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

The phase 3 POLARIX study demonstrated superior progression-free survivaland 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.

第三阶段POLARIX研究显示，在之前未接受治疗的DLBCL患者中，使用波拉珠单抗维多汀联合利妥昔单抗、环磷酰胺、多柔比星和泼尼松（Pola-R-CHP）与R-CHOP（利妥昔单抗、环磷酰胺、多柔比星、长春新碱和泼尼松）相比，无进展生存期更长，安全性相似。

Here, we evaluate HRQoL through patient-reported outcome (PRO) instruments to fully characterize the patient experience in the POLARIX study.

在这里，我们通过患者报告的结果(PRO)工具来评估健康相关生活质量(HRQoL)，以全面描述POLARIX研究中患者的体验。

Changes from baseline in HRQoL, lymphoma symptoms, and gastrointestinal (GI) symptoms were assessed, as well as incidenceand severity of common symptoms by PROs vs clinician-reported adverse events (AEs).

通过PROs评估了从基线开始的健康相关生活质量(HRQoL)、淋巴瘤症状和胃肠道(GI)症状的变化，以及常见症状的发生率和严重程度，与临床医生报告的不良事件(AEs)进行了比较。

Baseline characteristics of PRO-evaluable patients (N = 874) were consistent.

可评估患者的结果测量（PRO）基线特征（N = 874）是一致的。

Comparison between PROs and clinician-reported AEs revealed a notable discordance; patients generally reported a higher incidenceof symptoms than clinicians, emphasizing the need for patient-centric tools to accurately capture the patient experience.

与临床医生报告的不良事件（AEs）相比，结果测量（PROs）显示出显著的不一致性；患者通常报告的症状发生率高于临床医生，强调了需要以患者为中心的工具来准确捕捉患者体验。

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.

两种治疗均显示出在健康相关生活质量（HRQoL）和淋巴瘤症状方面的快速且持续改善，尤其是在全球健康状况/生活质量、淋巴瘤症状、疲劳、角色、情感和社会功能方面看到了最显著的改善。

GI symptoms (diarrhea, constipation, nausea, and vomiting) were generally similar between treatment arms and returned to baseline levels after treatment completion.

胃肠道症状（腹泻、便秘、恶心和呕吐）在治疗组之间普遍相似，并在治疗结束后恢复到基线水平。

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.

这些健康相关生活质量（HRQoL）数据强调了患者报告的结果（PROs）作为补充，与临床医生报告的不良事件（AEs）一起，用于评估新疗法（包括Pola-R-CHP）的有效性和耐受性的重要性，这可能代表了之前未治疗的弥漫性大B细胞淋巴瘤（DLBCL）患者报告的HRQoL的新基准。

This trial was registered at www.clinicaltrials.gov as NCT03274492.

这项试验已在www.clinicaltrials.gov上注册，注册号为NCT03274492。