Details

Autor(en) / Beteiligte

• Al-Ali, Haifa
• Mesa, Ruben
• Hamer-Maansson, J.E.
• Braunstein, Evan
• Harrison, Claire

Titel

MPN-571 Effect of New or Worsening Anemia on Clinical Outcomes in Patients With Myelofibrosis (MF) Treated With Ruxolitinib (RUX): A Post Hoc Analysis of the COMFORT-I and -II Trials

Ist Teil von

• Clinical lymphoma, myeloma and leukemia, 2023-09, Vol.23, p.S404-S404

Ort / Verlag

Elsevier Inc

Erscheinungsjahr

2023

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Transient dose-dependent anemia is a known consequence of RUX treatment. Assess impact of new/worsening anemia induced by RUX on spleen volume response (SVR), symptom severity, and overall survival (OS) in patients with MF. Post hoc analysis of the COMFORT-I/II RUX arms. Patients were categorized by baseline anemia: nonanemic (hemoglobin [Hb] >100g/L), anemic non-transfusion dependent (NTD; Hb <100g/L, received <2 units red blood cells [RBCs]), and anemic transfusion dependent (TD; Hb <100g/L, received ≥2 units RBCs) over 8 (COMFORT-I) or 12 weeks (COMFORT-II) before first RUX dose. Percentage of patients with SVR35 (≥35% reduction in spleen volume from baseline; pooled Week 24 and Week 48 COMFORT-I/II data), ≥50% reduction in MF Symptom Assessment Form total symptom score (TSS response; COMFORT-I data), or ≥6.5-point increase in Functional Assessment of Cancer Therapy–Lymphoma total score (FACT-Lym TS response; COMFORT-II data) at Week 24. Outcomes were stratified by presence/absence of new/worsening anemia (Hb decrease ≥15g/L or new transfusion requirement postbaseline until Week 12). OS for each cohort evaluated by Kaplan-Meier methods (P-value per log rank test); other P-values calculated per Fischer exact method. 277 patients were included (nonanemic, 55.6%; NTD, 19.9%; TD, 24.5%). SVR35 rates at Week 24 among patients with, compared to those without, new/worsening anemia were 48.8% vs 43.2% (nonanemic), 33.3% vs 23.1% (NTD), and 41.4% vs 28.2% (TD). Similar results were seen at Week 48. Percentages of patients with TSS response in those with vs without new/worsening anemia were 51.1% vs 42.9% (nonanemic), 42.1% vs 40.0% (NTD), and 46.7% vs 54.2% (TD); percentages with FACT-Lym TS response were 48.6% vs 43.6%, 52.2% vs 50.0%, and 28.6% vs 53.3%, respectively. Median OS was not reached in either group among baseline-nonanemic patients and 50.0 vs 38.4 months (with vs without new/worsening anemia, respectively) among baselineanemic patients. All outcome comparisons between groups were not significant. The onset of new/worsening anemia postbaseline did not diminish clinical benefit of RUX treatment vs patients without new/worsening anemia. RUX was associated with improved spleen volume and symptoms in patients with MF regardless of baseline anemia status. Incyte