Feng Juan, Yuan Rui-Feng, Tang Hai-Long, Bai Qing-Xian, Yang Lan, Dong Hong-Juan, Liang Rong, Zhang Tao, Gu Hong-Tao, Gao Guang-Xun
Department of Hematology, Xijing Hospital, Air Force Medical University, Xi'an 710032, Shannxi Province, China.
Department of Hematology, Xijing Hospital, Air Force Medical University, Xi'an 710032, Shannxi Province, China,E-mail:
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2023;31(4):960-966. doi: 10.19746/j.cnki.issn.1009-2137.2023.04.005.
AbstractObjective: To investigate the efficacy and safety of venetoclax-based induction chemotherapy in newly diagnosed (ND) patients ineligible for intensive therapy and patients with relapsed/refractory (R/R) acute myeloid leukemia (AML).
The clinical data of 51 newly diagnosed patients ineligible for intensive therapy and patients with R/R AML treated in the Department of Hematology of Xijing Hospital from February 1, 2021 to April 30, 2022 were retrospectively analyzed. The incidence of complete remission (CR)/CR with incomplete hematological recovery (CRi), objective remission rate (ORR), minimal residual disease (MRD) status, advense events (AE), overall survival (OS) and progression-free survival (PFS) were analyzed.
Among 51 patients, 32 patients were newly diagnosed patients unfit for intensive therapy, with a median age of 60 (29-88) years, and 19 patients were R/R patients, with a median age of 49 (22-92) years. The median cycles of VEN-based treatment in the two groups were both 2. The CR/CRi rates in the ND-AML and R/R-AML group after one course of induction treatment were 65.6% and 36.9%, respectively, and the ORR were 81.3% and 42.1%, respectively. The cumulative CR/CRi rates after 1-3 courses of VEN-based treatment were 71.9% and 47.4%, respectively. The MRD negativity rates of patients achieving CR/CRi were 69.6% and 33.3%, respectively. In the ND-AML and R/R-AML group, the median PFS were 8(5-11) and 3(1-5) months, and the median OS were 13 (6-20) and 5 (3-7) months, respectively. The median OS of patients achieving CR/CRi in both groups was significantly better than that of patients not achieving CR/CRi (13 months 4 months; OS not reached 4 months). During the first induction cycle, the incidence of grade 3 or higher granulocytopenia, anemia and thrombocytopenia was 96%, 90.2% and 84.3%, respectively. 30 patients (58.8%) had granulocytopenia with fever. The most common non-hematological AE was infection (12/51, 23.5%), followed by gastrointestinal symptoms (6/51, 11.8%).
The VEN-based strategy has good treatment response and tolerance in newly diagnosed patients unfit for intensive therapy and R/R AML. The most common AEs are hematological toxicities and infection.
摘要
探讨维奈克拉诱导化疗在不适合强化治疗的新诊断（ND）患者及复发/难治性（R/R）急性髓系白血病（AML）患者中的疗效和安全性。
回顾性分析2021年2月1日至2022年4月30日在西京医院血液科治疗的51例不适合强化治疗的新诊断患者及R/R AML患者的临床资料。分析完全缓解（CR）/伴有血液学不完全恢复的CR（CRi）发生率、客观缓解率（ORR）、微小残留病（MRD）状态、不良事件（AE）、总生存期（OS）和无进展生存期（PFS）。
51例患者中，32例为不适合强化治疗的新诊断患者，中位年龄60（29 - 88）岁，19例为R/R患者，中位年龄49（22 - 92）岁。两组基于维奈克拉的治疗中位疗程均为2个。ND - AML组和R/R - AML组经过1个疗程诱导治疗后的CR/CRi率分别为65.6%和36.9%，ORR分别为81.3%和42.1%。经过1 - 3个疗程基于维奈克拉的治疗后的累积CR/CRi率分别为71.9%和47.4%。达到CR/CRi的患者的MRD阴性率分别为69.6%和33.3%。在ND - AML组和R/R - AML组中，中位PFS分别为8（5 - 11）个月和3（1 - 5）个月，中位OS分别为13（6 - 20）个月和5（3 - 7）个月。两组中达到CR/CRi的患者的中位OS显著优于未达到CR/CRi的患者（13个月对4个月；OS未达到对4个月）。在第一个诱导周期中，3/4级及以上粒细胞减少、贫血和血小板减少的发生率分别为96%、90.2%和84.3%。30例患者（58.8%）发生粒细胞减少伴发热。最常见的非血液学AE是感染（12/51，23.5%），其次是胃肠道症状（6/51，11.8%）。
基于维奈克拉的策略在不适合强化治疗的新诊断患者及R/R AML中具有良好的治疗反应和耐受性。最常见的AE是血液学毒性和感染。
