Ruxolitinib versus best available therapy for polycythemia vera intolerant or resistant to hydroxycarbamide in a randomized trial.
Harrison, Claire N Nangalia, Jyoti Boucher, Rebecca Jackson, Aimee Yap, Christina O'Sullivan, Jennifer Fox, Sonia Ailts, Isaak Dueck, Amylou C Geyer, Holly L
Harrison, Claire N
Nangalia, Jyoti
Boucher, Rebecca
Jackson, Aimee
Yap, Christina
O'Sullivan, Jennifer
Fox, Sonia
Ailts, Isaak
Dueck, Amylou C
Geyer, Holly L
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2023-05-01
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Abstract
One hundred eighty patients were randomly assigned. CR was achieved in 40 (43%) patients on ruxolitinib versus 23 (26%) on BAT (odds ratio, 2.12; 90% CI, 1.25 to 3.60; P = .02). Duration of CR was superior for ruxolitinib (hazard ratio [HR], 0.38; 95% CI, 0.24 to 0.61; P < .001). Symptom responses were better with ruxolitinib and durable. EFS (major thrombosis, hemorrhage, transformation, and death) was superior for patients attaining CR within 1 year (HR, 0.41; 95% CI, 0.21 to 0.78; P = .01); and those on ruxolitinib (HR, 0.58; 95% CI, 0.35 to 0.94; P = .03). Serial analysis of JAK2V617F variant allele fraction revealed molecular response was more frequent with ruxolitinib and was associated with improved outcomes (progression-free survival [PFS] P = .001, EFS P = .001, overall survival P = .01) and clearance of JAK2V617F stem/progenitor cells. ASXL1 mutations predicted for adverse EFS (HR, 3.02; 95% CI, 1.47 to 6.17; P = .003). The safety profile of ruxolitinib was as previously reported.
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Harrison CN, Nangalia J, Boucher R, Jackson A, Yap C, O'Sullivan J, Fox S, Ailts I, Dueck AC, Geyer HL, Mesa RA, Dunn WG, Nadezhdin E, Curto-Garcia N, Green A, Wilkins B, Coppell J, Laurie J, Garg M, Ewing J, Knapper S, Crowe J, Chen F, Koutsavlis I, Godfrey A, Arami S, Drummond M, Byrne J, Clark F, Mead-Harvey C, Baxter EJ, McMullin MF, Mead AJ. Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial. J Clin Oncol. 2023 Jul 1;41(19):3534-3544. doi: 10.1200/JCO.22.01935. Epub 2023 May 1.
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Article