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

• Main Authors: E N Parovichnikova, G A Kliasova, A N Sokolov, V V Troitskaia, A V Kokhno, L A Kuz'mina1, I I Shaforostova, V V Ryzhko, S K Kravchenko, S N Bondarenko, V A Lapin, A S Pristupa, T S Konstantinova, T P Zagoskina, I V Ialykomov, V I Moskov, L V Anchukova, T S Kaporskaia, E M Volodicheva, K D Kaplanov, E V Kondakova, O S Samoĭlova, L V Gavrilova, S M Kulikov1, V G Savchenko
• Format: Article
• Language: Russian
• Published: "Consilium Medicum" Publishing house 2012-07-01
• Series: Терапевтический архив
• Subjects: results of the aml-01.10 protocol; high-dose anthracycline antibiotic
• Online Access: https://ter-arkhiv.ru/0040-3660/article/view/31036
• ISSN: 0040-3660; 2309-5342

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.