Wang Cai-Zhao, Chu Xiao-Xia, Yu Hong-Yan, Yang En-Qin, Wang Ling, Deng Xiu-Zhi, Ran Xue-Hong, Wang Li-Qing, Zhao Chun-Ting, Liu Xiao-Dan
Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China.
Department of Hematology, Yantai Yuhuangding Hospital, Yantai 264000, Shandong Province, China.
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2023 Aug;31(4):1005-1013. doi: 10.19746/j.cnki.issn.1009-2137.2023.04.012.
To observe the efficacy and safety of different induction regimens of same total dosage of azacitidine (Aza), including standard dose (standard dose group) and low-dose long-term (adjusted dose group), in the treatment of elderly acute myeloid leukemia (AML).
A total of 103 elderly patients with AML (non-acute promyelocytic leukemia) from January 2020 to June 2021 were enrolled. Aza was administered at the standard dose of 75 mg/(m·d) for 7 days in the standard dose group (50 cases), while at 100 mg/d for 7-12 days in the adjusted dose group (53 cases). The administration days in adjusted dose group was calculated based on the total standard dose of the patient's single course of treatment. The efficacy and safety between standard dose group and adjusted dose group were compared. Subgroup analysis were performed in the two groups for Aza alone, Aza combined with BCL-2 inhibitor, and Aza combined with low-dose chemotherapy for efficacy and safety.
There were no significant differences in overall response rate (ORR), incidence of adverse reaction, and 1-year overall survival (OS) rate between standard dose group and adjusted dose group ( >0.05). The ORR of combination was higher than that of Aza alone ( < 0.05), while there was no significant difference in ORR between Aza combined with BCL-2 inhibitor and Aza combined with low-dose chemotherapy ( >0.05). The combination of BCL-2 inhibitor did not increase the incidence of adverse reactions compared wtih Aza alone. There was a higher risk of myelosuppression and pulmonary infection with a combination of low-dose chemotherapy than with a combination of BCL-2 inhibitor and Aza alone ( <0.05). No significant difference was observed in 1-year OS between Aza alone, Aza combined with BCL-2 inhibitor, and Aza combined with low-dose chemotherapy ( >0.05).
Both two induction regimens can be used in elderly AML patients who cannot tolerate intensive chemotherapy with similar overall effectiveness and safety. Aza combined with low-dose chemotherapy may result in increased ORR and an increased incidence of serious adverse reactions, and may not result in longer survival compared with Aza alone. Aza combined with BCL-2 inhibitor not only has similar effect in complete remission, objective response rate, and OS compared with Aza combined with low-dose chemotherapy, but also has higher safety.
观察相同总剂量阿扎胞苷（Aza）的不同诱导方案，即标准剂量（标准剂量组）和低剂量长期（调整剂量组），治疗老年急性髓系白血病（AML）的疗效和安全性。
纳入2020年1月至2021年6月共103例老年AML患者（非急性早幼粒细胞白血病）。标准剂量组（50例）阿扎胞苷按75mg/(m²·d)的标准剂量给药7天，而调整剂量组（53例）按100mg/d给药7 - 12天。调整剂量组的给药天数根据患者单疗程的总标准剂量计算。比较标准剂量组和调整剂量组的疗效和安全性。对两组中单独使用Aza、Aza联合BCL - 2抑制剂以及Aza联合低剂量化疗的疗效和安全性进行亚组分析。
标准剂量组和调整剂量组在总缓解率（ORR）、不良反应发生率和1年总生存（OS）率方面无显著差异（P>0.05）。联合用药的ORR高于单独使用Aza（P<0.05），而Aza联合BCL - 2抑制剂与Aza联合低剂量化疗的ORR无显著差异（P>0.05）。与单独使用Aza相比，联合BCL - 2抑制剂并未增加不良反应的发生率。与BCL - 2抑制剂和Aza单独联合相比，低剂量化疗联合使用时骨髓抑制和肺部感染的风险更高（P<0.05）。单独使用Aza、Aza联合BCL - 2抑制剂以及Aza联合低剂量化疗之间的1年OS无显著差异（P>0.05）。
两种诱导方案均可用于不能耐受强化化疗的老年AML患者，总体有效性和安全性相似。Aza联合低剂量化疗可能导致ORR增加和严重不良反应发生率增加，与单独使用Aza相比可能不会带来更长生存期。Aza联合BCL - 2抑制剂与Aza联合低剂量化疗相比，在完全缓解、客观缓解率和OS方面不仅效果相似，而且安全性更高。
