POLARIX trial: PROs vs clinician-reported AEs

Results from the phase III POLARIX trial (NCT03274492) demonstrated superior progression-free survival (PFS) with polatuzumab vedotin + rituximab + cyclophosphamide + doxorubicin + prednisone (Pola-R-CHP) vs rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone (R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The Lymphoma Hub has previously covered the primary results, descriptive analysis outcomes, safety and efficacy in older patients, Asian population analysis, Pola-R-CHP vs R-CHOEP outcomes, and the 5-year follow-up results from this trial. 

Results from an analysis comparing patient-reported outcomes (PROs) with clinician-reported adverse events (AEs) in 874 patients from the POLARIX trial were recently published in Blood by Thompson et al.

Key data: Comparison between PROs and clinician-reported AEs revealed notable discordance, with patients reporting a higher incidence of symptoms, including fatigue (97.2% vs 25.7%), constipation (68.4% vs 29.2%), diarrhea (55.5% vs 25.7%), nausea (57.6% vs 39.6%), and vomiting (24.4% vs 15.0%). Both Pola-R-CHP and R-CHOP similarly improved health-related quality of life (HRQoL) and lymphoma symptoms, with clinically meaningful improvements observed in global health status/quality of life (GHS/QoL); lymphoma symptoms; physical, role, emotional, and social functioning; and fatigue. 

Key learning: The Pola-R-CHP regimen demonstrated rapid and sustained improvements in HRQoL in patients with previously untreated DLBCL. PROs captured substantially higher symptom incidence than clinician-reported AEs, emphasizing the complementarity of patient-centric tools alongside clinician assessments in evaluating treatment efficacy and tolerability in previously untreated DLBCL.