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Title: [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].
Author: Hu Y, Jin J, Zhang Y, Hu JD, Li JM, Wei XD, Gao SJ, Zha JH, Jiang Q, Wu J, Mendes W, Wei AH, Wang JX.
Journal: Zhonghua Xue Ye Xue Za Zhi; 2021 Apr 14; 42(4):288-294. PubMed ID: 33979972.
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. 目的： 探讨Venetoclax联合低剂量阿糖胞苷（LDAC）在不能耐受强化诱导化疗的中国急性髓系白血病（AML）患者中的疗效及安全性。 方法： 一项Ⅲ期随机、双盲安慰剂对照试验（VIALE-C）中中国队列的结果。在本项国际临床试验中，入组了不适合接受强化化疗、新诊断为AML的18岁或以上的成人患者。在全球范围内，患者（211例）按2∶1的比例随机分配接受Venetoclax+LDAC或安慰剂+LDAC（28 d为1个周期），在第1~10天接受LDAC。主要研究终点为总生存（OS）；次要研究终点包括缓解率、无事件生存期及不良事件（AE）。 结果： 入组15例中国患者（Venetoclax组9例；安慰剂组6例）。中位年龄为72（61~86）岁。与安慰剂组相比，Venetoclax组的死亡风险下降38%（HR=0.62，95%CI 0.12~3.07）。对延长6个月随访进行的计划外分析显示，Venetoclax组的中位OS时间为9.0个月，安慰剂组为4.1个月。完全缓解（CR）率与血细胞计数未完全恢复的CR（CRi）率分别为33%（3/9）和0（0/6）。最常见的非血液学AE（Venetoclax组与安慰剂组）为低钾血症（5/9和4/6）、呕吐（4/9和3/6）、便秘（2/9和4/6）和低白蛋白血症（1/9和4/6）。 结论： Venetoclax联合LDAC在中国患者中表现出有意义的疗效和可管理的安全性特征，这与在全球VIALE-C人群中的观察结果一致，使其成为不适合接受强化化疗的新诊断AML患者的一个重要治疗选择。.

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