PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study

作者：Carrie A. Thompson, Marek Trněný, Franck Morschhauser, Gilles Salles, P. M. Reagan, Mark P. Hertzberg, Huilai Zhang, Catherine Thiéblemont, Bei Hu, Gustavo Fonseca, W. Kim, Maurizio Martelli, Amitkumar Mehta, Avrita Singh, Mark Yan, Jamie Hirata, Matthew Sugidono, Calvin Lee, Jeff P. Sharman, Neha Mehta–Shah, Christopher R. Flowers, Hervé Tilly, Neil Chua, Olivier Casasnovas, Fiona Miall, Tae Min Kim, Cheng‐Hong Tsai, Sunita D. Nasta, Seung‐Tae Lee, Jonathan W. Friedberg · 发表于：Blood · 年份：2025 · DOI：10.1182/blood.2025028848 · 被引用次数：3 · 研究领域：Lymphoma Diagnosis and Treatment

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, ...