OBJECTIVES: Patient-reported outcomes (PROs) including quality of life (QoL) and symptoms, assessed at a single time point, are shown to predict overall survival (OS) in cancer. Very limited efforts, however, are made to understand how longitudinal changes in PROs can impact OS. The objective of the study was to explore whether changes in PROs could predict OS in patients with diffuse large B-cell lymphoma (DLBCL) newly treated with obinutuzumab/rituximab plus chemotherapy in the GOYA phase III study.

METHODS: Patients were included if they completed the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and Functional Assessment of Chronic illness Therapy-Lymphoma (FACT–Lym) lymphoma subscale (LYMS) at both the study baseline and cycle 3 day 1 (C3D1). Patients were deemed to have a clinically meaningful change if they had a score change of 10 points in QLQ-C30, 3 in the LYMS subscale, and 1 in the LYMS individual items. The predictive value of changes in PROs for OS was assessed using Cox regression models, with hazard ratios (HRs) rescaled to represent the clinically meaningful change.

RESULTS: The study included 1132 patients. From baseline to C3D1, adjusting for treatment, baseline patient characteristics, and baseline PRO score, every 10-point increase (improvement) in emotional functioning was associated with 12% lower risk of death (p=0.04). Every 1-point increase (worsening) in fever symptoms was associated with 41% higher risk of death (p=0.01). Every 1-point increase (worsening) in lumps or swelling symptoms was associated with 29% higher risk of death (p=0.02). No significant associations were observed between changes in some LYM symptoms such as itching and risk of death (p>0.05).

CONCLUSIONS: Our findings suggest that changes in PROs, measured by the EORTC QLQ-C30 and FACT–Lym LYMS, contain added predictive value for OS in DLBCL.