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Meta-analyses estimated HRs for recurrence-related time-to-event outcomes (disease-free and event-free survival). Grade\u2009\u2265\u20093 treatment-related adverse events were pooled as relative risks (RRs). Risk of bias was assessed using the Cochrane RoB 2 tool.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Out of 5202 records screened, six RCTs including 3485 patients were eligible. Modifications to intravesical BCG alone (three trials,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009895) did not significantly improve recurrence-related outcomes. Systemic ICIs given additional to intravesical BCG significantly reduced recurrence-related events compared to BCG alone (HR 0.77, 95%CI 0.6\u20130.97,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20091899; number needed to treat at two years: 25), but increased grade\u2009\u2265\u20093 treatment-related adverse events by a statistically and clinically significant margin (RR 3.97, 95% CI 2.53\u20136.22,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20091879; number needed to treat to harm one patient: 5). Sensitivity analysis using the ALBAN alternative endpoint of high-grade recurrence-free survival yielded HR 0.78 (95% CI 0.59\u20131.02), not reaching statistical significance. Limitations included heterogeneity in trial design and endpoint definitions.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In BCG-na\u00efve NMIBC, systemic ICIs combined with intravesical BCG improve recurrence-related outcomes but are offset by a substantially increased risk of severe treatment-related adverse events. These findings highlight the need for careful, risk-based, biomarker-guided patient selection to balance over- and undertreatment within a shared decision-making process.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00345-025-06180-5","type":"journal-article","created":{"date-parts":[[2026,1,5]],"date-time":"2026-01-05T20:42:21Z","timestamp":1767645741000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["First-line treatments for BCG-na\u00efve non-muscle invasive bladder cancer: a systematic review and meta-analysis"],"prefix":"10.1007","volume":"44","author":[{"given":"Navid","family":"Roessler","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brigida A.","family":"Maiorano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcin","family":"Miszczyk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiichiro","family":"Miyajima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shota","family":"Inoue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"von Deimling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malte W.","family":"Vetterlein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margit","family":"Fisch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Moschini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pawel","family":"Rajwa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Necchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morgan","family":"Roupret","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Pradere","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"D\u2019Andrea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Gontero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre I.","family":"Karakiewicz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shahrokh F.","family":"Shariat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,5]]},"reference":[{"issue":"6","key":"6180_CR1","doi-asserted-by":"publisher","first-page":"531","DOI":"10.1016\/j.eururo.2024.07.027","volume":"86","author":"P Gontero","year":"2024","unstructured":"Gontero P, Birtle A, Capoun O, Comp\u00e9rat E, Dominguez-Escrig JL, Liedberg F, Mariappan P, Masson-Lecomte A, Mostafid HA, Pradere B et al (2024) European association of urology guidelines on Non-muscle-invasive bladder cancer (TaT1 and carcinoma in Situ)-A summary of the 2024 guidelines update. 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