Seven-day Venetoclax Combined With Dose-adjusted Intensive Chemotherapy as Induction Treatment in Newly Diagnosed Acute Myeloid Leukemia.
In 259 newly diagnosed AML patients drawn from two clinical trials and one retrospective study, seven-day venetoclax plus one of three dose-adjusted intensive chemotherapy regimens produced a 90.3% composite complete remission rate, 92.2% flow-cytometric MRD negativity, and estimated 24-month overall survival of 72.9%.
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In 259 newly diagnosed AML patients drawn from two clinical trials and one retrospective study, seven-day venetoclax plus one of three dose-adjusted intensive chemotherapy regimens produced a 90.3% composite complete remission rate, 92.2% flow-cytometric MRD negativity, and estimated 24-month overall survival of 72.9%.
Research significance
The reported clinical outcomes support seven-day venetoclax plus dose-adjusted intensive chemotherapy as a potentially active induction strategy; it may preserve efficacy while reducing myelosuppression relative to longer venetoclax schedules, but that comparative safety advantage is an inference because no longer-duration control group or detailed toxicity comparison is reported.
Source abstract
While venetoclax (VEN) combined with intensive chemotherapy (IC) has demonstrated efficacy in newly diagnosed acute myeloid leukemia (AML), the optimal duration of VEN administration remains uncertain, leading to variability in its application during induction therapy. Herein, we reported the data of 259 ND AML patients who received 7-day VEN combined with dose-adjusted IC (DA, HAA, or HAD) as induction treatment, to further validate the efficacy and explore the safety of this combination. This study evaluated a truncated 7-day VEN regimen combined with dose-adjusted IC (DA, HAA, or HAD) as induction therapy. The patients included in this study were derived from 2 clinical trials (VEN+DA: ChiCTR2200061524; VEN+HAA: NCT05893472) and 1 retrospective study (VEN+HAD). All induction regimens include a 7-day oral administration of VEN, in combination with either DA, HAA, or HAD regimen. The composite complete remission rate was 90.3%, with a minimal residual disease (MRD) negativity rate of 92.2% as assessed by flow cytometry. After a median follow-up of 18 months, the median overall survival and event-free survival (EFS) were not reached. The estimated 24-month OS, EFS, and relapse-free survival (RFS) rates for the entire cohort were 72.9%, 69.3%, and 70.2%, respectively. No significant differences in survival outcomes were observed among the 3 treatment regimens (OS: P = .68; EFS: P = .73; RFS: P = .34). The median time of the absolute neutrophil count recovered to≥ 0.5 × 109/L and the platelet count to≥ 30 × 109/L after induction therapy was 14 (range: 5-52) days and 13 (range: 4-63) days, respectively. In conclusion, a 7-day VEN schedule maintains high efficacy while potentially reducing myelosuppressive risks of longer regimens.