Efficacy And Prognosis Of VA Versus "7+3" In Newly Diagnosed Elder Patients With Acute Myeloid Leukemia

Objective:To compare the effect,adverse reaction and prognosis of Venetoclax(VEN)combined with Azacitidine(AZA)versus"7+3"in newly diagnosed elder patients with acute myeloid leukemia(AML).Methods:From January 2021 to January 2022,the clinical data of 79 newly diagnosed elder patients with AML at the Second Hospital of Shanxi Medical University and the Shanxi Bethune Hospital were retrospectively analyzed,including VA group(41)and“7+3”group(38),then response,overall survival(OS),progression-free survival(PFS)and adverse reactions between the two groups were compared.The propensity score matching(PSM)method was used to balance confounding factors,including age,risk stratificationthen and ECOG score.41 patients receiving VA and 38 patients receiving"7+3"were matched as 1∶1,and the matching tolerance was0.2.SPSS 25.0 statistical software was used for statistical analysis.Independent sample t test or nonparametric rank sum test was used for measurement data,Chi-square test or Fisher exact probability method was used for counting data rates,Kaplan-Meier method was used for survival analysis,and Log-rank test was used for comparison between groups.All comparisons were bilateral tests,and P<0.05 was considered statistically significant.Results:1.Clinical characteristics of AML patients:79 newly diagnosed elder patients with AML,with a median age of 66(60-92)years.There were 50 males(63.3%)and 29females(36.7%).51 cases(64.5%)had at least one gene mutation,and the mutation frequency of DNA methylation genes was the highest,including DNMT3A(21.5%),IDH1/2(12.6%)and TET2(21.5%).There were 23 cases(56.1%)of DAN methylation mutation in VA group and 17 cases(44.7%)in 7+3 group.There was no significant difference between the two groups(P=0.313).2.Comparison of clinical features between VA group and"7+3"group before and after PSM:general data(age,risk stratification,ECOG score)of patients were matched.Age,sex,risk stratigraphy,gene mutation,physical status score,blood cell count at initial diagnosis,bone marrow primitive cell count,and active infection at initial diagnosis were not statistically significant in the two groups after matching(P>0.05).3.Comparison of efficacy between the VA group and the"7+3"group after PSM:The patients of the two groups received at least two courses of treatment.In VA versus"7+3"groups,the overall response rate(ORR)was 68%vs 84%,and the complete remission(CR)was 60%vs 68%(P>0.05),and the CR patients with incomplete hematologic recovery(CRi)was 4%vs 4%,and the partial remission(PR)was 4%vs12%.ORR(P=0.185)and(CR+CRi;CRc)(P=0.544)were not statistically significant.The early mortality rates was 12%vs 4%(P=0.609).In the VA group,there were 5non-remission(NR)patients,4 with chromosome 7 abnormality(7q-/-7),and 1 with ETV6 gene mutation.There was no significant difference in the negative conversion rate of minimal residual disease(MRD)between the VA group and the"7+3"group at the first and second course(24%vs 24%,40%vs 36%)(P>0.05).Progression-free survival(PFS)rate of patients receiving VA or"7+3"was different between MRD~+group and MRD~-group.The PFS rate was higher in MRD~-group and lower in MRD~+group(P=0.234;P=0.007).The recurrence rate in the"7+3"group was higher than that in the VA group(32%vs 16%),but there was no statistical difference(P=0.185).4.Overall survial(OS)and PFS of the VA group and the"7+3"group after PSM:the median followed-up time was 10 and 15 months,respectively,and there was no significant difference in the rates of OS and PFS at 6 months(84%vs 92%,P=0.389;84%vs 92%,P=0.258)and at 1 year(52%vs 52%,P=0.351;52%vs 52%,P=0.351).5.Main adverse reactions:The side effects of hematological in two groups mainly includedⅢ-Ⅳmyelosuppression,and the incidence rate of it had no statistical difference(P>0.05).Median time of neutrophil recovery was 27(11-70)d vs 25(14-61)d(P=0.161)and platelet recovery was 27(11-75)d vs 25(16-50)d(P=0.270),respectively.The infection rate was lower in VA group(56%)than in"7+3"group(88%)(P=0.012),and the rate of lung infections was 36%and 64%(P=0.048),the difference was statistically significant.Conclusion:1.The short-term effect,OS and PFS of VA are similar to"7+3"in the treatment of newly diagnosed elder AML.2.The VA has a lower incidence of infection than the"7+3"in the treatment of newly diagnosed elder AML.3.The presence of chromosome 7 abnormality(7q-/-7)may be a poor prognostic factor for elderly AML patients treated with VA.4.The VA has a good effect on elder AML patients with RUNX1 mutations.