Comparison of the effectiveness of supportive chemotherapy for patients with acute myeloid leukemia

Introduction. Achieving complete remission and prolonging event-free survival is the primary task of chemotherapeutic treatment for patients with acute myeloid leukemia (AML). Supportive therapy is a possible way to maintain complete remission.

Aim: to compare two variants of supportive treatment (5+5 and 6-MP + Mtx) in patients with AML in the first complete remission after completion of the induction and consolidation programs.

Materials and methods. The single-center randomized study included 34 AML patients treated from 2017 to 2021. The median age was 36 (18–56) years, the ratio of men to women was 18:16. After completing the induction and consolidation program, randomization was performed for different branches of supportive chemotherapy: 5+5 (cytarabine 50 mg/m² 2 times/day, mercaptopurine 60 mg/m² days 1–5, a total of 6 courses) — first group (18 patients), and 6-MR + Mtx (6-mercaptopurine 50 mg/m² daily, methotrexate 15 mg/m² once/week) — second (16 patients). Courses of maintenance therapy were conducted until the total completion of treatment, the implementation of allogenic hematopoietic stem cell transplantation (allo-HSCT), the development of relapse, or death of the patient.

Results. The two-year overall survival in the 5+5 group was 93 %, in 6-MP + Mtx group 68 % (p = 0.0814). Mortality in both groups was associated with complications in the post-transplant period. The actual OS and the hypothetical one — without performing allo-HSCT, did not differ. Thus, the fact of performing allo-HSCT does not affect the effectiveness of maintenance therapy courses. The two-year disease-free survival rate (DFS) was 66 % in the 5+5 group and 63 % in the 6-MP + Mtx group (p = 0.42). From the time of randomization, 8 patients (24 %) have relapsed and 1 patient died from complications after allo-HSCT.

Conclusion.  During treatment under the maintenance therapy programs 5+5 and 6-MP+Mtx, similar OS and RFS were achieved. During 5+5 program, hospitalization in a day hospital is required. The 6-MP+Mtx program has similar effectiveness, however, the entire period of supportive treatment can be carried out on an outpatient basis but lasts 24 months compared to 6 months when using the 5+5 program. The choice of maintenance therapy according to the 5+5 program is optimal from the point of view of the quality of life of patients.

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