Blood: Venetoclax joint LDAC improves clinical prognosis in AML patients not suitable for intensive chemotherapy

For patients with acute myeloid leukemia (AML) who are unable to tolerate intensive chemotherapy, effective treatment options are limitedThis study is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial that recruited 211 newly diagnosed AML patients over the age of 18 who do not apply intensive chemotherapyThe subjects were randomly divided into the venetoclax group (143 persons) or the placebo group (68 people) at 2:1, and the two groups were combined with low doses of acesssssss (LDAC) for the first 10 days of each courseThe primary endpoint is the overall survival period (OS);the median age of the patients in the subject was 76 years (36-93 years), 38% of the patients were secondary AML, and 20% were previously treated with an under-methylation (HMA)The main analysis showed that the risk of death in the venetoclax group was reduced by 25% compared to LDAC alone (the risk ratio was 0.75 (95% CI 0.52-1.07), p-0.11), although there was no statistical difference; Analysis after 6 months of additional follow-up showed that the median OS in the venetoclax group was 8.4 months (HR 0.70; 95% CI 0.50-0.98; p-0.04)Cr/CRi for venetoclax combined LDAC therapy was 48%, compared with 13% for LDAC treatment aloneAdverse reactions at level 3 and above were (Ven vs LDAC): febrile neutrophil reduction (32% vs 29%), neutrophil reduction (47% vs16%) and platelet reduction (45% vs 37%)within a controlled safety range, Venetoclax combined LDAC therapy can significantly improve AML mitigation and OS compared to LDAC aloneThis study confirms that venetoclax combined with LDAC is an important first-line treatment for AML patients who are not suitable for intensive chemotherapy