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Midostaurin plus decitabine in older, unfit patients with AML or higher-risk MDS: Final analysis from the phase II HOVON 155 trial
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The randomized, multicenter, phase II HOVON155 trial evaluated the addition of midostaurin to 10-day decitabine in patients aged ≥66 years with newly diagnosed AML or higher-risk MDS who are ineligible for intensive chemotherapy.1 This trial included patients with both wild-type and FLT3-mutated disease.1 Patients were randomized 1:1 to receive decitabine alone (n = 70) or in combination with midostaurin (n = 70).1 Results from the final analysis of this trial were published in Annals of Hematology by Huls et al.1 |
| Key learnings |
| The addition of midostaurin to the 10-day decitabine regimen, compared with decitabine alone, did not improve CR/CRi rates during the first 3 cycles (24% vs 34%). |
| Median OS was similar between patients treated with midostaurin plus decitabine (4.8 months) and decitabine alone (7.4 months); 1-year OS rates were also similar (31% vs 37%; p = 0.021). |
| Midostaurin was well-tolerated, with AE and early death (<30 days) rates comparable between groups. |
| The lack of therapeutic benefit seen in this study with the addition of midostaurin suggests that it should not be routinely combined with decitabine in this patient population. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; CR, complete remission; CRi, CR with incomplete count recovery; MDS, myelodysplastic syndromes; OS, overall survival.
- Huls G, Chitu DA, Tick L, et al. Midostaurin added to 10-day decitabine, for patients unfit for intensive chemotherapy with AML and higher risk MDS, irrespective of FLT3 mutational status, does not improve outcome. Ann Hematol. 2024. Online ahead of print. DOI: 1007/s00277-024-06033-y
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