학술논문
维奈克拉联合CACAG方案治疗难治/复发急性髓系白血病的前瞻性临床研究 / Venetoclax Combined with CACAG Regimen in the Treatment of Patients with Refractory/Relapse Acute Myeloid Leukemia:A Prospective Clinical Study
Document Type
Academic Journal
Author
高文静; 杨晶晶; 李猛; 温亚男; 焦一帆; 乐凝; 刘宇辰; 王楠; 黄赛; 窦立萍; GAO Wen-Jing; YANG Jing-Jing; LI Meng; WEN Ya-Nan; JIAO Yi-Fan; LE Ning; LIU Yu-Chen; WANG Nan; HUANG Sai; DOU Li-Ping
Source
中国实验血液学杂志 / Journal of Experimental Hematology. 32(1):90-95
Subject
Language
Chinese
ISSN
1009-2137
Abstract
目的:探讨维奈克拉联合CACAG方案治疗难治/复发急性髓系白血病(R/R AML)的有效性和安全性.方法:本研究为前瞻性单臂临床研究,入组患者均符合R/R AML诊断标准.采用阿扎胞苷(75 mg/m2,d 1-7)、阿糖胞苷(75-100 mg/m2,q12h,d 1-5)、阿柔比星(20 mg,d 1、3 和 5)、西达本胺(30 mg,d 1 和4)、维奈克拉(100 mg d 1,200 mg d 2,400 mg d 3-14,与唑类药物联用,减量为100 mg/d)、重组人粒细胞集落刺激因子(300 μg/d,直至中性粒细胞恢复)的治疗方案,主要研究终点为1疗程后总反应率.结果:自2022年1月至2023年4月共入组19例患者,1个疗程后总反应率为81.3％(13/16),完全缓解率为68.8％(11/16),部分缓解率为12.5％(2/16),在11例获得完全缓解(CR/CRi)的患者中,达CRm8例,未达CRm 3例.截至2023年3月27日,中位随访时间为111(19-406)d.6个月的总生存率和无进展生存率均为55.7％;1年的总生存率和无进展生存率分别为46.4％和47.7％.此外,相比于未达CRm组,CRm组患者具有较高的PFS(377 vs 111 d,P=0.046).治疗相关不良反应主要是3-4级骨髓抑制,并发不同程度的感染(n=12)、低钾血症(n=12)、低钙血症(n=10)和肝酶升高(n=8)等,其中3-4级占比为47.4％(9/19).结论:维奈克拉联合CACAG方案是R/R AML患者有效的挽救性治疗方案,缓解率高且安全性良好.
Objective:To investigate the efficacy and safety of Venetoclax combined with CACAG regimen in treatment of patients with refractory/relapse acute myeloid leukemia(R/R AML).Methods:The study was a singlecenter prospective clinical trial.The enrolled patients met the criteria for R/R AML.Treatment included Azacidine(75mg/m2,d1-7),Ara-C(75-100 mg/m2,q12h,d1-5),Aclacinomycin(20 mg d1,d3,d5),Chidamide(30 mg d1,d4),Venetoclax(100 mg d1,200 mg d2,400 mg d3-d14,in combination with Triazole Drug,reduced to 100 mg/d),and granulocyte colony-stimulating factor(300 μg/d until neutrophil recovery).The primary endpoint of observation was overall response rate after 1 course of treatment.Results:A total of 19 patients were enrolled from January 2022 to April 2023.After 1 course of treatmen,the overall response rate was 81.3％(13/16),the CR rate was 68.8％(11/16),and the PR was 12.5％(2/16).Among the 11 patients who got CR/CRi,8 cases achieved CRm(minimal residual disease negative CR)and 3 cases did not.As of March 27,2023,the median follow-up time was 111(19-406)days.The six-month overall survival and progression-free survival rates were both 55.7％,the 1-year overall survival and progression-free survival rates were 46.4％and 47.7％,respectively.In addition,compared with the non-CRm group,CRm patients had a better PFS(377 days vsi11 days,P=0.046).Treatment-related adverse events were mainly 3-4 degrees of bone marrow suppression,complicated by various degrees of infection(n=12),hypokalemia(n=12)and hypocalcemia(n=10)and elevated liver enzymes(n=8),of which 3/4 degrees accounted for 47.4％(9/19).Conclusion:The Venetoclax combined with CACAG regimen is an effective salvage therapy for patients with R/R AML,with high remission rate and safety profile.
Objective:To investigate the efficacy and safety of Venetoclax combined with CACAG regimen in treatment of patients with refractory/relapse acute myeloid leukemia(R/R AML).Methods:The study was a singlecenter prospective clinical trial.The enrolled patients met the criteria for R/R AML.Treatment included Azacidine(75mg/m2,d1-7),Ara-C(75-100 mg/m2,q12h,d1-5),Aclacinomycin(20 mg d1,d3,d5),Chidamide(30 mg d1,d4),Venetoclax(100 mg d1,200 mg d2,400 mg d3-d14,in combination with Triazole Drug,reduced to 100 mg/d),and granulocyte colony-stimulating factor(300 μg/d until neutrophil recovery).The primary endpoint of observation was overall response rate after 1 course of treatment.Results:A total of 19 patients were enrolled from January 2022 to April 2023.After 1 course of treatmen,the overall response rate was 81.3％(13/16),the CR rate was 68.8％(11/16),and the PR was 12.5％(2/16).Among the 11 patients who got CR/CRi,8 cases achieved CRm(minimal residual disease negative CR)and 3 cases did not.As of March 27,2023,the median follow-up time was 111(19-406)days.The six-month overall survival and progression-free survival rates were both 55.7％,the 1-year overall survival and progression-free survival rates were 46.4％and 47.7％,respectively.In addition,compared with the non-CRm group,CRm patients had a better PFS(377 days vsi11 days,P=0.046).Treatment-related adverse events were mainly 3-4 degrees of bone marrow suppression,complicated by various degrees of infection(n=12),hypokalemia(n=12)and hypocalcemia(n=10)and elevated liver enzymes(n=8),of which 3/4 degrees accounted for 47.4％(9/19).Conclusion:The Venetoclax combined with CACAG regimen is an effective salvage therapy for patients with R/R AML,with high remission rate and safety profile.