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Venetoclax combined low methylation drugs are the new standard of care for patients with acute myeloid leukemia (AML) who are 75 years of age and older or are not suitable for a new diagnosis of intensive chemotherapy.
efficacy studies have shown that the 10-day treatment plan has demonstrated superior efficacy in patients with high-risk AML in Phase 2 clinical trials.
, DiNardo and others speculate that Venetoclax's combination of siddica 10-day therapy may improve the efficacy of newly diagnosed or recurring/recurring AML patients.
The study was a single-center Phase 2 trial that recruited newly diagnosed AML patients over the age of 60 who were not suitable for intensive chemotherapy, AML patients with secondary bone marrow growth abnormality syndrome or chronic myeloid monocytoblast leukemia, and patients with recurring/resoccurring AML.
was induced chemotherapy at 20 mg/m2 (static drops, 10 days in a series) and Venetoclax 400 mg/day (oral) and then consolidated chemotherapy at 5 days at West Tythabin and Venetoclax.
end point is the overall mitigation rate.
secondary endpoint is safety, overall survival, and mitigation duration.
January 19, 2016 - December 16, 2019, 168 patients were recruited, 70 of whom (42%) were newly diagnosed AML, 1 5 (9%) were untreated secondary AML, 28 (17%) were treated secondary AML, and 55 (33%) were recurring/re treatable AML.
71 years of age (IQR 65-76), 30% of patients with ECOG performance status of 2 points.
the medium follow-up time for all patients was 16 months (95% CI 12-18; actual follow-up 6.5 months; IQR 3.4-12.4).
overall remission rate was 74% (125/168): newly diagnosed AML, untreated secondary AML, treated secondary AML and recurring/resusable AML were 89%, 80%, 61% and 62%, respectively.
most common adverse reactions requiring urgent treatment include infections (47%) associated with a reduction in grade 3-4 neutral granulocytes and a decrease in feberative neutral granulocytes (29%).
139 patients (83%) experienced severe adverse reactions, the most common being neutral granulocyte-reduced fever (38%), followed by pneumonia (10%) and sepsis (10%).
30-day mortality rate was 3.6% (95% CI 1.7-7.8) for all patients.
the medium overall survival of newly diagnosed AML, untreated secondary AML, treated secondary AML and recurring/resusable AML patients was 18.1 months (95% CI 10.0-not achieved), 7.8 months (2.9-10.7), 6.0 months (3). .4-13.7) and 7.8 months (5.4-13.3), with the medium duration of mitigation not reached (9.0-not reached), 5.1 months (0.9-not reached), under-reached (2.5-not reached), and 16.8 months (6.6-bit reached).
the safety of Venetoclax's combined Siddarabin 10-day therapy is controllable, and the anti-tumor activity of newly diagnosed AML and recurring/refractic AML is high.
results could be validated by larger randomized trials in the future.
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