Venetoclax with low-dose cytarabine, a forgotten combination in patients with acute myeloid leukemia ineligible for intensive chemotherapy: a systematic review.

Lauro Fabián Amador-Medina, Erick Crespo-Solís, Francisco Javier Turrubiates-Hernández, Karla Edith Santibañez-Bedolla
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Abstract

Background: Based on the VIALE-A and VIALE-C studies, the Food and Drug Administration approved venetoclax in 2020 in combination with azacitidine or low-dose cytarabine for the treatment of patients with acute myeloid leukemia ineligible for intensive chemotherapy. After the publication of these studies, venetoclax/azacitidine was assumed to be superior to venetoclax/low-dose cytarabine; however, these studies were not designed to demonstrate superiority between these combinations. Therefore, we conducted a systematic review to describe overall survival, complete remission rate, and composite complete remission rate to assess response of these two regimens in patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.

Materials and methods: The PubMed and Web of Science databases were searched for retrospective studies and complete remission, composite complete remission, and overall survival rates were recorded.

Results: Only 11 of the 815 publications identified were eligible to be included n this review, ten studies evaluated the venetoclax/azacitidine combination and one study evaluated the venetoclax/low-dose cytarabine combination. The median overall survival for venetoclax/azacitidine was 10.75 months, whereas for venetoclax/low-dose cytarabine the median overall survival had not been reached at the time of publication. Composite complete remission was 63.3 % for venetoclax/azacitidine and 90 % for venetoclax/low-dose cytarabine. Adverse events were similar for both combinations.

Conclusions: A limited number of studies investigating the venetoclax/low-dose cytarabine combination exist. Based on the available data, the superiority of venetoclax/azacitidine over venetoclax/low-dose cytarabine cannot be assumed for all acute myeloid leukemia patients who are ineligible for intensive chemotherapy. Venetoclax/low-dose cytarabine can still be considered as an option for the drug combinations currently under investigation.

Venetoclax与小剂量阿糖胞苷--不符合强化化疗条件的急性髓性白血病患者的忘我组合:系统综述。
背景:基于VIALE-A和VIALE-C研究,美国食品和药物管理局于2020年批准了venetoclax与阿扎胞苷或小剂量阿糖胞苷联合用于治疗不符合强化化疗条件的急性髓性白血病患者。这些研究发表后,人们认为 Venetoclax/阿扎胞苷优于 Venetoclax/小剂量阿糖胞苷;然而,这些研究并非旨在证明这些组合之间的优越性。因此,我们进行了一项系统性综述,以描述新诊断的急性髓性白血病患者的总生存期、完全缓解率和复合完全缓解率,评估这两种方案对不符合强化化疗条件的患者的反应:在PubMed和Web of Science数据库中检索回顾性研究,记录完全缓解率、复合完全缓解率和总生存率:在815篇文献中,只有11篇符合纳入本综述的条件,其中10篇研究评估了venetoclax/阿扎胞苷联合疗法,1篇研究评估了venetoclax/小剂量阿糖胞苷联合疗法。Venetoclax/阿扎胞苷的中位总生存期为10.75个月,而Venetoclax/小剂量阿糖胞苷的中位总生存期在发表时尚未达到。Venetoclax/阿扎胞苷的复合完全缓解率为63.3%,Venetoclax/小剂量阿糖胞苷的复合完全缓解率为90%。两种组合的不良反应相似:研究文尼他克/小剂量阿糖胞苷组合的研究数量有限。根据现有数据,对于所有不符合强化化疗条件的急性髓性白血病患者,不能认为 Venetoclax/azacitidine 优于 Venetoclax/ 小剂量阿糖胞苷。对于目前正在研究的药物组合,仍可考虑将 Venetoclax/ 小剂量阿糖胞苷作为一种选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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