{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T09:44:50Z","timestamp":1777628690025,"version":"3.51.4"},"reference-count":18,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T00:00:00Z","timestamp":1774915200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T00:00:00Z","timestamp":1774915200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJUI Compass"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The objective of this study is to assess the efficacy, safety and change in quality of life associated with ICI\u2010BCG (I\u2009+\u2009M) compared to BCG (I\u2009+\u2009M) in patients with BCG\u2010na\u00efve HR\u2010NMIBC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Material and Methods<\/jats:title>\n                    <jats:p>A systematic search was run on PubMed, Embase and CENTRAL from inception to 29 October 2025. Phase 3 randomized controlled trials comparing safety, efficacy and quality of life (QOL) for patients with BCG\u2010na\u00efve HR\u2010NMIBC receiving ICI\u2010BCG (I\u2009+\u2009M) versus BCG (I\u2009+\u2009M): hazard ratios (HR) and 95% confidence interval (95% CI) for HG\u2010RFS (high\u2010grade recurrence free survival), odds ratio (OR) and 95% CI for Grade \u22653 treatment\u2010related adverse events (G3\u2009+\u2009TRAEs), and mean difference (MD) and 95% CI for changes in quality of life (QOL measured using EORTC QLQ C30). A priori defined subgroups included presence of CIS, presence of papillary tumours, age &lt;65 or \u226565\u2009years, male\/female, and BCG strain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Pooled results indicated that ICI\u2010BCG (I\u2009+\u2009M) was not associated with a reduction in HG\u2010RFS (HR: 0.78; 95% CI: 0.59\u20131.02). However, on sensitivity analysis excluding ALBAN (for differences in trial design and patients included), ICI\u2010BCG (I\u2009+\u2009M) was associated with a reduction in HG\u2010RFS (HR: 0.68; 95% CI: 0.54\u20130.85) with an absolute risk reduction of 4.4\u20137.3% in 36\u2010month HG\u2010RFS. ICI\u2010BCG (I\u2009+\u2009M) was associated with an increased risk of G3\u2009+\u2009TRAEs (OR: 4.76; 95% CI: 3.01\u20137.53). ICI\u2010BCG (I\u2009+\u2009M) was associated with a non\u2010clinically significant decline in QOL (MD: \u22123.25; 95% CI: \u22125.11 to \u22121.39). Heterogeneity between trials was minimal (\n                      <jats:italic>\u03c4<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      \u2009&lt;\u20091). Risk of bias was low in all included studies.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This pooled analysis provides data for patient\u2010specific counselling on the use of ICI\u2010BCG (I\u2009+\u2009M) for BCG\u2010naive HR\u2010NMIBC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bco2.70194","type":"journal-article","created":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T06:19:13Z","timestamp":1775024353000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Addition of immune checkpoint inhibitors to intravesical BCG for high\u2010risk BCG\u2010na\u00efve non\u2010muscle invasive bladder cancer: Systematic review and meta\u2010analysis"],"prefix":"10.1002","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5486-749X","authenticated-orcid":false,"given":"Renil S.","family":"Titus","sequence":"first","affiliation":[{"name":"Department of Urology Houston Methodist Hospital  Houston Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos","family":"Riveros","sequence":"additional","affiliation":[{"name":"Department of Urology Houston Methodist Hospital  Houston Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eusebio Luna","family":"Velasquez","sequence":"additional","affiliation":[{"name":"Department of Urology Houston Methodist Hospital  Houston Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David\u2010Dan","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Division of Urology, Department of Surgery University of Toronto  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suran","family":"Somawardana","sequence":"additional","affiliation":[{"name":"Rice University  Houston Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amar","family":"Singh","sequence":"additional","affiliation":[{"name":"Southwestern University  Georgetown Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dharam","family":"Kaushik","sequence":"additional","affiliation":[{"name":"Department of Urology Houston Methodist Hospital  Houston Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guru","family":"Sonpavde","sequence":"additional","affiliation":[{"name":"Advent Health Cancer Institute  Orlando Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandre","family":"Zlotta","sequence":"additional","affiliation":[{"name":"Division of Urology, Department of Surgery University of Toronto  Toronto Ontario Canada"},{"name":"Division of Urology Mount Sinai Hospital  Toronto Ontario Canada"},{"name":"Division of Urology, Department of Surgery University Health Network  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Girish","family":"Kulkarni","sequence":"additional","affiliation":[{"name":"Division of Urology, Department of Surgery University of Toronto  Toronto Ontario Canada"},{"name":"Division of Urology, Department of Surgery University Health Network  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Srikala S.","family":"Sridhar","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Princess Margaret Cancer Centre, University Health Network University of Toronto  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5990-4026","authenticated-orcid":false,"given":"Christopher J. D.","family":"Wallis","sequence":"additional","affiliation":[{"name":"Division of Urology, Department of Surgery University of Toronto  Toronto Ontario Canada"},{"name":"Division of Urology Mount Sinai Hospital  Toronto Ontario Canada"},{"name":"Division of Urology, Department of Surgery University Health Network  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raj","family":"Satkunasivam","sequence":"additional","affiliation":[{"name":"Department of Urology Houston Methodist Hospital  Houston Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,3,31]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21834"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eursup.2010.08.005"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.64.4070"},{"key":"e_1_2_10_5_1","unstructured":"Research C for DE and.FDA approves pembrolizumab for BCG\u2010unresponsive high\u2010risk non\u2010muscle invasive bladder cancer.2024. 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