Background: We conducted a study exploring the clinical safety and efficacy of decitabine in patients withacute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), combined with a complex karyotype.Materials and
Methods: From April 2009 to September 2013, a total of 35 patients with AML/MDS combinedwith a complex karyotype diagnosed in the First Affiliated Hospital of Soochow University were included forretrospective analysis. All patients were treated with decitabine alone (20mg/m2 daily for 5 days) or combinationAAG chemotherapy (Acla 20mg qod*4d, Ara-C 10mg/m2 q12h*7d, G-CSF 300μg qd, the dose of G-CSF adjustedto the amount in blood routinely).
Results: In 35 patients, 15 exhibited a complete response (CR), and 6 a partialresponse (PR), the overall response rate (CR+PR) being 60% (21 of 35). Median disease-free survival was 18months and overall survival was 14 months. In the 15 MDS patients with a complex karyotype, the CR rate was53.3% (8 of 15); in 20 AML patients with complex karyotype, the overall response rate was 65% (13 of 20). Theresponse rate of decitabine alone (22 cases) was 56.5% (13 of 22), while in the combination chemotherapy group(13 cases), the effective rate was 61.5% (8 of 13)(P>0.05). There are 15 patients with chromosome 7 aberration,after treatment with decitabine, 7 CR, 3 PR, overall response rate was 66.7% (10 of 15). Of 18 patients with 3 to5 kinds of chromosomal abnormalities, 66.7% demonstrated a response; of 17 with more than 5 chromosomalabnormalities, 52.9% had a response. In the total of 35 patients, with one course (23 patients) and ≥two courses(12 patients), the overall response rate was 40.9% and 92.3% (P<0.05). Grade Ⅲ to IV hematological toxicitywas observed in 27 cases (75%). Grade Ⅲ to IV infections were clinically documented in 7 (20%). Grades Ⅰ toⅡ non-hematological toxicity were infections (18 patients), haematuria (2 patients), and bleeding (3 patients).With follow-up until September 2013, 7 patients were surviving, 18 had died and 10 were lost to follow-up. Inthe 6 cases who underwent allogeneic hematopoietic stem cell transplantation (HSCT) all were still relapse-freesurvivors.
Conclusions: Decitabine alone or combination with AAG can improve outcome of AML/MDS witha complex karyotype, there being no significant difference decitabine in inducing remission rates in patientswith different karyotype. Increasing the number of courses can improve efficiency. This approach with fewertreatment side effects in patients with a better tolerance should be employed in order to create an improvedsubsequent chance for HSCT.