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.
Markus Moehler, Marcia Cruz Correa, Do Youn Oh et al.
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In 30 seconds
This analysis of the randomised RATIONALE-305 trial examined whether longitudinal patient-reported outcomes (PROs) were associated with progression-free survival (PFS) and overall survival (OS) in patients with advanced gastric or gastroesophageal junction adenocarcinoma and PD-L1 TAP score ≥ 5%. A three-component joint model linked changes in questionnaire scores and recurrent symptomatic deterioration with survival outcomes. Among 475 patients, deterioration in global health status/quality of life, pain, and dietary restrictions were leading predictors of PFS risk. Across questionnaire domains, tislelizumab plus chemotherapy was associated with lower risks of progression or death (PFS HRs 0.55-0.65) and death (OS HRs 0.65-0.73) than placebo plus chemotherapy.
Key findings
- Recurrent symptomatic deterioration in global health status/quality of life, pain, and dietary restrictions were leading predictors of PFS risk.
- Across questionnaire domains, PFS HRs were 0.55-0.65, corresponding to a 35-45% reduction in risk of progression or death with tislelizumab plus chemotherapy.
- Across questionnaire domains, OS HRs were 0.65-0.73, corresponding to a 27-35% reduction in risk of death with tislelizumab plus chemotherapy.
- Tislelizumab plus chemotherapy was associated with improved global health status/quality of life (p = 0.01) and reduced dietary restrictions (p = 0.05) in PFS and OS models.
Why it matters
The findings indicate that changes in patients’ reported wellbeing and symptoms carry prognostic information alongside clinical outcomes in this trial population. Tracking these domains may help clinicians recognise worsening disease-related burden and interpret patients’ experience over time. The results also show that treatment-group differences in reported outcomes and survival were evaluated together, rather than treating questionnaire scores as isolated measures.
What to keep in mind
The analysis was restricted to the PD-L1 TAP score ≥ 5% subgroup and used a joint model to assess prognostic associations; these findings do not establish that changes in PROs cause changes in survival.