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  

Short-term Effect of Venetoclax Combined with Azacitidine and“7+3”Regimen in the Treatment of Newly Diagnosed Elder Patients with Acute Myeloid Leukemia

作　　者：刘霞霞 文晓玲 黎若祺 张夏林[2] 张恬波 董春霞[1] 王梅芳[1] 张建华[1] 杨林花[1] 张睿娟[2] 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 Universiy,Taiyuan 030001,Shari Province,China;Deparment of Hematology,The Third Hospital of Shanxi Medical University,Sharxi Bethune Hospital,Shanwi Academy of Medical Sciences,Tongji Shanxi Hospital,Taiyuan 030032,Shanxi Province,China)

机构地区：[1]山西医科大学第二医院血液科,山西太原030001 [2]山西医科大学第三医院血液科(山西白求恩医院山西医学科学院同济山西医院),山西太原030032

出　　处：《中国实验血液学杂志》2024年第1期96-103,共8页Journal of Experimental Hematology

基　　金：山西白求恩医院人才引进项目(2021RC017)。

摘　　要：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。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),progression-free 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 w as 84%vs 92%(P=0.258).The main hematological adverse reactions in tw o groups w ere stageⅢ-Ⅳmyelosuppression,and the incidence rate w as not statistically different(P>0.05).The median time of neutrophil recovery in tw o groups w as 27(11-70)d,25(14-61)d(P=0.161),and platelet recovery w as 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 w as statistically significant(P=0.048).Conclusion:The short-term effect of VEN+AZA group and"7+3"regimens in eldrly AM L patients are similar,but the VEN+AZA regimen had a low er incidence of infection.The presence of chromosome 7 abnormality(7q-/-7)may be a poor prognostic factor for elderly AM L patients treated w ith VEN+AZA.

关 键 词：急性髓系白血病 维奈克拉 抗肿瘤联合化疗方案 疗效 安全性 

分 类 号：R733.71[医药卫生—肿瘤]