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Prognostic utility of ELN risk criteria for stratifying survival outcomes in patients with ND AML ineligible for intensive chemotherapy
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Results from a retrospective pooled analysis of data from the phase III VIALE-A trial (NCT02993523) and a phase Ib trial (NCT02203773) were published by Döhner et al.1 in Blood. The study investigated the prognostic utility of the 2017 and 2022 ELN risk criteria for stratifying survival outcomes in older treatment-naïve patients with AML who were ineligible for intensive chemotherapy. A total of 279 patients treated with Ven + Aza and 113 treated with Pbo + Aza were assessed.1 |
| Key learnings |
| Most patients were classified as having adverse-risk AML based on the ELN 2017 or 2022 criteria (60.2% and 72.8% for Ven + Aza and 65.5% and 75.2% for Pbo + Aza, respectively). |
| Using the ELN 2022 criteria, the mOS improved with Ven + Aza vs Pbo + Aza in the favorable- (39.0 vs 11.0 months), intermediate- (15.2 vs 9.1 months), and adverse- (12.7 vs 9.3 months) risk groups. |
| Patients treated with Ven + Aza were categorized into higher-, intermediate-, and lower-benefit groups (52%, 25%, and 23% of patients, respectively) using a novel 4-gene prognostic mutational model (TP53, FLT3-ITD, NRAS, and KRAS); each linked with a mOS of 26.5 months, 12.1 months, and 5.5 months, respectively. |
| The findings suggest that the 2017 and 2022 ELN risk groups did not provide clinically meaningful stratification for patients treated with Ven + Aza. Further validation of the mutational model in larger independent datasets, particularly in those with high-risk AML, is warranted. |
Abbreviations: AML, acute myeloid leukemia; Aza, azacitidine; ELN, European LeukemiaNet; ITD, internal tandem duplication; mOS, median overall survival; ND, newly diagnosed; Pbo, placebo; Ven, venetoclax.
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