Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
Prognostic associations between patient-reported outcomes and progression-free and overall survival in advanced gastric or gastroesophageal junction adenocarcinoma with PD-L1 TAP score ≥ 5%: results from the RATIONALE-305 trial
By Moehler M, Correa MC, Oh DY and 8 others.
Abstract
Purpose
In RATIONALE-305, tislelizumab plus chemotherapy improved overall survival (OS) versus placebo plus chemotherapy in advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) with programmed death-ligand 1 (PD-L1) tumor area positivity (TAP) score ≥ 5% and in all patients. Here, we present a three-component joint model (JM) developed to evaluate associations between patient-reported outcomes (PROs) and risk of progression-free survival (PFS) and OS events.
Methods
Longitudinal PRO data were analyzed using the EORTC QLQ-C30 and QLQ-STO22. The JM linked: (1) a linear mixed model (LMM) for change from baseline in PRO scores; (2) a Cox model for time to recurrent symptomatic deterioration (RS-D); and (3) a Cox model to evaluate the RS-D event frailty prediction of PFS and OS.