{
  "abstract": "Background\n\nNeoadjuvant and perioperative immunotherapy have transformed the treatment landscape of muscle-invasive bladder cancer, with multiple strategies now available. In the absence of randomized head-to-head evidence, cross-trial comparisons are increasingly used to contextualize outcomes, but they may be affected by differences in study populations, treatment strategies, endpoint definitions, and follow-up maturity. We compared event-free survival (EFS) using reconstructed individual patient data from KEYNOTE-905/EV-303 and PURE-01.Patients and methods\n\nIndividual patient data were reconstructed from published Kaplan-Meier curves. EFS was compared using Kaplan-Meier estimates, Cox regression, and log-rank tests. Sensitivity analyses included proportional hazards assessment, restricted mean survival time, and common follow-up analyses at 12, 24, and 36 months.Results\n\nThe analysis included 325 patients (170 KEYNOTE-905/EV-303; 155 PURE-01) and 93 EFS events. EFS did not differ significantly between perioperative enfortumab vedotin-pembrolizumab and neoadjuvant pembrolizumab (hazard ratio 1.33, 95% confidence interval 0.87-2.03; P = 0.181), with evidence of nonproportional hazards (P = 0.021). Restricted mean survival time and common follow-up analyses yielded consistent results.Conclusions\n\nThis reconstructed indirect comparison does not permit inference on comparative efficacy or the contribution of individual therapeutic components. Differences in study populations, treatment strategies, and follow-up maturity warrant caution. Complementary survival analyses may help generate hypotheses for studies designed to disentangle individual agents and perioperative treatment phases.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Medical Oncology, Comprehensive Cancer Center, IRCCS San Raffaele, Milan, Italy. Electronic address: maiorano.brigida@hsr.it.",
    "Department of Medical Oncology, Comprehensive Cancer Center, IRCCS San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy."
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 2,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "B A Maiorano"
    },
    {
      "affs": [
        1
      ],
      "name": "A Necchi",
      "orcid": "0000-0002-3007-2756"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/7b9905cdxms57.bib",
  "cited_by": 0,
  "doi": "10.1016/j.esmoop.2026.108597",
  "fulltext_url": "https://europepmc.org/articles/PMC13677583",
  "id": "7b9905cdxms57",
  "issns": [
    "2059-7029"
  ],
  "landing_url": "https://europepmc.org/article/MED/42854586",
  "language": "eng",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2746|Bladder and Urothelial Cancer Treatments"
    ]
  ],
  "openalex": "W7214002102",
  "pdf_url": "https://europepmc.org/articles/PMC13677583?pdf=render",
  "pmcid": "PMC13677583",
  "pmid": "42854586",
  "published": "2026-09-22",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/7b9905cdxms57.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:18:12Z",
      "native_id": "MED:42854586",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42854586"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2746|Bladder and Urothelial Cancer Treatments",
      "subfield": "surgery"
    }
  ],
  "title": "Indirect comparison of reconstructed individual patient data from KEYNOTE-905/EV-303 and PURE-01: complementary analyses for interpreting event-free survival in muscle-invasive bladder cancer.",
  "title_text": "Indirect comparison of reconstructed individual patient data from KEYNOTE-905/EV-303 and PURE-01: complementary analyses for interpreting event-free survival in muscle-invasive bladder cancer.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:18:12Z",
  "url": "https://research.draconitic.com/paper/7b9905cdxms57",
  "venue": "ESMO open",
  "versions": []
}