Venetoclax with low-dose cytarabine for patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy: results from the Chinese cohort of a phase three randomized placebo-controlled trial
10.3760/cma.j.issn.0253-2727.2021.04.004
- VernacularTitle:Venetoclax联合低剂量阿糖胞苷治疗不耐受强化化疗的初治急性髓系白血病患者：一项Ⅲ期随机、安慰剂对照试验中中国队列结果
- Author:
Yu HU
1
;
Jie JIN
;
Yu ZHANG
;
Jianda HU
;
Junmin LI
;
Xudong WEI
;
Sujun GAO
;
Jiuhong ZHA
;
Qi JIANG
;
Jun WU
;
Wellington MENDES
;
H. Andrew WEI
;
Jianxiang WANG
Author Information
1. 华中科技大学同济医学院附属协和医院，武汉 430022
- Keywords:
Leukemia, myeloid, acute;
Venetoclax;
Low-dose cytarabine
- From:
Chinese Journal of Hematology
2021;42(4):288-294
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the safety and efficacy of venetoclax with low-dose cytarabine (LDAC) in Chinese patients with acute myeloid leukemia (AML) who are unable to tolerate intensive induction chemotherapy.Methods:Adults ≥ 18 years with newly diagnosed AML who were ineligible for intensive chemotherapy were enrolled in this international, randomized, double-blind, placebo-controlled trial. Globally, patients ( n=211) were randomized 2∶1 to either venetoclax with LDAC or placebo with LDAC in 28-d cycles, with LDAC on days 1-10. The primary endpoint was OS; the secondary endpoints included response rates, event-free survival, and adverse events. Results:A total of 15 Chinese patients were enrolled (venetoclax arm, n=9; placebo arm, n=6) . The median age was 72 years (range, 61-86) . For the primary analysis, the venetoclax arm provided a 38% reduction in death risk compared with the placebo[hazard ratio ( HR) , 0.62 (95% CI 0.12-3.07) ]. An unplanned analysis with an additional 6 months of follow-up demonstrated a median OS of 9.0 months for venetoclax compared with 4.1 months for placebo. The complete remission (CR) rates with CR with incomplete blood count recovery (CRi) were 3/9 (33%) and 0/6 (0%) , respectively. The most common non-hematologic adverse effects (venetoclax vs placebo) were hypokalemia[5/9 (56%) vs 4/6 (67%) ], vomiting[4/9 (44%) vs 3/6 (50%) ], constipation[2/9 (22%) vs 4/6 (67%) ], and hypoalbuminemia[1/9 (11%) vs 4/6 (67%) ]. Conclusion:Venetoclax with LDAC demonstrated meaningful efficacy and a manageable safety profile in Chinese patients consistent with the observations from the global VIALE-C population, making it an important treatment option for patients with newly diagnosed AML who are otherwise ineligible for intensive chemotherapy.
