التفاصيل البيبلوغرافية
| العنوان: |
Ruxolitinib reduces JAK2 p.V617F allele burden in patients with polycythemia vera enrolled in the RESPONSE study. |
| المؤلفون: |
Vannucchi, Alessandro, Verstovsek, Srdan, Guglielmelli, Paola, Griesshammer, Martin, Burn, Timothy, Naim, Ahmad, Paranagama, Dilan, Marker, Mahtab, Gadbaw, Brian, Kiladjian, Jean-Jacques, Vannucchi, Alessandro Maria, Burn, Timothy C |
| المصدر: |
Annals of Hematology; Jul2017, Vol. 96 Issue 7, p1113-1120, 8p |
| مصطلحات موضوعية: |
POLYCYTHEMIA vera, PROTEIN-tyrosine kinase inhibitors, JANUS kinases, ALLELES, HEALTH outcome assessment, PATIENTS, THERAPEUTICS, PROTEIN metabolism, HETEROCYCLIC compounds, BONE marrow diseases, COMPARATIVE studies, CROSSOVER trials, GENES, RESEARCH methodology, MEDICAL cooperation, GENETIC mutation, PROTEINS, RESEARCH, TIME, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness, CHEMICAL inhibitors |
| مستخلص: |
In patients with polycythemia vera (PV), an elevated JAK2 p.V617F allele burden is associated with indicators of more severe disease (e.g., leukocytosis, splenomegaly, and increased thrombosis risk); however, correlations between allele burden reductions and clinical benefit in patients with PV have not been extensively evaluated in a randomized trial. This exploratory analysis from the multicenter, open-label, phase 3 Randomized Study of Efficacy and Safety in Polycythemia Vera With JAK Inhibitor INCB018424 Versus Best Supportive Care trial evaluated the long-term effect of ruxolitinib treatment on JAK2 p.V617F allele burden in patients with PV. Evaluable JAK2 p.V617F-positive patients randomized to ruxolitinib (n = 107) or best available therapy (BAT) who crossed over to ruxolitinib at week 32 (n = 97) had consistent JAK2 p.V617F allele burden reductions throughout the study. At all time points measured (up to weeks 208 [ruxolitinib-randomized] and 176 [ruxolitinib crossover]), mean changes from baseline over time in JAK2 p.V617F allele burden ranged from -12.2 to -40.0% (ruxolitinib-randomized) and -6.3 to -17.8% (ruxolitinib crossover). Complete or partial molecular response was observed in 3 patients (ruxolitinib-randomized, n = 2; ruxolitinib crossover, n = 1) and 54 patients (ruxolitinib-randomized, n = 33; ruxolitinib crossover, n = 20; BAT, n = 1), respectively. Among patients treated with interferon as BAT (n = 13), the mean maximal reduction in allele burden from baseline was 25.6% after crossover to ruxolitinib versus 6.6% before crossover. Collectively, the data from this exploratory analysis suggest that ruxolitinib treatment for up to 4 years provides progressive reductions in JAK2 p.V617F allele burden in patients with PV who are resistant to or intolerant of hydroxyurea. The relationship between allele burden changes and clinical outcomes in patients with PV remains unclear. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
