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.

Authors

Markus Moehler, Marcia Cruz Correa, Do Youn Oh, Rui-Hua Xu, Ken Kato, Afsaneh Barzi, Frederick B Barnes, Yaling Xu, Tao Sheng, Gisoo Barnes, Timothy Victor

Published in

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. Volume 35. Issue 11. Oct 25, 2026. Epub Oct 25, 2026.

Abstract

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.
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.
475 patients in the PD-L1 ≥ 5% subgroup (tislelizumab + chemotherapy, n = 238; placebo + chemotherapy, n = 237) were evaluated. In PFS and OS LMMs, tislelizumab + chemotherapy versus placebo + chemotherapy was associated with improved GHS/QoL (global health status/quality of life) (p = 0.01) and reduced dietary restrictions (p = 0.05). In the OS LMM, tislelizumab + chemotherapy was associated with reduced upper GI symptoms (p = 0.01) and reductions in dietary restrictions (p = 0.02). RS-D in GHS/QoL, pain, and dietary restrictions were leading predictors of PFS risk. Across all QLQ-C30 and QLQ-STO22 domains, tislelizumab plus chemotherapy significantly reduced the risk of progression or death (PFS HRs 0.55-0.65; 35-45% reduction) and death (OS HRs 0.65-0.73; 27-35% reduction); all p ≤ 0.01.
PROs have significant prognostic value for disease progression and survival in patients with PD-L1 TAP score ≥ 5%.
NCT03777657 ( http://clinicaltrials.gov ).

PMID:
42927580
Bibliographic data and abstract were imported from PubMed on 26 Oct 2026.

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