Evidence map›Paper›PMID 42696081›Full record

ArticleInternational urology and nephrology2026

Time-dependent effects of BCG plus immune checkpoint inhibitors in BCG-naive high-risk non-muscle-invasive bladder cancer: a reconstructed patient-level analysis.

Shugo Yajima, Soichiro Yoshida, Wei Chen, Hiroshi Fukushima, Hajime Tanaka, Hiroyuki Sato, Akihiro Hirakawa, Hitoshi Masuda, Yasuhisa Fujii

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Article in International urology and nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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5 · Who and what money

Authors and funding

9 authors.

Shugo YajimaDepartment of Urology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. shuyajim@east.ncc.go.jp.ORCID http://orcid.org/0000-0003-2300-8446
Soichiro YoshidaDepartment of Urology, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan. s-yoshida.uro@tmd.ac.jp.ORCID http://orcid.org/0000-0003-2757-8083
Wei ChenDepartment of Urology, Zigong Fourth People's Hospital, School of Medicine, Sichuan University of Science & Engineering, Zigong, Sichuan, China.
Hiroshi FukushimaDepartment of Urology, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan.
Hajime TanakaDepartment of Urology, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan.
Hiroyuki SatoDepartment of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan.
Akihiro HirakawaDepartment of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan.
Hitoshi MasudaDepartment of Urology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Yasuhisa FujiiDepartment of Urology, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThree phase 3 trials (CREST, POTOMAC, ALBAN) adding an immune checkpoint inhibitor (ICI) to Bacillus Calmette-Guérin (BCG) in BCG-naive high-risk non-muscle-invasive bladder cancer (NMIBC) reported different results. We used reconstructed individual patient-level data (rIPD) to examine the overall event-free survival (EFS) effect and its change over time.

methodsThis post hoc analysis used data reconstructed from published Kaplan-Meier curves rather than original trial datasets, harmonized as EFS. A trial-stratified Cox model estimated the pooled hazard ratio (HR). Two-parameter Weibull models described the timing of events (scale, β) and the temporal pattern of risk (shape, α), with proportional hazards assessed by Schoenfeld residuals and log-log plots. The trials differed in agent, endpoint definition, and BCG schedule.

resultsReconstructed event counts and HRs closely matched reported values. The pooled EFS HR was 0.76 (95% confidence interval [CI] 0.63-0.91), and 0.68 (95% CI 0.54-0.85) after excluding ALBAN. Weibull-based cumulative HRs suggested differing time patterns: the fitted cumulative HR decreased over time in CREST, remained broadly stable in POTOMAC, and approached 1 in ALBAN. Model-based 5-year EFS differences (11.5%, 8.4%, and 0.4%) were exploratory, relying on extrapolation in CREST and sparse tail data in ALBAN.

conclusionICI plus BCG was associated with improved EFS, mainly reflecting CREST and POTOMAC. A single-pooled HR may obscure regimen-level differences in how the benefit evolves over time. Given the reconstructed data, between-trial differences, and restriction to efficacy, these findings are hypothesis-clarifying rather than practice-changing.

Indexed as

BCGImmune checkpoint inhibitorNon-muscle-invasive bladder cancerParametric survival analysisProportional hazardsReconstructed individual patient data

Identifiers

PMID42696081

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.