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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.
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