ArticleOncology and therapy2025
Real-World Experience with Venetoclax Treatment for Newly-Diagnosed Acute Myeloid Leukemia in Japan (VENUS Study): An Interim Analysis Focusing on Neutropenia Management.
Article in Oncology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Review
- Real-world outcomes of venetoclax and azacitidine in Japanese patients with newly diagnosed acute myeloid leukemia (VENUS study).International journal of hematology · 2026Article
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionVenetoclax has demonstrated clinical benefit for newly-diagnosed acute myeloid leukemia (AML), but significant neutropenia is a concern. Data on the time course of neutrophil counts for across treatment cycles in real-world settings remain limited. We report an interim analysis of the VENUS study, which examined neutropenia management in patients with AML receiving venetoclax with azacitidine (VEN/AZA) in Japan.
methodsThis multicenter (10 sites), retrospective, observational study included adults with newly-diagnosed AML ineligible for intensive chemotherapy and initiating venetoclax treatment. Treatment patterns, granulocyte colony-stimulating factor (G-CSF) use, antifungal prophylaxis, and time course of neutrophil counts were analyzed for patients who received > 1 cycle of venetoclax.
resultsVenetoclax was administered for a median 27.0 days in Cycle 1 and then a median 21.0 (range 14.0-22.0) days for subsequent cycles, with median dose holds at the end of each cycle of 8.5-15.0 days. Patients (n = 81) receiving G-CSF were treated with VEN/AZA for a median of 6.0 cycles versus 3.0 in those who did not receive G-CSF (n = 39). In Cycle 1, median neutrophil counts decreased to < 500/µl during Days 8-28 but recovered to > 500/µl by Days 29-35. Median nadir neutrophil count was reached during Days 22-28 in almost all subsequent cycles until Cycle 10. Neutrophil counts decreased to < 500/µl in some cycles but improved to > 500/µl by the next week, suggesting neutrophil levels without higher risk of infection in most patients after Cycle 2 with venetoclax dosing schedule modifications and G-CSF administration. Eighty-eight (73.3%) patients received antifungal prophylaxis, but risk-based antifungal prophylaxis may be considered.
conclusionThis real-world analysis provides insight into the timing of neutrophil count recovery with dosing schedule modification of venetoclax and G-CSF use in patients with newly-diagnosed AML receiving VEN/AZA, informing timing of the use of antifungal prophylaxis for patients at higher risk.
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