PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study.
Journal
Blood
Journal Volume
147
Journal Issue
3
Start Page
254
End Page
265
ISSN
1528-0020
Date Issued
2026-01-15
Author(s)
Thompson, Carrie
Trněný, Marek
Morschhauser, Franck
Salles, Gilles
Reagan, Patrick M
Hertzberg, Mark
Zhang, Huilai
Thieblemont, Catherine
Hu, Bei
Fonseca, Gustavo
Kim, Won Seog
Martelli, Maurizio
Mehta, Amitkumar
Singh, Avrita
Yan, Mark
Hirata, Jamie
Sugidono, Matthew
Lee, Calvin
Sharman, Jeff P
Mehta-Shah, Neha
Flowers, Christopher R
Tilly, Hervé
Chua, Neil
Casasnovas, René-Olivier
Miall, Fiona
Kim, Tae Min
Nasta, Sunita
Lee, Seung Tae
Friedberg, Jonathan W
Abstract
Diffuse large B-cell lymphoma (DLBCL) poses a challenge in hematology given its varied symptoms, and the complex interplay between disease and treatment effects on health-related quality of life (HRQoL). The phase 3 POLARIX study demonstrated superior progression-free survival and a similar safety profile with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with previously untreated DLBCL. Here, we evaluate HRQoL through patient-reported outcome (PRO) instruments to fully characterize the patient experience in the POLARIX study. Changes from baseline in HRQoL, lymphoma symptoms, and gastrointestinal (GI) symptoms were assessed, as well as incidence and severity of common symptoms by PROs vs clinician-reported adverse events (AEs). Baseline characteristics of PRO-evaluable patients (N = 874) were consistent. Comparison between PROs and clinician-reported AEs revealed a notable discordance; patients generally reported a higher incidence of symptoms than clinicians, emphasizing the need for patient-centric tools to accurately capture the patient experience. Both treatments exhibited rapid and sustained improvements in HRQoL and lymphoma symptoms, with the most substantial improvements seen in global health status/QoL, lymphoma symptoms, fatigue, role, emotional, and social functioning. GI symptoms (diarrhea, constipation, nausea, and vomiting) were generally similar between treatment arms and returned to baseline levels after treatment completion. These HRQoL data underscore the complementarity of PROs, as an adjunct to clinician-reported AEs, in evaluating the efficacy and tolerability of new treatments, including Pola-R-CHP, which may represent a new benchmark for patient-reported HRQoL in previously untreated DLBCL. This trial was registered at www.clinicaltrials.gov as NCT03274492.
Type
journal article