维奈克拉(Venetoclax)联合阿扎胞苷和西达本胺治疗难治复发急性髓系白血病6例报告并文献复习

Combination of Venetoclax,Azacitidine and Chidamide in treating refractory and relapsed acute myeloid leukemia:six cases reports and literature review

目的探讨维奈克拉(Venetoclax)联合阿扎胞苷和西达本胺方案治疗难治复发急性髓系白血病(refractory/relapsed acute myeloid leukemia,R/R AML)患者的临床疗效和安全性。方法回顾性分析2021年3月15日至2021年11月30日于北京大学人民医院血液科采用Venetoclax联合阿扎胞苷和西达本胺方案治疗的6例R/R AML患者的疗效及安全性,同时监测并统计患者在诱导期间不同时间点(第7天、第14天、第21天和第28天)的Venetoclax稳态谷浓度(C_(min))。结果6例R/R AML患者中,3例观察到临床反应,其中完全缓解(complete remission,CR)2例,CR伴血液学不完全恢复(CR with incomplete hematological recovery,CRi)1例。中位随访时间为178 d,5例患者存活,总生存率为83.3%(5/6)。6例患者诱导第7天、第14天、第21天和第28天的Venetoclax稳态C_(min)分别为(3181.67±1631.90)ng/mL,(2688.67±1926.36)ng/mL,(2142.17±1380.35)ng/mL,(2766.67±1138.55)ng/mL。结论Venetoclax联合阿扎胞苷和西达本胺方案可提高R/R AML患者的疗效,有望成为该类患者挽救性治疗的可行选择之一。

Objective To investigate the clinical efficacy and safety of Venetoclax combined with Azacitidine and Chidamide in treating the patients with refractory and relapsed acute myeloid leukemia(R/R AML).Methods The efficacy and safety of Venetoclax combined with Azacitidine and Chidamide for 6 R/R AML patients treated in the Department of Hematology,Peking University People's Hospital,from March 15,2021 to November 30,2021,were retrospectively analyzed.The steady-state trough concentrations(C_(min))of Venetoclax at different times during the induction period(day 7,14,21 and 28)were monitored and counted.Results Among the 6 R/R AML patients,3 patients showed clinical response,including 2 complete remission(CR)and 1 CR with incomplete hematological recovery(CRi).The median follow-up time was 178 days.There were 5 patients currently alive,with an overall survival(OS)rate of 83.3%(5/6).The steady-state C_(min) of Venetoclax on day 7,14,21 and 28 were(3181.67±1631.90)ng/mL,(2688.67±1926.36)ng/mL,(2142.17±1380.35)ng/mL,(2766.67±1138.55)ng/mL,respectively.Conclusions Venetoclax combined with Azacitidine and Chidamide can improve the clinical efficacy in R/R AML patients,and such a combination is expected to be one of the feasible options for the salvage therapy of R/R AML patients.