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Harrison, Claire N.; Nangalia, Jyoti; Boucher, Rebecca; Jackson, Aimee; Yap, Christina; O'Sullivan, Jennifer; Fox, Sonia; Ailts, Isaak; Dueck, Amylou C.; Geyer, Holly L.; Mesa, Ruben A.; Dunn, William G.; Nadezhdin, Eugene; Curto-Garcia, Natalia; Green, Anna; Wilkins, Bridget; Coppell, Jason; Laurie, John; Garg, Mamta; Ewing, Joanne; Knapper, Steven; Crowe, Josephine; Chen, Frederick; Koutsavlis, Ioannis; [...]

Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial

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  • Medientyp: E-Artikel
  • Titel: Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial
  • Beteiligte: Harrison, Claire N.; Nangalia, Jyoti; Boucher, Rebecca; Jackson, Aimee; Yap, Christina; O'Sullivan, Jennifer; Fox, Sonia; Ailts, Isaak; Dueck, Amylou C.; Geyer, Holly L.; Mesa, Ruben A.; Dunn, William G.; Nadezhdin, Eugene; Curto-Garcia, Natalia; Green, Anna; Wilkins, Bridget; Coppell, Jason; Laurie, John; Garg, Mamta; Ewing, Joanne; Knapper, Steven; Crowe, Josephine; Chen, Frederick; Koutsavlis, Ioannis; [...]
  • Erschienen: American Society of Clinical Oncology (ASCO), 2023
  • Erschienen in: Journal of Clinical Oncology
  • Sprache: Englisch
  • DOI: 10.1200/jco.22.01935
  • ISSN: 0732-183X; 1527-7755
  • Schlagwörter: Cancer Research ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>PURPOSE</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>PATIENTS AND METHODS</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> 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 &lt; .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. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> 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. </jats:p></jats:sec>