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Hydroxyurea (HU) is the most commonly used cytoreductive therapy in patients diagnosed with myeloproliferative neoplasms (MPN); however, treatment presents leukemogenic potential. Pegylated interferon alfa-2 (pegIFNα-2) offers an alternative therapeutic approach, with high response rates and disease modification potential. Each treatment presents its advantages and disadvantages; therefore, the phase III DALIAH trial (NCT01387763) was conducted to compare low-dose pegIFNα-2 with HU in patients diagnosed with MPN.
During the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, Knudsen presented a final analysis of the phase III DALIAH trial. We summarize the key results below.
Check out our top abstracts, presented at the 65th ASH Annual Meeting and Exposition, here. For more information on the DALIAH trial and the quality of life outcomes experienced by patients who were enrolled, read our previous MPN Hub article.
The baseline patient characteristics are shown in Table 1.
Table 1. Baseline patient characteristics*
Characteristic,% (unless otherwise specified) |
HU |
IFN combined |
Total |
p value |
---|---|---|---|---|
Median age, years |
68 |
59 |
62 |
<0.0001 |
Male |
63 |
54 |
56 |
0.37 |
MPN diagnosis |
||||
ET |
39 |
24 |
36 |
0.09 |
PV |
41 |
55 |
44 |
0.15 |
Pre-PMF |
9 |
3 |
8 |
0.32 |
PMF |
11 |
18 |
12 |
0.27 |
IFN treatment type |
||||
pegIFNα-2a |
— |
50 |
50 |
— |
pegIFNα-2b |
— |
50 |
50 |
— |
JAK2V617F allele burden |
37 |
33 |
34 |
0.78 |
ET, essential thrombocythemia; HU, hydroxyurea; IFN, interferon; pegIFN, pegylated interferon; PMF, primary myelofibrosis; PV, polycythemia vera. |
Figure 1. Patients who remained on treatment and experienced a molecular response with either HU or pegIFNα-2*
HU, hydroxyurea; IFN, interferon; pegIFNα-2, pegylated interferon alfa-2.
*Adapted from Knudsen.1
Figure 2. Patients who remained on treatment and experienced a complete hematologic response with either HU or pegIFNα-2*
HU, hydroxyurea; IFN, interferon; pegIFNα-2, pegylated interferon alfa-2.
*Adapted from Knudsen.1
The percentage of patients who experienced no change or improvement in bone marrow fibrosis grading was similar with both pegIFNα-2 and HU treatment; however, a higher percentage of patients treated with pegIFNα-2 experienced a worsening of fibrosis (Figure 3).
Figure 3. Patients who experienced a change in bone marrow fibrosis grade, treated with pegIFNα-2 or HU*
HU, hydroxyurea; IFN, interferon; pegIFNα-2, pegylated interferon alfa-2.
*Adapted from Knudsen.1
This final analysis of the DALIAH trial showed no difference in molecular or complete hematologic response between pegIFNα-2 and HU. However, there was a greater reduction in JAK2V617F allele burden with pegIFNα-2 treatment at 36 months and beyond compared with HU. Treatment discontinuation was higher with pegIFNα-2 treatment, despite a low-dose approach. Patients with good tolerability to pegIFNα-2 therapy experienced superior efficacy beyond 36 months compared with HU.
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