Objective: To compare the short-term effect and adverse reaction of venetoclax (VEN) combined with azacitidine (AZA) versus "7+3" regimen in newly diagnosed elder patients with acute myeloid leukemia (AML).
Methods: From January 2021 to January 2022, the clinical data of seventy-nine newly diagnosed elder patients with AML at the Second Hospital of Shanxi Medical University and the Shanxi Bethune Hospital were retrospectively analyzed, including VEN+AZA group (41 cases) and "7+3" group (38 cases). The propensity score matching(PSM) method was used to balance confounding factors， then response， overall survival(OS), progressionfree survival(PFS) and adverse reactions between the two groups were compared.
Results: The ORR of VEN+AZA group and "7+3" group was 68% and 84%, respectively, and the CRc was 64% and 72%, respectively, the differents were not statistically significant (P >0.05). In the VEN+AZA group, there were 5 non-remission (NR) patients, 4 with chromosome 7 abnormality (7q-/-7), and 1 with ETV6 gene mutation. Median followed-up time between the two groups was 8 months and 12 months, respectively, and the 6-months OS was 84% vs 92% (P =0.389), while 6-months PFS was 84% vs 92% (P =0.258). The main hematological adverse reactions in two groups were stage Ⅲ-Ⅳ myelosuppression, and the incidence rate was not statistically different(P >0.05). The median time of neutrophil recovery in two groups was 27(11-70) d, 25(14-61) d （P =0.161）, and platelet recovery was 27(11-75) d, 25(16-50) d （P =0.270）, respectively. The infection rate of VEN+AZA group was lower than that of "7+3" group (56% vs 88%, P =0.012）. The rate of lung infections of two groups was 36% and 64%, respectively, the difference was statistically significant (P =0.048).
Conclusion: The short-term effect of VEN+AZA group and "7+3" regimens in eldrly AML patients are similar， but the VEN+AZA regimen had a lower incidence of infection. The presence of chromosome 7 abnormality（7q-/-7） may be a poor prognostic factor for elderly AML patients treated with VEN+AZA.
题目: 维奈克拉联合阿扎胞苷与“7+3”方案在新诊断老年急性髓系白血病中近期疗效的初步观察.
目的: 比较维奈克拉(VEN)联合阿扎胞苷（AZA)与标准“7+3”方案诱导治疗新诊断老年急性髓系白血病（AML）的近期疗效及不良反应。.
方法: 回顾性分析山西医科大学第二医院和山西白求恩医院自2021年1月至2022年1月间接受VEN+AZA方案(41例)或“7+3”方案（38例）诱导治疗且资料完整的79例老年AML患者的临床数据，采用倾向性评分匹配法（PSM）均衡组间混杂因素后，比较组间缓解率、总生存时间（OS）、无进展生存时间（PFS）以及不良反应。.
结果: VEN+AZA组总反应率（ORR）为68%，“7+3”组为84%，其中复合缓解率（CR+CRi；CRc）分别为64%和72%，两组ORR（P =0.185）及CRc（P =0.544）均无统计学差异。VEN+AZA组的5例未缓解（NR）患者中，4例伴7号染色体异常（7q-/-7），1例伴ETV6基因突变。两组中位随访时间分别为8和12个月，6个月OS、PFS率均无统计学差异（84% vs 92%，P =0.389；84% vs 92%，P =0.258）。两组的血液学不良反应主要是Ⅲ-Ⅳ级骨髓抑制，其发生率比较无统计学意义（P ＞0.05）。两组中性粒细胞恢复中位时间分别为 27（11-70） 和 25（14-61）d（P ＝0.161），血小板恢复中位时间分别为27（11-75）和25（16-50）d（P =0.270），差异无统计学意义。VEN+AZA组感染发生率低于“7+3”方案组（56% vs 88%，P =0.012），两组肺部感染率分别为36%和64%（P =0.048），差异均有统计学意义。.
结论: VEN+AZA和标准“7+3”方案治疗新诊断老年AML的近期疗效相近，但VEN+AZA组感染发生率低。伴有7号染色体异常（7q-/-7）可能是老年AML患者接受VEN+AZA治疗的不良预后因素。.
Keywords: venetoclax; acute myeloid leukemia; antineoplastic combined chemotherapy protocols; efficacy; safety.