses). CONCLUSION; The long-term results of treatment for AML were virtually unchanged regardless significant therapy intensification. Mortality remained high during induction treatment and in the postremission period. Its cause is severe infectious complications developing during myelotoxic agranulocytosis. The results of the analysis provide the basis for developing a new AML treatment protocol that should take into account all the merits and demerits of the previous protocols and provide a toxicity-treatment efficiency balance.

Results of the Second Russian Multi-Center Study of Acute Promyelocytic Leukemia (APL) Treatment are summed up. Overall 5-year survival of 102 APL patients treated by the 7 + 3 protocol (rubomycin dose 60 mg/m(2)) in combination with ATRA, two similar consolidation courses, and 2 years of maintenance therapy was 68.3%, relapse-free survival 77.4%, probability of complete remission prolongation 89.5%. High early mortality (15%) and mortality during complete remission (10%) reduced significantly the total efficiency of APL treatment. Experience gained in accompanying therapy of APL patients largely determined the remote results of treatment: overall and relapse-free survival of APL patients in centers, which included more than 10 patients in the study, was 89 and 95%, respectively, vs. just 58 and 69% in centers with groups of I to 8 patients. Relapse-free survival and probability of prolongation of complete remission did not differ much in patients receiving maintenance therapy by different protocols (cytostatic alone or alternation of ATRA and chemotherapy courses), but the incidence of relapses was somewhat higher (p = 0. 16) in patients receiving reduced cytostatic loading. Leukocyte count (more or less than 10 x 10(9)/L is not a factor determining the remote results of treatment - relapse-free survival (82 and 84% respectively) and probability of complete remission prolongation (90 and 91% respectively), but early mortality of patients with leukocyte counts of more than 10 x 10(9)/L was significantly higher than that of patients with lower leukocyte counts (30 and 9.4% respectively).

AIM:Systematization of the results of 20-year multicenter randomized trial of the efficacy of treatment of acute myeloid leukemia (AML) of adults; presentation of the design of the study of the strategy of consolidation and maintenance therapy after high-dose consolidation initiated in 2007.MATERIAL AND METHODS:Treatment outcomes on the protocol AML-01.01 are presented for 354 AML patients from 29 hematological centers located in 22 towns of Russia and 2 towns of Ukraine. The patients were randomized into 3 groups by variant of therapy: 124 patients (62 males and 62 females; age median 42 years) received 4 courses of 7+3+VP-16 and 5 courses of maintenance therapy (7+3 with thioguanin); 130 patients (65 males and 65 females, age median 41 year) received 2 courses of 7+3+VP-16, 2 courses 7+3, maintenance--5 courses 7+3 with thioguanin; 126 patients (57 males and 68 females, age median 40 years) were given 2 courses of 7+3+VP-16, 2 HAD courses, treatment discontinuation.RESULTS:A complete remission after the first course of 7+3+VP-16 was achieved in 55% patients, after the second course--in 30% after the course 7+3+VP-16 or 7+3 with mitoxantron, in 70%--after NAM. Overall and recurrence-free survival were 18 and 35%; 30 and 20%; 36 and 30%, respectively. There was no significant difference in efficacy of the treatment scheme.CONCLUSION:The multivariate analysis has shown that a leading factor having impact on treatment results was the number of randomized patients: the less patients were randomized, the worse were the results.

Inter-regional register of hemopoietic cell transplantation unites 13 transplantation centers in 7 Russian cities and keeps data on 1174 transplantations carried out in 1996-2006. Quantitative and qualitative analysis of transplantation activity of hematological hospitals of Russian cities is carried out.

Over the last decade all large cooperative trials have shown that induction and/or consolidation intensification by either the introduction of additional cytotoxic drugs (etoposide, idarubicin, aclarubicin, mitoxantrone) to cytosine-arabinoside (Ara-C) plus daunorubicin or Ara-C dose escalation or timing (double induction) provides 30–40% 5 years disease-free survival (DFS) in primary AML (J.Bishop et al 1996, A.Burnett et al 1998, Th.Buchner et al. 1999). A very limited number of randomized studies exist on comparing different maintenance strategies in AML, because widely used high-dose consolidation and late intensification therapy substantially reduces or eliminates the beneficial effect of low-dose maintenance attained after standard induction/consolidation (Th. Buchner et al 1985, J. Hewlett et al 1995).