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Peer-reviewedCC BY-NC-ND 4.0Quality of Life Research

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 Moehler1
  • Marcia Cruz Correa2
  • Do Youn Oh3
  • Rui-Hua Xu4
  • Ken Kato5
  • Afsaneh Barzi6
  • Frederick B. Barnes6
  • Yaling Xu7
  • Tao Sheng8
  • Gisoo Barnes6
  • Timothy Victor6,9
9 affiliations
  1. 1Department of Internal Medicine I, Johannes Gutenberg-University Clinic, Mainz, Germany
  2. 2School of Medicine, University of Puerto Rico, San Juan, Puerto Rico
  3. 3Department of Internal Medicine, Seoul National University Hospital Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea
  4. 4Collaborative Innovation Center of Cancer Medicine, Department of Medical Oncology, University Cancer Center State Key Laboratory of Oncology in South China, Guangzhou, China
  5. 5Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan
  6. 6BeOne USA, Ltd, San Mateo, CA USA
  7. 7BeOne (Shanghai) Co., Ltd, Shanghai, China
  8. 8BeOne (Beijing) Co., Ltd, Beijing, China
  9. 9University of Pennsylvania, Philadelphia, PA USA
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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.

Results: 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.

Conclusion: PROs have significant prognostic value for disease progression and survival in patients with PD-L1 TAP score ≥ 5%.

Registration number: NCT03777657 (http://clinicaltrials.gov).

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s11136-026-04416-4.

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Cite

BibTeXRIS
BibTeX
@article{moehler2026prognostic,
  title = {{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}},
  author = {Markus Moehler and Marcia Cruz Correa and Do Youn Oh and Rui-Hua Xu and Ken Kato and Afsaneh Barzi and Frederick B. Barnes and Yaling Xu and Tao Sheng and Gisoo Barnes and Timothy Victor},
  journal = {Quality of Life Research},
  year = {2026},
  month = oct,
  doi = {10.1007/s11136-026-04416-4},
  url = {https://doi.org/10.1007/s11136-026-04416-4},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - 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
AU  - Markus Moehler
AU  - Marcia Cruz Correa
AU  - Do Youn Oh
AU  - Rui-Hua Xu
AU  - Ken Kato
AU  - Afsaneh Barzi
AU  - Frederick B. Barnes
AU  - Yaling Xu
AU  - Tao Sheng
AU  - Gisoo Barnes
AU  - Timothy Victor
PY  - 2026
DA  - 2026/10/25
JO  - Quality of Life Research
DO  - 10.1007/s11136-026-04416-4
UR  - https://doi.org/10.1007/s11136-026-04416-4
AB  - 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.  Results: 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.  Conclusion: PROs have significant prognostic value for disease progression and survival in patients with PD-L1 TAP score ≥ 5%.  Registration number: NCT03777657 (http://clinicaltrials.gov).  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s11136-026-04416-4.
SN  - 0962-9343
SN  - 1573-2649
ER  -