dc.contributor.author | Harrison, CN | |
dc.contributor.author | Nangalia, J | |
dc.contributor.author | Boucher, R | |
dc.contributor.author | Jackson, A | |
dc.contributor.author | Yap, C | |
dc.contributor.author | O'Sullivan, J | |
dc.contributor.author | Fox, S | |
dc.contributor.author | Ailts, I | |
dc.contributor.author | Dueck, AC | |
dc.contributor.author | Geyer, HL | |
dc.contributor.author | Mesa, RA | |
dc.contributor.author | Dunn, WG | |
dc.contributor.author | Nadezhdin, E | |
dc.contributor.author | Curto-Garcia, N | |
dc.contributor.author | Green, A | |
dc.contributor.author | Wilkins, B | |
dc.contributor.author | Coppell, J | |
dc.contributor.author | Laurie, J | |
dc.contributor.author | Garg, M | |
dc.contributor.author | Ewing, J | |
dc.contributor.author | Knapper, S | |
dc.contributor.author | Crowe, J | |
dc.contributor.author | Chen, F | |
dc.contributor.author | Koutsavlis, I | |
dc.contributor.author | Godfrey, A | |
dc.contributor.author | Arami, S | |
dc.contributor.author | Drummond, M | |
dc.contributor.author | Byrne, J | |
dc.contributor.author | Clark, F | |
dc.contributor.author | Mead-Harvey, C | |
dc.contributor.author | Baxter, EJ | |
dc.contributor.author | McMullin, MF | |
dc.contributor.author | Mead, AJ | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2023-06-30T14:12:21Z | |
dc.date.available | 2023-06-30T14:12:21Z | |
dc.date.issued | 2023-07-01 | |
dc.identifier.citation | Journal of Clinical Oncology, 2023, pp. JCO2201935 - | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5859 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/JCO.22.01935 | |
dc.description.abstract | PURPOSE: Polycythemia vera (PV) is characterized by JAK/STAT activation, thrombotic/hemorrhagic events, systemic symptoms, and disease transformation. In high-risk PV, ruxolitinib controls blood counts and improves symptoms. PATIENTS AND METHODS: MAJIC-PV is a randomized phase II trial of ruxolitinib versus best available therapy (BAT) in patients resistant/intolerant to hydroxycarbamide (HC-INT/RES). Primary outcome was complete response (CR) within 1 year. Secondary outcomes included duration of response, event-free survival (EFS), symptom, and molecular response. RESULTS: 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. CONCLUSION: The MAJIC-PV study demonstrates ruxolitinib treatment benefits HC-INT/RES PV patients with superior CR, and EFS as well as molecular response; importantly also demonstrating for the first time, to our knowledge, that molecular response is linked to EFS, PFS, and OS. | |
dc.format | Print-Electronic | |
dc.format.extent | JCO2201935 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | |
dc.relation.ispartof | Journal of Clinical Oncology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.title | Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-03-21 | |
dc.date.updated | 2023-06-27T08:51:09Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1200/JCO.22.01935 | |
rioxxterms.licenseref.startdate | 2023-05-01 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37126762 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1200/jco.22.01935 | |
icr.researchteam | Clin Trials & Stats Unit | |
dc.contributor.icrauthor | Yap, Christina | |
icr.provenance | Deposited by Mrs Jessica Perry (impersonating Prof Christina Yap) on 2023-06-27. Deposit type is initial. No. of files: 1. Files: Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial..pdf | |