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THE RESULTS OF THE RETROSPECTIVE MULTICENTRE STUDY OF THE THERAPY OF PH-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA ACCORDING TO THE PROTOCOLS OF THE RUSSIAN RESEARCH GROUP


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Abstract

Introduction. Since 2009, the RALL Group has been treating Ph-positive ALL by protocols based on a continuous chemotherapeutic approach with TKI combination. Based on the results of the studies received in 2011, a protocol was developed for ALL-2012 for the treatment of Ph-positive ALL, in which chemotherapy was de-escalated. Aim. The aim of the study was to compare the efficacy and long-term results in patients treated by ALL-2009 protocol with TKI and ALL-2012 protocol. Materials and methods. The study included patients with newly diagnosed Ph-positive ALL who received therapy from 2009 to 2017 in one of 3 centers: 12 patients who were treated according to the ALL-2009 protocol with TKI, and 23 patients treated according to the ALL-2012 protocol. The study does not include patients who have been treated in other centers. Results. Two deaths were recorded on each protocol: ALL-2009 with imatinib - 1 (8%) in induction and 1 (8%) in consolidation; ALL-2012 - 1 (4%) patient in induction and 1 (4%) in consolidation treatment. There were no significant differences in the frequency of complete remissions after induction courses, and their incidence was 83% and 87%, respectively. In group of patients that were treated by ALL-2009 protocol with ITK, the frequency of complete molecular remission after 2 courses of induction therapy (the 70th day of the protocol) was 43% (3 of 7 patients), and those who received therapy by ALL-2012 protocol - 55% (in 11 of 20 patients). The differences in the frequency were not statistically significant (p > 0.05). Refractory of the disease was detected in 1 (8%) of the patients on the ALL-2009 protocol with ITK and in 1 (4%) of the patients on the ALL-2012 protocol. In all patients with Ph-positive ALL (n = 35) the overall survival was 55% and the disease-free survival was 40%. Fourteen (40%) of 35 patients underwent transplantation of hematopoietic stem cells. The conclusion. According to the retrospective multicentre study of the RALL, it was shown that de-intensification of chemotherapeutic treatment against the background of constant therapy of TKI did not affect the effectiveness of therapy.


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