{
  "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.\n\nMethods: 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.\n\nResults: 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.\n\nConclusion: PROs have significant prognostic value for disease progression and survival in patients with PD-L1 TAP score ≥ 5%.\n\nRegistration number: NCT03777657 (http://clinicaltrials.gov).\n\nSupplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s11136-026-04416-4.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Internal Medicine I, Johannes Gutenberg-University Clinic, Mainz, Germany",
    "School of Medicine, University of Puerto Rico, San Juan, Puerto Rico",
    "Department of Internal Medicine, Seoul National University Hospital Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea",
    "Collaborative Innovation Center of Cancer Medicine, Department of Medical Oncology, University Cancer Center State Key Laboratory of Oncology in South China, Guangzhou, China",
    "Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan",
    "BeOne USA, Ltd, San Mateo, CA USA",
    "BeOne (Shanghai) Co., Ltd, Shanghai, China",
    "BeOne (Beijing) Co., Ltd, Beijing, China",
    "University of Pennsylvania, Philadelphia, PA USA"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 11,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Markus Moehler"
    },
    {
      "affs": [
        1
      ],
      "name": "Marcia Cruz Correa"
    },
    {
      "affs": [
        2
      ],
      "name": "Do Youn Oh"
    },
    {
      "affs": [
        3
      ],
      "name": "Rui-Hua Xu"
    },
    {
      "affs": [
        4
      ],
      "name": "Ken Kato"
    },
    {
      "affs": [
        5
      ],
      "name": "Afsaneh Barzi"
    },
    {
      "affs": [
        5
      ],
      "name": "Frederick B. Barnes"
    },
    {
      "affs": [
        6
      ],
      "name": "Yaling Xu"
    },
    {
      "affs": [
        7
      ],
      "name": "Tao Sheng"
    },
    {
      "affs": [
        5
      ],
      "name": "Gisoo Barnes"
    },
    {
      "affs": [
        5,
        8
      ],
      "name": "Timothy Victor",
      "orcid": "0000-0001-6975-1468"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/cb8mkdaq49prg.bib",
  "cited_by": 0,
  "doi": "10.1007/s11136-026-04416-4",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13696556/",
  "id": "cb8mkdaq49prg",
  "issns": [
    "0962-9343",
    "1573-2649"
  ],
  "landing_url": "https://doi.org/10.1007/s11136-026-04416-4",
  "language": "en",
  "licence": "CC-BY-NC-ND-4.0",
  "licence_label": "CC BY-NC-ND 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Article"
    ],
    [
      "openalex",
      "2740|Gastric Cancer Management and Outcomes"
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  "openalex": "W7223570840",
  "pdf_url": "https://europepmc.org/articles/PMC13696556?pdf=render",
  "pmcid": "PMC13696556",
  "pmid": "42927580",
  "published": "2026-10-25",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/cb8mkdaq49prg.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:53Z",
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  "subjects": [
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      "field": "medicine",
      "origin": "openalex:2740|Gastric Cancer Management and Outcomes",
      "subfield": "general"
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  ],
  "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:33:52Z",
  "url": "https://research.draconitic.com/paper/cb8mkdaq49prg",
  "venue": "Quality of Life Research",
  "versions": []
}