[Preliminary results of a multicenter randomized study on the treatment of acute promyelocytic leukemias]. / Predvaritel'nye rezul'taty mnogotsentrovogo randomizirovannogo issledovaniia po lecheniiu ostrykh promielotsitarnykh leikozov.

AIM: To study efficacy of maintenance therapy of patients with acute promyelocytic leukemia (APL) in the APL treatment Russian multicenter trial. MATERIAL AND METHODS: The trial was made with participation of 18 hematological departments of clinics in Russia. A total of 68 APL patients entered the trial. The maintenance therapy consisted of 5-day courses of cytostatic drugs which alternated or did not alternate with 5-day courses of ATRA. Cytogenetic tests were made in 31 patients, t(15;17) was detected in 26 of them. Molecular examination conducted in 28 patients discovered chimeric transcript PML/RARa in 26 of them. Of 20 patients examined in Hematological Research Center, 7 (35%) had a bcr 1/2 variant of the transcript PML/RARa, 13 (65%)--bcr 3 variant. RESULTS: 65 patients were eligible for assessment. A complete remission was achieved in 90% cases. No resistance was observed. In follow-up within 30 months the recurrence rate was similar on both treatments. The results of the induction therapy and survival in patients with different variants of the transcripts were also similar. Overall 2.5 year survival for all the patients was 77%, recurrence-free--80%. The survival analysis in patients with leukocytosis higher and lower 10 x 10(9)/l found no statistical differences by the survival. Patients with hyperleukocytosis had higher early lethality than patients with leukocytes under 10 x 10(9)/l (25% vs 5.3%, p = 0.03). CONCLUSION: The APL 06.01 protocol showed high efficacy of the relevant maintenance which provides a complete molecular remission in the majority of patients with probable recurrence-free 2.5 year survival 80%.

[Prevention of neuroleukemia by intrathecal administration of cytosar and methotrexate in acute lymphoblastic leukemia in adults]. / Profilaktika neiroleikemii intratekal'nymi vvedeniiami tsitozara i metotreksata pri ostrom limfoblastnom leikoze u vzroslykh.

AIM: To find out whether efficacy of neuroleukemia (NL) prevention by intrathecal administration of cytosar and methotrexate in remission induction phase in adult patients with acute lymphoblastic leukemia (ALL) depends on the risk factors. MATERIALS AND METHODS: The study covered 68 ALL patients. The diagnosis was made by cytological, histological and cytochemical tests of the peripheral blood and bone marrow. Immunophenotyping was performed in 48 patients. The treatment followed the German protocol 04.89 in modification of the Hematological Research Center of the Russian Academy of Medical Sciences. Prevention of NL consisted in intrathecal administration of cytosar (30 mg), methotrexate (15 mg) and dexamethasone (4 mg) once a week for 6 weeks beginning on induction day 1, further in consolidation, reinduction and once in 3 months in maintenance. Radiation of the brain was not conducted. Treatment of leuroleukemia consisted of intrathecal administration of the above drugs twice a week up to normalization of the liquor with subsequent their administration 5 times and craniospinal radiation in a dose 36 Gy. Further intrathecal administrations were made according to the protocol. RESULTS: Correlation was not found between age of the patients and frequency of neuroleukemia onset, between neuroleukemia incidence and peripheral blood leukocytosis at diagnosis. Results of NL prevention with cytosar and methotrexate given intrathecally in induction of remission (14.6% of neurorecurrences) are comparable with the results of NL prevention by radiation of the brain with intrathecal administration of methotrexate obtained in the German cooperative trial. CONCLUSION: NL prevention in ALL adult patients by intrathecal cytosar and methotrexate in remission induction is effective.

[The empirical antibiotic therapy of patients with acute leukemias: the results of a multicenter study]. / Empiricheskaia antibioticheskaia terapiia u bol'nykh ostrymy leikozami: itogi mnogotsentrovogo issledovaniia.

AIM: To evaluate efficacy of ampicilline/sulbactame and fluconasole in the regimen of empirical antibiotic therapy in patients with acute leukemia. MATERIALS AND METHODS: The trial covered 14 hematological departments of Russia and 1 of Ukraine. Acute myeloid leukemia patients were included. 92 cases of fever in 56 patients with analysis of efficacy in 66 cases were considered. At the first stage of empirical antibiotic therapy, cefoperason (4 g/day) and gentamycin (240 mg/day) were administered. If no response was reached, ampicilline/sulbactam (7.5 g/day) was added. This was the second stage. If no response occurred for 5 days the three drugs were joined by fluconasol (400 mg followed by 200 mg). RESULTS: Fever of unclear genesis was cured in 82% (28 of 34), clinical infection--in 80% (20 of 25), microbiologically confirmed infection--in 4 of 7 cases. A complete response to the empirical antibiotic therapy was registered in 52 of 66 cases (79%). 7(10.5%) patients died of infectious complications. 7(10.5%) received other antibiotics.