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The impact of post-remission G-CSF on outcomes in the VIALE-A and VIALE-C trials
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A post hoc analysis assessed the impact of post-remission G-CSF in patients with ND AML who were ineligible for intensive chemotherapy and received venetoclax + azacitidine or venetoclax + LDAC in the phase III VIALE-A (NCT02993523) and VIALE-C (NCT03069352) trials, respectively.1 Results were published in the American Journal of Hematology by DiNardo et al.1 |
| Key learnings |
| The median DOR was 25.5 months and 15.3 months in patients who received G-CSF vs 12.8 months and 11.5 months in those who received no G-CSF in the VIALE-A and VIALE-C trials, respectively. |
| The median OS was 30.8 months and 23.0 months in patients who received G-CSF vs 21.1 months and 13.7 months in those who received no G-CSF in the VIALE-A and VIALE-C trials, respectively. |
| Patients who received G-CSF post-remission with venetoclax-based treatment in the VIALE-A and VIALE-C trials had shorter delays between treatment cycles vs patients who did not receive G-CSF, with no new safety signals. |
| Results suggest that incorporating G-CSF to the recommended dose modifications of venetoclax does not negatively impact OS or DOR, is well tolerated, and reduces delays between treatment cycles, potentially contributing to improved outcomes in patients with ND AML. |
Abbreviations: AML, acute myeloid leukemia; DOR, duration of response; G-CSF, granulocyte-colony stimulating factor; LDAC, low-dose cytarabine; ND, newly diagnosed; OS, overall survival.
- DiNardo CD, Pratz KW, Panayiotidis P, et al. The impact of post-remission granulocyte colony-stimulating factor use in the phase 3 studies of venetoclax combination treatments in patients with newly diagnosed acute myeloid leukemia. Am J Hematol. Online ahead of print. DOI:10.1002/ajh.27515
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