Liu Xia-Xia, Wen Xiao-Ling, Li Ruo-Qi, Zhang Xia-Lin, Zhang Tian-Bo, Dong Chun-Xia, Wang Mei-Fang, Zhang Jian-Hua, Yang Lin-Hua, Zhang Rui-Juan
Department of Hematology, The Second Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China.
Department of Hematology,The Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, Shanxi Province, China.
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2024 Feb;32(1):96-103. doi: 10.19746/j.cnki.issn.1009-2137.2024.01.016.
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).
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.
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 ( >0.05). In the VEN+AZA group, there were 5 non-remission (NR) patients, 4 with chromosome 7 abnormality (7q-/-7), and 1 with gene mutation. Median followed-up time between the two groups was 8 months and 12 months, respectively, and the 6-months OS was 84% 92% ( =0.389), while 6-months PFS was 84% 92% ( =0.258). The main hematological adverse reactions in two groups were stage Ⅲ-Ⅳ myelosuppression, and the incidence rate was not statistically different( >0.05). The median time of neutrophil recovery in two groups was 27(11-70) d, 25(14-61) d （ =0.161）, and platelet recovery was 27(11-75) d, 25(16-50) d （ =0.270）, respectively. The infection rate of VEN+AZA group was lower than that of "7+3" group (56% 88%, =0.012）. The rate of lung infections of two groups was 36% and 64%, respectively, the difference was statistically significant ( =0.048).
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.
比较维奈克拉（VEN）联合阿扎胞苷（AZA）与“7+3”方案治疗新诊断老年急性髓系白血病（AML）患者的短期疗效及不良反应。
回顾性分析2021年1月至2022年1月山西医科大学第二医院和山西白求恩医院79例新诊断老年AML患者的临床资料，分为VEN+AZA组（41例）和“7+3”组（38例）。采用倾向评分匹配（PSM）法平衡混杂因素，然后比较两组的缓解情况、总生存期（OS）、无进展生存期（PFS）及不良反应。
VEN+AZA组和“7+3”组的客观缓解率（ORR）分别为68%和84%，完全缓解伴血细胞计数不完全恢复（CRc）分别为64%和72%，差异无统计学意义（P>0.05）。VEN+AZA组有5例未缓解（NR）患者，4例有7号染色体异常（7q-/-7），1例有基因突变。两组的中位随访时间分别为8个月和12个月，6个月总生存率分别为84%和92%（P=0.389），6个月无进展生存率分别为84%和92%（P=0.258）。两组主要血液学不良反应均为Ⅲ-Ⅳ度骨髓抑制，发生率差异无统计学意义（P>0.05）。两组中性粒细胞恢复中位时间分别为27（1170）天、25（1461）天（P=0.161），血小板恢复中位时间分别为27（1175）天、25（1650）天（P=0.270）。VEN+AZA组感染率低于“7+3”组（56%对88%，P=0.012）。两组肺部感染率分别为36%和64%，差异有统计学意义（P=0.048）。
VEN+AZA组与“7+3”方案治疗老年AML患者的短期疗效相似，但VEN+AZA方案感染发生率较低。7号染色体异常（7q-/-7）可能是VEN+AZA方案治疗老年AML患者预后不良的因素。
