[The first results of treatment for adult acute myeloid leukemia according to the AML-01.10 protocol of the Research Group of the Hematology Centers of Russia].
Autor: | Parovichnikova EN, Kliasova GA, Sokolov AN, Troitskaia VV, Kokhno AV, Kuz'mina LA, Shaforostova II, Ryzhko VV, Kravchenko SK, Bondarenko SN, Lapin VA, Pristupa AS, Konstantinova TS, Zagoskina TP, Ialykomov IV, Moskov VI, Anchukova LV, Kaporskaia TS, Volodicheva EM, Kaplanov KD, Kondakova EV, Samoĭlova OS, Gavrilova LV, Kulikov SM, Savchenko VG |
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Jazyk: | ruština |
Zdroj: | Terapevticheskii arkhiv [Ter Arkh] 2012; Vol. 84 (7), pp. 10-5. |
Abstrakt: | Aim: To give the preliminary results of the AML-01.10 Russian multicenter randomized trial to treat adult acute myeloid leukemia (AML), the basic principle of which is to use high-dose anthracycline antibiotics in induction/consolidation. Subjects and Methods: By December 2011, 145 patients with AML had been randomized from 18 hematology centers of 15 cities and towns of the Russian Federation; the median age of all the patients was 44 years. Seventy-one patients were analyzed in August 2011 (a 1.5-year follow-up). Results: The efficiency of 2 courses 7+3 using high-dose daunorubicin (60 mg/m2 per administration) and continuous infusion of cytarabine during the second course was high and comparable with that in the use of a high-dose HAM protocol as a second induction course and can achieve a complete remission in 74.6%. The protocol toxicity evaluated from its early mortality (11.3%) and its death in complete remission (16.6%) was permissible, particularly by taking into consideration the multicenter pattern of the trial. At the completion of analysis, 53 (68.8%) out of the 77 patients on whom the data on their vital status were available were alive. In this follow-up period, the frequency of recurrences was 19.2% (10/52). Only 3 (4.2%) patients out of the 71 patients in whom the efficiency of the protocol had been completely evaluated underwent allogeneic bone marrow transplantation. Conclusion: The total high dose (720 mg/m2) of anthracycline antibiotics, which is used in the period of induction and consolidation, determines the long periods of myelosuppression and intercourse intervals. Protocol deviations (no course of consolidation therapy, lower-dose idarubicin during consolidation therapy, a course of low-dose cytarabine, between the courses of induction and consolidation chemotherapy, and very long intercourse intervals) were recorded in a total of 20 (28%) patients. |
Databáze: | MEDLINE |
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