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The study was a Phase Ib 3\u2009+\u20093 dose\u2010escalation design with sub\u2010urothelial injection of durvalumab at three pre\u2010determined doses (25, 75, 150\u2009mg) diluted in 25\u2009mL normal saline, injected at 25 locations (25\u2009\u00d7\u20091\u2009mL injections), at least 2\u2009weeks before RC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 11 patients were recruited (10 male, one female). No significant changes were reported on American Urological Association Symptom Score or O\u2019Leary Interstitial Cystitis Scale. In all, 14 adverse events (AEs) were reported (10 Grade 1, three Grade 2, one Grade 3), none considered immune\u2010related. No Grade 4 or 5 AEs were recorded. All the patients underwent RC. Tissue immune populations changed following durvalumab injection (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.012), with a statistically significant increase in M2\u2010macrophage (CD163) when comparing the 25\u2013150\u2009mg dose (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.021). Basal\/mixed cancers showed a larger CD163 increase than luminal cancers (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.033).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Sub\u2010urothelial injection of durvalumab is feasible and safe without immune\u2010related AEs and shows local immunological effects.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.16325","type":"journal-article","created":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T04:04:12Z","timestamp":1710216252000},"page":"283-290","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["The\n                    <scp>SUB<\/scp>\n                    \u2010urothelial\n                    <scp>DUrvalumab InjEction<\/scp>\n                    \u20101 (\n               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